login
Password reminder
Cardiac Rhythm News
Contact the editor Visit Cardiac Rhythm News Twitter feed Visit Cardiac Rhythm News Facebook page
 

Mixed evidence on use of radiofrequency catheter ablation for AF


Monday, 13 Jul 2009 13:24
Carolyn Clancy
Carolyn Clancy


Little is known about the long-term benefits catheter ablation for atrial fibrillation and the best methods and circumstances for applying it, according to a new report funded by the US Department of Health & Human Services’s (HHS) Agency for Healthcare Research and Quality (AHRQ).


The report examines the use of radiofrequency catheter ablation to treat AF. The new comparative effectiveness report found that the procedure has been shown to provide benefits in maintaining normal heart rhythm over short periods of time (up to one year) but found little evidence indicating whether the procedure reduces the chance that patients will experience atrial fibrillation over the long term.


The report, which compared radiofrequency ablation to medication-based therapy, also found that the effect of the procedure on stroke, a major risk for patients with atrial fibrillation, is unknown.
"Radiofrequency holds promise for treating atrial fibrillation, but it is clear that more research is needed to demonstrate its potential long-term benefits," said AHRQ director Carolyn M Clancy. "This report crystallises the questions that researchers need to ask going forward."


The report calls for more research on the effect of catheter ablation on quality of life. In particular, more research is needed for groups of patients for whom the research is especially lacking, such as women, the elderly, and patients who have other conditions such as heart failure or high blood pressure.


Earlier this year, HHS’ FDA approved the first two ablation catheters indicated for use in treating atrial fibrillation, in the US. However, physicians often use other catheters that have not been approved by the FDA for atrial fibrillation. The FDA also found that there is no conclusive evidence that people whose symptoms are reduced with ablation are less likely to have a stroke. Therefore, the FDA explicitly endorsed existing clinical guidelines that recommend that patients at risk for stroke continue to take preventive blood-thinning medications after radiofrequency catheter ablation.


As a condition of catheter approvals, the FDA mandated that the catheters’ manufacturer must conduct two post approval studies (PAS) to collect long term safety data. The mandated studies apply only to FDA-approved catheters, and not to devices used off-label in clinical practice. The first PAS is a post approval registry, which will collect safety (adverse event) data and operator experience information through seven days post-treatment with the approved ablation catheters. The study will also collect data on long-term safety data, such as death, stroke, myocardial infarction, clinically manifested pulmonary vein stenosis, etc., at five years post-treatment. The second PAS is a subgroup analysis from an ongoing larger study that will look at the incidence of stroke, and compare the three-year incidence of stroke between patients treated with the approved ablation catheters versus patients treated with medication. This study will analyse total mortality, serious bleeding and cardiac arrest.


Also, last week, the FDA approved a new medication, dronedarone, for treatment of atrial fibrillation.


Information, including the new report, can be found at www.effectivehealthcare.ahrq.gov.




Add New Comment

Most popular


New bidirectional mechanical lead extraction device is safe and efficient with high success rates in long implanted leads
Thursday, 17 Mar 2016
A new bidirectional rotational mechanical lead extraction sheath is both safe and effective in performing lead extraction, according to a study published online ahead-of-print in Europace. Clinical ... New bidirectional mechanical lead extraction device is safe and efficient with high success rates in long implanted leads

First leadless pacemaker approved in the USA
Wednesday, 06 Apr 2016
Medtronic has announced it has received US Food and Drug Administration (FDA) approval for its Micra Transcatheter Pacing System (TPS). The leadless device, which is 93% smaller than conventional ... First leadless pacemaker approved in the USA

FDA proposes ban on most powdered medical gloves
Tuesday, 22 Mar 2016
The US Food and Drug Administration has announced a proposal to ban most powdered gloves in the USA. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness ... FDA proposes ban on most powdered medical gloves

Features


How innovation can unleash tremendous growth in the $3.4 billion AF ablation market
Monday, 29 Feb 2016
Shlomo Ben-Haim (London, UK), a professor of medicine and serial entrepreneur in the medical device industry, examines the drivers of expansion of the atrial fibrillation (AF) ablation market, the ... How innovation can unleash tremendous growth in the $3.4 billion AF ablation market

Hybrid and surgical atrial fibrillation ablation: Opportunity, threat or both?
Monday, 15 Feb 2016
Despite major advances in techniques and technology over the past 15 years, the clinical outcomes for catheter ablation in non-paroxysmal atrial fibrillation patients remain disappointing, write Tom W... Hybrid and surgical atrial fibrillation ablation: Opportunity, threat or both?

Profiles


Jonathan Kalman
Monday, 18 Jan 2016
A leading heart rhythm expert in Australia, Jonathan M Kalman directs both clinical and research ... Jonathan Kalman

Michael Glikson
Wednesday, 14 Oct 2015
Michael Glikson (Tel Hashomer, Israel) has contributed to the development of technologies for CRT, ... Michael Glikson

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions