Latest News - Neuro News

Black women have a higher incidence of multiple sclerosis than white women

2013-05-09T11:10:00Z

Multiple sclerosis is more common in black women than in white women, according to a Kaiser Permanente, Oakland, USA, study published in Neurology. The findings run contrary to the widely accepted belief that black people are less susceptible to multiple sclerosis, according to the authors of the study.

The authors examined the electronic health records of more than 3.5 million members of Kaiser Permanente Southern California between January 2008 and December 2011 and identified 496 people newly diagnosed with multiple sclerosis. Of the diagnosed cases, black patients had a 47% higher risk of multiple sclerosis than white patients. Hispanic and Asian patients had a 50% and 80% lower risk compared to white patients, respectively.

In the study it was also found that 70% of multiple sclerosis cases occurred in females, but the preponderance of females diagnosed was more pronounced among black patients than white patients. In addition, black women had a higher incidence of multiple sclerosis than white patients of both genders, while black men had a similar risk of being diagnosed with the disease compared to white men. The lower risk among Hispanic and Asian patients was true for both sexes.

“Our findings do not support the widely held belief that black patients have a lower risk of multiple sclerosis than white patients, but that multiple sclerosis risk is determined by complex interactions between race, ethnicity, sex, environmental factors and genotypes,” said study lead author Annette Langer-Gould, of the Kaiser Permanente Southern California Department of Research and Evaluation, USA. “Although additional research is needed, possible explanations for the higher incidence of multiple sclerosis in black women include a greater prevalence of hormonal, genetic, or environmental risk factors such as smoking, compared to patients from other racial or ethnic groups.”

The study estimated that 19,000 people per year—250 people per week—are newly diagnosed with multiple sclerosis in the USA. The researchers identified the average age of multiple sclerosis diagnosis as 41.6 years, but found onset occurred anywhere between 8.6 and 78.3 years among the study participants. The study also found the median time from symptom onset to multiple sclerosis diagnosis was four months, but could be as long as 40 years. Hispanic and Asian patients were generally younger at the time of multiple sclerosis diagnosis than white and black patients.

According to the researchers, the belief that multiple sclerosis is rare in blacks is based on worldwide prevalence studies and a single study of Korean War veterans in the 1950s, which found white men were twice as likely to receive disability compensation for multiple sclerosis as black men. “A possible explanation for our findings is that people with darker skin tones have lower vitamin D levels and therefore an increased risk of multiple sclerosis. However, this does not explain why Hispanic patients and Asian patients have a lower risk of multiple sclerosis than white patients, or why only black women but not black men are at a higher risk of multiple sclerosis,” said Langer-Gould. “Our findings indicate that including persons from different racial and ethnic groups in future studies of multiple sclerosis susceptibility and prognosis will likely reveal important insights into the causes of this often debilitating disease.”

This study is part of Kaiser Permanente’s ongoing investigations into diverse and representative member population as a way to better understand multiple sclerosis, according to a press release. In January, a Kaiser Permanente study, also published in Neurology, found obesity in teenage girls was associated with an increased risk of developing multiple sclerosis. Researchers are also currently recruiting patients for the MS Sunshine Study to examine the complex interactions between multiple sclerosis risk factors such as sunshine, low vitamin D, skin tone, infections, other environmental and genetic factors across racial/ethnic groups. Researchers expect to release findings of this study in 2015.

Integra LifeSciences debuts Camino Platform at AANS

2013-05-09T10:59:00Z

Integra is a provider of advanced intracranial pressure monitoring systems. Over 800 centres, according to a company release, in the USA use the Camino platform for conditions that cause an elevated intracranial pressure, including traumatic brain injury, subarachnoid haemorrhage, and stroke.

The new Camino platform includes the Integra Camino Intracranial Pressure and Temperature Monitor and Integra Camino Flex Ventricular Catheter. Both products have received 510(k) clearance from the US Food and Drug Administration (FDA), and were featured at the American Association of Neurological Surgeons Annual Scientific Meeting (AANS), 27 April–1 May 2013, in New Orleans, USA.

Peter Ligotti, Integra’s vice president of Marketing, Neurosurgery said: “Our Camino monitor has been completely updated and modernised, making it easier to use. It also offers our customers convenient options for utilising both our current Camino fibre optic catheter technology, as well as the newest addition to the family, the Camino ventricular catheter, which utilises strain gauge technology.”

According to the company, unlike other tunnelled ventricular catheters that depend upon cerebrospinal fluid flow to measure intracranial pressure, Integra’s Camino Flex Ventricular Catheter continuously monitors intracranial pressure independently in the ventricles, even when cerebrospinal fluid flow cannot be established. A multilumen design also allows for simultaneous cerebrospinal fluid drainage and intracranial pressure monitoring, providing uninterrupted measurement of patient pressure.

UCLA perform new transcarotid stenting with dynamic flow reversal procedure

2013-05-08T17:28:00Z

Physicians at Ronald Reagan UCLA Medical Center are the first on the West Coast to perform a new, less-invasive procedure that is part of a clinical trial to help clear plaque from the carotid arteries, according to a release. The procedure took place on 28 March.

Current treatment options include traditional open surgery to clean out the carotid artery and a minimally-invasive alternative that uses a stent to keep the artery open. However, each option has some limitations. Traditional surgery involves a large incision along the neck and carries risk of surgical complications. The stent procedure is less invasive, but some studies have shown that it causes a higher risk of stroke than the surgical procedure.

Now, a new technique and device system is being tested called transcarotid stenting with dynamic flow reversal, or the Silk Road Procedure. It, according to the release, allows physicians to deliver a stent directly into the carotid artery from the neck, offering a shorter, potentially safer route than the usual method of guiding a stent from an artery in the groin, which carries a risk of plaque dislodging.

A unique aspect of the new system is the ability to temporarily divert blood flow away from the plaque during the procedure to help ensure that the patient’s brain is fully protected from plaque debris at all times. Physicians redirect blood flow from the carotid artery where the team is working into tubing set up outside the body and then back into the body via the femoral vein located near the groin.

“We’re always seeking new options for patients with the ultimate goal of treating these carotid artery blockages with the least procedural risk,” said Wesley Moore, UCLA study investigator and professor emeritus of vascular surgery, David Geffen School of Medicine at UCLA, USA. “We look forward to contributing to this important research.”

Ronald Reagan UCLA Medical Center is one of 25 centres around the world participating in the study—the ROADSTER trial, designed for high surgical risk patients who may be older or have especially narrowed arteries.

The study is funded by Silk Road Medical, developers of the transcarotid stenting with dynamic flow reversal system.

Benefits of intra-operative neuromonitoring might not outweigh the costs

2013-05-07T18:20:00Z

Researchers announced interesting findings during the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (27 April–1 May 2013, New Orleans, USA) regarding the value of intra-operative neuromonitoring when comparing its use in influencing patient outcomes compared to the added cost it incurs.

In the study entitled “Comparative effectiveness, cost utility and cost benefit analysis of intra-operative neuromonitoring in cervical spine surgery: Where is the value?”, presenting author Scott Parker and colleagues found that in a real world comparative effectiveness study of patients undergoing cervical spine surgery for degenerative spondylosis, intra-operative neuromonitoring was associated with significant added cost without a corresponding benefit in safety or patient outcomes.

“This [study] highlights where you have to look deeper into the details to understand the type of treatment being conducted,” said study co author Matthew McGirt. “Different treatments can be of high value in some situations, and lack value in other situations. This is a lesson on how important it is to have clinical expertise and a focused look at value.”

In the study, all patients undergoing cervical spine surgery for degenerative spondylosis were enrolled into a prospective registry. Data collected included demographics, treatment variables and 90-day surgical morbidity. Patient-reported outcomes, return to work and medical resource utilization were prospectively recorded at baseline and three months.

CPT codes 95920 [baseline electrophysiologic testing (per hour)], 95295/95926 [SSEP], 95928/95929 [MEP] and 95937 [neuromuscular junction testing] were used to calculate the cost of intra-operative neuromonitoring from a payer perspective. The cost of intra-operative neuromonitoring per reduction in surgical morbidity (cost-benefit), and the difference in mean total cost per QALY-gained with intra-operative neuromonitoring via incremental cost-effectiveness ratio [ICER] (cost-utility), were assessed.

A total of 180 patients underwent cervical surgery (102 with intra-operative neuromonitoring, 78 without), and baseline characteristics were similar between the two groups. Intra-operative neuromonitoring changes were only noted in four patients, and surgical strategy was only modified in one patient. There was no difference in 90-day morbidity and patient-reported outcomes improvement at three months between the two groups.

The average added cost of intra-operative neuromonitoring per patient was US$1,208 (Medicare) and US$2,053 (private payer) with no reduction in morbidity. The ICER for intra-operative neuromonitoring vs. not was US$358,205/QALY.

The researchers concluded that, for certain low-risk cervical procedures with specific patient populations, intra-operative neuromonitoring appears to be an area where cost can be saved without sacrificing surgical quality or patient safety. “Cost-effectiveness and value are going to be ever-more important as we go forward,” noted McGirt. “As physicians, we owe it to everybody, including our patients, to provide care in a sustainable way. We need to take a critical look at how we do that. intra-operative neuromonitoring, we felt up front has a lot of value and a lot of importance, that allows us to do safe spinal surgery. Intra-operative neuromonitoring is a critical adjunct for a lot of different cases. And it’s important to note that these conclusions should not be extrapolated to high-risk spine surgeries such as spine tumours, trauma or deformity. But we looked at the lowest-risk population, at one specific subset of disease states, and did a traditional value analysis. We asked what the costs were that we put into the system, and based on evidence, our results showed this particular patient subset might allow us to cost-cut in a patient-centered way. It isn’t always about doing more — sometimes it’s about learning to do less.”

Promising results for clinical trial for stem cell-based treatment of ALS presented at AANS

2013-05-07T18:04:00Z

Researchers who completed the first American clinical trial involving stem cell-based treatment of amyotrophic lateral sclerosis (ALS) demonstrated encouraging results, noting that this delivery approach could be a helpful therapeutic approach for other traumatic spine-related problems. The group focused on the safety of a direct microinjection-based technique and neural stem cell transplantation to the cervical and thoracolumbar spinal cord.

Eighteen microinjection procedures delivered NSI-566RSC, a human neural stem cell, to a total of 15 patients in five cohorts. Each of the injection procedures consisted of five injections of 10µl at 4mm intervals. Group A (n=6) was non-ambulatory and received unilateral (n=3) or bilateral (n=3) thoracolumbar microinjection. Groups B through E were ambulatory and received unilateral (group B, n=3) or bilateral (group C, n=3) bilateral thoracolumbar microinjection. Groups D and E received unilateral cervical (group D, n=3) or cervical plus bilateral thoracolumbar microinjection (group E, n=3).

Detailed pre- and post-operative neurological outcomes were recorded, such as post-operative pain, as well as urologic, sensory and motor functions. The results of this study, “Intraspinal stem cell transplantation in ALS, a phase I trial: cervical microinjection safety outcomes,” was presented by Jonathan Patrick Riley, Department of Neurological Surgery, Emory University, Atlanta, USA. In the results, researchers noted that the unilateral cervical (group D, n=3) and cervical plus thoracolumbar microinjections (group E, n=3) have been completed in ambulatory patients, and that no neurological worsening was witnessed to follow either cervical or thoracolumbar microinjection.

The researchers did note that one cervical microinjection patient developed a post-operative kyphotic deformity, which prompted the addition of a laminoplasty in subsequent patients. Neurologic morbidity was not observed with the delivery of a cellular payload to the cervical or thoracolumbar spine spinal cord within the test groups of this at-risk patient group. This led the researchers to opinion that more consideration should be given to this delivery approach as a possible option for neurodegenerative, oncologic and traumatic spinal cord disorders.

“We are excited that the safety results of this trial have borne out what has been shown by our preclinical studies—that both the cervical and thoracolumbar spinal cord are able to safely tolerate multiple targeted injections of a cellular graft,” said Riley. “These results support the exploration of the cellular graft ‘dose range’ that may be delivered and safely tolerated. Identification of a safe dose range that the spinal cord toleratesis an important first step prior to completion of phase II efficacy studies.”

Jonathan Patrick Riley disclosed that Neuralstem provided other financial or material support

Medtronic announces FDA Class I recall of deep brain stimulation lead cap

2013-05-03T15:33:00Z

Medtronic has issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits. The US Food and Drug Administration (FDA) has classified the communication as a Class I Recall.

Medtronic, according to a company release, has received reports of deep brain stimulation leads being damaged due to twisting of the connector within the lead cap during the surgical procedure. The lead cap is included in deep brain stimulation lead kits and dystonia therapy kits and is sometimes used temporarily to protect the end of a deep brain stimulation lead after it has been implanted. The deep brain stimulation lead cap is not used in all deep brain stimulation procedures, and is not permanently implanted. Depending on the extent of lead damage due to twisting of the connector during the placement and removal of the lead cap, lead replacement may be required or optimal therapy may not be achieved.

In the case of lead damage, Medtronic advised, if at the beginning of therapy patients are receiving therapy as expected, they are not likely to be affected by this issue. Patients with questions relating to this issue are encouraged to talk with their physicians.

A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use deep brain stimulation lead caps.

Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, and the FDA’s MedWatch Program at www.fda.gov/MedWatch.

Study demonstrates significant pain reduction with Dfine Star tumour ablation system for spinal metastases

2013-05-03T12:03:00Z

Dfine, the developer of minimally invasive radiofrequency targeted therapies for the treatment of vertebral pathologies, released study results highlighting the clinical benefits of advanced Targeted-Radiofrequency Ablation(t-RFA) therapy for the management of patients experiencing painful spinal lesions. Eighty-five per cent of patients with metastatic disease will develop spinal metastases—of these nearly 75% will involve the axial skeleton.

The poster, titled “Targeted radiofrequency ablation of spinal metastases: Initial multicenter experience,” authored by Nam D Tran, Neuro-Oncology Surgeon at the H Lee Moffitt Cancer Center, Neurosurgery at the University of South Florida College of Medicine, USA, noted that the Star Tumor Ablation System represents a safe and effective new technique for the treatment of painful malignant spinal metastases. Tran and colleagues from Washington University in St Louis and the University of California San Diego, USA, conducted a retrospective review of 85 patients treated with the Star System, followed by cement augmentation, at three centers over the past 12 months. Spinal metastases involved a wide spectrum of tumor etiology and location extending from T2-S2. Pain relief, as measured by Visual Analogue Scale (VAS), decreased from 7.4 pre-procedure to 2.8 at one month and 1.8 at six months (p <0.001).

“We have found the Star System to be an effective new tool in our efforts to mitigate the progression of neurological complications caused by spinal tumors,” Tran said. “It is a valuable addition to our neurosurgical armamentarium, one that provides significant and rapid pain relief in a minimally invasive procedure, and restores quality of life for these patients before they require more extensive surgery.”

“It is exciting to see how the Star System has been integrated into the neurosurgical suite at Moffitt Cancer Center,” said Kevin Mosher, chief executive officer of Dfine. “The adoption of the Star System at Moffitt, a true multidisciplinary cancer centre, is an exciting milestone for the company and supports our belief that targeted radiofrequency ablation can play a significant role in the treatment of patients with metastatic spinal tumours.”

Phase I study of transcranial MR-guided focused ultrasound thalamotomy sees reduced tremor

2013-05-03T10:33:00Z

Research findings offered on 29 April 2013 at the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (27 April–1 May 2013, New Orleans, USA) showed that the use of transcranial MR-guided focused ultrasound for producing a thalamotomy can have significant positive effects on subjects suffering from essential tremor.

A preliminary clinical trial suggested that acoustic energy could be delivered precisely to generate a focal stereotactic ablation deep within the brain. In a Food and Drug Adminstration (FDA)-approved clinical trial, 15 patients with medication-refractory essential tremor underwent transcranial MR-guided focused ultrasound thalamotomy targeting the Vim nucleus.

Adverse events were recorded throughout the study, according to a press release, with comprehensive neurologic assessments for sensation, gait, strength and balance. A 160-point validated rating scale of tremor was used to assess the procedure’s efficacy in the patients, and a quality-of-life-in-essential-tremor questionnaire was obtained at pre, three-months and twelve-months post treatment. In addition, MR assessments were made of the lesions at one day, one week, one month and three months. The results of this study, “The one year results of a phase I study of transcranial MR guided focused ultrasound thalamotomy for the treatment of medication refractory essential tremor", were presented by William Jeffrey Elias, University of Virginia School of Medicine, Charlottesville, USA.

According to Elias, results showed a 67% reduction in contralateral hand tremor at one year. This unilateral reduction of tremor in the dominant hand resulted in substantial improvements in daily disabilities (83%) and quality of life as assessed by clinicians and the subjects. Adverse events from the therapy were minimal and consisted mostly of mild paresthesia of the face or hand, but it is important to note that this preliminary feasibility study was not powered to determine the true safety and efficacy of the treatment. The researchers concluded that this initial investigation of transcranial MR-guided focused ultrasound thalamotomy seems feasible and safe enough to proceed with more comprehensive clinical trials. Elias noted that the investigators “plan to follow these patients annually just as we do in our clinic with other movement-disorder procedures. We also are planning a long-term follow-up for our next multi-center and international clinical trial, which is scheduled to begin this summer.”

Elias added that “it is important to realise from these results and those of other tremor procedures that tremor suppression in the dominant hand, even if it is 75% on a rating scale, translates to very significant improvement in functional abilities. Our patients experienced almost no residual disabilities in day-to-day activities with this degree of tremor suppression.” He also noted that the researchers were “extremely surprised” by the amount of interest the tremor community had in this clinical trial. “We have been contacted by more than 2,000 people with tremor, which I think reflects their desire for more treatment options than we currently offer.”

Disclosure: William Jeffrey Elias disclosed that the Focused Ultrasound Surgery Foundation provided grant/research support and an honorarium.

Implanted device predicts epilepsy seizures in humans

2013-05-02T17:02:00Z

For the first time, a small device implanted in the brain has accurately predicted the onset of seizures in some adults who have epilepsy that does not respond to drugs, according to a small proof-of-concept study published online first in The Lancet Neurology.

“Knowing when a seizure might happen could dramatically improve the quality of life and independence of people with epilepsy and potentially allow them to avoid dangerous situations such as driving or swimming, or to take drugs to stop seizures before they start, rather than continuously as at present”, explained lead author Mark Cook from the University of Melbourne in Australia.

The technology, developed by NeuroVista, is designed to detect abnormal electrical activity in the brain that precedes a seizure using electrodes implanted between the skull and brain surface which constantly monitor electrical activity (electroencephalography; EEG) data.The electrodes are connected to a second device implanted under the skin of the chest which transmits this information wirelessly to a hand-held device that calculates the probability of a seizure. Three coloured lights warn patients of the high (red), moderate (white), or low (blue) risk of an impending seizure.

More than 60 million people worldwide have epilepsy, 30–40% of these patients are unable get their seizures under control with existing treatments, according to a Lancet Neurology release.

The Australian feasibility study included 15 people with focal epilepsy aged 20–62 years who had experienced between two and 12 seizures per month and had not had their seizures controlled despite use of at least two anti-epileptic drugs.

During the first month after surgical implant, the system was set for detection only while EEG data containing a minimum of five seizures was collected and analysed to construct an individualised algorithm of seizure likelihood.

The researchers measured the system’s performance, clinical effectiveness, and safety for 4 months after implant and 4 months following activation.

During the initial data collection, the system correctly predicted seizures with a “high warning” sensitivitygreater than 65%, and worked to a level better than chance, in 11 of the 15 adults. In eight of the 11 patients who went on to have the device activated and to use the system for 4 months, sensitivity ranged from 56% to 100%.

The technology appeared to be relatively safe, with a similar safety profile to other implanted devices such as deep brain stimulators for Parkinson’s disease. Three patients experienced serious device-related adverse events, with two requiring the device to be removed.

Notably, the study also revealed substantial disparities between reported and detected events, with most participants greatly underestimating the number of their seizures. For example, one patient who reported having 11 seizures per month actually had 102. “Our findings have pronounced implications for trials of new epilepsy treatments which often rely on patient-reported events as the primary efficacy endpoint”, the authors wrote.

Cook is optimistic that if the findings are replicated in larger, longer studies, this technology will improve management strategies including developing methods of preventing seizures using direct electrical stimulation or fast-acting drug therapies.

Writing in an accompanying commentary, Christian Elger andFlorian Mormann from the University of Bonn Medical Centre in Germany said, “[These results] are a major milestone in epileptology [the study of epilepsy], showing for the first time (to our knowledge) that prospective seizure prediction is possible…[but] whether this performance is also sufficient for clinical application is unclear; this will depend on how well patients tolerate false alarms or missed seizures, and will ultimately need to be decided on an individual basis. Nevertheless, the presented results suggest that at least some patients would view the warning device as beneficial.”

IMRIS to exhibit VISIUS iCT imaging solution at AANS

2013-04-29T12:20:00Z

IMRIS has announced that it will exhibit its novel intraoperative computed tomography (CT) solution with, according to the company, state-of-the-art imaging that is currently under development at the American Association of Neurological Surgeons (AANS) Annual Meeting (27 April to 1 May, New Orleans, USA).

VISIUS iCT is pending US FDA 510(k) approval and is not available for sale in any market.

According to a company release, like the VISIUS Surgical Theatre with iMRI, the VISIUS iCT will move on demand using ceiling-mounted rails for improved access in the operating room so no patient transport is required for imaging. The multifunctional environment eliminates space compromises of floor rail or wheeled portable systems to optimise workflow and may improve surgical outcomes. Developed for cranial and spinal surgery, the system is also intended to provide physicians with advanced image quality with access to a full range of software applications for intelligent dosing.

The IMRIS comprehensive and interactive AANS booth will also have on display its latest neurosurgical advancements in robotics with the SYMBIS Surgical System, operating room tables, head fixation devices and imaging coils. The SYMBIS Surgical System is FDA 510(k) pending and not available for sale in any market.

The central theme of the AANS 2013 educational sessions relates to advancing patient safety. Scheduled presentations by faculty members will be an opportunity to demonstrate the current and future impact of intraoperative MRI and CT imaging in cranial and spinal neurosurgery.

Clinical studies show that transporting patients for intraoperative imaging—even for short distances—poses risks related to the movement of monitoring equipment, cardiac and respiratory issues, and workflow and positioning ramifications.

VISIUS Surgical Theatre systems are intended to limit compromising patient risk in the neurosurgical environment by eliminating patient transport and maintaining patient positioning throughout surgical procedures. This true intraoperative advantage preserves established surgical access and techniques while assisting in critical decision-making and enhancing treatment precision.

Boston Scientific launches Fixate Tissue Band in the USA

2013-04-18T13:19:00Z

Boston Scientific has announced that it has acquired the Fixate Tissue Band, which is a novel suturing device for the placement of a spinal cord stimulation lead or pain pump catheter, from Anulex Technologies and that it has launched the device onto the USA market.

“Anchoring a lead can be a time consuming part of the spinal cord stimulation procedure, and lead migration resulting in the need for revision is a known complication of spinal cord stimulation,” said Richard Bowman, of the Center of Pain Relief in Charleston, USA. He added: “The Fixate device improves the surgical technique by allowing the lead anchor to be secured tightly to tissue in a quick and efficient way with a small anchoring incision.”

According to a company press release, bench test data show that, on average, the Fixate Tissue Band can place a suture in under one minute. The semi-automated design provides ease of use for physicians and offers a minimally invasive inline design.

The band is intended to be an accessory to the leads/catheter component of spinal cord stimulator/pain pump systems functioning to secure the lead to the fascia or interspinous/supraspinous ligament.

Boston Scientific launches Precision Spectra Spinal Cord Stimulator System in the USA

2013-04-12T14:38:00Z

According to the company, the Precision Spectra System is the world’s first and only spinal cord stimulation system with Illumina 3D software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. It has received US Food and Drug Administration (FDA) approval. Boston Scientific is expected to introduce the system at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale, USA.

“The Precision Spectra System represents a paradigm shift in spinal cord stimulation,” said Giancarlo Barolat, medical director of Barolat Neuroscience in Denver, USA. “The Illumina 3D Software is the first spinal cord stimulation system programming technology based on ports—twice that of any other spinal cord stimulation system—the Precision Spectra technology gives physicians more flexibility to customise therapy for patients.”

Until now, according to Boston Scientific, spinal cord systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. Additional lead ports give physicians more flexibility to cover their patients’ pain at the time of implant and more flexibility to adapt to changing pain patterns in the future. With more contacts, the Precision Spectra System also offers more coverage of the spinal cord for the management of chronic pain.

“The Precision Spectra System is a major milestone in the advancement of spinal cord stimulation therapy,” said Maulik Nanavaty, president of the Neuromodulation business unit at Boston Scientific.

Boston Scientific is expected to make continued investments in clinical studies to further understand the needs of chronic pain patients and has recently begun the following trials:

OPTIONS trial: An ongoing prospective, multicentre, single-arm study to further characterise the benefits of having a 32-contact option using the Precision Spectra System.
MAP trial: An ongoing cross-sectional, multicentre study to estimate the prevalence of multiple areas of pain in spinal cord stimulation-eligible patients with certain diseases.

In addition to the Precision Spectra System, Boston Scientific has recently new products in Europe and the USA, and has received expanded indications in Europe:

Head-only magnetic resonance imaging conditional CE mark approval for the Precision Plus spinal cord stimulation system (not available for use or sale in the USA)
Peripheral nerve stimulation CE mark approval for the Precision Plus spinal cord stimulation system (in the USA, this is not available for use or sale)
Vercise Deep Brain Stimulator System CE mark approval for parkinson’s sisease (investigational device and not available for sale in the USA)
Infinion 16 Percutaneous spinal cord stimulation lead with US FDA and CE mark approval

Medtronic initates US trial to investigate the use of peripheral nerve stimulation for chronic back pain

2013-04-11T18:11:00Z

Medtronic announced the first patient enrolments in the SubQStim II pivotal clinical trial to pursue US Food and Drug Administration (FDA) approval of peripheral nerve stimulation, also known as subcutaneous nerve stimulation, for the reduction of chronic, intractable post surgical back pain.

Medtronic received CE mark for the first 16-electrode, fully implantable system for the percutaneous delivery of peripheral nerve stimulation in the management of chronic back pain in May 2011, according to the company.

Peripheral nerve stimulation using a fully implantable system is not currently approved by the FDA for use in the USA. The SubQStim II pivotal study is a randomised, controlled, blinded, parallel arm, multicentre trial to assess the safety and efficacy of peripheral nerve stimulation for chronic, intractable post surgical back pain.

The study is expected to recruit up to 323 people at 30 US centres who will receive peripheral nerve stimulation using a Medtronic neurostimulation system. Patients will be randomised to a treatment or control group for the first three months and will continue to participate in open-label follow-up for up to five years, according to a company release.

“The SubQStim II pivotal study will provide new information about subcutaneous nerve stimulation as a potentially valuable treatment option for US patients with chronic, intractable back pain who have found insufficient relief with other treatment options,” said the study’s coordinating investigator, George Mandybur, associate professor and Director Stereotactic and Functional Neurosurgery at the University of Cincinnati and a neurosurgeon with the Mayfield Clinic, USA.

The first enrolments were performed by principal investigators Yeshvant Navalgund, DNA Advanced Pain Treatment Center in Greensburg, Pennsylvania, USA, and D Joseph Meyer, Columbia Interventional Pain Center in Columbia, USA. “Study findings will provide an unprecedented understanding of how leads placed in the subcutaneous tissue layer work with neurostimulation devices to help patients manage their chronic back pain,” said Navalgund.

Medtronic recently initiated the SubQStim I post-market study in Europe, Israel, Australia and Canada to evaluate the effectiveness of peripheral nerve stimulation plus optimal medical management for low back pain, compared to optimal medical management alone in patients with failed back surgery syndrome.

In January, the company announced the beginning of PROMISE, a prospective, randomised study of multicolumn implantable lead stimulation for predominant low back pain. PROMISE is the first ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5 multicolumn surgical leads plus optimal medical management to optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain, according to Medtronic.

First paclitaxel drug-eluting balloon for intracranial stenosis achieves CE mark

2013-04-11T17:58:00Z

Aachen Resonance reported it had obtained the first CE approved drug-eluting balloon for neurointerventions. According to the company, the Neuro Elutax SV paclitaxel drug-eluting balloon is a highly flexible hydrophilic, neurointerventional rapid exchange balloon with an even 360-degree coating of 2.2µg/mm2 of paclitaxel.

The current treatment preference for intracranial atherosclerotic disease is not intervention but medical management with neurosurgeons reluctant to request stenting by the interventionalist since the SAMMPRIS trial, according to a company release.

Over the years several reported studies using cardiology drug-eluting balloons off label in intra/extra cranial in-stent restenois have demonstrated positive results but the navigation of stiff cardiology drug-eluting balloons in tortuous vessels has been challenging for neurointervetionalists.

According to Aachen Resonance there is no “wash off effect” often associated with cardiology and peripheral drug-eluting ballons, or the need to pre-dilate as the short inflation time of 15 to 30 seconds is enough to allow a micro drug bolus to be delivered to the lesion site with the aid of the hydrophilic coating over a 0.014 wire. The uptake and the longevity of the paclitaxel in the vessel wall is highly effective, they stated.

Alexander Rueben, co-founder of Aachen Resonance said of theNeuro Elutax SV: “To have a highly effective drug coating that does not wash off and without compromising the flexibility of the small Neuro standard balloons required several new innovations in drug coating technology. We are delighted with the results and what it means to patients suffering from intracranial atherosclerotic disease.”

Steve Dechan of Platform-14, a distributor of the device said: “There is no doubt that this is an important breakthrough in the treatment of intracranial stenosis. The 12-month follow-up in de novo stenosis lesions and in-stent restenoses has shown excellent results. The vessels of the brain react well to the micro bolus of paclitaxel which interferes with the behavior of the microtubules, while the instructions for use remain the same as plain angioplasty; it negates the need for intracranial stenting in treating stenosis”.

Monteris Medical’s NeuroBlate System receives 510(K) clearance

2013-04-11T17:47:00Z

Monteris Medical announced that the US Food and Drug Administration (FDA) have issued a second 510(k) clearance for their magnetic resonance imaging (MRI)-guided ablation device for brain tumours and other lesions. The NeuroBlate System is a second generation device employing a surgical laser to ablate diseased brain tissue with updated visualisation provided by active MRI, according to the company. A first generation system has been available in US hospitals since 2010.

Gene Barnett, Burkhardt chair in Neurosurgical Oncology, Cleveland Clinic Neurological and Cancer Institutes, Cleveland, USA said: “The NeuroBlate System will make laser ablation of brain lesions accessible to more neurosurgeons by virtue of its intuitive user interface and time-saving enhancements. Cleveland Clinic will soon be employing this tool to treat brain tumour patients who are seeking a minimally invasive option or are not candidates for traditional surgery.”

“Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow,” said John Schellhorn, president and CEO. “The NeuroBlate System provides neurosurgeons controlled, three-dimensional ablation via a powerful software platform. It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy. We believe the NeuroBlate System will offer a new option for surgeons managing patients with brain tumors and other neurologic lesions.”

St Jude Medical receives CE mark for deep brain stimulation systems for primary and secondary dystonia

2013-04-11T17:32:00Z

On 10 April 2013, St Jude Medical announced European CE mark approval of its Brio, Libraand LibraXPdeep brain stimulation systems for managing the symptoms of intractable primary and secondary dystonia. This approval represents the first regulatory agency approval for the use of deep brain stimulation to manage both primary and secondary dystonia, according to the company.

“Dystonia strikes people of all ages including children and young adults, often leaving them disabled and sometimes wheelchair bound,” said Elena Moro, professor of neurology at the University Hospital Center of Grenoble, France. “For patients who do not respond to medications, deep brain stimulation therapy may alleviate symptoms such as repetitive, twisting movements, allowing them to improve their independence and overall quality of life.”

Deep brain stimulation therapy for dystonia involves the delivery of mild electrical pulses to a specific target in the brain. Stimulation is delivered to one of two regions, the subthalamic nucleus or the globus pallidus interna, areas of the brain involved with controlling movement. Irregular nerve signals responsible for some of the disabling symptoms are stimulated by deep brain stimulation therapy, ultimately helping the patient improve movement, according to St Jude Medical press release.

“This CE mark is the first approval by a regulatory agency for the use of deep brain stimulation therapy to manage the symptoms of both primary and secondary dystonia, broadening the treatment options for patients in Europe whose lives are impacted by this disabling disease,” said Eric S Fain, president of the St Jude Medical Implantable Electronic Systems Division. “This approval represents a significant milestone for St Jude Medical as we continue to develop therapies to treat a broad range of neurological conditions.”

Flow diversion is a game changer

2013-04-09T14:52:00Z

At the Carotid Challenge session, which took place at the Charing Cross Symposium (CX35) on 9 April in London, UK, 62% of delegates said that they believed flow diversion was a “game changer” after Andrew Platts, London, UK, spoke to them about the intervention for the anterior cerebral circulation.

Platts said that a flow diverting stent was designed to redirect flow forces away from vulnerable arterial lesions and aneurysms. He reviewed information that was derived from early cases using flow diverters, and reported that: anticoagulation alone would not prevent acute stent thrombosis; that verified platelet inhibition is mandatory before or immediately after flow diverting stents are placed; and that typically both aspirin and clopidogrel (Plavix; Bristol-Myers Squibb and Sanofi Aventis) should be administered from six weeks to three months after implantation and that after this timeframe, just one of the agents should be continued. Platts added that new devices were due to enter the market soon, including intra-aneurysmal flow diverters.

He then presented updates from the UK Flow Diverter Registry. The devices used in the registry were Silk (42 patients) and Pipeline (161 patients). In terms of deployment, the flow diverters that were deployed successfully were 171. To date, according to the registry, 174 aneurysms (of 216 aneurysms overall; 87%) had not ruptured.

Platts noted that these were only preliminary data and that the characteristics (including the aneurysms) of the patients in the registry were diverse. However, he did add that the registry reflected “real-world practice and outcomes” and emphasised that complication rates observed with the devices were not insignificant.

According to Platts, flow diverting stents can remodel flow and the vessel and preserve flow in covered branches. He also noted that flow diverting stents require a validated platelet inhibition but they “add a new tool in the management of aneurysmal disease.”

In the discussion after his talk, Platts said that flow diverters, in his opinion, were a safe way of managing fusiform aneurysms which are rare. In acute subacharanoid haemorrhage, he said that putting a patient on dual-antiplatelet agents in the presence of an aneurysm that has not been excluded from the circulation (flow diverter does not control the flow within the aneurysm) was ill-advised.

In the vote at the end of the session that asked the question: “Is intracranial flow diversion a game changer?”, 62% of the audience voted yes.

Gamma Knife Perfexion system used at Sacred Heart Health System to treat patients in Florida

2013-04-04T14:04:00Z

American Shared Hospital Servicesa provider of turn key technology solutions for advanced radiosurgical and radiation therapy services, announced today that the Gamma KnifePerfexion system has been supplied to Sacred Heart Health System in Florida, USA, and has been used to treat patients.

Noting that Sacred Heart is a new hospital affiliation for American Shared, AMS chairman and chief executive officer Ernest A Bates, said: “This latest addition to our Perfexion portfolio demonstrates that neurosurgeons and radiation oncologists who know the competing technologies best continue to demand this unequaled stereotactic radiosurgery system for treating cancers and other diseases of the brain. We see additional opportunities to place Gamma Knife Perfexions at new and existing AMS sites both in the USA and internationally.”

According to a release, AMS is the largest owner of Gamma Knife Perfexion systems worldwide and has placed twelve Perfexion systems in the USA and one in Turkey; a fourteenth system is scheduled to be installed at Northern Westchester Hospital in Mt Kisco, New York, USA in the second quarter.

Posterior artery aneurysm re-rupture could be due obscured aneurysm neck by a clot during intervention

2013-03-27T10:18:00Z

The findings of study led by Adam A Dmytriw and published in Journal of NeuroInterventional Surgery indicated that the rupture of posterior communicating artery aneurysms, where clots obscure the aneurysm neck in the immediate post-coiling period (≤3days), is rare but has a 70% mortality rate.

Dmytriw et al said that rupture in the post-coiling period is extremely rare but is “considered urgent as re-rupture carries a mortality of approximately 70%.” They added that, prior to their study, there had been little discussion of re-rupture in the immediate post-coiling period and that early re-treatment is necessary to prevent further haemorrhage but can be complicated by the placement of coils.

From January 2002 to July 2012, out of 472 coilings performed, two cases of aneurysm rupture in the immediate post-coiling period related to a clot obscuring the aneurysm neck during intervention were found.

In the first case, the patient was treated for subarachnoid haemorrhage secondary to the rupture of a left posterior communicating artery aneurysm, which measured 5.3mmx3mm with a neck measuring 2.5mm (World Federation of Neurological Societies (WFNS) score 2, Fisher grade 2). According to the authors, coil embolization was used to treat the aneurysm but it was difficult to coil due to the wide-neck. Post-intervention (three days), a computed tomography (CT) scan showed more subarachnoid haemorrhage and the patient underwent clipping of the coiled aneurysm. Dmytriw et al said: “Intraoperative observations suggested the point of rebleeding was probably at the neck of the aneurysm.”

The second case, after CT/CTA was diagnosed with a right temporal haemtoma secondary to saccular right posterior communicating artery aneurysm rupture, which measured 7.5mmx4.7mm with a neck size of 2.5mm (WFNS grade 3, Fisher grade). The patient underwent endovascular coiling with multiple platinum coils (packing density 21%). According to the authors, coiling was complicated by thrombus formation along the distal and medial aspect of the coil mass. Post-procedure CT showed new blood in the temporal haematoma and the patient subsequently underwent craniotomy for excavation of the haematoma and clipping of the aneurysm. Dmytriw et al reported that, intraoperatively, the re-rupture point appeared to be over the dome rather than the neck of the aneurysm.

“Our cases show, rebleeding of the posterior communicating artery aneurysms may not be fatal but may result in increased morbidity,” said Dmytriw and colleagues. “Rebleeding requires immediate surgical intervention. Repeat endovascular coiling may be a viable option if there is significant residual filling of the aneurysm.”

“However, in a setting of rebleeding in the post-coiling period, assessment of residual filling is not straightforward,” they added. “Clipping represents the preferred treatment. However, clip placement may be rendered more difficult due to the presence of substantial coil mass at the base of a very recently treated aneurysm.”

The authors said that, although re-rupture of coiled aneurysms is rare, incomplete treatment of an aneurysm is a risk factor as visualisation becomes difficult in the setting of intraoperative thromboembolic complication. “Shorter and more frequent follow-up may be help[ful] in preventing these re-ruptures,” they concluded.

The Second Annual UAE Epilepsy Congress to be held in Abu Dhabi

2013-03-27T10:01:00Z

Abu Dhabi will host the Second Annual UAE Epilepsy Congress (26–27 April 2013). The congress is hosted under the umbrella of the Emirates League Against Epilepsy (ELAE), and endorsed by the Abu Dhabi Health Services Co (SEHA), the Commission of Eastern Mediterranean Affairs (CEMA) and the International League Against Epilepsy (ILAE). The congress is accredited by the Health Authority of Abu Dhabi (HAAD).

The congress has been organized, according to a release, as part of ongoing efforts to provide education to healthcare professionals and to enhance the overall healthcare standards in the fight against Epilepsy in the region. With the participation of renowned international and regional faculty, the two-day comprehensive program will present cutting edge topics in clinical epileptology. This year’s key note speaker at the congress will be Emilio Perucca, the president-elect of ILAE.

This year’s plenary sessions will address a broad range of topics covering: challenges in epilepsy diagnosis, tactics of AED management, medical causes of epilepsies, childhood epilepsy and intractable epilepsy. Furthermore, debate sessions are organised to raise engaging and controversial topics that are facing clinicians in the fields of epileptology in a forum that is intended to enhance healthcare professional’s knowledge about epilepsy. “Our goal is to provide insight and strategies to enhance the quality of life for people with epilepsy,” said Taoufik Alsaadi, conference chairman and president of the UAE chapter of the ILAE, and head the Neurology department at Sheikh Khalifa Medical City (SKMC) in Abu Dhabi.

Epilepsy is a brain disorder in which a person has repeated seizures over time through episodes of disturbed brain activity that are due to abnormal electrical discharges on the brain’s nerve cells. Epileptic brain activity causes changes in attention or behavior while symptoms vary from person to person. "Epilepsy is not a single entity but a family of more than 40 syndromes and believed to be the most common serious neurological condition that affects more than 120,000 people in the UAE", added Alsaadi.

The Second Annual UAE Epilepsy Congress will take place at the Eastern Mangroves Hotel in Abu Dhabi and is expected to attract healthcare professionals from all over the region. “I trust that the latest advancements and cutting edge research in the field that will be presented at the congress will shed more light on this disorder and will provide a high quality of educational and networking opportunities that aim at tackling epilepsy in several domains," concluded Alsaadi.

The American Academy of Neurology launches app for identifying concussion in sports injury

2013-03-20T11:05:00Z

The American Academy of Neurology (AAN) has launched a new app called "Concussion QuickCheck", to help coaches, athletic trainers, parents and athletes quickly evaluate if someone may have a concussion and needs to see a licensed health care provider, such as a neurologist, who is specialised in concussion, according to a society release.

The app, which is available for iPad, IOS (Apple), Android, and mobile, was developed in partnership with the Academy’s updated guideline for diagnosing and evaluating sports concussion. The announcement of the new app was made at the Academy’s Annual Meeting in San Diego, USA, (in conjunction with the release of the updated sports concussion guideline.

Key information and tools in the Concussion Quick Check app include:

Common signs of concussion
Symptoms of concussion
Things the athlete may tell you
What to do if an athlete has a head injury during a game
What to do if it appears the athlete has a concussion
When an athlete should return to the game
Help finding a neurologist near you (with global positioning system capability)
Help finding state laws on concussion
More about the Academy’s new guideline for diagnosing, treating and managing sports concussion

“The American Academy of Neurology, the world’s largest association of neurologists, is the trusted authority in managing sports concussion,” said Christopher C Giza, David Geffen School of Medicine and Mattel Children’s Hospital, University of California Los Angeles, USA, and a member of the American Academy of Neurology, who helped develop the content for the Concussion Quick Check app. “We hope this easy-to-access tool will help coaches, athletic trainers, parents and athletes alike to quickly determine if an athlete shows signs of concussion and needs to see a licensed health care professional trained in managing concussion, such as a neurologist. It’s a perfect tool to have on your iPad or smart phone when coaching or watching a game from the sidelines.”

The American Academy of Neurology issues updated sports concussion guidelines

2013-03-19T11:38:00Z

According to the American Academy of Neurology (AAN) more than one million athletes experience a concussion every year in the USA. The AAN released an evidence-based guideline for evaluating and managing athletes with concussion. This new guideline replaces the 1997 AAN guideline on the same topic. The new guideline is published in the 18 March 2013 in Neurology and was developed through an objective evidence-based review of the literature by a multidisciplinary committee of experts and has been endorsed by a broad range of athletic, medical and patient groups, according to a release.

“Among the most important recommendations the Academy is making is that any athlete suspected of experiencing a concussion immediately be removed from play,” said co-lead guideline author Christopher C Giza, David Geffen School of Medicine and Mattel Children’s Hospital, University of California Los Angeles, USA, and a member of the AAN. “We have moved away from the concussion grading systems we first established in 1997 and are now recommending concussion and return to play should be assessed for each athlete individually. There is no set timeline for safe return to play.”

The updated guideline recommended that athletes with suspected concussion be immediately taken out of the game and not returned until assessed by a licensed health care professional trained in concussion, and return to play slowly and only after all acute symptoms are gone. Athletes of high school age and younger with a concussion should be managed more conservatively in regard to return to play, as evidence showed that they take longer to recover than college athletes.

According to the AAN the guideline was developed by reviewing all available evidence published through June 2012. These practice recommendations are based on an evaluation of the best available research. In recognition that scientific study and clinical care for sports concussions involves multiple specialties, a broad range of expertise was incorporated in the author panel. To develop this document, the authors spent thousands of work hours locating and analysing scientific studies. The authors excluded studies that did not provide enough evidence to make recommendations, such as reports on individual patients or expert opinion. At least two authors independently analysed and graded each study.

According to the guidelines:

Among the sports in the studies evaluated, risk of concussion is greatest in football and rugby, followed by hockey and soccer. The risk of concussion for young women and girls is greatest in soccer and basketball.
An athlete who has a history of one or more concussions is at greater risk for being diagnosed with another concussion.
The first 10 days after a concussion appears to be the period of greatest risk for being diagnosed with another concussion.
There is no clear evidence that one type of football helmet can better protect against concussion over another kind of helmet. Helmets should fit properly and be well maintained.
Licensed health professionals trained in treating concussion should look for ongoing symptoms (especially headache and fogginess), history of concussions and younger age in the athlete. Each of these factors has been linked to a longer recovery after a concussion.
Risk factors linked to chronic neurobehavioral impairment in professional athletes include prior concussion, longer exposure to the sport and having the ApoE4 gene.
Concussion is a clinical diagnosis. Symptom checklists, the Standardised Assessment of Concussion (SAC), neuropsychological testing (paper-and-pencil and computerised) and the Balance Error Scoring System may be helpful tools in diagnosing and managing concussions but should not be used alone for making a diagnosis.

Signs and symptoms of a concussion include:

Headache and sensitivity to light and sound.
Changes to reaction time, balance and coordination.
Changes in memory, judgment, speech and sleep (loss of consciousness or a “blackout” happens in less than 10% of cases).

“If in doubt, sit it out,” said Jeffrey S Kutcher, University of Michigan Medical School, USA, and a member of the AAN. “Being seen by a trained professional is extremely important after a concussion. If headaches or other symptoms return with the start of exercise, stop the activity and consult a doctor. You only get one brain; treat it well.”

The guidelines stated that while an athlete should immediately be removed from play following a concussion, there is currently insufficient evidence to support absolute rest after concussion. Activities that do not worsen symptoms and do not pose a risk of repeat concussion may be part of concussion management.

The guidelines are endorsed by the National Football League Players Association, the American Football Coaches Association, the Child Neurology Society, the National Association of Emergency Medical Service Physicians, the National Academy of Neuropsychology, the National Association of School Psychologists, the National Athletic Trainers Association and the Neurocritical Care Society.

InspireMD receives CE mark for Carotid Embolic Protection Stent

2013-03-18T15:44:00Z

InspireMD is the developer of the MGuard Embolic Protection Stent and announced on 15 March 2013 that the company received CE mark approval for its self-expanding Nitinol carotid Embolic Protection Stent. This carotid embolic protection stent is based on the proprietary MicroNetmesh protection platform technology used to treat myocardial infarction patients with InspireMD’s commercially available coronary Embolic Protection Stent stents, MGuard and MGuard Prime.

When treating carotid arterial disease, close to half of carotid artery stenting procedures cause distal embolic events that may lead to stroke within 30 days, according to InspireMD. The InspireMD Carotid Embolic Protection Stent is wrapped with a MicroNetmesh to prevent embolic events during and post carotid artery stenting procedure. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris from falling into the bloodstream and causing a potentially fatal downstream blockage or stroke.

In coronary procedures, InspireMD’s Embolic Protection Stent technology has already shown improvements through the MASTER trial findings that revealed a statistically and clinically significant acute advantage of MGuard Embolic Protection Stent with regard to ST segment resolution. As a result, MGuard Embolic Protection Stent may hold the potential to lower the incidence of adverse events and prolong survival of heart attack victims. The new InspireMD Carotid Embolic Protection Stent will be available in a matrix of sizes ranging from small diameters of 5x20mm to large diameters up to 10x60mm for large carotid arteries.

InspireMD’s president and CEO, Alan Milinazzo, commented: “The CE mark approval for our MGuard carotid system is a major milestone for the company and is further validation of the Micronet technology. We look forward to accelerating our clinical development programme with our carotid system. The CE mark should enhance our partnership strategy in the near term.”

InspireMD’s Embolic Protection Stent technology

The InspireMD Embolic Protection Stent system technology is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus that caused the blockage from breaking off. The embolic protection is comprised of an ultra-thin polymer micron net that is integrated with the stent. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard Embolic Protection Stent is CE mark approved. InspireMD’s Coronary Embolic Protection Stent is also CE mark approved. MGuard is not approved for sale in the USA by the US Food and Drug Administration.

Philips aims to screen one million people for obstructive sleep apnoea sleep disorder

2013-03-15T17:52:00Z

In an effort to help obstructive sleep apnoea sufferers identify and combat the disorder, Philips Electronics announced on 15 March 2013 it will screen one million people worldwide for obstructive sleep apnoea over the next five years.

Philips’ programme, consistent with its stated commitment to improve access to health care and save lives, will include screening across North America, Europe and Asia. The programme uses an online risk assessment on its World Sleep Day website. Individuals who have symptoms or believe they may be at-risk are encouraged to take the online risk assessment test. Upon completion, it will provide their risk level for obstructive sleep apnoea and encourage follow up with their health care provider.

"Obstructive sleep apnoea steals health from its sufferers and put them on a path to potentially life-threatening diseases,” said Brent Shafer, CEO, Philips Home Healthcare Solutions. “It is our goal to use our innovative solutions to help obstructive sleep apnoea sufferers identify and combat this very serious disorder."

Obstructive sleep apnoea is one of the most common sleep disorders, and affects approximately 5% to 6% of the adult population. It is characterised by a narrowing or closing of the upper airway, which hinders breathing during sleep.

Sleep is often labelled as the ‘third pillar of good health’, along with diet and exercise. Philips research suggests that more than two-thirds of all people with sleep apnoea are not diagnosed.

The most common cause of obstructive sleep apnoea is weight gain. Other signs and symptoms of sleep apnea include:

• Frequent loud snoring

• Pauses in breathing or gasping for breath

• Obesity

• Regularly falling asleep in situations, such as reading, watching TV or driving

• High blood pressure

“There are three important steps to helping individuals with obstructive sleep apnoea: awareness, diagnosis and treatment. Each is integral to improving the sleep quality and overall health of individuals around the world,” said Lee-Chiong, chief medical liaison for Philips Home Healthcare Solutions. “Philips’ pledge helps individuals take the first step to make them aware of their risk for obstructive sleep apnoea.”

Early detection of natalizumab treatment for multiple sclerosis complication may improve survival

2013-03-15T14:13:00Z

The drug natalizumab is effective for treating multiple sclerosis, according to a release, but it increases the risk of a rare but potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). A study presented at the American Academy of Neurology’s 65th Annual Meeting in San Diego, USA, 16–23 March, suggested that early detection of PML may help improve survival and disability levels.

The study examined 319 people with multiple sclerosis who were treated with natalizumab and diagnosed with PML. Because of the risk of PML, people taking natalizumab are monitored by their physicians for possible symptoms of the brain infection. The study compared people who had symptoms of PML at the time of diagnosis to people who had no symptoms of the infection, but who were diagnosed with the disease by brain scans and tests in the spinal fluid for the virus that causes the infection. The level of disability for the people in the study was assessed before the PML diagnosis, at the time of diagnosis, and again six months and one year after the diagnosis.

A total of 21 people had no PML symptoms at the time of their diagnosis, while 298 people had symptoms. The preliminary data from the study suggest that people who have no symptoms at diagnosis may have improved survival and less disability than those who had developed symptoms prior to their diagnosis, according to study author Tuan Dong-Si, medical director, Biogen Idec in Weston.

At the time of PML diagnosis, those patients with no symptoms had an average score of 67 on the Karnofsky Performance Scale, which measures disability, while those with symptoms had a score of 54. A Karnofsky score of 70 indicates that the individual may be able to care for him or herself, but may be unable to carry on normal activities or do active work. A Karnofsky score of 50 indicates that a person may require considerable assistance and frequent medical care. One year after PML diagnosis, the average Karnofsky score of those people with no symptoms at diagnosis was 70, compared to 47 for those with symptoms at diagnosis. Karnofsky scores of less than 50 indicate that the individual may be unable to care for him or herself and may require institutional care or the equivalent.

As of 1 January 2013, all 21 patients (100%) with no symptoms at the time of PML diagnosis were alive, compared to 77% of the people with symptoms at the time of diagnosis. “These results suggest that the consequences of PML infection can be mitigated by early detection of the disease,” said Dong-Si.

Natalizumab is generally prescribed for people who have not responded to or cannot tolerate other treatments for multiple sclerosis.

Study suggests possible marker of Alzheimer's disease associated with worse sleep quality

2013-03-14T17:54:00Z

Yo-El S Ju, Washington University School of Medicine, St Louis, and colleagues suggested in a study published online first in JAMA Neurology, that amyloid deposition in the preclinical stage of Alzheimer’s disease appears to be associated with worse sleep quality but not with changes in sleep quantity.

The cross-sectional study from October 2010 to June 2012 recruited cognitively normal individuals (n=145) 45 years of age or older and actigraphy data to measure sleep were recorded for 142 participants. Sleep was measured for two weeks and cerebrospinal fluid B-amyloid42 levels were used to determine whether amyloid deposition was present or not. Amyloid deposition was present in 32 participants (22.5%), according to the study results.

“This group had worse sleep quality, as measured by sleep efficiency (80.4% vs. 83.7%) compared with those without amyloid deposition […] in contrast, quantity of sleep was not significantly different between groups, as measured by total sleep time,” said the authors.

Frequent napping, three or more days per week, also was associated with amyloid deposition (31.2% vs. 14.7%), according to the study results.

InVivo Therapeutics submits updated IDE to begin spinal cord injury human study of its biopolymer scaffolding

2013-03-13T18:04:00Z

InVivo Therapeuticsa developer technologies for the treatment of spinal cord injuries and other neurotrauma conditions, announced the company has submitted an updated Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) requesting permission to begin human studies in order to test its biopolymer scaffolding for the treatment of acute spinal cord injury.

The updated IDE submission is in response to InVivo’s applications from 12 April 2012 meeting with the FDA. The filing contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device. Once approved, the IDE would allow InVivo to conduct an open-label human study to collect safety and efficacy data to support FDA approval of the first in-cord treatment for spinal cord injury. According to the company, it is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device (HUD).

“We are prepared to safely treat acute spinal cord injury patients, and in the coming months we hope to have the first opportunity to translate to humans the positive effect from the scaffold that we observed in our 2008, 2009, and 2011 non-human primate studies,” said Frank Reynolds, InVivo chief executive officer. “Our technology remains the only treatment to have demonstrated functional recovery when applied to non-human primates with spinal cord injury, and this first study has the potential to change the treatment options for neurotrauma patients forever.”

“We look forward to receiving feedback from the FDA and to getting started on this historical first-in-man clinical trial,” Reynolds added.

“We appreciate the collaborative dialogue we have had with the FDA. Since our April 2012 meeting, we’ve established regulatory processes to treat neurotrauma with biomaterials, and we’ve completed knowledge transfer with the FDA that we believe will benefit all of our additional products in development. We expect to bring a wide range of neurotrauma treatments to patients as quickly as possible with the potential for two new 510(k) products to hit the market in late 2014. In addition to the scaffolding device for SCI, we are developing products for conditions such as pain, fibrosis, and drug delivery, and we continue to make excellent progress in these applications as well,” said Brian Hess, InVivo chief technology officer.

