Integral Components of a Comprehensive Program to Treat Carotid Artery Disease

Can you talk about the value of a comprehensive clinical program for the treatment of carotid artery disease (CAD)? How important is a thorough body of evidence?

A rigorous clinical program for the treatment of CAD provides physicians with a foundation of clinical evidence to guide the selection of an appropriate treatment strategy for each patient. It also provides the resources, such as training programs, that consolidate this information and help physicians execute treatment plans. The majority of treatments for CAD over the past 50 years were not based on evidence from controlled clinical trials. When the Food and Drug Administration was formed in the 1970s, it was not structured to evaluate surgical trials; instead, it was geared towards the evaluation of pharmaceuticals. In addition, the first clinical trials for carotid artery stenting (CAS) were done almost 40 years after carotid endarterectomy was first performed in 1955. So, it is extremely crucial to clearly separate historical, anecdote-driven treatment recommendations from guidelines based on evidence from clinical trials when determining whether to use a pharmaceutical, endovascular or surgical approach to treating CAD.

What are the essential training components of a carotid artery disease program?

It will be at least five years until specialty training exists that is comprehensive enough to cover all the various specialty requirements. Until then, we have to work together in a multidisciplinary format and rely on training that helps fill the gaps for each of the disciplines. CAS, for example, is the first endovascular procedure in which training transcends the traditional specialty barriers, with cardiologists, radiologists, neurologists, neurosurgeons and vascular surgeons all offering unique perspectives and skill sets. A comprehensive training program for CAD management that supports different specialties must have both a cognitive and technical component, since proper decision-making is dependent on knowledge of both elements. For example, a non-interventionalist may require more technical training, while an interventionalist may require more cognitive training. The cognitive component of a program should address various therapies such as antiplatelets and antithrombotics, and should include vascular disease management criteria as part of the American Heart Association’s “Get With the Guidelines” program. This is all evidence-based information that should be included in a ready-to-reference format detailing the current consensus and supporting research. For referring physicians, imaging guidelines for the vascular laboratory, and information regarding the interpretation of duplex, electrocardiogram, magnetic resonance imaging and transcranial Doppler are integral. Most importantly for this group, a training program should address how to follow up with patients with an abnormal carotid plaque who do not yet require intervention. The technical component of a program involves physician and staff training in CAD management. Understanding which patients are best treated with medical management, and which ones are better suited to stenting or endarterectomy is critical. In addition, device training, imaging interpretation and simulation are also key components. Simulation training has existed in other medical fields and is now playing a significant role in the treatment of CAD. It offers physicians a meaningful and relevant treatment experience and may support a credentialing requirement for physicians on the pathway to CAS.

What is the role of training in managing high-risk patients?

In CAS trials, the concept of a high-risk patient is an emerging concept, drawn from an accumulation of experience in regards to the limitations of stents in certain anatomies, such as patients who have extreme tortuosity, or who lack a proper “landing zone” for placing a distal protection device beyond the stenosis. There are still physicians who argue that there is no such thing as a high-risk patient. Nevertheless, we have to rise to meet this challenge, and that requires an understanding that this is a procedure with a very low margin for safety. Careful planning and expert execution of the technique is absolutely crucial. For CAS, a true expert is not somebody who knows how to bail out of a tricky situation; it is someone who knows how not to get into the situation in the first place. This is where a comprehensive curriculum that enables physicians to identify higher anatomical risk predictors, and to learn which patients to completely avoid and which ones to defer to an expert is critical.

Boston Scientific is the only company to seek a carotid indication for accessory products that are used in CAS. In addition, Boston Scientific offers a surgical portfolio. How important is it to you as a physician to have one source for all products specifically indicated for treatment of CAD?

It is extremely important. A program that encompasses all aspects of disease management — from the clinical evidence to the training to the technology — and all specialties is going to be more credible as opposed to a program directed to one specialty and for one therapy. An unbiased, all-encompassing program such as the one sponsored by Boston Scientific has elevated credibility and makes it easy to access information and therefore arrive at appropriate treatment decisions.