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Training and certification for carotid stenting: Is the fox guarding the hen house?

When a new procedure, such as carotid stenting, makes the transition from a tightly controlled, highly regulated investigational procedure to a widely available clinical option, how should the minimum training requirements for physicians be established? Traditionally, professional specialty societies have taken the lead in bringing together investigator-experts to develop training guidelines for their peer group [1–4]. The rationale is that a cardiologist who is an expert in the new procedure is the best person to make recommendations for training other cardiologists, and that a radiologist is best able to make training recommendations for other radiologists, and that a surgeon is best able to make recommendations for other surgeons. In the best case, a consensus is achieved across a broad range of specialty experts, overcoming any inherent self-interest, manifested as turf battles, to establish minimum thresholds for physician training. These collaborating physicians are in the best position to balance the patient’s need to have access to the new procedure in their community with the primary goal of ensuring patient safety through reasonable training requirements. Such a coalition among cardiologists, represented by the Society of Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology (ACC), vascular internists, represented by the Society of Vascular Medicine and Biology (SVMB), and surgeons, represented by the Society of Vascular Surgery (SVS), was established and resulted in the publication of a consensus document on physician training requirements, in response to the approval of Guidant Corporation’s carotid artery stent (CAS) systems by the FDA and the subsequent decision by Medicare to reimburse hospitals and physicians this procedure [5]. Nonetheless, confusion now arises because Guidant’s proposal for training cardiologists to use their equipment, which was accepted by the FDA, falls short of the consensus guidelines developed by the coalition of professional societies [5]. Specifically, Guidant has identified three levels of providers [6]. Level 1 physicians are carotid stent investigators who have performed five CAS cases as a primary operator using the Guidant CAS system. Level 2 physicians have either attended another manufacturer’s CAS training program and performed 5 CAS cases as a primary operator, or have performed at least 10 CAS procedures as a primary operator. A level 3 physician may never have deployed a carotid stent, but must have performed 25 carotid angiograms, have experience with 10 peripheral self-expanding stent cases, and performed 10 procedures with 0.014@ monorail systems, all as a primary operator. Guidant’s training program for level 3 physicians includes a 2-day regional training course, in-hospital proctoring, and staff training. The regional training course includes 9 hr of didactic training, 3 hr of patient case review presented by physicians, and 4 hr of simulation and product training presented by Guidant trainers. After completing the regional training, the physician may request a 1-day proctoring session provided by Guidant, but this is not required. Unfortunately, the company has no authority to audit or regulate physician practice and must rely on an honor code regarding documentation of a physician’s experience. For example, if a physician claims to be fully trained in CAS in a foreign country, Guidant has no method of verifying that experience. Unfortunately, the manufacturer (Guidant) can only sell their CAS product to a customer (the physician) that the company deems qualified to use their product. Obviously, Guidant has a serious conflict of interest in being able to regulate