Brain imaging after mild head injury or concussion can show lesions associated with traumatic brain injury

2013-03-13T16:48:00Z

Brain imaging soon after mild traumatic brain injury or mild concussion can detect tiny lesions that may eventually provide a target for treating people with mild traumatic brain injury, according to a study released 12 March 2013 and that will be presented at the American Academy of Neurology’s 65th Annual Meeting in San Diego, USA, March 16–23, 2013.

Studies of brain tissue once a person has died have previously shown that different types of lesions are associated with more severe traumatic brain injury. “Our study suggests that imaging may be used to detect and distinguish between these lesions in a living person with mild traumatic brain injury and this finding has important implications for treatment,” said Gunjan Parikh, National Institute of Neurological Disorders and Stroke, University of Maryland R Adams Cowley Shock Trauma Center in Baltimore, (Parikh is also a member of the American Academy of Neurology).

The study involved 256 people (average age of 50) who were admitted to the emergency department at Suburban Hospital in Bethesda and Washington Hospital Center in the District of Columbia after mild head injuries. They underwent magnetic resonance imaging (MRI) brain scans. Of those, 104 had imaging evidence of haemorrhage in the brain (67% reported loss of consciousness, and 65% reported amnesia, or temporary forgetfulness). People with haemorrhages underwent more detailed brain scans with advanced MRI within an average of 17 hours after the injury.

Advanced imaging showed that—of those 104 people with imaging evidence of haemorrhage—20% had microbleed lesions and 33% had tube-shaped linear lesions. Microbleeds were distributed throughout the brain whereas linear lesions, which were found mainly in one area, were more likely to be associated with injury to adjacent brain tissue.

The investigators hypothesised that the linear lesions seen on MRI may represent a type of vascular injury that is seen in brain tissue studies of people with more severe traumatic brain injury. “If that theory is confirmed, it may provide an opportunity to develop treatment strategies for people who have suffered a mild traumatic brain injury,” said Parikh.

The study was supported by the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke and the Center for Neuroscience and Regenerative Medicine at the Uniformed Services University of the Health Sciences, a collaborative effort among NIH, the Department of Defense and Walter Reed National Military Medical Center to develop innovative approaches to brain injury diagnosis and recovery.

Study examines cerebrospinal fluid markers in relation to Alzheimer's disease

2013-03-12T17:39:00Z

A study by Maureen Handoko, University of Minnesota, Minneapolis, USA, and colleagues, suggested that in cognitively intact older adults cerebrospinal fluid amyloid-β trimers and Αβ*56 were elevated in patients at risk of Alzheimer’s disease.

The cerebrospinal fluid sampling study included 48 older adults with mild cognitive impairment or Alzheimer’s disease, 49 age-matched cognitively intact control participants, and 10 younger, normal control participants. In the study the two specific Αβ oligomers in cerebrospinal fluid were examined to analyse the relationship of aging and Alzheimer’s with tau in the cerebrospinal fluid.

Cerebrospinal fluid Αβ trimers and AB*56 also showed stronger relationships with tau than did Αβ1-42, a surrogate for Αβ fibril deposition, according to the study results.

“These findings suggest that prior to overt symptoms, one or both of the Αβ oligomers, but not fibrillar Αβ, is coupled to tau; however this coupling is weakened or broken when Alzheimer’s disease advances to symptomatic stages,” Handoko and others noted.

The authors suggested that more research was required. “Additional molecular studies in animals and cells, as well as longitudinal clinical studies in humans, may better define the pathogenic roles of these oligomers and elucidate their molecular interactions with tau” they concluded.

Microvention announces the opening of neurovascular manufacturing facility in Costa Rica

2013-03-12T10:21:00Z

On 6 March 2013, MicroVention announced that its new manufacturing facility in San Jose, Costa Rica has opened. The company also held a Grand Opening Ceremony to commemorate this venture for MicroVention. The new plant represents MicroVention’s first manufacturing facility outside the USA and the first neurovascular manufacturing facility in Costa Rica, which is located at the Coyol Free Zone in the Alajuela region of Costa Rica.

The Plant opening ceremony was attended by numerous dignitaries and executives from the business district including the vice president of Costa Rica, Luis Lieberman Ginsburg. Other executives who attended from MicroVention’s parent company included Yutaro Shintaku, president and representative director; Shinjiro Sato, senior executive officer, group president, Cardiac and Vascular Business Group (both of Terumo Corporation located in Tokyo, Japan) and Hideo Arase, president and CEO of Terumo Americas Holding. Also in attendance was the Costa Rican investment promotion agency (CINDE) which, according to a company release, supported MicroVention in establishing its plant in Costa Rica.

“MicroVention will be the first company specialising in the neurovascular segment, and we are excited to welcome MicroVention to the Alajuela region,” commented Gabriela Llobet, CINDE´s director general.

“We are very excited about the initiation of our first manufacturing facility in Costa Rica and commemorating the opening with many of our new partners celebrating with us. Our intent was to create a world-class facility extension of our corporate manufacturing plant in Tustin, CA, USA, and we have achieved that goal today,” said Richard Cappetta, president and chief executive officer of MicroVention.

In attendance besides the company’s president and CEO were several other members of the MicroVention executive staff including William R Hughes, chief operating officer and treasurer; Cherie Henket, vice president, Human Resources; Matt Fitz Sr vice president, Research and Development and Operations; Uichi Okina, vice president, Strategic Planning, Business Development; and Charlie Noel, Vice President, Operations.

According to the company, approximately 12,000 people currently work in the Life Sciences Sector in Costa Rica. MicroVention will be the first company specialising in the neurovascular segment in Costa Rica.

Deep brain stimulation could help treat severely anorexic patients who have failed all other treatments

2013-03-07T11:23:00Z

A pilot study, published in The Lancet, on deep brain stimulation to treat anorexia, which was primarily intended to assess the safety of the procedure, reported at least half of the six anorexic patients who took part in the study showed improvements in mood and Body Mass Index (BMI). However, larger trials are required to confirm the effectiveness of the technique in treating patients with severe anorexia.

Deep brain stimulation is currently used to treat several neurological disorders, including Parkinson’s disease and chronic pain, and investigations are exploring its use for treating other disorders, such as depression and epilepsy, but this is the first time that it has been used to treat patients with severe anorexia which has not responded to other treatment. Although the treatment requires surgery, it is minimally invasive, and completely reversible.

Researchers at the Krembil Neuroscience Centre and University Health Network, Canada, used magnetic resonance imaging (MRI) to identify a specific area of the brain—a bundle of white matter below the corpus callosum, the thick bundle of nerve fibres which divides the left and right sides of the brain—which has previously been used for deep brain stimulation in patients with depression. Once the target area had been identified, electrodes were then implanted into the area and connected to a pulse generator, which was implanted under the skin. The device was activated 10 days after it had been implanted.The researchers measured acute changes in the patients’ mood and anxiety levels to determine the correct level of stimulation.

At the time of surgery, the female patients were aged between 24 and 57, and had been suffering from anorexia for between four and 37 years. Although the pilot study was primarily intended to assess the safety of the procedure in this patient group, the researchers also recorded changes in the participants’ mood, compulsive behaviour and abnormal eating patterns, which they measured using standardised tests. The treatment appeared to be relatively safe, with just one patient experiencing a serious adverse event following the treatment, a seizure which occurred two weeks after the initial operation, which was related to a metabolic disorder the patient was suffering as a result of her anorexia.

In the weeks before surgery, five of the six patients had recently been attending inpatient treatment, which had resulted in some weight gain. After two months, all six patients had lost weight, returning to their usual baseline, in line with the researchers’ expectations—studies of deep brain stimulation for patients with depression have usually observed a latency period of a few months before the treatment becomes effective. However, three months after the treatment, this pattern began to reverse, with five of the six patients stabilised or gained weight, relative to two months after the operation. At nine months, three patients were maintaining a higher weight than before the treatment started—the longest period of sustained increase in weight that any of them had achieved since the onset of illness. Around half of the patients also experienced improvements in their mood or reduced obsessive-compulsive behaviour.

According to Andres Lozano, Toronto Western Research Institute, Toronto, Canada, a neurosurgeon in the field of deep brain stimulation, and one of the lead researchers, the results are particularly encouraging because they seem to point to a genuine therapeutic effect, rather than a placebo or hunger-increasing effect. He said: “The initial weight loss argues against a primary effect of deep brain stimulation on hunger, appetite, or metabolic rate. It also suggests that there is little in the way of a placebo-related benefit to the surgery.” Lozano added: “The finding of improvements in mood and anxiety in patients who were still underweight is especially striking, in view of the well known poor response of underweight patients to conventional pharmacotherapies or psychotherapies.”

In an accompanying commentary, Janet Treasure and Ulrike Schmidt both of the Institute of Psychiatry, King’s College London, London, UK, wrote: “The personal and social costs of eating disorders in general are large, and nowhere are these more evident than in patients with severe and enduring anorexia nervosa. New effective treatments for these patients are sorely needed […] the findings of this proof-of-concept study are promising and will give hope to patients with especially pernicious forms of the disorder and their families. The fact that the procedure was associated in some patients with improvements in affective and obsessional symptoms is of key importance, since such improvements will go some way towards reassuring patients that deep brain stimulation is not just another treatment designed to fatten them up without making them feel better.”

Study suggests lower extremity functional electrical stimulation cycling can promote neurological recovery in chronic spinal cord injury patients

2013-03-05T17:03:00Z

A study from the International Center for Spinal Cord Injury, published ahead-of-print, has found that long-term lower extremity functional electrical stimulation cycling, as part of a rehabilitation regimen, is associated with substantial improvements in individuals with chronic spinal cord injury. Improvements include neurological and functional gains, as well as enhanced physical health demonstrated by decreased fat, increased muscle mass and improved lipid profile. Prior to this study’s publication on 4 March 2013 in the Journal of Spinal Cord Medicine, the benefits of activity-based restorative therapy programmes, such as functional electrical stimulation cycling, were largely anecdotal.

According to a release, small electrical pulses are applied to paralysed muscles to stimulate movement during functional electrical stimulation cycling. In the case of functional electrical stimulation cycling, functional electrical stimulation pulses prompt the legs of an individual with spinal cord injury to cycle on an adapted stationary recumbent bicycle. The repetitive activity offers cardiovascular exercise similar to that which an able-bodied individual achieves through walking, but this new research shows that the results go far beyond basic health benefits.

“Exercise has not been commonly advocated for individuals with paralysis because of the assumption that it is of little benefit and it is challenging to exercise limbs that an individual cannot voluntarily move,” said John W McDonald, senior study author and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute, USA. “However, we found that functional electrical stimulation cycling is a practical form of exercise that provides substantial benefits, including improved physical integrity, enhanced neurological and functional performance, increased muscle size and strength, reduced muscle spasticity and improved quality of life.”

Participants included in the study were 45 individuals diagnosed with chronic spinal cord injury, defined as paralysis continuing more than 16 months following injury. Twenty five patients with chronic spinal cord injury were assigned to the functional electrical stimulation cycling group at the Washington University Spinal Cord Injury Program. These patients were matched by age, gender, injury level/severity and duration of injury to 20 control patients who received no active physical therapy.

On average, patients did functional electrical stimulation cycling for 29.5 months, with an average distance of 10,466 complete cycles of the two pedals per week, the equivalent of taking 20,931 steps. In the retrospective analysis conducted by Kennedy Krieger researchers, improved motor function was observed in 80% of the functional electrical stimulation group, compared to only 45% of control subjects. Clinically important gains in neurological function were also observed in the functional electrical stimulation group such as response in pinprick sensation was observed in 56% of the functional electrical stimulation group compared with 25% of the control group, while 14 of the 25 functional electrical stimulation subjects showed response in light touch scores compared to six of the 20 controls.

Results also showed that functional electrical stimulation cycling enhanced muscle strength without increasing spasticity, a common side effect of paralysis that varies from mild muscle stiffness to severe, uncontrollable leg movements. The functional electrical stimulation group was found to be on fewer anti-spasticity medications with lower doses than the control group, suggesting that the lower level of spasticity observed in the functional electrical stimulation group was not due medication differences between the participants.

Functional electrical stimulation cycling was also associated with improvements in quality of life and correlated with overall improved health. Functional electrical stimulation and control groups showed no significant difference in total thigh volume; however, total thigh fat, measured by MRI, was 44.2% less in the functional electrical stimulation group than in the controls.

According to McDonald, this is a key finding because intramuscular fat is associated with glucose intolerance, a complication affecting nearly two-thirds of individuals with chronic spinal cord injury.

The results of this study support the hypothesis that activity-based rehabilitative strategies can play an important role in promoting physical integrity and functional recovery, even when implemented years after an injury, and provide rationale for a large prospective randomised clinical trial to evaluate the efficacy of activity-based restorative therapies using functional electrical stimulation in persons with chronic spinal cord stimulation.

NeuroDerm phase I study of ND0612 reports positive results for the treatment of Parkinson's disease

2013-03-05T16:36:00Z

NeuroDerm announced on 4 March 2013, the results of a phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson’s disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously subcutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson’s disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson’s disease.

In this double-blind, placebo controlled, dose-escalation trial in young, healthy volunteers, ND0612 was shown to be safe and tolerable in all of the tested doses, according to a press release. Furthermore, clinically meaningful levodopa concentrations were reached and, for the first time in man, steady state levodopa concentrations were maintained in a practical manner both day and night. The full results of this study will be presented at a future scientific meeting.

“ND0612’s success in its first phase I trial means that clinically significant steady state levodopa concentrations can, for the first time, be maintained, both day and night, through a conveniently administered drug. With ND0612, steady state levodopa levels, the elusive holy grail of Parkinson’s levodopa therapy, should be available to all Parkinson’s disease patients. Moreover, as ND0612 bypasses the gastrointestinal tract, steady state levodopa levels should be little influenced by intestinal absorption or oral ingestion of food or drugs. We believe that ND0612 could become a breakthrough treatment option that may establish a new, significantly higher standard of care for Parkinson’s patients.”

About ND0612

According to the company, ND0612 is a proprietary formulation of levodopa and carbidopa administered through a pump patch that enables convenient and steady state levodopa plasma levels. Levodopa and carbidopa (traditionally co-administered with levodopa to prevent its breakdown) are nearly always administered orally and have an unfavourable pharmacokinetic profile due to short half life and low bioavailability. Continuous subcutaneous delivery of levodopa and carbidopa is a novel approach designed to improve their pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations, thereby significantly ameliorating motor fluctuations and non-motor complications in Parkinson’s disease.

Research funded by the ALS Association found gene mutations can cause amyotrophic lateral sclerosis and other brain, muscle and bone diseases

2013-03-05T14:17:00Z

Researchers supported by The ALS Association have discovered how mutations in new amyotrophic lateral sclerosis (ALS) genes cause not only ALS but also other diseases of the brain, muscle and bone, according to a release on 3 March 2013,. The results also shed light on the disease pathways of ALS due to other genes and may set the stage for development of new treatments to interrupt these processes. The study was published in the journal Nature.

ALS, also known as Lou Gehrig’s Disease in the USA, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. There is currently no known cause of the disease.

The research was led by J Paul Taylor, Department of Developmental Neurobiology at St Jude Children’s Research Hospital in Memphis, USA, and colleagues. They received funding through The ALS Association’s TREAT ALS (Translational research advancing therapies) programme.

The researchers discovered that mutations in genes for certain RNA-binding proteins cause them to switch between alternate shapes and aggregate, and to promote the same conformational change and aggregation of the normal protein. This behaviour has been seen in other neurodegenerative diseases, collectively called prion diseases, including mad cow disease and Creutzfeldt-Jakob disease. In those diseases, this ability leads to spread of the disease throughout the nervous system.

“This discovery may lead us to think more broadly about how ALS progresses within the brain and to ask whether a similar spreading process is occurring,” said Lucie Bruijn, chief scientist for The ALS Association.

The researchers also found that mutations in proteins called heterogeneous ribonuclear proteins (hnRNPs) caused an inherited disease in a small number of families with symptoms of ALS, the frontotemporal dementia, the muscle disease inclusion body myopathy, and the bone disorder Paget’s disease of bone. This cluster of symptoms, according to the study, has recently been recognised as a unique disorder called multisystem proteinopathy. The mutations increased the tendency of the hnRNP proteins to clump together and to induce non-mutated forms of the protein to do so as well. hnRNP proteins normally link to another ALS-associated protein called TDP-43, and the two were found together in the aggregates.

“While these mutations are themselves a very rare cause of ALS, they may provide an important clue about how other forms of ALS spread over time,” Bruijn said. “Preventing protein aggregation may be a viable therapeutic approach for many forms of ALS.”

Advice from NICE aims to improve commissioning of care for people with epilepsy

2013-02-28T12:03:00Z

The National Institute for Health and Clinical Excellence (NICE) on the 28 February 2013 issued an updated guide for commissioners to support the integrated commissioning of high-quality, evidence-based services for the diagnosis and management of the epilepsies in adults, children and young people. The guide focuses on improving the diagnosis of epilepsy and ensuring that diagnosis and treatment are both confirmed and reviewed as necessary.

The guide also focuses on tailoring treatment to individual circumstances and the needs of people with epilepsy so that they are offered the most suitable treatment. The guide, according to a release, will help commissioners towards achieving the outcomes set out in the NHS, Public Health and Adult Social Care Outcomes Frameworks, as well as achieving improvement areas in the Clinical Commissioning Group outcomes indicator set.

Illustrated throughout with service model example from across the spectrum of epilepsy services, the guide highlights the benefits of adhering to the NICE quality standards for the epilepsies in adults and the epilepsies in children and young people in terms of appropriate and urgent referral for people with suspected epilepsy, prompt access to diagnostic investigations, including the use of magnetic resonance imaging (MRI), and the importance of review and re-access to appropriate care for people with epilepsy.

The guide recommends that commissioners should consider commissioning services for the diagnosis and management of the epilepsies in adults, children and young people in several different ways, working with a range of partners and stakeholders, including clinical commissioning groups, health and wellbeing boards, social care organisations and regional epilepsy networks to ensure strategic and integrated service planning. Commissioners will also need to work with primary, secondary and tertiary care, ambulance trusts, third sector organisations and employment agencies, as well as service-users and carers, when planning services for people with epilepsy. This will ensure that people receive the recommended level of high-quality care and relevant information to reduce misdiagnosis rates, epilepsy-related deaths and avoidable emergency hospital admissions.

The guide also includes two commissioning and budgeting tools to help users determine the level of service that might be needed locally and to help calculate the cost of commissioning care for adults and children and young people with epilepsy using indicative benchmarks and/or their own local data.

J Helen Cross, The Prince of Wales’s chair of Childhood Epilepsy and honorary consultant in Paediatric Neurology, UCL-Institute of Child Health, Great Ormond Street Hospital for Children, London and Young Epilepsy, UK, said: “This guide for commissioners recognises the importance of placing people with epilepsy, their family and carers firmly at the centre of care. In doing so the guide focuses on areas of real concern to people with epilepsy such as accurate and timely diagnosis, appropriate communication, the need for regular and structured reviews and transition from children’s services to adult services. It highlights the need for commissioners to ensure that a structured, multi-dimensional, multi-agency care pathway is in place to provide optimal management of all individuals with a suspected or confirmed diagnosis of epilepsy.”

While the guide for commissioners draws on existing NICE recommendations and the NICE quality standards on the epilepsies in adults and the epilepsies in children and young people, it does not constitute formal NICE guidance and is intended as a tool to help the NHS improve patient care through effective commissioning.

In addition to the guide for commissioners, NICE has also published summarised support for commissioners to accompany the NICE quality standards on the epilepsies in adults and the epilepsies in children and young people which have also been published.

FDA Advisory Panel recommends the approval of the NeuroPace RNS System for medically refractory epilepsy

2013-02-28T11:34:00Z

NeuroPace announced that on February 22, 2013 the US Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh the risks of its use. NeuroPace is seeking approval for the RNS System for treating adults with partial onset seizures that have not been controlled with two or more antiepileptic medications. The final decision regarding approval of the device is made by the FDA.

“We have worked for over 15 years to develop and clinically evaluate the RNS System. We are very excited that patients and physicians who need new treatment options so desperately are now likely to have the RNS System commercially available in the near future,” said Frank Fischer, CEO of NeuroPace.

The RNS System has been evaluated in three clinical trials, including the prospective, randomised, double blinded, sham-stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in the treatment group compared to a 17.3% reduction in the sham-stimulation control group during a three month blinded evaluation period. This difference was statistically significant (p=0.012). Long-term results demonstrated sustained improvements in seizure frequency with median seizure frequency reductions of 44% and 53% at one and two years post-implant, respectively.

“There is strong clinical evidence that this new therapy offers substantial benefits to a significant population of people with medically refractory partial onset seizures,” said Martha Morrell, NeuroPace chief medical officer and clinical professor of Neurology at Stanford University, USA. “We look forward to working closely with the FDA to finalise both the labelling and the post-approval study commitments so that this technology can become available to patients as quickly as possible.”

The FDA accepted the company’s Premarket Approval (PMA) application in November 2010 based on data from the pivotal study. A total of 256 patients have been implanted with the RNS System, and more than 1,200 patient years of experience with responsive stimulation have been accumulated to date, according to the company.

About the RNS System

The RNS System is the first closed-loop responsive brain stimulation system designed to treat partial onset seizures. The system detects abnormal electrical activity in the brain through leads containing electrodes that are placed at the patient’s seizure focus. When detection thresholds are met, the device delivers small bursts of electrical stimulation to suppress the abnormal activity before any seizure symptoms occur. Physicians can program the detection and stimulation parameters of the implanted RNS Neurostimulator non-invasively to customise therapy for individual patients.

New quality standards for the epilepsies in adults, young people and children has been published by NICE

2013-02-27T16:46:00Z

The new quality standards on epilepsy, announced by NICE on 27 February 2013, consist of a prioritised set of specific, concise and measurable statements that, when delivered collectively, should contribute to improving the effectiveness, quality, safety and experience of care for people with the condition.

The quality standard for the epilepsies in children and young people contains nine statements. These include:

• Children and young people presenting with a suspected seizure are seen by a specialist in the diagnosis and management of the epilepsies within two weeks of presentation.
• Children and young people with a history of prolonged or repeated seizures have an agreed written emergency care plan.

The quality standard for the epilepsies in adults also contains nine statements, including:

• Adults having initial investigations for epilepsy undergo the tests within four weeks of them being requested.
• Adults with epilepsy are seen by an epilepsy specialist nurse who they can contact between scheduled reviews.

“The nature of epilepsy means that it can be difficult to diagnose accurately. Therefore, a key part of these new quality standards is focused on improving this, and ensuring that diagnosis and treatment are confirmed and reviewed as necessary,” said Gillian Leng, deputy chief executive and director of Health and Social Care at NICE. “I am sure these quality standards will be useful aids to all those involved in the care and treatment of this serious neurological condition.”

Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “We are really pleased that quality standards for epilepsy have been produced. We know from a recent studywe carried out that many people with epilepsy are not getting the care they should. If the new standards are implemented consistently and effectively, care for people with epilepsy will be vastly improved.”

“Epilepsy Society welcomes these quality standards which recognise the importance of getting a correct diagnosis, optimum treatment and the role of the epilepsy specialist nurse in patient care,” said Amanda Cleaver, Communications and Campaigns manager at the Epilepsy Society.

The new quality of standard to the epilepsies in adults is available on the NICE website www.guidance.nice.org.uk/QS26

The quality of standard for children and young people is also on the NICE website www.guidance.nice.org.uk/QS27

UK’s NICE publishes final guidance recommending apixaban to prevent stroke in non-valvular atrial fibrillation patients

2013-02-27T16:42:00Z

On 27 February, the UK’s National Institute for Health and Clinical Excellence (NICE) released final guidance recommending apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) as an option for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation.

The guidance also recommends that the decision about whether to start treatment with apixaban should be made after an informed discussion about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate and rivaroxaban, and in light of a person’s current level of international normalised ratio (INR) control if they are already taking warfarin.

Apixaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with with non-valvular atrial fibrillation and one or more risk factors such as prior stroke or transient ischaemic attack, age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure (New York Heart Association [NYHA] class 2 or higher).

The final guidance is available here.

High-frequency spinal cord stimulation appears to be efficacious in chronic back pain patients

2013-02-26T09:42:00Z

A study, published ahead-of-print in Neuromodulation, and led by Jean-Pierre Van Buyten, AZ Nikolaas, St Niklaas, Belgium, has examined the use of high-frequency spinal cord stimulation for the treatment of chronic back pain patients or patients with failed back surgery syndrome.

The trial was a prospective, open-label, multicentre European trial and the authors aimed to assess the Senza rechargeable spinal cord stimulation system (Nevro), which is capable of delivering stimulation pulse rates up to 10kHz without producing paraesthesia.

The authors, therefore, enrolled patients who fulfilled the criteria: 18 years or over at times of enrolment, primary diagnosis of chronic back pain with or without leg pain (intensity 5 out of 10 over the last 30 days on the visual analogue scale), previous failed response to six months of conventional treatment, and able to comply with the follow-up requirements of the study.

“Between August 2009 and February 2011, a total of 83 patients were enrolled and entered the trial phase of the study, with one patient withdrawing from the study during this phase,” said van Buyten and colleagues. “Of the 82 patients who completed the trial [phase], 88% (72 patients) had a successful trial and, consequently, underwent permanent implant.”

The patients underwent a baseline evaluation and at 30 days they were implanted with either a percutaneous trial (UK) or tunnelled trial (Belgium). At the end of the trial phase period, according to Van Buyten et al, only those patients with a successful outcome (50% reduction in pain intensity and ability to cope with the spinal cord stimulation requirements) were included in the second part of the study and were implanted with a permanent pulse generator.

The authors reported that in the patients implanted pulse generator, the device was then connected to the leads and implanted subcutaneously. After permanent implantation the patients were followed up at one, three and six months. “At six months, the reported visual analogue scale for back pain was 2.7 compared with 8.4 at baseline, a 78% median reduction. Visual analogue scores corresponding to leg pain also decrease from 5.4 at baseline to 1.4 at six months yielding an 83% median decrease,” they said.

“The reduction in back pain is statistically significant (p=0.001). Seventy four per cent of patients had greater than 50% pain relief and 47% of the patients had greater than 80% pain relief,” they added.

The Owestry Disability Index (ODI) and sleep disturbances were reported at six months to be significantly lower compared to baseline. Van Buyten and colleagues said that ODI values decreased from 55 at baseline down to 37 (p=0.001). They added that 57% patients had an improvement of 14 points or more, and mean sleep disturbances decreased from 3.7 at baseline to 1.3 at six months.

In the study, it was also reported that, previous to implantation, there was widespread use of opioids but this was reduced in 62% of patients at implantation and, at follow-up, a further 38% discontinued use.

“Eighty five per cent of patients were satisfied or very satisfied with the high-frequency spinal cord stimulation system, and 85% of them would recommend or highly recommend it to others with similar pain,” said van Buyten et al.

In all patients (83) who underwent trial and/or implantation 51 adverse effects were reported in 38 patients. According to the authors, the most commonly occurring adverse effects were pocket pain (31%), and lead migration (22%) and, because of these events, 13 patients underwent re-intervention.

“The results from this clinical study demonstrated that patients with chronic, intractable back and leg pain had significant pain relief after six months with the high-frequent spinal cord stimulation system,” concluded van Buyten and others. “The high-frequency spinal cord stimulation system appears to be efficacious in many back pain patients that fail to benefit from conventional stimulation.”

NIH-funded study confirms consistently good acute stroke outcomes with Penumbra System

2013-02-25T11:20:00Z

On 13 February 2013 Joseph Broderick University of Cincinnati, USA, and principle investigator of the Interventional Management of Stroke III (IMS III) trial, announced the overall results and major subgroup analyses at the International Stroke Conference in Honolulu, Hawaii. Thomas Tomsick, principle investigator and primary interventional investigator announced results comparing outcomes by intra-arterial approach.

The IMS III trial was a prospective, randomised trial comparing two different treatment approaches—combined intravenous and intra-arterial therapy, and standard intravenous r-tissue plasminogen activator (r-tPA)—to restore blood flow to the brain. The primary goal was to determine if individuals with ischaemic stroke treated using a combined intravenous and intra-arterial approach to recanalisation started within three hours of onset are more likely to have a better outcome than individuals treated with standard intravenous r-tPA alone. IMS III began enrolling in 2006.

In the device-based intra-arterial intervention subset, The Penumbra Aspiration Thrombectomy System showed 84.6% TICI 2-3 revascularisation of ICA and/or M1 occlusions vs. 72.8% for the Retriever category overall (72.7% for the Merci Retriever and 75% for the Solitaire Stent Retriever). Penumbra Aspiration Thrombectomy also achieved 33.3% of patients living independently with a good clinical outcome vs. 23.5% for the Retriever category overall (23.4% for the Merci Retriever and 25% for the Solitaire Stent Retriever.) The study showed that the proportion of good clinical outcomes increased with greater reperfusion rates.

The safety record of the Penumbra System also fared very well when compared to the Retriever category devices. Mortality among patients with ICA and/or M1 occlusions treated with the Penumbra System was very low at 17.9% vs. 33.3% for Retrievers (33.8% for the Merci Retriever and 25% for the Solitaire Stent Retriever). Embolization to New Territory (ENT) when using the Penumbra System occurred only 3.7% of the time vs. 23.0% of the time when Retrievers were used in any treated vessel (22.1% for the Merci Retriever and 40% for the Solitaire Stent Retriever.) The study demonstrated that a stroke patient’s chance of achieving functional independence was very poor when ENT occurred. Without ENT, 30.2% of patients made a good recovery. When ENT occurred, only 17.9% of patients made a good recovery.

IMS III subgroup comparisons by intra-arterial approach
ICA and/or M1 occlusions	Penumbra System (n=39)	Retrievers Overall (n=81)
Efficacy endpoints
Revascularization (TICI 2-3)	84.6%	72.8%	Merci: 72.7% Solitaire: 75%
Functional independence (mRS <= 2 at 90 days)	33.3%	23.5%	Merci: 23.4% Solitaire: 25%
Safety endpoints
Mortality	17.9%	33.3%	Merci: 33.8% Solitaire: 25%
Embolization to New Territory (ENT) per Core Lab (all treated vessels)	3.7% (n=54)	23.0% (n=100)	Merci: 22.1% Solitaire: 40%

“I am not surprised that the Penumbra System data is better than the other interventional techniques in the IMS III trial,” said Blaise Baxter, director of Interventional Services at Erlanger Hospital in Chattanooga, Tennessee, USA. “The newest devices in the Penumbra System armamentarium, like the 5MAX Reperfusion Catheter, allow us to stay at the site of occlusion using direct aspiration to make sure we remove all of the clot and prevent any embolization to otherwise unaffected territories.”

J Mocco, associate professor of Neurological Surgery, Vanderbilt University Medical Center in Nashville, Tennessee, USA, and principle investigator for the prospective, randomised THERAPY trial of acute stroke intervention said, “The IMS III trial did not use an imaging-based patient selection criteria to screen patients for enrolment. In fact, over 20% of patients enrolled in the intra-arterial arm of IMS III did not even receive intra-arterial therapy. The vast majority of these were because the patient was deemed to have no significant brain artery blockage.”

“Moving forward it is critically important to identify those patients that have a high potential for benefit from intra-arterial intervention, meaning those with a treatable brain occlusion, as well as those hypothesised to have a low likelihood of improving with intravenous tPA alone. The THERAPY trial uses a very easy to implement clot length criteria which we believe will identify exactly this patient group. The ease of determining clot length, and its ability to define a large treatment effect for endovascular therapy, has now been shown in two large trials, one out of Germany, and another recently presented by Albert Yoo et al from Massachusetts General Hospital, USA, here at the International Stroke Conference,” Mocco continued.

“A growing consensus among top stroke hospitals was achieved during a packed meeting at the International Stroke Conference. This consensus points toward a trial design that includes both appropriate imaging-based screening criteria, and the use of the most modern and advanced technologies including Direct Aspiration, and clot capture devices like the Penumbra 3D. THERAPY’s design, and its inclusion of the latest technologies, is strongly supported by data from large, NIH-funded studies such as IMS III and MR Rescue. We owe a huge debt to the work of those pioneering investigators in helping to point the way forward,” concluded Mocco.

InSightec's ExAblate Neuro receives the FDA approval for its pivotal phase III trial for essential tremor

2013-02-22T17:27:00Z

InSightec announced on 19 February 2013 that it has received FDA approval to begin its pivotal phase III clinical trial for treatment of essential tremor using ExAblate Neuro. This trial is intended to provide the safety and effectiveness data about the use of ExAblate Neuro in order to support Food and Drug Administration (FDA) pre-marketing approval, according to a company release.

ExAblate Neuro uses MR guided focused ultrasound therapy to provide an incision-less treatment, through the intact skull, with no ionising radiation. ExAblate MR guided focused ultrasound (MRgFUS) uses high intensity ultrasound waves to destroy target tissue in the brain while the patient lies in an MRI, which provides continuous visualisation, plan, guidance, monitoring, and control of the treatment.

The phase III study will be a multicentre, double blinded, randomised control trial, with one year follow-up. Patients who enrol in the trial will be randomised to either ExAblate treatment or no treatment. The first patients are expected to be enrolled in mid 2013.

“We are very excited about the beginning of this pivotal trial for the ExAblate Neuro,” said Jim Davis, CEO of InSightec. “It offers the hope of improved quality of life for people suffering with essential tremor. Results from the early studies showed that patients experienced immediate and durable symptom improvement.”

The trial is based on the safety and initial effectiveness results from 15 patients treated in FDA feasibility trial sponsored by the Focused Ultrasound Foundation.

“The feasibility study results were highly encouraging. They validated the potential of focused ultrasound to treat essential tremor patients for whom currently available medications do not work and surgery is not an option,” said Neal Kassell, founder and chairman of Focused Ultrasound Foundation. “If the pivotal trial confirms early results, it could lead to the availability of a new, non invasive treatment option.”

In December 2012 ExAblate Neuro was granted the CE mark for essential tremor, tremor dominant Parkinson’s disease, and neuropathic pain.

ElectroCore receives Australian and Colombian regulatory approval for GammaCore Vagal Nerve Stimulation Therapy

2013-02-22T16:34:00Z

On 19 February 2013, ElectroCore, a company developing effective, non-invasive Vagal Nerve Stimulation therapies for medical conditions including primary headaches, announced that its GammaCore therapy has been approved for commercial sale by the Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia. GammaCore’s non-invasive, non-pharmaceutical, neuromodulation therapy is indicated for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and Hemicrania Continua) and medication overuse headache in adults.

GammaCore is currently available to patients in Australia who are under the care of a physician and can be ordered through ElectroCore Australia. ElectroCore plans to make the device available in Colombia in the first half of 2013.

“These approvals represent significant additional regulatory validation of the GammaCore technology as a safe and effective therapy,” said J P Errico, CEO of ElectroCore. “These approvals are great news for patients in Australia and Colombia who suffer from primary headache, as they provide another non-invasive treatment option.”

ElectroCore recently received US Food and Drug Administration (FDA) approval to begin its pivotal study of GammaCore as an acute treatment for cluster headaches. This trial, expected to begin enrolment during the first quarter of 2013, will study the acute benefits of treatment of cluster headache events in 150 subjects at fifteen sites across the USA. Based on the results of the study, ElectroCore intends to submit a Pre Market Approval (PMA) for FDA approval of GammaCore for the acute treatment of cluster headaches. GammaCore is not currently available for sale in the USA.

In January, the company announced that initial enrolment had begun for its FDA-approved chronic migraine prevention study using GammaCore. The randomised, sham-controlled study is enroling patients at seven sites across the USA. The study, which is expected to offer an initial read out during the first half of this year, will include 60 patients who suffer with migraine more than fifteen days per month.

About GammaCore

GammaCore is a non-invasive, vagus nerve stimulator that produces a mild electrical signal which is transmitted to the vagus nerve through the skin. GammaCore is currently available in the European Union, Canada, South Africa, India, New Zealand, and Malaysia. In Canada, GammaCore is indicated to treat cluster headache only.

Massachusetts General Hospital launches the Institute for Heart, Vascular and Stroke Care

2013-02-22T10:50:00Z

On 21 February, the Massachusetts General Hospital, Boston, USA, announced the launch of the Mass General Institute for Heart, Vascular and Stroke Care.

According to a Massachussetts General Hospital press release this is one of the only institutes in the world to integrate cardiovascular and cerebrovascular care.

The Mass General Institute for Heart, Vascular and Stroke Care delivers leading research and comprehensive clinical care to advance the diagnosis and treatment of cardiovascular and cerebrovascular disease. By matching each patient with the right specialist working in a multidisciplinary team, the Mass General Institute for Heart, Vascular and Stroke Care pioneers a patient- and disease-focused care model.

“Through the Institute we will continue to advance and improve the field of medicine with a cross-disciplinary team and an integrated approach to research and quality patient care,” said Michael R Jaff, chair, Institute for Heart, Vascular and Stroke Care and medical director, Mass General Vascular Center. “Unlike others before us, the Institute integrates cerebrovascular and cardiovascular care, with the goal of discovering the medicine of tomorrow and improving patient outcomes. We intend to arm medical practitioners from around the world with the latest research and tools to make positive changes in the diagnosis, treatment and care of patients.”

The Mass General Institute for Heart, Vascular and Stroke Care is built on four key pillars that include a fully integrated, personalised clinical care model, broad educational initiatives, quality and public policy advocacy leadership and robust funding programmess in clinical and translational research.

Institute leadership includes:

Michael R Jaff, chair, Institute for Heart, Vascular and Stroke Care and medical director, Vascular Center
G William Dec, co-director, Corrigan Minehan Heart Center and chief, Cardiology Division
Thoralf M Sundt, co-director, Corrigan Minehan Heart Center and chief, Cardiac Surgery
Lee H Schwamm, vice chairman, Department of Neurology and director, MGH TeleStroke & Acute Stroke Services
Kevin Whitney, associate chief nurse
Ann L. Prestipino, senior vice president, Massachusetts General Hospital

Stathis Antoniades, senior administrative director, Cardiology
Lauren Ellis, managing director, Institute for Heart, Vascular and Stroke Care and Vascular Center

The Mass General Institute for Heart, Vascular and Stroke Care has established SPARK grants to further deliver innovation and yield critical medical breakthroughs with direct funding of clinical and translational research projects. The SPARK grants are funded through a generous philanthropic gift allowing the Institute to directly support the interdisciplinary projects of young and mid-career physician-scientists while bringing ground-breaking science and discovery to the forefront of the medical community.

The Mass General Institute for Heart, Vascular and Stroke Care will host an Independent Certified Continuing Medical Education (CME) Session at ACC.13 on Friday, 8 March from 5.00–8.00 pm. Registration is now open for the session, titled “Novel therapeutic strategies for systemic cardiovascular disease: an integrated approach to treating heart failure and valve disease, vascular disease and stroke.

The course aims to:

Implement new strategies for the treatment of valvular heart disease

Describe the options for the latest therapies in atrial fibrillation and choose the appropriate therapy for an individual patient

Evaluate the role of coordinated care for the management of massive and submassive pulmonary embolism

Review current approaches in the treatment of thoracic aortic disease

Click here to learn more about the course and register for the session.

Cooling the brain may prevent trauma-induced epilepsy

2013-02-21T17:22:00Z

A new study in rats suggests that gently cooling the brain after injury may prevent patients often experience epileptic seizures that are difficult to control in weeks, months and years after severe head injury. The researchers reported their findings in Annals of Neurology.

“Traumatic head injury is the leading cause of acquired epilepsy in young adults, and in many cases the seizures can not be controlled with medication,” said Matthew Smyth, lead author of the study and associate professor of neurological surgery and of paediatrics at Washington University School of Medicine in St Louis, USA. “If we can confirm cooling’s effectiveness in human trials, this approach may give us a safe and relatively simple way to prevent epilepsy in these patients.”

Smyth has been exploring the possibility of using cooling to prevent seizures or reduce their severity. “Warmer brain cells seem to be more electrically active, and that may increase the likelihood of abnormal electrical discharges that can coalesce to form a seizure,” he said. “Cooling should have the opposite effect.”

Smyth and colleagues at the University of Washington and the University of Minnesota, USA, tested potential therapies in a rat model of brain injury. These rats develop chronic seizures weeks after the injury. Researchers devised a headset that cools the rat brain. They were originally testing its ability to stop seizures when they noticed that cooling seemed to be not only stopping but also preventing seizures.

Scientists redesigned the study to focus on prevention. Under the new protocols, they put headsets on some of the rats that cooled their brains by less than four degrees Fahrenheit. Another group of rats wore headsets that did nothing. Scientists who were unaware of which rats they were observing monitored them for seizures during treatment and after the headsets were removed.

Rats that wore the inactive headset had progressively longer and more severe seizures weeks after the injury, but rats whose brains had been cooled only experienced a few very brief seizures as long as four months after injury.

Brain injury also tends to reduce cell activity at the site of the trauma, but the cooling headsets restored the normal activity levels of these cells.

The study is the first to reduce injury-related seizures without drugs, according to Smyth.

“Our results show that the brain changes that cause this type of epilepsy happen in the days and weeks after injury, not at the moment of injury or when the symptoms of epilepsy begin,” he said. “If clinical trials confirm that cooling has similar effects in humans, it could change the way we treat patients with head injuries, and for the first time reduce the chance of developing epilepsy after brain injury.”

Smyth and colleagues have been testing cooling devices in humans in the operating room, and are planning a multi-institutional trial of an implanted focal brain cooling device to evaluate the efficacy of cooling on established seizures.

Study shows continued improvement in patients’ neuropathic pain scores after deep brain stimulation

2013-02-21T15:49:00Z

According to a study by Sandra G J Boccard, University of Oxford, Oxford, UK and colleagues, and published in Neurosurgery, deep brain stimulation patients with difficult-to-treat neuropathic pain can lead to long-term improvement in pain scores and other outcomes.

In the study it was demonstrated how some outcomes show continued improvement after the first year, which is one of the largest studies of deep brain stimulation for neuropathic pain performed to date.

The authors reviewed their 12-year experience with deep brain stimulation for neuropathic pain. Although deep brain stimulation has also been used to treat various types of chronic pain, its role in patients with neuropathic pain remains unclear.

Between 1999 and 2011, that authors’ programme evaluated 197 patients with chronic neuropathic pain for eligibility for deep brain stimulation. Of these, 85 patients proceeded to treatment. The patients who underwent deep brain stimulation were 60 men and 25 women, (average age 52 years). Stroke was the most common cause of neuropathic pain, followed by head and face pain, spinal disease, amputation, and injury to nerves from the brachial plexus.

In 74 patients, a trial of deep brain stimulation produced sufficient pain relief to proceed with implantation of an electrical pulse generator. Of 59 patients with sufficient follow-up data, 39 had significant improvement in their overall health status up to four years later. Thus, 66% of patients “gained benefit and efficacy” by undergoing deep brain stimulation, according to Boccard et al.

The benefits of deep brain stimulation varied for patients with different causes of neuropathic pain. Treatment was beneficial for 89% for patients with amputation and 70% of those with stroke, compared to 50% of those with brachial plexus injury.

On average, scores on a 10-point pain scale (with 10 indicating the most severe pain) decreased from about 8 to 4 within the first three months, remaining about the same with longer follow-up. Continued follow-up in a small number of patients suggested further improvement in other outcomes, including quality-of-life scores.

According to the authors, deep brain stimulation has been regarded as potentially useful for patients with severe neuropathic pain that is not relieved by other treatments. However, because of the difficulties of performing studies of this highly specialised treatment, there has been relatively little research to confirm its benefits; only about 1,500 patients have been treated worldwide. The new study—accounting for about 5% of all reported patients—used up-to-date deep brain stimulation technologies, imaging, and surgical techniques.

Boccard and others acknowledged the limitations of their study—especially the lack of complete patient follow-up. However, they said their experience is sufficiently encouraging to warrant additional studies, especially with continued advances in stimulation approaches and technology. They concluded: “Clinical trials retaining patients in long-term follow-up are desirable to confirm findings from prospectively assessed case series.”

Fukuda Denshi to distribute Boston Scientific Neuromodulation devices in Japan

2013-02-21T12:09:00Z

Boston Scientific Japan, on 20 February 2013, reached an agreement with Fukuda Denshi to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout. Fukuda Denshi will begin distributing Boston Scientific Neuromodulation products on 1 April 2013.

Boston Scientific is developer of Neuromodulation devices used to manage chronic neuropathic pain. The Boston Scientific Spinal Cord Precision Plus System is the only device on the market, according to a company release, with 16 dedicated, independent current sources designed to precisely target patient pain and the only device to offer patients wireless charging and wireless remote control to treat their pain. The remote controller is designed for patient ease of use due to its small size.

“We are pleased to reach this agreement with Fukuda Denshi to distribute our Neuromodulation products in Japan,” said Yusuke Naiki, president, Boston Scientific Japan. “Fukuda Denshi has been an established player in Japan for more than 70 years, with a proven track record and a long and successful history of delivering results. We look forward to a successful relationship.”

According to the company, currently, more than 60,000 patients worldwide are using the Precision Plus System.

New research indicates use of Medtronic deep brain stimulation therapy is beneficial earlier in the progression of Parkinson’s disease

2013-02-21T11:44:00Z

Results from a clinical study published 14 January 2013 in The New England Journal of Medicine show that use of Medtronic deep brain stimulation therapy provides superior benefits for patients with early motor complications from Parkinson’s disease when compared with best medical treatment only, according to a company release.

The large, multicentre, randomised, controlled trial to evaluate Parkinson’s patients with early motor complications showed patients treated with deep brain stimulation therapy and best medical treatment reported a mean improvement of 26% in their disease-related quality of life at two years (p=0.002), compared with no improvements in patients treated with best medical therapy alone. The clinical trial included 251 people with Parkinson’s disease at 17 centres in Germany and France and followed them over the course of two years.

Additional key EARLYSTIM study findings at two years include:

A 53% improvement in motor skills (in an off-medication condition) in patients treated with Medtronic deep brain stimulation therapy, compared to no change in those receiving best medical therapy only (p<0.001).
A 30% improvement in various activities of daily life, including speech, handwriting, dressing and walking, in participants with Medtronic deep brains stimulation therapy while in the worst condition (“off time”), compared to a 12% decline in those receiving best medical therapy only (p<0.001).

A 61% improvement in levodopa-induced complications, including dyskinesias and motor fluctuations, in participants receiving Medtronic deep brain stimulation therapy at two years, compared to a 13% worsening in those only receiving best medical therapy (p <0.001).
A 39% reduction in daily levodopa equivalent dosage in the Medtronic deep brain stimulation therapy group, versus a 21% increase in dosage in participants receiving best medical therapy alone (p<0.001).

“These results signal a shift in the way patients with Parkinson’s disease can be treated, and prove that deep brain stimulation therapy can improve patients’ quality of life even in the earlier stages of Parkinson’s disease, when fluctuations and dyskinesia just start and clinicians traditionally rely solely on drugs,” said Günther Deuschl, professor of Neurology at Christian-Albrechts-University in Kiel, Germany, and lead investigator of the EARLYSTIM study for Germany.

“These results can allow clinicians to feel confident using deep brain stimulation therapy earlier in the progression of the disease for patients meeting the appropriate selection criteria,” said Yves Agid, professor of Neurology, Pitié-Salpêtrière University Hospital in Paris, France, and lead investigator of the EARLYSTIM study for France.

According to the company release, currently, deep brain stimulation therapy is primarily used to treat Parkinson’s patients in the advanced stages of Parkinson’s disease with disabling levodopa-induced motor complications which can no longer be treated successfully with medication alone. EARLYSTIM trial participants on average had been experiencing symptoms of Parkinson’s disease with mean disease duration of 7.5 years, roughly five years less than participants in earlier trials, allowing researchers to test the benefits of deep brain stimulation therapy when motor fluctuations and dyskinesia are of recent onset and occupational and psychosocial competence is still maintained. The enrolled patient population was also at an earlier stage of the disease as evaluated by disability staging criteria of the Hoehn & Yahr scale, which is a commonly used system for describing how the symptoms of Parkinson’s disease progress.

“This is an exciting new development in the management of Parkinson’s disease. This study shows that it is not only safe to treat Parkinson’s patients at an earlier stage with deep brain stimulation, but also that patients receive therapeutic benefits over best medical management. In other words, this expands the range of the therapeutic window during which patients can benefit from deep brain stimulation,” said Lothar Krinke, vice president and general manager of the global deep brain stimulation business in Medtronic’s Neuromodulation division.

The clinical trial’s primary safety parameters, such as psychological well-being and memory, and the overall incidence of adverse events did not differ significantly between the two treatment groups. Compared to best medical therapy, there were more patients in the neurostimulation group with serious adverse events. This safety profile is similar in type and frequency to current Medtronic deep brain stimulation therapy for Parkinson’s disease.

University of Tsukuba Hospital neurosurgeons perform initial cases using recently installed VISIUS Surgical Theatre with iMRI

2013-02-14T09:58:00Z

On 13 February 2013, IMRIS announced neurosurgeons at University of Tsukuba Hospital in Ibaraki, Japan, performed initial tumour removal cases using its VISIUS Surgical Theatre. The intraoperative MRI system is the only one of its kind in Japan that allows for high quality image scanning during an operation without moving the patient, according to a company release.

“We hope these first cases are examples of the improved neurosurgical outcomes we expect with our ability to scan during the procedure using the VISIUS iMRI system,” said Akira Matsumura, one of two neurosurgeons conducting the initial cases.

The VISIUS Surgical Theatre at University of Tsukuba Hospital provides a surgical environment that enhances the surgeon’s vision at critical times in the procedure and facilitates decision making and precision through image guidance technology. The theatre includes both an advanced operating room with iMRI for neurosurgery and an adjoining room for diagnostic imaging. A high-field 1.5 Tesla MR scanner moves on-demand on ceiling-mounted rails from the diagnostic room into the OR to provide intraoperative images of diagnostic quality—without introducing patient risk that would come from moving the patient. It is intended that the surgical theatre delivers real-time information while preserving optimal surgical access and techniques.

Using iMRI, the surgical team can assess if all of a tumor is removed before completing the procedure. During the Tsukuba first case, which was a low-grade glioma, an intraoperative scan found a small amount of tumour remained that was then completely removed and confirmed with a final scan. The second case was a transsphenoidal sella tumour and iMRI confirmed that initial resection was complete. Studies show that improved patient outcomes are associated with complete tumour resection.

Designed to meet each hospital’s specific clinical application needs, VISIUS Surgical Theatres can be configured to incorporate MR, CT imaging or X-ray angiography, providing true intraoperative imaging for open surgical applications with no patient transport. The breadth of open surgical applications and catheter-based treatments in IMRIS suites creates opportunities for multiple departments to collaborate on its investment and to optimise its utilisation.

Penumbra launches 5MAX DDC and 4MAX DDC Distal Delivery Catheters

2013-02-14T09:39:00Z

On 4 February 2013, at the 3rd Society of NeuroInterventional Surgery (SNIS) International Endovascular Stroke Conference and Joint Cerebrovascular Section Annual Meeting (4–5 February 2013, Honolulu, Hawaii), the Penumbra 5MAX DDC and 4MAX DDC distal delivery catheters were launched.

The new devices, according to a company release, are designed to simplify delivery of a wide variety of endovascular therapies to the brain. The DDC family delivers distal delivery capability via a novel advanced polymer and Nitinol coil reinforcement design at the distal tip to enable easy tracking through tortuous vessels. All DDC catheters have large tapered lumens, which are compatible with most microcatheter-delivered neuro endovascular therapies today. The DDC exclusive tapered lumen design enables higher contrast flow and better visualisation while maintaining the flexibility to help physicians deliver therapies more efficiently.

“The support provided by the 4MAX DDC helped stabilise the tip of my coil delivery catheter enabling significantly more control over coil loops as I delivered and positioned them in a very challenging aneurysm,” said John M Whapham, medical director of Stroke and Endovascular Neurosurgery at Mercy St Vincent’s Medical Center in Toledo, Ohio, USA, who performed one of the first DDC cases in the United States. “The new 4MAX DDC design tracked significantly more smoothly than currently available intermediate catheters and thus may help reduce vessel trauma. Further, it provides the first practical delivery technology which combines guide catheter-like support proximally, with microcatheter-like properties as it is navigated more distally.”

Whapham added: “The DDC family will be my go-to catheter for a wide variety of patients and therapies due to the ability to bring a stable catheter construct to even the most distal anatomy.”

A novel balloon technique is safe during endovascular intervention for vertebral artery thrombus to prevent embolization

2013-02-13T09:33:00Z

A case report by Vikram Huded, Narayana Institute of Neurosciences, Bangalore, India, and published online in BMJ Case Reports, has suggested that, if medical management fails, after identification of a thrombus in the vertebral artery, then endovascular intervention—the crossover balloon technique—is safe.

Huded and colleagues said that currently there are “no clear guidelines for endovascular treatment if a patient fails medical management.” Therefore the authors reported on a novel technique used to prevent embolization of vertebral thrombus during endovascular intervention.

The novel technique was undertaken after the patient, National Institutes of Health Stroke Scale (NIHSS) score of four increased to five (and increase in the infarct in the cerebellum and brainstem) and failed medical mangament. The authors reported that the patient, CT angiography “showed a right sided V2 segment narrowing with a floating thrombus distal to it. The rest of the vertebrobasilar circulation was normal. He also had a high-grade stenosis of the left internal carotid artery.”

Huded et al, in order to avoid embolization of the clot to the basilar artery, employed the crossover balloon technique for endovascular clot retrieval.

Crossover balloon technique

The authors accessed the bilateral femoral artery using a 6F sheath and a 6F guiding catheter was introduced into the right vertebral artery, which was followed by another 6F guiding catheter into the left vertebral artery.

Huded et al said: “A 5x15mm Hyperglide balloon (ev3) was negotiated from the left vertebral artery to the right vertebral artery and placed distal to thrombus via the verterbrobasilar junction. The balloon was inflated there by occluding the right vertebral artery distal to the thrombus, thus preventing the thrombus from embolizing into the basilar artery.”

“Mechanical aspiration of the clot was done through the guiding catheter, which was placed in the right vertebral artery using a 25ml syringe. Following mechanical aspiration, the right vertebral artery was stented using a 3.5x23mm bare metal balloon-mounted stent (Abbott Vascular) and the balloon stent was inflated to 8mm,” Huded and colleagues added.

According to the study, following stenting, mechanical aspiration was performed proximal to the Hyperglide balloon using Slipcath (Cook Medical) 125cm catheter and 25ml syringe. The Hyperglide balloon was then deflated and the post-procedure angiogram which, according to the authors, showed no residual narrowing and no evidence of thrombus.

