The first set of guidelines concerning the detection, diagnosis and treatment of peripheral arterial disease (PAD), have been published by American Heart Association (AHA) and the American College of Cardiology (ACC). The guidelines were developed by a task force in collaboration with the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology (SIR) and the Society for Vascular Medicine and Biology. They are also officially endorsed by the National Heart, Lung, and Blood Institute, the Society for Vascular Nursing, TransAtlantic Inter-Society Consensus and the Vascular Disease Foundation.
Although primarily aimed at specialists, physicians, nurses and other healthcare professionals, the guidelines are so broad-based that they are also expected to benefit a large segment of the public. For diseases that affect 12 million Americans, the emphasis of the guidelines is very much on prevention and early detection.
PAD broadly encompasses the vascular diseases caused primarily by atherosclerosis and thromboembolic pathophysiological processes that alter the normal structure and function of the aorta, its visceral arterial branches and the arteries of the lower extremity. PAD is the preferred clinical term for stenotic, occlusive and aneurysmal diseases of the aorta and its branch arteries, exclusive of the coronary arteries.
The guidelines represent the best practice for managing PADs. They strongly emphasise the fact that early detection and treatment of PAD can prevent disability and save lives. In developing the guidelines, the task force analysed thousands of scientific studies, giving the greatest weight to well-designed randomised clinical trials, but also taking into account smaller studies and expert opinion as needed. The guidelines provide a summary of both evidence and opinion based recommendations for best medical practice in the care of patients with vascular disease. Some of the recommendations for risk factor identification and management (measuring the ankle-brachial index, using statins, anti-hypertensives, ACE inhibitors, antiplatelet medications, and smoking cessation interventions) could become part of a "pay for performance" programme for the care of vascular patients. Following these guidelines should result in reduced suffering and mortality from PAD.
Dr David Sacks, secretary of the SIR, commented, "There is enormous credibility when recommendations come from multiple specialties. The collaboration to produce these guidelines is confirmation that even though physicians may compete with each other, and societies may have disagreements, we will work together to do what is best for patient care. There were some medical disagreements however on how aggressive to be in the search for renal artery stenosis and the treatment of such disease. The low levels of evidence and weak recommendations supporting renal interventions is reflective of this. In addition, there were some political disagreements as to 'branding' of the document as a product of the ACC/AHA, rather than an equal product from all of the participating societies. These political disagreements were satisfactorily resolved and we look forward to working together as equals in future documents."
SIR played a pivotal role in the formation of the guidelines. There were three co-chairs in the writing group, one of whom was Dr Ziv Haskal. In addition, there were two other SIR members in the writing group, Drs Curt Bakal and Sacks, the latter was the official SIR representative. SIR's representatives were involved in drafting the document, discussing revisions, and creating levels of evidence and clinical recommendations.
Highlights of the guidelines include: recommended questions and observations that can uncover hidden signs of PAD; clinical signs that a patient may have renal artery stenosis; recommendations on when an aneurysm should be treated with surgery or catheter-based therapy or when 'watchful waiting' is the best course; a critical analysis of the strengths and weaknesses of vascular imaging tests and other diagnostic methods; an emphasis on therapeutic choice, including the role of exercise, diet, smoking cessation and medications; clinical pathways and treatment algorithms to guide clinical decision-making; and an objective review of the benefits and drawbacks of surgical and catheter-based therapies.
"We have hammered out, to the best of our abilities, recommendations for clinical practice, but we've also been very clear about the relative strengths and weaknesses of each recommendation," said Haskal, a professor of radiology and surgery, and director of the Division of Vascular and Interventional Radiology at New York-Presbyterian Hospital/Columbia University Medical Center, NY. "These greyer areas mark some of the most important opportunities for future research."
The new guidelines have also received industry support. "The guidelines underscore [the fact] that there is a growing patient population that suffers from PAD and an emergent demand for a wide range of technologies to treat the condition," said Dr Dennis Donohoe, vice president of clinical and regulatory affairs, Cordis.
Dr Mary Argent-Katwala, analyst at Decision Resources, a research and advisory firm, added: "These guidelines will emphasise that peripheral arterial disease should be considered a manifestation of serious underlying atherosclerotic disease that necessitates management of cardiovascular risk factors... This revised approach to peripheral arterial disease will be a primary driver of increased drug use in this patient population."
Sacks also commented on the importance of having all the societies involved adopting the guidelines: "The guidelines need to be made widely available to all physicians caring for patients with PAD. Screening and treatment algorithms need to be accepted. Societies can incorporate such education in their meetings, publish material in their journals, and include the guidelines as part of our training programmes.
Carotid stenting guidelines
Separately, Sacks also discussed why the SIR had not endorsed the carotid stent training guidelines, published in November 2005 by the Society for Cardiac Angiography and Interventions, Society for Vascular Surgery and the Society for Vascular Medicine and Biology (SCAI/SVS/SVMB).
He explained: "While the SIR agrees completely that it is critical that physicians be appropriately trained to perform carotid stenting, including technical expertise gained through case experience, book knowledge, and judgement, because of the disagreements on training required to perform carotid stenting, we were unable to agree to the radiology/neurology/neurosurgery criteria. This led to the generation of a separate document by the former specialties, which was understandably written without input from SIR."
However, SIR has previously co-authored training criteria to address these issues:
1. - Barr JD, Connors III JJ, Sacks D, et al. Quality improvement guidelines for the performance of cervical carotid angioplasty and stent placement. JVIR 2003; 14:1079-1093.
2. - Connors JJ, Sacks D, Furlan AJ et al, for the NeuroVascular Stroke Coalition Writing Group. Training, competency, and credentialing standards for diagnostic cervicocerebral angiography, carotid stenting, and cerebrovascular intervention: A joint statement from the American Academy of Neurology, American Association of Neurological Surgeons, American Society of Interventional and Therapeutic Neuroradiology, American Society of Neuroradiology, Congress of Neurological Surgeons, AANS/CNS Cerebrovascular Section, and the Society of Interventional Radiology. JVIR 2004; 15:1347-1356.
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