Post-intervention, the patient was extubated and after 12 hours he complained of headache and was drowsy. A repeat CT showed cerebellar oedema due to earlier infarct. Therefore the patient underwent emergency posterior fossa decompression, however, after the procedure, his NIHSS score was four and his Barthel index improved from five to 65, according to the authors.

“Stenting of the vertebral artery in the presence of a thrombus is difficult owing to the risk of embolization, as is the case with placement of distal protection through the same artery,” said Huded et al. “We believe that, in patients with vertebral artery thrombus who fail medical management, this is a safe and novel technique.”

Research presented at ISET shows controversial multiple sclerosis treatment may ease symptoms

2013-02-12T17:37:00Z

Although using angioplasty to treat multiple sclerosis is highly controversial, sufferers often insist it helps—in some cases dramatically, such as allowing them to walk without assistance. Patients with less-severe multiple sclerosis also reported additional quality of life improvements, such as being able to talk more clearly, after having treatment to open blocked blood vessels in the chest and neck, according to research presented at the International Symposium on Endovascular Therapy (ISET), 19–23 January 2013, Miami, Florida, USA.

A controversial theory holds that multiple sclerosis symptoms may be caused by narrowed veins leading away from the brain, which interrupts blood flow between the brain and heart. This condition, called chronic cerebrospinal venous insufficiency (CCSVI), is treated with minimally invasive angioplasty to open up those narrowed veins. In the research presented at ISET, more than 65% patients treated for CCSVI report quality of life improvements three months after treatment.

“The patients reported improvement in common multiple sclerosis symptoms such as brain fog, frozen extremities, dizziness, bladder control and speech, and over time, they continued to improve,” said Marco Magnano, professor of interventional radiology at the Residency of Vascular Surgery of University of Catania, Sicily. “Although this could be due to the placebo effect, you have to wonder how that alone could help patients get out of the wheelchair, or forgo a cane or crutches.”

In the study, 170 patients were evaluated using the expanded disability status scale (EDSS), a standard method used to quantify the level of disability in multiple sclerosis patients. Using the EDSS, patients rank their symptoms from 0 to 10 (higher numbers indicating more severe disability.) Prior to treatment, the patients in the study averaged 4.5, meaning they had some limitation of activity and were able to walk without resting for slightly more than 300 yards. Three months after treatment, they improved to an average of 4.0, meaning they were up and about 12 hours a day and able to walk without resting for more than 500 yards. The patients who initially scored higher on the disability scale were less likely to improve.

The EDSS focuses on physical abilities, therefore the multiple sclerosis patients also filled out a questionnaire to gauge their quality of life, including participation in activities such as reading, recreation and socialising. Patients answered each of 16 quality of life questions with answers ranging from 1 to 7 (the higher score indicating better quality of life). Out of a total possible score of 112, patients overall improved from 64 before treatment to 70 after one month and 71 after three months. Six-month follow up in 77 patients suggests the benefits may wane, but scores remain better than they were before treatment.

“In about a quarter of the cases, the treated veins restenose which correlates with symptoms worsening again and suggests this condition is valid,” said Magnano. “More studies are necessary, but it is certainly premature to discount this treatment for multiple sclerosis.”

Study says that there is no evidence to support concerns that neurodegenerative disease-associated proteins transmit Alzheimer’s or Parkinson’s disease

2013-02-12T11:46:00Z

On 4 February 2013, in a study published online in JAMA Neurology, by David Irwin, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA, and colleagues, reported a first group of recipients of cadaver-derived human growth hormone (c-hGH) who do not appear to be at increased risk for Alzheimer and Parkinson disease despite their likely exposure to neurodegenerative disease-associated proteins and elevated risk of infectious prion protein-related disease.

Irwin et al looked for evidence for human-to-human transmission of Alzheimer disease, Parkinson disease, and related neurodegenerative disease-associated proteins in c-hGH recipients. (Image: A=AB, the main component of Alzheimer’s disease-associated plaques, B=Tau, the main component of Alzheimer’s disease-associated tangles, C=Alpha-synuclein, the main component of Lewy bodies in Parkinson’s disease).

The study included 34 routine autopsy patients and a group of c-hGH recipients in the National Hormone and Pituitary Program (NHPP). No cases of Alzheimer’s disease or Parkinson’s disease were identified, according to the study results.

“We found no evidence to support concerns that neurodegenerative disease-associated proteins underlying Alzheimer’s disease and Parkinson’s disease transmit disease in humans despite evidence of their cell-to-cell transmission in model systems of these disorders. Further monitoring is required to confirm these conclusions,” the authors added.

Zhengzhou neurosurgeons perform first iMRI case in VISIUS Surgical Theatre in China

2013-02-08T17:05:00Z

IMRIS has announced that neurosurgeons at the First Affiliated Hospital of Zhengzhou University in Zhengzhou City, China, have successfully performed the first case involving an adult male brain tumour patient using the recently installed VISIUS Surgical Theatre.

According to a company release the system allows for multiple MR scanning during brain tumour operations without compromising patient safety, the VISIUS Surgical Theatre features a high-field MR scanner that travels on demand using ceiling-mounted rails into a state-of-the-art neurosurgical operating room. As in this initial case, serial scanning gives the surgeon the ability to assess and perform further resection to remove as much tumour as possible.

With integrated technologies and control systems for imaging, patient-handling and information management, the VISIUS Surgical Theatre provides intraoperative vision to surgeons to assist in their surgical decision-making and enhance treatment precision. When not needed for intraoperative imaging, the scanner remains in a diagnostic room where it can be used for inpatient and outpatient imaging.

Zhengzhou University Hospital is the third IMRIS system installed in China. Other locations are: PLA General Hospital in Beijing and Huashan Hospital at Fudan University in Shanghai. Two other VISIUS Surgical Theatres are currently being installed at Peking Union Medical College Hospital in Beijing and First Affiliated Hospital of Jilin University in Changchun.

The day before the first procedure, Xianzhi Liu, chief neurosurgeon, reviewed the surgical suite with province health department representatives. "Since we are the biggest and leading hospital in Henan province," he said, "we have a responsibility to our patients to utilise cutting edge technology that brings the most precise surgical capabilities."

When the hospital announced purchase of the VISIUS Surgical Theatre in March 2012, Kan Quancheng, hospital president, said the suite "is the essential, leading-edge technology that will take us to the next level of research and clinical practice, especially in neurosurgery."

Brain stimulation in conjunction with antidepressants may help depression, study says

2013-02-08T12:23:00Z

Using weak electrical currents passed into the brain through a headband may help relieve depression symptoms for some patients when combined with an antidepressant, according to a US and Brazilian study.

Researchers wrote in JAMA Psychiatry had found that after six weeks of treatment with a combination of brain stimulation (transcranial direct current stimulation) and sertraline (Zoloft), nearly two-thirds of depressed participants got significantly better.

In major depressive disorder, the combination of transcranial direct current stimulation and sertraline increases the efficacy of each treatment," wrote lead researcher Felipe Fregni from the Harvard Medical School, Harvard, USA.

For the study, Fregni and Brazilian colleagues randomly assigned 120 people in Brazil with moderate to severe depression to one of four treatments: brain stimulation and sertraline, brain stimulation and a placebo drug, sham stimulation and sertraline, or sham stimulation and a placebo.

No transcranial direct current stimulation devices, including the one used in the study, are approved by the US Food and Drug Administration (FAD) for use on the brain, but older types of non-invasive brain stimulation are approved and becoming established treatment options for depression, the researchers noted.

Electrical current therapy was given for 30 minutes at a time over 12 total sessions.

At the beginning of the study, participants in each of the four groups had an average depression score between 30 and 31 on a 0 to 60 scale (higher score meant worse depression).

After six weeks, people in the combined stimulation and sertraline group saw their depression drop to a score of 13, on average, compared to 25 among people who received both fake treatments.

"In the field of depression, it’s important to know about treatment options, and medications alone don’t work for everyone," said Sarah Lisanby, a psychiatrist who studies brain stimulation at Duke University, North Carolina, USA. "Now there’s a broadened array of new, device-based therapies that allow us to affect brain function in less invasive ways."

Data on side effects suggested that the trancranial direct current stimulation had no effect on cognition, according to the researchers. Skin redness was more common with the real device than the sham stimulator.

The drug alone and electrical stimulation alone were similarly effective at easing depression symptoms, Fregni’s team said. However, the dose of sertraline used—50mgper day—might have been too low to help most people, psychiatrists said.

Philip Janicek, from Rush University Medical Center in Chicago, USA, said it was still unclear whether this type of stimulation can help people with depression.

"Transcranial direct current stimulation could very well be an effective treatment," he said, though he added that at this point he would not recommend it based on the current evidence.

Nevro announces publication of six-month clinical data for Senza HF10 High-Frequency Spinal Cord Stimulation therapy in Europe

2013-02-06T11:39:00Z

On 6 February 2013, Nevro, a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, announced the publication of six-month safety and efficacy data from a European study evaluating the company’s Senza High-Frequency Spinal Cord Stimulation system. The Senza system is authorised for sale in Europe and Australia.

The findings were published in Neuromodulation: Technology at the Neural Interface. The 83-patient study evaluated patients with predominant back or leg pain, including a subset of patients who previously failed traditional low-frequency spinal cord stimulation treatment. In the challenging cohort, the data demonstrated that the Senza system provided significant and sustained relief for low back pain and leg pain in more than 70% of treated patients, and did so without triggering paresthesia. Patients using the Senza system also experienced significant reductions in pain medication use, significant improvement in their disability, and significant improvement in their ability to sleep.

“The results of this study provide further evidence of the favourable safety and efficacy profile of Nevro’s High-Frequency Spinal Cord Stimulation system,” said Jean-Pierre Van Buyten, director of the Multidisciplinary Pain Centre at AZ Nikolaas, Belgium, and lead author of the study. “Patients with intractable back and leg pain are usually desperate for relief and for a solution that will allow them to resume a normal life. I have seen firsthand with my own patients the vast improvements in quality of life that Nevro’s system has provided.”

The prospective, open-label, multicentre European trial enrolled 83 patients with significant back pain. After a trial period, 88% (72 of 82) of patients reported a significant improvement in Visual Analog Scale (VAS) pain scores and underwent permanent implantation of the Senza system. For patients receiving permanent implants, mean back pain VAS of 8.4 before treatment was reduced 68%, to 2.7 at six months (p<0.001). Mean leg pain VAS of 5.4 before treatment was reduced 74%, to 1.4 at six months (p<0.001). Of the 72 patients still participating in the European trial at six months, 74% (53 of 72) had greater than 50% back pain relief six months after implantation.

The Senza system delivers Nevro’s HF10 Spinal Cord Stimulation therapy, which provides electrical pulses to the spinal cord at a rate up to 10kHz to reduce the sensation of pain. The electrical pulses are conveyed by small electrodes placed near the spinal cord and connected to a compact battery-powered generator implanted under the skin. Data from this and other European clinical studies suggest that Nevro’s HF10 Spinal Cord Stimulation therapy may offer the ability to treat low back pain and other challenging conditions, including chronic pain patients who do not respond to traditional low-frequency spinal cord stuimulation therapy.

The Senza system is currently the subject of the SENZA-RCT study, a prospective, randomised, controlled pivotal study in the USA to further evaluate the safety and efficacy of Nevro’s Senza system in patients with chronic pain. The unblinded study will enrol up to approximately 300 patients at up to 15 leading pain centres across the USA and will compare its performance against treatment with traditional low-frequency spinal cord stimulation. In the United States, the system is limited by to investigational use and is not available for promotion or sale.

PROMISE study to investigate neurostimulation for failed back surgery syndrome launched by Medtronic

2013-02-04T14:47:00Z

A company release on the 28 January from Medtronic announced the start of PROMISE (Prospective, randomised study of multicolumn implantable lead stimulation for predominant low back pain). This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5 multicolumn surgical leads plus optimal medical management to the administration of optimal surgery syndrome alone in patients with failed back surgery syndrome and predominant low back pain.

“Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief,” said Bart Edmiston, principal investigator for the PROMISE study at The Neuroscience Center, Ocean Springs, Mississippi, USA, which enrolled the study’s first patient on 8 January 2013. “The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery.”

It is estimated that more than 100 million US adults and one in five European adults live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10% of the US population alone. Failed back surgery syndrome is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of failed back surgery syndrome patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.

Medtronic neurostimulation therapy (also known as spinal cord stimulation) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.

PROMISE is a prospective, randomised, open-label, parallel-group, clinical study enroling up to 300 individuals suffering from predominant chronic low back pain due to failed back surgery syndrome at 30 centres in the USA , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and UK). It is the first large-scale, randomised, controlled clinical trial designed to assess the value of spinal cord stimulation for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.

“Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study,” said Philippe Rigoard, the study’s global principal investigator, who started enrolling patients 14 January at Poitiers University Hospital, Poitiers, France. “If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with failed back surgery syndrome.”

PROMISE participants will be randomised 1:1 to receive treatment with either spinal cord stimulation with optimal medical management or optimal medical management only. After a six-month observational phase, the study will compare the proportion of participants in the spinal cord stimulation group who report more than 50% reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the optimal medical management-only group. Health care utilisation data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of spinal cord stimulation.

“Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from failed back surgery syndrome,” said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic. “PROMISE provides the opportunity to assess not only the degree of pain relief provided by spinal cord stimulation plus optimal medical management compared to optimal medical management alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication.”

The American Heart Association/American Stroke Association launches the Together to End Stroke initiative to reduce disability

2013-02-01T11:19:00Z

The American Heart Association/American Stroke Association is to launch the Together to End Stroke, a national initiative to bring stroke awareness to the forefront of Americans’ minds and to educate them that stroke is largely preventable and treatable.

Covidien, a global medical products leader and national sponsor of the initiative, is helping the Association to drive awareness with a stated goal of building healthier lives by reducing disability and death from stroke by 20% by 2020.

According to a survey commissioned by the American Heart Association/American Stroke Association in November 2011, 93% of Americans do not think of stroke as a major health concern, despite the fact that it is the fourth leading cause of death and a leading cause of long-term, severe disability.

Together to End Stroke has identified stroke symptoms that can be easily recognised:

F—Face drooping

A—Arm weakness

S —Speech difficulty
T —Time to call 911

“The survey results are concerning and emphasise the need to do a much better job to make stroke awareness a priority across the nation. The American Heart Association/American Stroke Association is committed to leading this effort. We have to take people from a place of not knowing and not talking about stroke to a place of enlightenment and empowerment that together and individually, we can end stroke,” said Ralph L Sacco, chairman of Neurology and executive director, McKnight Brain Institute; chief of Neurology, Jackson Memorial Miller School of Medicine University of Miami, USA.

“We are so thankful that Covidien has stepped up to the plate as our first funder of this initiative, which will help us to provide the knowledge, tools and support to vastly reach stroke survivors, caregivers, friends and family of survivors, at-risk populations and medical professionals,” he said.

“Covidien is proud to sponsor the Together to End Stroke initiative. We recognise the importance that early detection and treatment can have on improving outcomes for stroke patients,” said Mark A Turco, chief medical officer, Vascular Therapies, Covidien. “We look forward to collaborating with the American Heart Association/American Stroke Association to build awareness about stroke, and to help efforts for stroke prevention, diagnosis and treatment.”

The Together to End Stroke initiative, which will officially launch 6–8 February at the American Stroke Association’s International Stroke Conference in Honolulu, Hawaii, will focus on tools and resources across the stroke continuum of care in the areas of prevention, pre-event, acute event and post stroke/rehabilitation and will include national branding and messaging, an online and digital strategy, local grassroots events and multicultural outreach.

To join the Together to End Stroke initiative and to access information and patient education resources to help bring stroke awareness to your community, visit strokeassociation.org/together.

Medical societies unite on patient-centered measures for nonsurgical stroke interventions

2013-02-01T10:58:00Z

The first outcome-based guidelines for interventional treatment of acute ischaemic stroke—providing recommendations for rapid treatment—will benefit individuals suffering from brain attacks, often caused by artery-blocking blood clots, according to a release. Representatives from the Society of Interventional Radiology and seven other medical societies created a multispecialty and international consensus on the metrics and benchmarks for processes of care and technical and clinical outcomes for stroke patients.

In February, the guidelines will be published first in Society of Interventional Radiology’s Journal of Vascular and Interventional Radiology and subsequently by each society either in its respective journal or on its website.

“These groundbreaking guidelines are the product of two years of collaboration among multidisciplinary teams from eight societies,” said Marshall E Hicks, president of the Society of Interventional Radiology, diagnostic imaging at the University of Texas, MD Anderson Cancer Center, Houston, Texas, USA. “With real progress being made in research and treatment of stroke over the last decade, this distinguished group of international authors—from societies whose members perform minimally invasive stroke treatments—felt that the time was right for a consensus on how to effectively treat and manage stroke patients,” he added.

“The one constant in stroke treatment is time,” noted David Sacks, interventional radiologist at Reading Hospital and Medical Center in West Reading, Pennsylvania, USA, and the study’s lead author. “Seconds count from time of admission to treatment. Meeting the outcomes described in these guidelines will ultimately benefit patients by requiring strict adherence to a rapid treatment schedule,” he added.

The guidelines recommend submission of outcomes to a national registry that will allow research and also comparisons between facilities. Sacks noted that the benchmarks in the paper are intended to be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularisation. He said that the guidelines may also be helpful to facilities that are interested in applying for accreditation as a comprehensive stroke centre.

“As the field of stroke revascularisation evolves, the guidelines will be revised as needed,” he added.

In 2003, the Journal of Vascular and Interventional Radiology published a joint society document to guide the design and reporting of stroke research; the new guidelines address clinical care. The co-authors completed a review of the relevant literature from 1986 through February 2012 as the basis for creating performance metrics and thresholds. “All society representatives vigorously discussed each issue based on the literature review and personal experience,” Sacks concluded.

Recall of Vycor Viewsite Brain Access System due to unidentified fibre found on device

2013-02-01T09:50:00Z

Vycor Medical has recalled its Vycor Viewsite Brain Access System because an unidentified black fibre was found on the device. This product may cause serious adverse health consequences, including death, according to a company release.

The Vycor Medical Viewsite Brain Access System serves as a self-retaining retractor system for brain tissue and provides access to allow the surgeon to see the surgical site during brain and spinal procedures.

Vycor Medical has called their customers requesting that they place products of Model #TC171105, Lot #VM83450, which was distributed from 8 June to 9 July 2012, into quarantine until further notice. Vycor Medical asked customers holding the affected lot numbers to call the company immediately.Customers in immediate need of the product should advise the Vycor customer service team who can assist in providing an alternative product.

The company encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the Food and Drug Administrations’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Neurostimulation from Medtronic receives CE mark for use with full-body MRI scans

2013-01-30T16:42:00Z

Medtronic has introduced in Europe their first implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions.

The first new system implants have been performed by JP Van Buyten and Iris Smet in

Belgium; Rasche and Tronnier in Germany; J De Andres in Spain; K Gatzinsky in Sweden, and Buchser in Switzerland.

Medtronic neurostimulation systems for the treatment of chronic pain recently received CE mark approval for compatibility with full-body MRI scans. Neurostimulation systems enhanced with this technology and using VectrisTM SureScan MRI leads include: RestoreSensor SureScan MRI, Prime Advanced SureScan MRI, RestoreAdvanced SureScan MRI, and RestoreUltra SureScan MRI. Medtronic SureScan neurostimulation systems for the treatment of chronic pain are not approved by the US Food and Drug Administration (FDA) for use in the USA.

“Neurostimulation therapy has become a mainstay of chronic pain management, and the introduction of full-body, MRI-compatible spinal cord stimulation systems is an important advancement that will help ensure neurostimulation patients have access to the diagnostic tools needed to quickly identify potentially critical health conditions,” said JP Van Buyten, AZ Niklaas Hospital, Belgium.”

Medtronic SureScan neurostimulation systems address a significant medical need for full-body

MRI compatibility by enabling patients who are receiving Medtronic neurostimulation therapy for chronic back and/or leg pain (spinal cord stimulation) to have access to the benefits of full-body MRI. Until now, spinal cord stimulation patients were denied full-body MRI scans because of fears of the system being affected by the large magnets involved in MRI.

“Delivering systems that are compatible with a full-body MRI scan means that spinal cord stimulation patients will not have to compromise when it comes to their healthcare, and they can feel secure knowing that MRI is a diagnostic option,” said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic.

Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.

These systems are the latest additions to a growing number of Medtronic devices which are safe for MRI access to any region of the body when used according to specified MR Conditions for Use, including the Medtronic SynchroMed II programmable drug infusion system and the Advisa DR MRI SureScan pacing system available outside the US In the US, such devices include the Medtronic SynchroMed II programmable drug infusion system and the Revo MRI SureScan pacing system which are safe for MRI access to any region of the body when positioning guidelines are followed.

About Medtronic Neurostimulation Therapy for Chronic Pain

Medtronic neurostimulation therapy for chronic pain uses a medical device placed under a patient’s skin to deliver mild electrical impulses to the spinal cord, which act to block pain signals from going to the brain. Instead of pain, patients feel a tingling sensation from the neurostimulation in areas where they had previously experienced pain.

Varian Medical Systems receives FDA 510(k) clearance for the Edge radiosurgery suite

2013-01-30T14:32:00Z

Varian Medical Systems has received FDA 510(k) clearance for the company’s Edge radiosurgery suite, a new dedicated system for performing advanced radiosurgery using real-time tumour tracking and motion management technologies.

“The Edge suite represents a new paradigm in radiosurgery, offering clinicians a system that combines Varian’s world-class technologies in an end-to-end solution for planning and delivering radiosurgery treatments,” said Chris Toth, vice president of marketing for Varian’s Oncology Systems business. “It integrates Varian’s state-of-the-art radiosurgery technology with tools for real-time imaging, tracking, and patient positioning. It enables fast, accurate delivery of stereotactic radiosurgery for treating lesions, tumours, and conditions anywhere in the body where radiotherapy is indicated, including tumours of the lung, prostate, spine and brain.”

The recent FDA 510(k) clearances cover the following technologies that are integrated into the Edge radiosurgery suite. These new technologies are also being made available as upgrades to other compatible Varian systems:

The PerfectPitch couch: An integrated six degrees of freedom treatment couch intended to position patients optimally, adjust their position to correct for any misalignments, and support them comfortably during treatment. The PerfectPitch couch has been designed for the accuracy and functionality required to deliver radiosurgery treatments in the brain and in the rest of the body.

The Advanced Motion and Image-Guided Radiotherapy package: An advanced motion management package that offers clinicians many options for using real-time imaging during radiotherapy treatments. It also enables expanded use of fluoroscopy and 4-D cone-beam CT—imaging techniques that show motion over time—to better compensate for tumour motion during treatment.

Intracranial radiosurgery package: An integrated set of technologies for planning and delivering stereotactic radiosurgery treatments for tumours or functional abnormalities in the brain. The intracranial radiosurgery package supports the accurate delivery of radiation using multiple beam shaping options, including Varian’s high-definition multileaf collimator and radiosurgery conical collimators, and is compatible with both frame-based and frameless patient immobilisation approaches.

Calypso system: According to the company, several enhancements have been incorporated into the Calypso system for real time tracking. The system utilises transponders, or position signaling devices, that are implanted in or around a tumour, or placed on the surface of the body and monitored to track motion during treatment. New enhancements increase the rate of transponder signal processing in order to track faster types of motion, such as respiratory motion, in real time. The system is also compatible with the couch rotations that are often used to optimise targeting during treatments in the lung. The new system also includes updated usability features designed to streamline treatments and enhance the user experience.

One optional Edge suite subcomponent is pending FDA 510(k) clearance: Calypso anchored Beacon transponders for implantation in the lung to guide lung radiosurgery procedures.

Mild traumatic brain injuries could be associated with cognitive impairment in athletes

2013-01-29T10:51:00Z

The relationship between professional boxers and neurodegenerative disease has been well documented. However, a study led by John Hart, Center for Brain Health, School of Behavioural and Brain Sciences, University of Texas at Dallas, USA, published online first in JAMA Neurology, has suggested that it is not only boxers who are at risk of cognitive impairment and depression but all athletes that experience concussion or blows to the head. Therefore, Hart and others aimed to assess cognitive impairment in retired National American Football League (NFL) players using neuroimaging.

The authors stated that traumatic brain injury has been noted as a potential risk factor for neurodegenerative diseases, which includes Alzheimer’s disease. They added: “An association between repeated concussion and mild cognitive impairment and reported memory impairments has also been suggested in retired NFL players.”

The study was comprised of 35 retired NFL players who underwent neurological evaluation. All players reported experiencing concussion ranging from a few seconds of confusion to loss of consciousness for several hours with a range of 1 to 13 concussions in their lifespan.

Twenty six healthy controls without a history of playing collegiate or professional American football and who had not experienced a concussion also underwent neuroimaging. The controls were then matched with the NFL players in terms of age, educational background and estimated IQ in order to compare cognitive results.

According to the results, the authors found that, out of the 35 NFL players, 20 (of which five were depressed without cognitive impairment) were cognitively normal (59%), four were diagnosed as having fixed cognitive deficit (12%), eight were diagnosed as having mild cognitive impairment, and two had dementia.

Hart et al also stated that out of the 35 participants, eight (24%) were diagnosed as having depression. Six participants were without previous diagnosis or treatment for depression. The authors noted that three out of the eight participants with depression had concurrent cognitive deficits that were not entirely associated with depression.

“These findings underscore the need for screening for depression and cognitive dysfunction in retired athletes,” said Hart and et al.

“If confirmed, the findings of studies such as these would support the used of magnetic resonance imaging, particularly diffusion tensor imaging, for monitoring the cumulative burden of concussions in athletes and others who have experienced multiple mild traumatic brain injuries,” said Ramon Diaz-Arrastia and Daniel Perl in an accompanying editorial.

Preoperative Onyx embolization of hypervascular head, neck, and spinal tumours is safe and effective

2013-01-29T10:43:00Z

A study published in the Journal of NeuroInterventional Surgery and jointly led by Leonardo Rangel-Castilla and Orlando M Diaz, Department of Neurosurgery and Interventional Neuroradiology, Methodist Neurological Institute, The Methodist Hospital, Weill Cornell College of Medicine, Houston, Texas, USA, has found that the use of the liquid embolic agent Onyx is safe and effective in the embolization of head, neck, and spinal tumours. According to the authors, the use of Onyx previous to their study had not been well researched.

In the retrospective analysis of 100 cases of preoperative head, neck, and spinal tumour embolization with Onyx, none the patients, under general anaesthesia, died or hadmajor complications. Rangel-Castilla et al reported minor complications in three patients where Onyx extravascularisation around the tumour occurred and in a further three patients groin haematoma occurred. Two patients had a myocardial infarction not relating to embolization and one patient had a repeated bicoronal craniotomy and second attempted tumour resection.

In the 48-hour post embolization period, 79 patients underwent surgical resection and a further six patients underwent surgery at later time (up to 188 days). Rangel-Castilla and others reported the estimated intraoperative blood loss (in 77 patients) as 2,000ml in three patients.

The implications for the use of Onyx for head, neck, and spinal tumour embolization are that it “highlights how neurointerventional embolization has become an important tool in the neurosurgical armamentarium.” The authors also reported that Onyx is useful in the control of intractable tumour bleeding, in the occlusion of tumour feeding arteries that are surgically inaccessible, and that it improves intraoperative visualisation.

The authors found that Onyx embolization was effective as it “precipitates gradually in a radial fashion, forming a cast. The slow precipitation property allows a more slow and precise injection, allowing deeper penetration into the tumour capillary bed.” However, Rangel-Castilla and Diaz also noted the disadvantages of Onyx which were that the injection needs a microcatheter compatible with dimethyl sulfoxide and the catheter needs to be exchanged with each artery embolization. They also noted that Onyx can migrate into the venous circulation or leak around the tumour.

Rangel-Castilla and Diaz said: “This study demonstrates the safety and efficacy of central nervous system tumours embolization with a liquid embolic agent. It penetrates deeply into the tumour, cuts the blood supply and kills the tumour. This makes a surgical resection easier, faster with less blood loss.”

To determine the long term efficacy of Onyx for head, neck, spine, and brain tumours for long term use randomised controlled trials are required, the authors concluded.

New extremely soft bare platinum coil is a safe and effective endovascular treatment for cerebral aneurysms

2013-01-29T10:31:00Z

The first use of a new extremely soft bare platinum coil has been reported in a study led by Kei Harada, Department of Neurovascular Surgery, Fukuoka Wajiro Hospital and Neuro-Vascular Center, Fukuoka, Japan, and published in the Journal of NeuroInterventional Surgery.

Treatment with coils, according to the authors, is a safe and less invasive than surgical clipping for the treatment of cerebral aneurysms, however there have been cases, in the past, at long-term follow-up, where the compaction of the coil ball or regrowth or recanalisation of the aneurysm has occurred. Therefore the authors aimed to assess the efficacy, safety and clinical performance of the extremely soft bare platinum coil for embolization of cerebral aneurysms using packing density as an indicator.

In order to achieve this, data from 92 aneurysms in 89 patients were analysed retrospectively. The EDC-10 ES (Kaneka Medix) was the coil used as a representative for the extremely soft bare platinum coil and the suitability of the patients for coiling treatment was decided by neurosurgeons and neurointerventionalists or if the patient refused clipping. According to the authors, 34 (37%) of the aneurysms were unruptured and 58 (63%) were ruptured with severe neurological condition (4–5 on the World Federation of Neurological Societies grade).

The mean volume of the 92 aneurysms was 131.3±171.6mm³, the mean±SD volume was 6.5±2.8mm, the aneurysm diameter was 5.8±2.4mm and dome and neck size was 3.3±1.4mm.

Harada et al stated that 41 of the embolizations were performed with simple techniques and, 51 with an adjunctive technique (of which 42 included the balloon-assist technique and 9 included the double catheter technique).

In the study it was said that the mean packing density was 29.5±10.6% and the mean±SD percentage EDC-10 ES volume was 40.5%±25.1%. The degree of occlusion was measured using the modified three-point Raymond score (RS). Initial angiographic results showed that the sac and the neck were occluded completely in 63 of the aneurysms (RS1). Complete occlusion was not achieved in 29 aneurysms graded at RS2 and in 18 RS3 cases. The authors said that these results indicate a favourable packing density and recanalisation rate and is therefore a good treatment, in the long-term, for cerebral aneurysms.

“Coil embolization is widely accepted as a safe and effective treatment for the treatment of cerebral aneurysms,” said Harada and colleagues. “These results show that improvement in the mechanical properties of embolization coils produces desirable effects on handling properties and contributes to a better outcome.”

Samsung Electronics America acquires NeuroLogica

2013-01-29T10:24:00Z

Samsung Electronics America, a subsidiary of Samsung Electronics, has announced its acquisition of NeuroLogica, a computed tomography (CT) company with headquarters in Danvers, Massachusetts, USA. Established in 2004, NeuroLogica develops medical imaging products and is known for its portable CT scanners, such as BodyTom and CereTom. Terms of the deal were not disclosed.

According to a company release, the acquisition of NeuroLogica is another important step in the expansion of Samsung’s medical imaging business. Samsung will continue to strengthen its capabilities and product portfolio to establish itself as a trusted leader in the health and medical equipment industry.

The company plans to leverage its global brand awareness and world-leading technology in consumer electronics, IT and communications with NeuroLogica in order to expand medical imaging business.

Functional Neuromodulation appoints Vince Owens to its board of directors

2013-01-23T17:08:00Z

Functional Neuromodulation, a company involved in the use and development of deep brain stimulation for Alzheimer’s disease and other memory disorders, has announced the appointment of Vince Owens to its board of directors. Owens has 25-year medical device industry experience as an executive and the founder and managing general partner of Guide Medical Ventures.

“Vince brings to the Board additional operational experience, strategic vision and a successful track record as an entrepreneur in neuromodulation, one of the fastest growing segments of the medical device industry,” said Dan O’Connell, Functional Neuromodulation co-founder and CEO. “We look forward to leveraging the expertise of Vince and our board as we propel the company forward and deepen our understanding of the use of deep brain stimulation for cognition in mild Alzheimer’s disease patients.”

Owens was previously co-Founder, CEO and director of Intelect Medical, a developer of deep brain stimulation technologies for patients with Parkinson’s and other neurological diseases. He was with the company from its inception in 2005 until its acquisition in 2011 by Boston Scientific for US$78 million. Prior to Intelect, Owens was founding CEO and a director of Biomec Cardiovascular, a developer of implantable devices for neuromodulation and cardiac rhythm management, which he led through acquisition by Enpath Medical.

“Given the profound economic and societal impact of Alzheimer’s Disease and recent disappointments in drug studies, there is an urgent need for effective treatments for patients. Deep brain stimulation represents a truly innovative and promising brain circuitry-based treatment method,” said Owens. “Alzheimer’s has the potential to become the largest deep brain stimulation market indication, and Functional Neuromodulation’s initial clinical research results and rapid execution of the ADvance study has been quite impressive.”

NICE recommends apixaban for some people with non-valvular atrial fibrillation

2013-01-23T12:22:00Z

On 23 January, the UK’s National Institute for Health and Clinical Excellence (NICE) issued a final draft guidance recommending apixaban (Eliquis, Bristol-Myers Squibb and Pfizer), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation.

The draft guidance also recommends that the decision about whether to start treatment with apixiban should be made after an informed discussion about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate and rivaroxaban, and in light of a person’s current level of international normalised ratio(INR) control if they are already taking warfarin.

Apixaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with with non-valvular atrial fibrillation and one or more risk factors such as prior stroke or transient ischaemic attack, age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure (New York Heart Association [NYHA] class 2 or higher).

Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke. Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, its use requires regular monitoring of the blood’s clotting properties and dose adjustments which can cause disruption and inconvenience. It also has multiple interactions with food, alcohol and drugs that can cause further inconvenience. The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person’s quality of life than atrial fibrillation itself. Apixaban, like rivaroxaban and dabigatran etexilate, which NICE recently approved as options for this indication, has potential benefits for people with AF in these circumstances because it does not require such regular monitoring and dose adjustments.

“From the evidence submitted, the Committee concluded that apixaban was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with apixaban resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. The Committee recognised that intracranial bleeding has a high mortality rate and a large impact on a person’s quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant.”

NICE has not yet issued final guidance to the NHS. The Institute announded that registered consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

The final guidance is likely to be published in February 2013.

To access the final draft guidance click here.

SanBio announces enrolment of the second cohort of patients in its clinical trial of stem cell therapy for chronic stroke

2013-01-16T14:53:00Z

SanBio has announced the successful enrolment of the second dose cohort of patients in its Phase I/IIa clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries.

The first 12 patients, of a planned total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University, the University of Pittsburgh and Northwestern University, USA, No safety concerns have been attributed to the cell therapy product.

SB623 is derived from adult bone marrow and has previously been proven to be safe and efficacious in rodent models of chronic stroke.

According to the company, SB623 is being delivered to the damaged region of the brain of patients who have suffered an ischaemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.

“We are pleased with the safety findings of the study thus far,” said Ernest Yankee, SanBio’s executive vice president of Development. “We anticipate completing the enrolment of the third and final dose cohort early in the year and reporting the results shortly thereafter.”

About SB623

SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.

Depressed post-stroke patients have a higher risk of death than their non-depressed counterparts

2013-01-16T14:30:00Z

People suffering from depression after a stroke may have a tripled risk of dying early and are at four times more likely to die from stroke than people who have not experienced a stroke or depression, according to a study that will be presented at the American Academy of Neurology’s 65th Annual Meeting in San Diego, (16–23 March).

“Up to one in three people who have a stroke develop depression,” said study author Amytis Towfighi, Keck School of Medicine, University of Southern California and Rancho Los Amigos National Rehabilitation Center, Los Angeles, USA. “This is something family members can help watch for that could potentially save their loved one.”

Towfighi noted that similar associations have been found regarding depression and heart attack, but less is known about the association between stroke, depression and death.

The research included 10,550 people between the ages of 25 and 74 who were followed for 21 years. Of those people, 73 had a stroke but did not develop depression, 48 had stroke and depression, 8,138 did not have a stroke or depression and 2,291 did not have a stroke but had depression.

According to the results of the study, the risk of dying from any cause was three times higher in individuals who had stroke and depression compared to those who had not had a stroke and were not depressed. The risk of dying from stroke was four times higher among those who had a stroke and were depressed compared to people who had not had a stroke and were not depressed.

“Our research highlights the importance of screening for and treating depression in people who have experienced a stroke,” said Towfighi. “Given how common depression is after stroke, and the potential consequences of having depression, looking for signs and symptoms and addressing them may be key.”

Internet-based survey shows patterns of variability in neurointerventional practice for acute ischaemic stroke

2013-01-15T10:32:00Z

A study, published in the Journal of NeuroInterventional Surgery and conducted by Brijesh P Mehta, Division of Neurointerventional Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, USA, and colleagues, has assessed the variability in neurointerventional practice for intra-arterial therapy with tPA for patients with major acute ischaemic stroke secondary to large vessel occlusions.

The authors aimed, using an internet-based survey, to focus on key areas of intra-arterial therapy (practice demographics, operator background, operational protocols, quality and safety assessments, and decision-making and treatment strategies) in order to “gain a better understanding of real-world practice patterns for intra-arterial therapy.”

The majority of the surveyed specialists belonged to a neurointerventional society (Society of Vascular and Interventional Neurology, Society of Neurointerventional Surgery and World Federation of Neurological Societies) and, according to Mehta et al, 140 responses (71 neurologists, 53 radiologists, 14 neurosurgeons and two dual training) were received and analysed (response rate 47.5%).

Most survey participants were in North America (76%) and the remaining participants were in Europe (9.3%), Australia or New Zealand (6.4%), South East Asia (6.4%), South America (1.4%) and Africa (0.7%), of which 71% were based at an academic centre.

Despite studies demonstrating the benefit of shorter time to vessel opening, it was reported that 71% (n=99) of operational protocols had not established a goal time from patient presentation to procedure initiation. Of those with an established goal (n=40), a time interval of 30–60 minutes from the emergency department to intra-arterial therapy was the most commonly used.

According to the authors, there have been recent reports suggesting that conscious sedation is associated with improved outcomes after intra-arterial therapy. However, many physicians prefer general anaesthesia due to the lack of patient movement, which is thought to minimise procedure related complications. Mehta et al reported an even distribution between conscious sedation (51%) and general anaesthesia (49%) reflecting the uncertainty in the field.

In terms of quality and safety the authors reported that high-volume centres more often tracked the interval times to intra-arterial therapy, and participation in clinical trials occurred more often in academic centres.

The survey highlighted a significant variability in decision-making. According to most participants (74%), the decision to initiate therapy was jointly made between the neurointerventionalists and stroke teams with less than eight hours (from symptom onset) as the most common time window for intra-arterial therapy in the anterior circulation, and 24 hours in the posterior circulation. There was a strong emphasis on using imaging findings for treatment selection but with strong variability in imaging technologies and a notable lack of specific imaging criteria.

Fifty five per cent only used CT-based approaches, and MRI was used by 40% (alone or in conjunction with other imaging modalities).

Bridging therapy was performed by 89% with a standard time interval for assessing the patient’s response to intravenous tPA before continuing with intra-arterial therapy used by 55%. In North America, the Penumbra mechanical thrombectomy system was the first-line treatment, and for other countries, retrievable stents were the primary treatment both for medium and large vessel occlusions. This may have been because the US Food and Drug Administration (FDA) had not approved the use of retrievable stents in North America at the time of the survey.

“The strengths of this study include its 48% response rate and inclusion of all neurointerventional specialties,” said Mehta. “The survey provides a comprehensive overview of real-world practice patterns for intra-arterial therapy in acute stroke.”

“Prospective clinical studies are needed to compare effectiveness of these variable approaches in order to develop evidence-based guidelines,” Mehta et al concluded.

Transbrachial carotid artery stenting with novel sheath guide is feasible and safe

2013-01-15T09:47:00Z

Takahisa Mori, Shonan Kamakura General Hospital Stroke Center, Kamakura City, Kanagawa, Japan, and colleagues reported on their first experience of transbrachial carotid artery stenting using a novel sheath guide in the Journal of NeuroInterventional Surgery.

Mori et al said: “previous studies have reported that transbrachial carotid artery stenting is effective in cases unsuitable for transfemoral carotid artery stenting due to aortic and peripheral arterial conditions.” They also stated that, previous to their study, there were no sheath guides specially made for the transbrachial approach but a guide designed for this approach had become commercially available, therefore the authors aimed to report on their initial experiences with the novel sheath for transbrachial carotid cannulation and its effectiveness as an alternative to transfemoral carotid artery stenting.

Mori said: “I expected to perform transbrachial treatment safely and reliably before I developed the novel sheath guide jointly with Medikit Japan a few years ago.”

Mori and colleagues evaluated results respectively of patients who underwent transbrachial carotid artery stenting between May 2011 and July 2012.

Technique

The guide that was used, according to the authors, was the MSK-guide 7.5x90 (Medikit) which was reported to have a U-shape specifically designed for transbrachial carotid cannulation. The authors positioned the MSK-guide in the ascending aorta with the coaxial technique which consisted of a 5F outside diameter catheter of 130cm length (Medikit) and introduced directly into the affected common carotid artery. The authors reported activated clotting time became shorter than 150s. The sheath guide was then removed and haemostasis was obtained by manual compression.

Mori and others evaluated the success of the procedure retrospectively. Of the 70 patients included in the study seven underwent non-elective emergency carotid artery stenting and 63 underwent elective carotid artery stenting. Of the 62 patients included in the study 17 had type I, 22 had type II and 23 had type III aortic arch type. According to the authors the patients had high-grade carotid stenosis and the operators had no problems using the right brachial artery as an access route.

“We were successful in carotid artery cannulation in a similar way to manipulation of a diagnostic catheter and stent deployment was successful in all 62 cases,” said Mori and others. “Our results suggest that transbrachial carotid artery stenting with the sheath guide specifically designed for transbrachial carotid artery cannulation is feasible and safe.”

However, the authors said: “Because of the small number of cases in the present study, a larger number of cases are required to confirm our results.”

Covidien opens patient enrolment for SWIFT PRIME acute ischaemic stroke study

2013-01-14T17:07:00Z

Covidien has announced the launch of a new study SWIFT PRIME (Solitaire FR as primary treatment for acute ischaemic stroke), which has enrolled its first patient at the University at Buffalo, USA. The new multicentre, randomised controlled trial will be one of the largest global studies to examine the adjunctive use of mechanical thrombectomy during the early stages of acute ischaemic stroke onset.

Covidien’s Solitaire FR Revascularisation Device will be used in the SWIFT PRIME study.

The SWIFT PRIME study, according to the company, intends to examine acute ischaemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with the Solitaire FR device. The study will also include an extensive health economics analysis.

“The launch of the SWIFT PRIME trial is an important milestone in the evolution of stroke therapeutics,” said Jeffrey L Saver, professor of Neurology, Geffen School of Medicine and director of University of California Los Angeles, Comprehensive Stroke Center, USA. “The goal of this international randomised trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR device in patients with acute ischaemic stroke.”

Saver is co-leader of the study alongside Elad I Levy, professor of Neurosurgery and Radiology, University at Buffalo, USA. Levy added, “SWIFT PRIME is the first multicentre prospective study that studies brain physiology when selecting patients for stent retriever treatment. We hope this study will help better understand the patient population that most benefits from thrombolysis combined with mechanical thrombectomy.”

The study may enrol up to 800 patients across 60 centres globally. Hans-Christoph Diener, professor of Neurology, University of Essen, Germany, and Vitor Mendes Pereira, director of Interventional Neuroradiology Division (Médecin Adjoint Responsible d’Unité), Service de Neuroradiologie, University Hospital of Geneva, Switzerland, will serve as the European principal investigator and European Interventional principal investigator, respectively.

“Technological innovation in mechanical thrombectomy represents one of the most promising new developments in stroke treatment,” said Mark Turco, chief medical officer, Covidien Vascular Therapies. “The Solitaire FR, an advanced stroke device, shows substantial improvements in outcomes over previous mechanical thrombectomy treatments. The SWIFT PRIME study is an important step in assessing both the clinical and economic value of our newest innovation in this area, underscoring Covidien’s commitment to the advancement of stroke care. We also look forward to the insights that the study will provide into critical components of stroke treatment, such as time and imaging.”

The Solitaire FR device received CE mark approval in 2009 and US Food and Drug Administration 510(k) marketing clearance in 2012.

New development at BrainStorm for commercialisation of NurOwn

2013-01-11T16:40:00Z

BrainStorm, a developer of adult stem cell technologies for neurodegenerative diseases, has announced that it has a development for commercialisation of its stem cell therapy candidate, NurOwn. The company has developed a proprietary method for cryopreservation, or freezing, of cells, which will enable long-term storage, and production of repeat patient doses of NurOwn without the need for additional bone marrow aspirations.

“Cryopreservation will enable us to create a personalised NurOwn stem cell bank for each patient, for ongoing, repeat treatments,” said Adrian Harel, BrainStorm’s CEO. “We will be in a position to produce repeat doses of NurOwn by thawing and processing the patients’ cryopreserved cells, and transporting these doses to medical centers for immediate transplantation.”

Cryopreservation of hematopoeitic stem cells for clinical use has been routinely performed for fifteen years. Cryopreservation of mesenchymal stem cells for clinical use is a more recent phenomenon, and is typically achieved using vapor phase nitrogen. At extreme, sub-zero temperatures, any biological activity, including the biochemical reactions that would cause cell death, is effectively stopped.

According to Harel: “Our unique method of expansion and differentiation of mesenchymal stem cells requires its own cryopreservation methodology. The company has been focused on this aspect of product development in recent months in order to be fully prepared for repeat dosing of amyotrophic lateral sclerosis patients.”

BrainStorm is currently launching a Phase IIa combined treatment, dose-escalating dose trial of its NurOwn cell therapy candidate in amyotrophic lateral sclerosis patients at the Hadassah Medical Center in Jerusalem. The company was recently fast-tracked by the Israeli Ministry of Health after reporting positive safety data for 12 patients in a Phase I/II trial.

BrainStorm is planning to expand its amyotrophic lateral sclerosis clinical development to the USA, pending Food and Drug Administration approval. The company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin amyotrophic lateral sclerosishuman clinical trials at these institutions.

Phenox receives CE mark approval for pCONus Bifurcation Aneurysm Implant

2013-01-11T11:54:00Z

Phenox has announced that the pCONus Bifurcation Aneurysm Implant has been granted CE mark approval for commercialisation within the European Union and any country that accepts CE mark approval. The pCONus implant is a new category of intraluminal stent intended to treat complex, wide neck intracranial bifurcation aneurysms.

Hermann Monstadt, managing director at phenox, said: “phenox continues to expand its portfolio of easy to use innovative tools to help physicians treat patients with complex intracranial aneurysms that have unmet clinical needs. This approval adds support to our strategy of focusing on creative solutions for complex clinical problems.”

The pCONus implant is a new class of endoluminal device that is designed to support the mass of coils at the level of the neck of wide neck bifurcation aneurysms that cannot be easily coiled or surgically treated. It combines features of an endoluminal stent with an intra-aneurysmal implant.

According to the company, the implant features a distal end that opens like a blossoming flower and its petals rest on the inside of the aneurysm along the neck. The body of the implant is deployed in the parent artery and anchors the device securely in place. The device can be deployed completely and recovered completely for optimal, accurate and safe repositioning. When the operator is satisfied with its position the aneurysm is then coiled by passing a microcatheter inside the stent and through a nylon net at the base of the petals. Once the coiling is complete and the physician has removed the coiling microcatheter, the pCONus Implant is detached via an electrolytic detachment process.

According to Ralf Hannes, chief technical officer at phenox, “the pCONus implant offers a significant reduction in the amount of metal typically implanted in “Y stenting” technique. The design of the cells and the implant structure are such that there is less than 5% metal to artery surface coverage.”

Hans Henkes, Katharinenhospital, Stuttgart, Germany said: “the pCONus implant allows me to simplify my treatment strategy for these extremely complex lesions. The simplicity of the system allows me to focus on the coil occlusion rather than the multiple devices that otherwise would be required to protect the branches of the parent artery. It makes a very complex, difficult procedure extremely simple and safe.”

Phenox is planning to conduct a post market surveillance study of 100 patients in order to capture long term data for up to 24 months post treatment.

Asahi Intecc to launch neurovascular guidewires in USA and Europe

2013-01-11T11:13:00Z

Asahi Intecc has announced that it will start the commercial distribution of its neurovascular guidewires (Asahi Chikai and Asahi Chikai 10) in the United States and Europe in January 2013.

The Asahi Chikai and Asahi Chikai 10 micro guidewires were developed as workhorse devices to treat intracranial aneurysms and cerebral arteriovenous fistulas and malformations. The guidewires have been sold in Japan since January 2010. According to the company, the guidewires balance distal flexibility with precise torqueability to ensure optimal performance in neurological interventional procedures.

Approximately 110,000 cerebrovascular procedures are performed annually in Japan, the United States and Europe, according to Asahi Intecc.

The guidewires will be sold via a direct sales team in the United States and through local distributors in Europe.

Late-life depression associated with prevalent mild cognitive impairment and an increased risk of dementia

2013-01-09T11:03:00Z

A study published online first in the Archives of Neurology has suggested that depression is associated with prevalent mild cognitive impairment and an increased risk of dementia in Medicare recipients of 65 years and older.

It has been reported that depressive symptoms occur in 3–63% of patients with mild cognitive impairment and some studies have shown an increased dementia risk in individuals with a history of depression. The mechanisms behind the association between depression and cognitive decline have not been made clear and different mechanisms have been proposed, according to the study background.

Edo Richard, University of Amsterdam, the Netherlands, and colleagues evaluated the association of late-life depression with mild cognitive impairment and dementia in a group of 2,160 community-dwelling Medicare recipients.

“We found that depression was related to a higher risk of prevalent mild cognitive impairment and dementia, incident dementia, and progression from prevalent mild cognitive impairment to dementia, but not to incident mild cognitive impairment,” the authors said.

Baseline depression was associated with prevalent mild cognitive impairment (odds ratio 1.4) and dementia (2.2), while baseline depression was associated with an increased risk of incident dementia (hazard ratio 1.7) but not with incident mild cognitive impairment (0.9). Patients with mild cognitive impairment and coexisting depression at baseline also had a higher risk of progression to dementia (hazard ratio 2.0), especially vascular dementia (4.3), but not Alzheimer disease (1.9), according to the study results.

“Our finding that depression was associated cross sectionally with both mild cognitive impairment and dementia and longitudinally only with dementia suggests that depression develops with the transition from normal cognition to dementia,” the authors concluded.

Managing atrial fibrillation may prevent the risk of stroke

2013-01-09T10:33:00Z

In a presentation at the UK Stroke Forum (4–6 December 2012, Harrogate, UK), Andre Ng, senior lecturer and consultant cardiologist, University of Leicester, Glenfield Hospital, Leicester, UK, spoke to delegates about the management of atrial fibrillation for the secondary prevention of stroke.

The speaker presented data that said atrial fibrillation increases the risk of stroke five-fold and that one third of atrial fibrillation patients will suffer a stroke in their lifetime. He added to this and said that atrial fibrillation is also responsible for 15–20% of ischaemic strokes and patients who have atrial fibrillation and have suffered a previous stroke or transient ischaemic attack are at a high risk of recurrent stroke with more disability.

The European Society of Cardiology guidelines for the management of atrial fibrillation in 2006 said that atrial fibrillation patients with a CHADS₂ score of 2 and above are at high risk of transient ischaemic attack or stroke. The guidelines were reviewed in 2010 and, according to Ng, the CHA₂DS₂VASc score is now used to measure the risk of stroke or transient ischaemic attack for patients with atrial fibrillation with a score of 2 indicating the patient should be treated with oral anticoagulants.

Drug treatments

Ng told delegates that, currently, the pharmacological options for atrial fibrillation patients for the prevention of stroke are vitamin K antagonists (VKA) such as warfarin, phenprocoumon, acenocoumarol and platelet inhibitors such as aspirin and clopidogrel. Ng said that the “classical” studies prove that treatment with warfarin prevents stroke. However, the speaker presented data from current trials on novel oral anticoagulants comparing warfarin and dabigatran (RE-LY trial), warfarin and rivaroxaban (ROCKET AF trial), and warfarin and apixaban (ARISTOTLE trial). The results of these trials, Ng told delegates, were that they all met their primary end points and therefore were proven to be as good as or better at reducing stroke than warfarin. Ng said that, for haemorrhagic stroke, the novel oral anticoagulants were superior for reducing stroke than warfarin and for ischaemic stroke were at least as good as warfarin.

Devices

Ng cited that “plugging” the left atrial appendage reduces clots forming that could lead to stroke this can be achieved percutaneously using devices such as Plaato (Appriva Medical), Watchman (Atritech/Boston Scientific) and Amplatzer plug (St Jude Medical). Ng also said devices such as the implantable cardiac monitor, Reveal XT (Medtronic), could capture data when patients are in atrial fibrillation and therefore monitor the risk of stroke.

Catheter ablation is an effective procedure in controlling symptoms in suitable atrial fibrillation patients and therefore may reduce the risk of stroke, according to Ng.

“In the management of atrial fibrillation for the secondary prevention of stroke diagnosis of atrial fibrillation needs to be actively sought, especially in patients who have had a stroke or a transient ischaemic attack,” said Ng. “A pragmatic approach would be, if an ischaemic cause cannot be found, to treat the patient with anticoagulants.”

“The novel oral anticoagulant drugs are at least as good, and in some instances better, than the current standard which is warfarin,” the speaker concluded.

Accordion effect and spindle shape deformation can affect high-porosity and flow-diverting stents in the treatment of intracranial aneurysms

2013-01-07T10:14:00Z

A study led by Fabrice Bing, University of Montreal Hospital Research Center, Notre-Dame Hospital, Montreal, Canada, and published ahead of print in Neuroradiology has tested the safety and efficacy of high-porosity and flow-diverting stents to treat intracranial aneurysms when used in vivo.

The authors aimed to find in vivo device deformities in relation to porosity in the part of the device lying over the aneurysm neck. The authors compared in vitro testing with in vivo testing in canines.

The flow diverting stents that were used in the study were Silk 3.5mmx30mm (Balt), Pipeline 4x16mm (ev3/Covidien), which are both commercially available, and a prototype flow-diverting stent—3.75x27mm (Microvention)—the three devices were used for the in vitro experiments. The prototype, according to the authors is a stent-in-stent construction that has an inner flow-diverting mesh attached to an outer high porosity stent.

In the in vitro segment of the study, the authors found that “different flow-diverters had different porosities and pore densities (p=0.001) but the measured porosity and pore density of each flow-diverter did not change significantly when deployed in straight glass tubes within a 1mm range.” Therefore no deformations were observed in in vitro experimentations.

A high porosity stent 4.5x30mm (Microvention) and the flow-diverter prototype stent were used for the in vivo experiments which were conducted in 11 beagles in which aneurysms were created in the right carotid artery. Bing and others predicted that: “The structural uniformity of these self-expanding devices may be altered in vivo due to arterial curves, bifurcations and aneurysm or branch ostia.”

In the study, four weeks post aneurysm creation, high-porosity and flow-diverting stents were implanted to bridge the aneurysm neck and the branch ostium. The authors reported that at two weeks angiography the devices had expanded focally at the level of the aneurysm neck leading to a spindle-shaped deformation. It was found, after the stent constructs were opened longitudinally, that the metallic struts across the aneurysm ostium was not uniform and “followed a reproducible pattern resembling an accordion.”

Bing and colleagues concluded the deformations in vivo did not occur in the in vitro. In the benchtop segment of the study, Bing and colleagues recreated the accordion effect and found that the correlations between the spindle-shaped deformation and the accordion effect was close and significant (0.81; p=0.005).

“The present work shows that substantial alteration in device porosity can occur at the most important portion of the stent, the one which overlies the aneurysm neck or branch origin,” commented Bing and others.

“Virtual and in vitro models do not suffice to understand and predict the in vivo behaviour of flow-diverters and stents in the treatment of aneurysms,” said Bing et al. “In vivo experimentations are needed to measure the true, final porosity of the device and size and number of residual pores in the neointiminal layer covering the aneurysm or branch ostia.”

Solitaire FR revascularisation device receives regulatory approval in Canada

2012-12-18T10:47:00Z

Covidien has announced that the Solitaire FR revascularisation device has been approved by Health Canada. The Solitaire FR is a mechanical thrombectomy device designed to retrieve blood clots and restore blood flow to the brain for patients suffering from acute ischaemic stroke.

"This new device is taking acute ischaemic stroke care to a new level," said Mayank Goyal, interventional neuroradiologist, Foothills Medical Centre, Calgary, Canada, and principal investigator of workflow and imaging for the SWIFT-Prime (Solitaire FR as primary treatment for acute ischaemic stroke) study. "It clearly surpasses the first generation of clot-removing procedures, which were only moderately successful in reopening target arteries, and gives us a far superior tool for revascularisation in stroke patients.”

According to the BURST (Canadian Stroke Network’s burden of ischaemic stroke) study, the healthcare costs for patients in Canada in the first six months after they have a stroke is more than CAD$2.5 billion a year.

“Stroke is a widespread public health issue, with approximately 50,000 Canadians experiencing a stroke annually,” said Stacy Enxing Seng, president, Vascular Therapies, Covidien. “Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated.”

The Solitaire FR device received CE Mark approval in Europe and has been sold in that region by Covidien since November 2009. Solitaire FR is also available in the USA, where it received US Food and Drug Administration (FDA) clearance in March 2012.

Apixaban now available in the UK for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation

2012-12-13T10:22:00Z

On 13 December, Bristol-Myers Squibb and Pfizer announced the UK availability of apixaban (Eliquis). The oral anticoagulant is a new prescription only treatment option for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors such as: prior stroke or transient ischaemic attack; age 75 years or older; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).

According to the NHS, atrial fibrillation is the most common heart rhythm disorder thought to cause approximately 12,500 strokes in the UK every year. The National Institute for Health and Clinical Excellence (NICE) estimates that in the UK, 1.2 million people have been diagnosed with AF and the prevalence is believed to be growing (Banach M, et al; Europace 2008 10: 1266–70).

“Atrial fibrillation causes a five-fold increase in stroke risk. AF-related strokes are often more severe and associated with more deaths than non-AF related strokes. For decades, the most commonly used anticoagulant has been warfarin. However, it requires on-going INR monitoring and can have undesirable drug and diet interactions. The availability of more recent medicines such as apixaban adds to the treatment options available to UK physicians,” said John Camm, clinical cardiologist, St George’s Hospital, London, UK.

Apixaban is a tablet taken twice a day at the recommended dose of 5mg (or 2.5mg in selected patients). The anticoagulant is part of the therapeutic class of factor Xa inhibitors and is the only oral anticoagulant with published prospective randomised trials in both a warfarin-unsuitable patient population and a warfarin-suitable patient population (Granger CB, et al; N Engl J Med 2011; 365:981-92 and Connolly SJ et al; N Engl J Med 2011 364(9):806-17).

The new licence is supported by the pivotal ARISTOTLE and AVERROES studies. ARISTOTLE evaluated apixaban vs. warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin, and AVERROES evaluated apixaban vs. aspirin in 5,599 patients with non-valvular AF who were considered unsuitable for warfarin.

“The findings from the ARISTOTLE study are important, it shows a good balance of efficacy and safety with apixaban, in that apixaban has demonstrated both superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding. In addition, ARISTOTLE is the first study to show a significant reduction in all-cause mortality versus warfarin. In this study, apixaban was better tolerated than warfarin, with fewer people stopping treatment.” John McMurray, Institute of Cardiovascular & Medical Sciences, University of Glasgow, UK.

Trudie Lobban, founder and CEO of the Atrial Fibrillation Association, said, “With AF becoming more common in the UK, more patients require anticoagulation to prevent AF-related stroke. Patients being treated with warfarin have to undergo frequent INR monitoring with regular blood tests. Having the choice of effective new treatments which do not require INR monitoring provides the option to tailor therapy to the individual patient. This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

Apixaban (2.5mg twice a day) is already indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.

Intra-arterial revascularisation with stents safe and effective for stroke patients with contraindication for intravenous thrombolysis

2012-12-12T11:43:00Z

Some stroke patients may benefit from cerebral angioplasty and stent placement, according to a new study published online ahead-of-print in the 11 December issue of the journal Radiology.

Martin Roubec, neurologist, Comprehensive Stroke Center, University Hospital Ostrava, Czech Republic and others set out to compare the safety and effectiveness of intra-arterial revascularisation using stents vs. no revascularisation in patients with contraindications to be treated with intravenous thrombolysis (IVT) or patients who failed to respond to IVT. Roubec stated: “As many as 70% of ischaemic stroke patients could have positive clinical outcomes with the additional use of intra-arterial revascularisation using stents.”

“Intravenous thrombolysis must be administered within four and a half hours of the onset of a stroke and cannot be used in patients who are taking anticoagulant medication,” said study author, David Školoudík, associate professor at University Hospital Ostrava. “Because of these limitations, the majority of ischaemic stroke patients receive no therapy at all.”

The study involved 131 acute ischaemic stroke patients treated over a two-year period at two comprehensive stroke centres in Ostrava and Olomouc, Czech Republic. The patients, including 74 men and 57 women (mean age 65.8), all had a blockage in the middle cerebral artery detected by computed tomography (CT) or magnetic resonance imaging (MRI).

Seventy-five patients were treated with IVT; 26 (35%) of whom achieved a favorable three-month outcome. The remaining 49 patients, for whom IVT failed to re-open the blocked artery, received either cerebral angioplasty/stent placement or no additional therapy.

Of the 23 patients who underwent angioplasty and stenting, 10 (43.5%) achieved a favorable three-month outcome. Of the 26 patients who received no more therapy, four (15.4%) had a favorable outcome.

The remaining two groups of patients were ineligible for IVT and received either revascularisation treatment or received no further therapy. Of the 31 patients who underwent angioplasty and stent placement, 14 (45.2%) achieved a favorable outcome. Of the 25 patients who received no therapy, two (8%) had a favorable outcome.

To perform the intra-arterial revascularisation procedure, the physicians used an imaging technique called digital subtraction angiography to visualise the blood vessels and a guide wire to maneuver a balloon-tipped catheter to the location of the blockage in the middle cerebral artery. Once the balloon was inflated, deflated and withdrawn, a stent was inserted to help the artery remain open. Patients with a favorable three-month outcome following the procedure were able to live independently and perform normal daily activities.

Roubec concluded: “We demonstrated that in patients with middle cerebral artery blockage after IVT failure or for whom IVT is contraindicated, revascularisation with stents is superior to providing no further therapy.”

Researchers discover new links leading to neuron death

2012-12-11T12:52:00Z

Researchers supported by The ALS Association have discovered an important process that puts neurons at risk of the cell death, which characterises numerous neurodegenerative diseases. The discovery, which was published on 10 December in the Proceedings of the National Academy of Sciences, highlights the links between several proteins known to go awry in ALS and a related disease, frontotemporal dementia (FTD).

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, currently, there is no cure, and only one drug approved by the US Food and Drug Administration (FDA) modestly extends survival.

“This new finding puts together several critical links in the chain leading to neuronal death,” said Lucie Bruijn, chief scientist for The ALS Association.

The first protein in the chain is called TDP-43. Lack of TDP-43 has previously been shown to cause both ALS and FTD. The new study showed that when there is too little TDP-43, another protein, called sortilin, is made in excess. Some copies of that protein are defective, the researchers found.

Both normal and defective sortilin bind to another protein, called progranulin, a growth factor for neurons. But when excess normal sortilin and the defective sortilin bind to progranulin, neurons become deprived of this important growth factor. Thus, too little TDP-43 leads to too much normal and defective sortilin, which diminishes the amount of neuroprotective progranulin. Lack of progranulin leads to death of neurons.

The research was led by Mercedes Prudencio and Leonard Petrucelli, both of the Mayo Clinic in Jacksonville, Florida, USA and Emanuele Buratti of the International Center for Genetic Engineering and Biotechnology in Trieste, Italy.

Prudencio is a recipient of the Milton Safenowitz Post-Doctoral Fellowship for ALS Research from The ALS Association. The ALS Association is especially committed to bringing new concepts and methods into ALS research, and young scientists play an important role in this process. Funding is generously provided by the Safenowitz family through the Greater New York Chapter of The ALS Association, in memory of Milton, who died in 1998 of the disease.

“We are extremely pleased that our support has helped Prudencio advance the field through this research,” Bruijn said. “The discovery of this mechanism is important for understanding how neurons die in ALS and FTD, and in the development of new therapies targeting this pathway.”

Stroke associated with a threefold increased future mortality in CREST

2012-12-11T12:37:00Z

Strokes, particularly those classified as severe, were uncommon after carotid intervention in the CREST trial. Strokes, however, were associated with significant morbidity and future mortality, a new analysis of the trial has shown. In the sub-analysis, published online ahead of print in Circulation, the authors stated that these strokes may be preventable.

“Stroke occurs more commonly after carotid artery stenting than carotid endarterectomy. Details regarding stroke type, severity, and characteristics have not been previously reported,” the investigators, led by Thomas G Brott, Mayo Clinic, Jacksonville, USA, wrote. In the sub-analysis, the group described the strokes occurring in CREST (Carotid revascularization endarterectomy versus stenting trial).

CREST is a randomised, open-allocation, controlled trial with blinded endpoint adjudication. Stroke was a component of the primary composite outcome. Patients who received their assigned treatment within 30 days of randomisation were included. Stroke was adjudicated by a panel of board-certified vascular neurologists with secondary central review of clinically-obtained brain images. Stroke type, laterality, timing, and outcome were reported.

A periprocedural stroke occurred among 81 of the 2,502 patients randomised and among 69 (3%) of the 2,272 in this analysis (patients who received their assigned treatment within 30 days of randomisation). The results of the sub-analysis showed that strokes were predominantly minor (81%, n=56), overwhelmingly ischaemic (90%, n=62), in the anterior circulation (94%, n=65), and ipsilateral to the treated artery (88%, n=61). There were seven haemorrhages, occurring 3–21 days post-procedure, and five were fatal. Major strokes occurred in 13 (0.6%) of the 2,272 patients. The estimated four-year mortality after stroke was 21.1% compared to 11.6% for those without stroke. The adjusted risk of death at four years was higher after periprocedural stroke (HR=2.78, 95% CI 1.63–4.76).

The authors wrote that although stroke was uncommon after carotid intervention, it was independently associated with a near threefold increased future mortality. “The delayed timing of major and haemorrhagic stroke after revascularisation suggests that these strokes may be preventable. Minor stroke occurred most commonly and temporally at the time of carotid artery stenting suggesting that carotid artery stenting has potential for further improvement from expected advances in technology, technique, and training,” they said.

Precision Spectra Spinal Cord Stimulator System gets the CE mark

2012-12-10T11:56:00Z

Boston Scientific has received CE mark approval and has begun the European market launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. The system is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain.

According to the company, the Precision Spectra System is the world’s first and only SCS system with 32 contacts and 32 dedicated power sources. The first commercial implant of the Precision Spectra System was performed in November 2012 by Simon Thomson, consultant in Pain Medicine and Neuromodulation, Basildon and Thurrock University Hospitals, UK.

Designed to manage chronic pain, spinal cord stimulators deliver electrical pulses from an implantable pulse generator to leads with stimulating contacts. These electrical pulses mask pain signals traveling to the brain. Until now, SCS systems have offered a maximum of 16 contacts and two lead ports, with each lead port allowing the placement of one lead. By providing 32 contacts and four lead ports—twice that of any other SCS system—the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain. Additional lead ports also give physicians more flexibility to treat their patients’ pain at time of implant and more flexibility to adapt to changing pain patterns in the future.

“Over the past 30 years, SCS systems have evolved from four to eight to 16 contacts. At each step, we have seen an improvement in our ability to cover pain,” said Thomson. “Now, by doubling the number of contacts to 32 while providing a dedicated power source for each contact, the Precision Spectra System advances our ability to provide pain relief.”

Boston Scientific plans to make significant investment in several clinical trials and build upon its current portfolio of chronic pain management and neuromodulation solutions.

The company has recently begun the following trials:

OPTIONS trial: A prospective, multicentre, single arm study to further characterise the benefits of having a 32 contact option using the Precision Spectra System.
MAP trial: A cross-sectional, multicentre study to identify the prevalence of multiple areas of pain in SCS-eligible patients with certain diseases.

The Precision Spectra SCS System is currently under review by the US Food and Drug Administration, and is not available for sale in the United States.

Alliance for MRI welcomes derogation by European Parliament committee on existing magnetic resonance imaging law

2012-12-07T15:32:00Z

The Alliance for MRI welcomed action by a European Parliament committee on Thursday 6 December that guarantees continued patient access to magnetic resonance imaging (MRI).

The Committee for Employment and Social Affairs exempted workers who deal with MRI from exposure limits contained in the “Directive on Protecting Workers from Exposure to Electromagnetic fields.” The committee-approved draft will be used as the basis of informal negotiations with Council. If agreement is reached, it will be voted on next year by the full Parliament.

“Today’s vote is an important step that reverses an earlier detrimental decision. Without this change patients could not have benefited from MRI in the diagnosis and treatment of life-threatening diseases,” said Gabriel Krestin, president of the European Society for Radiology.

The safe use of MRI is regulated through the Medical Devices Directive. During almost 30 years MRI has been used to create images of more than 600 million patients, without any evidence that workers have been harmed by exposure to electromagnetic fields.

The parliamentary committee’s action corrects problems with the original Directive and endorses an updated proposal by the European Commission on Protecting Workers. By subjecting MRI to overly restrictive limits the original version would have curtailed MRI-guided brain surgery and made MRI difficult to use in situations where close patient contact is required, including imaging of vulnerable patients and children. The exemption is also necessary for research and development and for routine cleaning and maintenance of MRI equipment.

Mary Baker, patient group representative from the European Brain Council said: “The derogation for magnetic resonance imaging that was endorsed today will ensure that serious medical conditions such as cancer will be diagnosed and treated to the benefit of patients in Europe. I am calling on all Members of the European Parliament to follow the example of their colleagues and to support the MRI derogation in the plenary vote in early 2013.”

About the Alliance for MRI

The ’Alliance for MRI’ is a coalition of European Parliamentarians, patient groups, leading European scientists and the medical community, who together are seeking to avert the serious threat posed by EU health and safety legislation to the clinical and research use of Magnetic Resonance Imaging (MRI).

The Alliance for MRI was officially launched in March 2007 in response to pending implementation of the EU Physical Agents 2004/40/EC (on electromagnetic fields) in April 2008. The Alliance was founded by the European Society of Radiology, the European Federation of Neurological Associations and Swoboda MEP, chair of the Socialist Group in the European Parliament.

ADvance study of deep brain stimulation for Alzheimer’s disease performs first successful implant in the USA

2012-12-07T12:24:00Z

The first US patient to enrol in the ADvance study was successfully implanted with a deep brain stimulation (DBS) system from Functional Neuromodulation. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s.

According to a company release, the ADvance study has had six implants conducted to date. The first US implant was done at Johns Hopkins and five patients have been implanted at the Toronto Western Hospital in Canada. The company release also said that the University of Pennsylvania has joined the study, bringing the total to five leading North American research centres participating in ADvance.

“In just two years, we have partnered with expert clinical researchers and assembled a lean team of seasoned professionals that have propelled the company through funding, regulatory requirements, study initiation and significant patient enrollment,” said Todd Langevin, president and COO of Functional Neuromodulation.

“Given the urgent need for progress and the ongoing challenges in drug research for Alzheimer’s, we are excited to assess a completely new circuitry-based approach that could offer hope,” commented David Wolk, assistant professor of Neurology and assistant director of the Penn Memory Center. “Pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression. ADvance will help us to determine whether stimulation of the fornix can drive activity in the memory circuit to improve memory and lead to better clinical outcomes.”

About ADvance

ADvance is a randomised double-blind controlled trial initially involving 20 people aged 55-80 with mild Alzheimer’s disease. Patients are currently being recruited to participate in the study at the Banner Alzheimer’s Institute in Phoenix, Johns Hopkins Bayview Medical Center, Toronto Western Hospital, University of Florida Center for Movement Disorders and Neurorestoration and the University of Pennsylvania.

The trial will compare the effects of DBS turned on to those observed with the system turned off. The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will be eligible to have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points.

ADvance is co-chaired by Andres Lozano, tasker chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and scientific founder of Functional Neuromodulation; and Constantine Lyketsos, Elizabeth Plank Althouse professor, Johns Hopkins University, and director, Johns Hopkins Memory and Alzheimer’s Treatment Center.

ExAblate Neuro transcranial focused ultrasound system gets the CE mark for the treatment of neurological disorders

2012-12-04T15:54:00Z

On 4 December, InSightec announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the CE mark for the treatment of neurological disorders including: essential tremor, Parkinson’s disease and neuropathic pain.

Treatment options for patients who do not respond to drug treatments include deep brain stimulation, radiofrequency ablation and radiosurgery which are invasive or involve ionising radiation and are associated with recognised risks such as high doses of ionising radiation or high risk of complications and side effects including infection, bleeding and collateral brain tissue damage.

According to the company, ExAblate Neuro integrates high intensity focused ultrasound surgery with continuous magnetic resonance imaging (MRI) to provide a non invasive, acoustic surgery platform for treating neurological disorders without ionising radiation through an intact skull.

“ExAblate offers great potential for treating brain disorders. Because of its targeting accuracy, real time treatment monitoring and ability to provide non-invasive brain treatment, there is hope that many people who suffer from neurological diseases can benefit from this treatment,” said Kobi Vortman, president of InSightec. “Results from the clinical studies showed that patients, many of whom suffered for years from neurological disorders, experienced immediate symptom improvement with a high safety profile. These patients are now better able to conduct activities of daily living and are also less dependent on external caregiver support.”

“ExAblate Neuro offers a non-invasive treatment with no ionising radiation, which treats tissue deep in the brain through an intact skull. MR guided focused ultrasound combines therapeutic acoustic ultrasound waves with continuous MRI guidance,” said Eyal Zadicario, vice president of R&D and director of InSightec’s Neuro programme. “The MRI enables physicians to visualise, plan, guide, monitor and control the treatment while the ultrasound acoustic energy destroys the targeted tissue in the brain.”

On 20 August 2012, the company announced the FDA approval to begin a phase I clinical trial evaluating the use of its ExAblate Neuro system for the treatment of patients with tremor dominant Parkinson’s Disease.

Toshiba launches Aquilion One Vision Edition CT scanner

2012-11-30T13:16:00Z

Toshiba launched its Aquilion One Vision Edition system at the Radiological Society of North America (RSNA) annual meeting (Chicago, USA, 25–30 November). The CT scanner is specially designed to detect cardiovascular and neurovascular diseases.

Aquilion One Vision Edition is equipped with a gantry rotation of 0.275 seconds, a 100 kw generator and 320 detector rows (640 unique slices) covering 16cm in a single rotation, with the industry’s thinnest slices, 500 microns (0.5 mm). The system can accommodate more patients with its 78cm bore and fast rotation, including bariatric and patients with high heart rates.

The system also includes Toshiba’s third-generation iterative dose reconstruction software, AIDR 3D, which incorporates significant system enhancements by reducing radiation dose compared with conventional scanning.

“Aquilion One Vision Edition reduces risk and maximises returns,” said Satrajit Misra, senior director, CT Business Unit, Toshiba. “It is capable of imaging the entire brain and heart in a single rotation with 500-micron accuracy, and can capture both anatomical and functional data.”

The system has been installed at Fujita Health University in Japan; National Heart, Lung, and Blood Institute (NHLBI) at National Institutes of Health in Bethesda, Md.; Radboud University Nijmegen Medical Centre in the Netherlands; Monash Medical Centre Clayton, Southern Health in Australia; Hong Kong Sanatorium & Hospital in Hong Kong; and Iwate Medical University in Japan. The company announced that future installations include University Health Network—Toronto General Hospital in Canada and Rigshospitalet in Denmark.

Mobile Cardiac Outpatient Telemetry helps to detect paroxysmal atrial fibrillation in cryptogenic stroke patients

2012-11-30T12:30:00Z

A study published in the Journal of the Neurological Sciences has found that Mobile Cardiac Outpatient Telemetry (MCOT) supports the detection of a high rate of occult paroxysmal atrial fibrillation (PAF) in cryptogenic stroke and transient ischaemic attack (TIA) patients.

Daniel J Miller, Department of Neurology, Henry Ford Hospital, Detroit, USA, and colleagues performed a retrospective analysis on patients evaluated by MCOT (CardioNet) monitoring within six months of a cryptogenic stroke or TIA. The researchers performed multivariate analysis with survival regression methods using baseline characteristics to determine predictive risk factors for detection of paroxysmal atrial fibrillation. Kaplan–Meier estimates were computed for 21-day PAF rates.

Miller et al analised 156 records and found that PAF occurred in 27 (17.3%) patients during MCOT monitoring of up to 30days. The authors found that the rate of PAF detection significantly increased from 3.9% in the initial 48hours, to 9.2% at 7days, 15.1% at 14days, and 19.5% by 21days (p<0.05).

The researchers also found that female gender, premature atrial complex on ECG, increased left atrial diameter, reduced left ventricular ejection fraction and greater stroke severity were independent predictors of PAF detection on multivariate analysis with strongest correlation seen for premature atrial complex on ECG (HR 13.7, p=0.001).

Miller, senior author of the study, commented: “This study highlights the importance of a standardised approach to the evaluation for potential arrhythmias in patients with cryptogenic stroke or TIA. Screening with a minimum of 21 days of outpatient telemetry monitoring with automated arrhythmia detection software should be considered a routine part of the stroke evaluation in these patients. Identification and treatment of atrial fibrillation in these patients will likely reduce the risk of future stroke.”

Miller et al concluded: “Length of monitoring is strongly associated with detection of PAF, with an optimal monitoring period of at least 21days. Of the predictors of PAF detection, the presence of premature atrial complexes on ECG held the strongest correlation with PAF.”

This recent clinical trial supports the results from a previous study, “Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic tia or stroke”, authored by AH Tayal et al, Allegheny General Hospital, Comprehensive Stroke Center, Pittsburgh, USA, and published in the 18 November 2008 issue of Neurology which concluded that the MCOTdetected a high rate of atrial fibrillation in patients that have experienced a TIA or stroke.

Stroke treatment performed by interventional radiologists in collaboration with diagnostic neuroradiologists and stroke neurologists is safe and efficacious

2012-11-29T11:26:00Z

A study, published in CardioVascular and Interventional Radiology, has investigated the possibility of collaboration between vascular interventional radiologists, diagnostic neuroradiologists and stroke neurologists for neurointerventional treatment of acute stroke as a strategy for centres lacking of specialised interventional neuroradiologists.

The study, led by Lars Fjetland, Department of Radiology, Stavanger University Hospital, Stavanger, Norway, and others aimed to “evaluate the safety and efficacy of neurointerventional procedures in acute stroke patients performed by vascular interventional radiologists in cooperation with diagnostic neuroradiologists and stroke neurologists and compare the results with those of previous reports from centres with specialised interventional neuroradiologists.”

The current literature on acute ischaemic stroke treatment with neurointerventional procedures such as intravenous thrombolysis with recombinant tissue-plasminogen activator (rt-PA), intra-arterial thrombolysis or mechanical thrombectomy, according to Fjetland et al, “comes mostly from high volume stroke centres, and the treatment is performed by interventional neuroradiologists.” However, the authors wrote, quoting Hirsh JA et al (J Neurointerv Sur; 1:27-31) “The availability of these centres and specialists is limited and not sufficient to give the population an equal offer of invasive stroke treatment.”

This study shows the experience of a university medical centre serving a population of approximately 330,000 inhabitants where invasive reperfusion is performed by vascular interventional radiologists in collaboration with diagnostic neuroradiologists and stroke neurologists, the authors wrote.

Thirty nine patients with acute ischaemic stroke who were not eligible for first-line intravenous thrombolysis were included in the study, from May 2009 to October 2011. The patients were treated with intra-arterial thrombolysis (Penumbra system) or mechanical thrombectomy (Solitaire FR thrombectomy system, eV3/Covidien). All patients underwent cerebral computed tomography (CT) and: “The decision about endovascular treatment was made by a team consisting of the treating stroke neurologist, a vascular interventional radiologist, and a diagnostic neuroradiologist,” the authors wrote. Five experienced vascular interventional radiologists performed the endovascular treatments.

According to the results, 14 patients (35.9%) had a good clinical outcome (mRS score ≤2) at 90 days post-procedure of which 10 patients were treated with the Penumbra system, one with the Solitaire FR, two with intra-arterial thrombolysis and one with guidewire/catheter manipulation. Eight patients (32%) with middle cerebral artery occlusion, three with basilar occlusion (50%) and three with (50%) with tandem lesions had good clinical outcome with an overall pre-procedure rate of 5.1%.

The results also showed that nine patients (22.5%) died during the first 90 days after treatment, six of them were >80 years old, and two died from cerebrovascular causes.

“In this study, we found that endovascular stroke treatment performed by interventional radiologists, working in close cooperation with diagnostic neuroradiologists and neurologists, appears to be a safe and feasible method of treating this devastating disorder,” said Fjetland et al.

The authors commented: “The presented approach of close cooperation among different specialties may yield a model by which to establish endovascular treatment possibilities in hospitals without interventional neuroradiologists.”

Active lifestyle boosts brain structure and slows Alzheimer’s disease

2012-11-28T14:23:00Z

An active lifestyle helps preserve gray matter in the brains of older adults and could reduce the burden of dementia and Alzheimer’s disease, according to a study presented at the annual meeting of the Radiological Society of North America (RSNA).

Cyrus Raji, radiology resident at the University of California in Los Angeles, USA, and colleagues recently examined how an active lifestyle can influence brain structure in 876 adults (average age 78 years) drawn from the multisite Cardiovascular Health Study. The patients’ condition ranged from normal cognition to Alzheimer’s dementia.

“We had 20 years of clinical data on this group, including body mass index and lifestyle habits,” Raji said. “We drew our patients from four sites across the country, and we were able to assess energy output in the form of kilocalories per week.”

The lifestyle factors examined included recreational sports, gardening and yard work, bicycling, dancing and riding an exercise cycle.

The researchers used magnetic resonance imaging (MRI) and a technique called voxel-based morphometry to model the relationships between energy output and gray matter volume.

“Voxel-based morphometry is an advanced method that allows a computer to analyse an MR image and build a mathematical model that helps us to understand the relationship between active lifestyle and gray matter volume,” Raji said. “Gray matter volume is a key marker of brain health. Larger gray matter volume means a healthier brain. Shrinking volume is seen in Alzheimer’s disease.”

After controlling for age, head size, cognitive impairment, gender, body mass index, education, study site location and white matter disease, the researchers found a strong association between energy output and gray matter volumes in areas of the brain crucial for cognitive function. Greater caloric expenditure was related to larger gray matter volumes in the frontal, temporal and parietal lobes, including the hippocampus, posterior cingulate and basal ganglia. There was a strong association between high energy output and greater gray matter volume in patients with mild cognitive impairment and Alzheimer’s disease.

“Gray matter includes neurons that function in cognition and higher order cognitive processes,” Raji said. “The areas of the brain that benefited from an active lifestyle are the ones that consume the most energy and are very sensitive to damage.”

A key aspect of the study was its focus on having variety in lifestyle choices, Raji noted.

“What struck me most about the study results is that it is not one but a combination of lifestyle choices and activities that benefit the brain,” he said.

Raji said the positive influence of an active lifestyle on the brain was likely due to improved vascular health.

“Virtually all of the physical activities examined in this study are some variation of aerobic physical activity, which we know from other work can improve cerebral blood flow and strengthen neuronal connections,” he said.

“Additional work needs to be done,” Raji added. “However, our initial results show that brain aging can be alleviated through an active lifestyle.”

Coauthors of the study are Michael Gach, Owen Carmichael, James T Becker, Oscar Lopez, Paul Thompson, William Longstreth, Lewis Kuller, and Kirk Ericson.

Researchers find evidence that brain compensates after traumatic injury

2012-11-27T13:56:00Z

A new study has found that diffusion tensor imaging may be able to predict which patients who have experienced concussions will improve. The results, presented at the annual meeting of the Radiological Society of North America (RSNA), suggest that, in some patients, the brain may change to compensate for the damage caused by the injury.

“This finding could lead to strategies for preventing and repairing the damage that accompanies traumatic brain injury,” said Michael Lipton, lead author of the study, associate director of the Gruss Magnetic Resonance Research Center, Albert Einstein College of Medicine and medical director of MRI services at Montefiore, the University Hospital and academic medical center for Einstein.

Each year, 1.7 million people in the USA, sustain traumatic brain injuries (TBI), according to the Centers for Disease Control and Prevention. Concussions and other mild TBIs (or mTBIs) account for at least 75% of these injuries. Following a concussion, some patients experience a brief loss of consciousness. Other symptoms include headache, dizziness, memory loss, attention deficit, depression and anxiety. Some of these conditions may persist for months or even years in as many as 30% of patients.

The study involved 17 patients brought to the emergency department at Montefiore and Jacobi Medical Centers and diagnosed with mTBI. Within two weeks of their injuries, the patients underwent diffusion tensor imaging (DTI), which “sees” the movement of water molecules within and along axons. DTI allows researchers to measure the uniformity of water movement (called fractional anisotropy or FA) throughout the brain. Areas of low FA indicate axonal injury while areas of abnormally high FA indicate changes in the brain.

“In a traumatic brain injury, it is not one specific area that is affected but multiple areas of the brain which are interconnected by axons,” said Lipton, who is also associate professor of radiology, of psychiatry and behavioral sciences, and in the Dominick P Purpura Department of Neuroscience at Einstein. “Abnormally low FA within white matter has been correlated with cognitive impairment in concussion patients. We believe that high FA is evidence not of axonal injury, but of brain changes that are occurring in response to the trauma.”

One year after their brain injury, the patients completed two standard questionnaires to assess their post-concussion symptoms and evaluate their health status and quality of life. “Most TBI studies assess cognitive function, but it is not at all clear if and how well such measures assess real-life functioning,” said Lipton. “Our questionnaires asked about post-concussion symptoms and how those symptoms affected patients’ health and quality of life.”

Comparing the DTI data to the patient questionnaires, the researchers found that the presence of abnormally high FA predicted fewer post-concussion symptoms and better functioning. The results suggest that the brain may be actively compensating for its injuries in patients who exhibit areas of high FA on DTI.

“These results could lead to better treatment for concussion if we can find ways to enhance the brain’s compensatory mechanisms.” Lipton said.

Coauthors of the study are Sara B Rosenbaum, Namhee Kim, Craig A Branch, Richard B Lipton and Molly E Zimmerman.

Worldwide incidence of traumatic brain injury could be six times higher than previous estimates

2012-11-26T15:19:00Z

The first study to estimate rates of traumatic brain injury (TBI), without relying on official figures, has suggested that the worldwide incidence of TBI could be six times higher than previously estimated. The New Zealand population-based study, published online first in The Lancet Neurology, found that rates of TBI (790/100 000 people per year), and particularly mild TBI (749/100 000), were far higher than in other high-income countries in Europe (47–453/100 000) and North America (51–618/100 000).

“Our estimates are the first to include more mild cases of TBI that are not usually treated in hospital and, thus, are often overlooked in official estimates,” explained Valery Feigin, director of the National Institute for Stroke and Applied Neurosciences, AUT University, Auckland, New Zealand and research leader.

“It is the first study to show that 95% of all TBI cases are mild and that the true annual incidence of mild TBI is substantially higher than recent World Health Organisation (WHO) estimates (100–300/100 000 people per year). Based on these findings, we estimate that some 54–60 million people worldwide sustain a TBI each year, of which some 2.2–3.6 million people incur moderate or severe TBI. This is almost six times higher than previous estimates and means that every second two people in the world are struck by a new TBI.”

TBI is the leading cause of long-term disability among children and young adults and cost the USA alone an estimated US$406 billion in 2000. TBI is projected to become the third largest cause of disease burden worldwide by 2020.

The BIONIC (Brain injury outcomes New Zealand in the community) study examined multiple overlapping sources of information (eg, public hospitals, family doctors, rehabilitation centres, coroner/autopsy records, rest homes, ambulance services, and prisons) to record all new cases of TBI that occurred over a one-year period (1 March 2010 to 28 February 2011) in an area (173,205 residents) representative of the New Zealand population in terms of demographic, ethnic, socio-economic, and urban and rural structure.

Rates of TBI were highest in children (0–14 years old) and younger adults (15–34 years old), accounting for almost 70% of cases, far higher than the 40–60% reported in previous studies.

Men were nearly twice as likely to have a mild TBI as women, and almost three times as likely to sustain a moderate or severe TBI. Maori people also fared worse than New Zealand Europeans, with a 23% greater risk of mild TBI.

Consistent with previous reports, the new figures also indicate that people living in rural areas have more than twice the risk of moderate or severe TBI than those living in urban areas, mainly due to transport accidents.

According to Feigin, “Our analysis raises some very important issues, in particular that healthcare policy and provision may be grossly inadequate for the huge and growing burden of TBI worldwide. More comparable population-based studies of TBI are urgently needed to inform effective treatment, prevention, and rehabilitation strategies.”

Feigin expanded on this saying: “Our research findings have some clear practical and research implications. For medical practice, our findings allow evidence-based planning and resource allocation for people with traumatic brain injury (eg, number of beds and services required for children and adults with acute brain injury) for a population served. Even more importantly, our findings showed that the true burden of traumatic brain injury is far greater than anybody anticipated and this is a time to act on developing more effective strategies to stop and, hopefully, reverse this silent epidemic. They also draw health-care policy makers’ attention to the need of public education about early symptoms of traumatic brain injury, especially mild injury, as well as the need for further development of effective strategies for brain injury prevention, with the emphasis on prevention of injuries due to falls in young adults and elderly. The unusually high proportion of brain injuries due to assaults also requires attention. For future research, our study underlines the obvious lack of prospective, truly population-based studies of traumatic brain injury incidence and outcomes and provides clear guidelines on how to conduct such studies in the most comprehensive and comparable way. Given the scope of the problem, more research is needed into the causes and management of traumatic brain injury.”

Nada Andelic, Oslo University Hospital, Norway, in a linked comment said that there is call for the development of national TBI surveillance systems to monitor trends and develop appropriate preventive measures, control strategies, and effective TBI care. She added, “A greater understanding of patient-specific characteristics is needed to reduce TBI risk at the individual level, and a focus on age, mechanism of injury, and severity-specific groups is needed to reduce the incidence of TBI at the population level.”

National Institute for Health and Clinical Excellence recommends BIS Brain Monitoring System to measure depth of anaesthesia

2012-11-26T14:56:00Z

UK’s National Institute for Health and Clinical Excellence (NICE) has recommends the use of electroencephalography (EEG)-based monitors, specifically the Bispectral Index (BIS, Covidien) monitor, as an option for measuring depth of anaesthesia.

The recommendation specifies that the BIS monitor should be used with all patients receiving total intravenous anaesthesia and during any type of general anaesthesia with patients considered at high risk of adverse outcomes. This includes patients at high risk of unintended awareness and patients at high risk of excessively deep anaesthesia. The BIS Brain Monitoring System helps clinicians assess patient consciousness levels through electrical activity in the brain.

The NICE guidance specifically recommends the BIS system as an option in the care of patients at high risk for unintended awareness (consciousness) or excessively deep anaesthesia levels during surgery. Both can lead to serious short- and long-term health risks, including post-traumatic stress disorder, heart attack, and stroke and in older patients, cognitive dysfunction or “brain fog.”

Patients at high risk for unintended awareness include older patients as well as those with morbid obesity, poor cardiovascular function, presence of two or more chronic diseases, high opiate or alcohol use, intravenous anaesthesia techniques and certain types of surgical procedures.

The recommendation for BIS monitoring as an option in patients receiving total intravenous anaesthesia was made because it is cost effective and because it is not possible to measure anaesthetic concentration in these patients.

“The NICE assessment and recommendations provide clear guidance to anaesthesia professionals regarding the use of depth of anaesthesia monitoring that will greatly improve patient care and safety for individuals at higher risk for adverse reactions to general anaesthesia,” said Scott Kelley, chief medical officer, Respiratory and Monitoring Solutions, Covidien. “With BIS brain monitoring technology, anaesthetists, in combination with their other standard practices, can accurately determine consciousness and tailor anaesthesia dosing to ensure optimal patient experience and minimise risks.”

The NICE Diagnostics Guidance is based on extensive clinical evidence and an assessment report prepared by the University of Southampton’s Southampton Health Technology Assessment Centre and input from a number of professional organisations and device manufacturers. Other brain monitoring technologies assessed as part of the clinical research include the GE Healthcare E-Entropy and Schiller Narcotrend-Compact M.

Perispinal administration of etanercept helps to improve neurological dysfunction following stroke or traumatic brain injury

2012-11-23T11:55:00Z

An observational study has provided clinical evidence that chronic neurological dysfunction from stroke or traumatic brain injury can rapidly improve following perispinal administration of etanercept, a drug that targets brain inflammation, even years or decades after the initial event. The study titled “Selective TNF (tumour necrosis factor) inhibition for chronic stroke and traumatic brain injury” has been published online ahead-of-print in the journal CNS Drugs and will be published in the 1 December print issue.

According to background information provided by study author Edward Tobinick, Institute of Neurological Recovery, Los Angeles, USA, and colleagues: “Brain injury from stroke and traumatic brain injury (TBI) may result in a persistent neuroinflammatory response in the injury penumbra. This response may include microglial activation and excess levels of tumour necrosis factor (TNF).”

The authors also suggested that from previous experimental data, etanercept, a selective TNF inhibitor, may improve microglial activation and modulate the adverse synaptic effects of excess TNF. Therefore, the researchers set out to evaluate the clinical response following perispinal administration of etanercept—a novel drug delivery method patented by Tobinick—in a cohort of patients with chronic neurological dysfunction after stroke and TBI. Tobinick et al wrote that “there is currently no drug treatment that is specifically approved to treat the spectrum of chronic neurological dysfunction affecting the 4.5 million survivors of stroke in the USA.”

Tobinick et al highlighted that previous clinical evidence has suggested “the potential of perispinal administration of etanercept for rapid relief of pain and neurological dysfunction due to herniated nucleus pulposus and spinal pain due to bone metastases.” Treatment of Alzheimer’s disease and related forms of dementia with perispinal etanercept has also been studied with results of “rapid and sustained improvement in cognitive function,” the authors wrote.

The study was conducted at the Institute of Neurological Recovery in California and Florida, USA, from 1 November 2010 to 14 July 2012 and included 629 patients treated open-label. The researchers reviewed 617 patients (mean age 65.8 years±13.15, range 13–97) treated an average of 42±57.84 months (range 0.5–419) after stroke, and 12 patients (mean age 34.7±13.8, range 19–52) treated an average of 115.2±160.22 months (range 4–537) after TBI.

Results

In the stroke group, the researchers found that there were statistically significant improvements immediately, one week and three weeks after treatment in motor impairment, spasticity, sensory impairment, cognition, psychological/behavioural function, aphasia and pain, and some other improvements such as reductions in pseudobulbar affect and urinary incontinence. In the TBI cohort, motor impairment and spasticity were statistically reduced. The authors also noted a strong positive effect of treatment in the subgroup of patients treated more than 10 years after stroke and TBI (see Table 1 and Table 2).

Table 1
STROKE COHORT: Changes in impairment, by impairment type and time point, after a single dose of perispinal etanercept
	Immediately	After 1 week	After 3 weeks
Motor	93.40%	89.80%	89%
p value	<0.0001	<0.0001	<0.0001

Spasticity	85.60%	82.90%	81%
p value	<0.0001	<0.0001	<0.0001

Cognitive	75.10%	86.50%	85.80%
p value	<0.0001	<0.0001	<0.0001

Aphasia	60.10%	76.40%	77.60%
p value	0.0008	<0.0001	<0.0001

Pain	50.20%	72.10%	73.10%
p value	>0.999	<0.0001	<0.0001
Patients N=617 / Average years: 65.8 / Average months since stroke: 42

Table 2
TBI COHORT: Changes in impairment, by impairment type and time point, after a single dose of perispinal etanercept
	Immediately	After 1 Week	After 3 Weeks
Motor	90.90%	100%	100%
p value	0.0117	0.001	0.0078

Spasticity	100%	100%	100%
p value	0.0039	0.0039	0.0312
Patients N=12 / Average years 34.7 / Average months since TBI: 115.2

The authors concluded that “Perispinal administration of etanercept produces clinical improvement in patients with chronic neurological dysfunction following stroke and TBI.” They also recognised the significance that the therapeutic possibilities extend beyond a decade after stroke and TBI. They also acknowledged the need to undertake randomised clinical trials “to further quantify and characterise the clinical response.”

Tobinick explained to NeuroNews how perispinal etanercept works and the reason why it is effective in the improvement of chronic neurological dysfunction, he commented: “The patented drug delivery method utilised in this study was perispinal extrathecal administration followed by Trendelenburg positioning, a brief, relatively non-invasive office procedure, not requiring anaesthesia, that delivers etanercept (or other large molecules) into the cerebrospinal venous system. This method bypasses the blood-cerebrospinal barrier, rapidly delivering etanercept into the cerebrospinal fluid and into the brain, resulting in rapid clinical improvement (beginning within minutes), due to neutralisation of excess TNF.”

Tobinick also commented on the significance of this study in terms of therapeutic possibilities for stroke and TBI patients: “These results demonstrate that it is now possible to provide rapid clinical benefit to patients even years or decades after stroke or TBI, utilising this unique therapeutic approach. This is the first effective treatment for the spectrum of chronic neurological dysfunction caused by stroke and/or TBI. These results also demonstrate the central involvement, and potential reversibility of pathophysiology mediated by excess TNF in chronic neurological disability caused by stroke and TBI.”

New balloon-stent technique for intracranial aneurysm treatment safe and feasible

2012-11-21T14:50:00Z

Alejandro M Spiotta, Department of Neurosurgery, Medical University South Carolina, Charleston, USA, reported his team’s experience with the new balloon-stent technique for intracranial aneurysm treatment using the Scepter C balloon catheter and the LVIS, a low-profile visualised intraluminal stent.

The first use of the novel balloon-stent technique for the treatment of intracranial aneurysms has been revealed in a paper led by Alejandro M Spiotta, Department of Neurosugery, Medical University South Carolina, Charleston, USA, published ahead-of-print in the Journal of Neurointerventional Surgery. The authors explained that the balloon-stent method proposed in this paper involves stent placement after completition of a balloon assisted coil embolization. The authors used the Scepter C (MicroVention) balloon in conjunction with a low-profile visualised intraluminal stent, the LVIS 2.5mm x 16mm stent (MicroVention).

“The introduction of balloon remodelling and stent-assisted coil embolization are two advances which have revolutionised the treatment of wide-necked aneurysms,” the authors explained. According to the literature, the authors reported, “Balloon remodelling involves the temporary inflation of a balloon across the neck of an aneurysm allowing for coil deployment into aneurysms with unfavourable neck to dome ratios. The technique of stent assisted coiling has also been widely adopted as a promising adjunct with potential mechanical, haemodynamic and biologic properties, imparting an advantage over coil embolization alone.” These two techniques may be used in combination to capitalise on the benefits provided by both, they commented.

The patient was a 51-year-old man with an unruptured middle cerebral artery bifurcation aneurysm which was treated with the balloon and, post coil embolization, the LVIS was delivered via the coaxial balloon catheter and deployed across the aneurysm neck. According to the results and follow-up angiograms the coil mass proved to be well-seated in the aneurysm sac and the parent vessel was patent.

The authors described the technique as follows: “Utilising an 18G Cook needle in a 6F Pinnacle sheath was placed into the right common femoral artery. Five thousand units of intravenous heparin and intermitted blouses were administered to maintain ACT 2—2.5 times the patient’s baseline. A 6F Neuro 070 guide catheter (Penumbra) with a 5F Berenstein diagnostic insert (Penumbra) was advanced into the aortic arch over a 0.038 inch Terumo Glidewire (MicroVention) to select the distal petrous segment of the internal carotid artery. Eight milligrams of verapamil was injected intra-arterially. Under roadmap guidance, a 4x4 Scepter C balloon catheter was advanced over a 0.014 inch Transcend EX platinum guidewire (Boston Scientific) into the inferior division branch and centred across the aneurysm neck.”

“An SL 10 microcatheter (Boston Scientific) was advanced over a 0.014 inch Trancent EX platinum guidewire into the middle cerebral aerty aneurysm. With intermittent balloon inflations lasting less than five minutes, the following Stryker (Boston Scientific) coils were introduced into the aneurysm and deployed. The microcatheter was removed. With the Scepter C balloon catheter kept in place, a LVIS 2.5mmx16mm stent was introduced centred across the aneurysm neck with the distal markers in the proximal M2 segment and the proximal markers in the mid M1 segment and the balloon catheter was withdrawn to unsheath and deploy the stent across the aneurysm neck and middle cerebral artery bifurcation.”

Spoitta et al said that the balloon-stent method does carry risk factors as it involves placement of the stent post balloon-assisted embolization which requires additional manoeuvres increasing the risk of coil disruption.

“In the case described, we found this technique to be safe and feasible, reducing both the number of steps involved in this technique and the opportunities for mechanical coil-related complications” concluded the authors. “We anticipate the adoption of this technique to be a valuable tool in the armamentarium of the neurointerventionalist.”

European Commission approves apixaban for prevention of stroke and systemic embolism in non-valvular atrial fibrillation patients

2012-11-21T14:33:00Z

The European Commission has approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors. This is the first regulatory approval in any market for apixaban on this indication.

According to a company release, apixaban is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality.

“Patients with atrial fibrillation have a five times greater risk of stroke and there remains a critical public health need for improved treatment options to reduce this risk,” said Lars Wallentin, director and professor of Cardiology, Uppsala Clinical Research Centre and University Hospital, Sweden. “The approval of Eliquis represents an important new treatment option for health care professionals, who now have an oral anticoagulant with superior outcomes versus warfarin in the reduction of stroke, major bleeding and death in patients with non-valvular atrial fibrillation.”

The European approval for apixaban is supported by the pivotal phase 3 trials ARISTOTLE and AVERROES, which evaluated approximately 24,000 patients with non-valvular atrial fibrillation in the largest completed clinical trial programme conducted to date in this patient population. The apixaban clinical programme is the only phase 3 clinical programme among the new oral anticoagulants to evaluate the safety and efficacy of apixaban versus aspirin in patients who were unsuitable for vitamin K antagonist (VKA) therapy.

Eliquis 5mg is indicated as a twice-daily oral medication for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Apixaban does not require international normalised ratio (INR) monitoring and there are no known dietary restrictions.

The first-line use of apixaban and other new oral anticoagulants is recommended in the European Society of Cardiology Guidelines for the management of atrial fibrillation where oral anticoagulation is recommended.

Worse clinical outcomes in stroke patients with difficult catheter access in endovascular procedures

2012-11-21T13:53:00Z

Marc Ribo, Unitat d’lctus, Hospital Vall d’Hebron, Barcelona, Spain, and colleagues, in a study published ahead-of-print in the Journal of Neurointerventional Surgery, said that difficult catheter access to the carotid artery during endovascular treatment of stroke patients is common and is associated with worse clinical outcomes.

The aim outlined in the study was to analyse the incidence and impact of a difficult transfemoral catheter access to the carotid artery on clinical outcome in acute ischaemic stroke patients who underwent endovascular procedures of which the data were prospectively recorded in a database and studied.

The authors, after femoral access was secured with an 11cm 8F sheath, attempted to catheterise the carotid artery ipsilateral to the intracranial occlusion followed by an angiogram to locate the target carotid. A 0.035 inch stiff guidewire was used to advance the guiding sheath with the Merci Balloon Guide Catheter (Concentric Medical/Stryker) or the Flexor Tuohy-Borst Side-Arm (Cook Medical). Follow-up was undertaken, by a neurologist, at 24 hours and seven days using the National Institutes of Health Stroke Scale (NIHSS) score.

Of the 130 patients included in the study, catheterisation of the target carotid artery was impossible in seven patients (5.4%) of which two had Leriche syndrome and five had an extremely tortuous aortic arch. These patients had significantly lower rates of recanalisation (14.3% vs. 80.5%; p<0.01) and a less favourable outcome (0% vs. 36%; p=0.038), the authors found.

The results also showed that the patients with an accessible carotid artery were considered to have difficult catheter access if time from arterial puncture to carotid catheterisation was >30 minutes. A negative correlation was found between time to carotid access and final recanalisation (r=–0.31, p<0.01). The authors also found, that patients with difficult catheter access also had a significantly longer procedure time but similar time from symptom onset to final recanalisation. At three months: “The rate of favourable outcome progressively decreased according to catheterisation time,” said Ribo et al. “However, the lower final recanalisation rates and longer procedure time after carotid catheterisation could be attributed, at least in part, to difficult access and proximal vessel tortuosity.”

“Difficult access is associated with worse clinical outcome. If catheter access through the femoral artery appears difficult, alternative access, such as direct carotid puncture, could be explored,” the authors concluded.

SAPPHIRE Worlwide registry highlights a higher risk of adverse events in symptomatic, older patients after carotid artery stenting

2012-11-14T14:34:00Z

Data from the large SAPPHIRE WW Worldwide registry suggest that age, symptomatic status, and physiological entry criteria represent high risk features for carotid artery stenting. Christopher Metzger, Wellmont CVA Heart Institute, Kingsport, USA, national co-principal investigator of the registry, presented periprocedural results of 15,000 carotid artery stenting patients at the TCT conference in Miami.

Metzger told delegates that carotid artery stenting remains a viable alternative to carotid endarterectomy, especially in patients considered high risk for surgery. However, he said, “Further studies are needed to determine which patients derive the greatest benefit from carotid artery stenting”. Metzger added that carotid artery stenting results continue to improve over time, in part because of operator experience and “the lessons learned”. He noted that SAPPHIRE Worldwide (SAPPHIRE WW) is the largest carotid artery stenting study to date with over 15,000 patients undergoing stenting with cerebral protection.

SAPPHIRE WW is a multicentre, prospective study to evaluate carotid artery stenting with the Precise nitinol stent (Cordis) and the Angioguard XP/RX emboli capture guidewire system. The inclusion criteria is symptomatic patients with stenosis ≥50% or asymptomatic with ≥80% stenosis and high-risk for adverse events for carotid endarterectomy. The primary endpoint is major adverse events including death of any cause, myocardial infarction or stroke to 30 days after the procedure.

Metzger said that, for the first 15,000 patients enrolled in the study, the mean age was 72.3±9.53 years, 61% were male and 30.5% were symptomatic (n=4,569). Also, 55.2% of the patients had coronary artery disease and 4.8% had renal insufficiency.

The results showed that, at 30 days, the major adverse events rate was 4.5%. The rate of death was 1.2%, myocardial infarction was 0.6% and the rate of any stroke was 3.3%. In a comparison of symptomatic and asymptomatic patients, major adverse events, death, stroke and stroke or death rates were statistically significantly higher in the symptomatic group (p<0.0001). Patients with only physiological risk (ie, heart failure, age ≥75 years, pulmonary disease) also experienced more adverse events than those with anatomic risks only (ie, previous endarterectomy recurrent stenosis, contralateral occlusion), and patients aged over 75 also had higher rates of death and stroke. There was no difference between results for men and women.

“What about myocardial infarction, does it matter?” asked Metzger. In SAPPHIRE WW, he said, 0.6% patients experienced a myocardial infarction after stenting. “This is significantly less than predicted for similar patients receiving carotid endarterectomy. If patients experienced a myocardial infarction, the 30-day mortality was 19%, and one year mortality was 25.4%, similar to what was seen in the CREST trial.”

To conclude his talk, Metzger stated that the SAPPHIRE WW, approved for 21,000 carotid artery stenting patients at more than 350 centres, is the largest carotid artery stenting trial to date. Enrolment started in 2006 and is ongoing. “SAPPHIRE WW will continue to provide important information which should help to identify patients who can be treated safely with carotid artery stenting,” he said.

Sorin acquires Neurotech

2012-11-13T15:10:00Z

Sorin has acquired Neurotech, a spin-off of Universite catholique de Louvain (UCL), Belgium. Neurotech designs cost-effective active implantable medical devices used in the treatment of neurological, psychiatric and related disorders.

Established in the end of nineties, Neurotech was co-founded by M Troosters and three members of UCL (C Trullemans, Cl Veraart and J Delbeke). During the first years of the company, the spin-off of two laboratories (Neural Rehabilitation Engineering and Microelectronics Laboratory) assisted in the development of a visual prosthesis in the frame of European grants. A world premiere took place in 1998, with the implantation of an optic nerve visual prosthesis at the Cliniques universitaires St-Luc, Brussels.

In 2002, the company identified a new application for the treatment of refractory epilepsy. A novel implantable vagus nerve stimulation system called ADNS-300. The CE marked system is able to stimulate and record compound action potentials from the vagus nerve, using this information to potentially personalise the therapy and provide an improved outcome. Chronic recording of the compound action potentials of the vagus nerve has been another world premiere for Neurotech, which it achieved in collaboration with the University of Gent’s department of Epileptology of P Boon.

Other prototypes were also developed by Neurotech to evaluate the use of neurostimulation to treat either refractory obstructive sleep apnea, or movement disorders respectively.

“I am very pleased that the unique technological building blocks we have developed for our products can now be used for the treatment of debilitating diseases otherwise refractory to other treatments, within Sorin Group,” said Michel Troosters, founder and past CEO, Neurotech.

“This acquisition represents a further important step forward in our long-term growth initiatives as announced in our recent strategic plan,” said Andre-Michel Ballester, CEO, Sorin Group.

Bruno Delvaux, principal of UCL, said: “Building bridges between science and industry for the benefits of society is one of the key missions of UCL. Our research, through an integrated technology transfer process, contributes directly to address unmet therapeutic needs.”