• Vascular Specialist Newspaper
• Volume 5 - 2009
• Number 9 online
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• Number 7 online
• Number 6
• Number 5 Online
• Number 4 online
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• Number 12 online
• Number 1
• Volume 4 - 2008
• Number 6
• Number 5
• Number 4
• Number 3
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• Number 1
• Volume 3 - 2007
• Number 6
• Number 5
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• Number 3
• Number 2
• Number 1
• Volume 2 - 2006
• Number 6
• Number 5
• Number 4
• Number 3
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• Volume 1 - 2005
• Number 2
• Number 1

At the completion of the SAPPHIRE study [Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy], a 6-5 vote by the CMS [Centers for Medicare and Medicaid Services] approved Medicare reimbursement for carotid stenting. Had a single vote changed, there would be no widespread use of this procedure. Who were these physicians who voted, what were their backgrounds, and did they have any proprietary interests? Ten of the 15 SAPPHIRE study authors were paid company consultants.

I have been a proponent of vascular surgeons utilizing interventional techniques since as early as 1984, as well as being certified in carotid stenting, so this is not about the old turf giving way to the new turf. I encouraged vascular surgeons to perform interventional techniques 25 years ago, long before they were promoted or vigorously embraced by the vascular community.

Where did this criterion of "high-risk" carotid surgical patients originate? Did cardiologists and interventional radiologists independently determine what was "high risk" and what was not? Almost each and every one of these "high-risk" criteria has been eliminated by careful data gathering and analysis by vascular surgeons. How can cardiologists or radiologists determine who is a high-risk carotid surgical patient and who is not, since they have never seen the inside of a carotid artery; nor have they ever performed carotid surgery? Older than 80, recurrent carotid stenosis, radiation-induced stenosis, and almost every one of the "high-surgical risk" categories has been rejected by the vascular surgery community. It has even been well documented that "cardiac clearance" for any elective vascular surgery patient is of no benefit to the patient except under special circumstances.

The criteria established by a "joint committee" that set the qualifications to perform carotid stenting had only token vascular surgery representation. Those adopted criteria put a great hardship on practicing community vascular surgeons and benefited most the physicians (most of whom were interventional cardiologists or radiologists) who had already performed the procedures in clinical trials, or could be taught and proctored by department colleagues or partners.

The majority of the prospective studies of carotid stenting were industry sponsored and undertaken by physicians with financial interest in a company or product. The SAPPHIRE study was cochaired by a vascular surgeon who had proprietary interest in the device. Seventy percent of the patients were asymptomatic. With the advent of statin drugs, blockers, better diabetes management, and better antiplatelet drugs, it is unclear that any therapy (whether carotid stenting or carotid endarterectomy) is indicated in any asymptomatic patients.

Had vascular surgeons been in charge of evaluating carotid stenting, it may never have been so widely used. This is because we have a relatively simple and minimally invasive operation that has a 95% short- and long-term success rate with a 50-year track record that encompasses a wide range of patients with significant comorbidities. It is one of the few surgical procedures in modern medicine that has been prospectively compared with medical treatment and is probably the most scrutinized surgical procedure in the history of medicine. This despite the fact that standards to credential physicians to perform this procedure are local hospital-based and frequently do not even require that the procedure be performed by a fellowship-trained, certified vascular surgeon.

The issues concern the tremendous amount of money invested by companies to develop carotid stenting systems and the fact that interventional cardiologists and radiologists want to perform the procedure--possibly for reasons related to money and turf. If a patient is a very high risk for anesthesia, it would seem questionable to perform any elective procedure (whether endarterectomy or stenting) on an asymptomatic patient for stroke prophylaxis, since the stroke risk without treatment is relatively low.

Longitudinal studies are demonstrating significant recurrent carotid stenosis occuring after carotid stenting. With the almost universal use of patching with carotid endarterectomy, modern follow-up studies indicate a long-term recurrent stenosis rate of less than 5%.

There are at least 15 relative or absolute contradictions to carotid stenting, including: age greater than 80, ulcerated carotid plaque, proximal calcified atherosclerosis, distal carotid tortuosity, uncooperative patient, proximal innominate tortuosity, 98% carotid stenosis, presence of clot, patient cannot take Plavix or aspirin, inability to deploy distal protection device, tandem carotid lesions, long carotid stenosis, inability to access carotid artery, severe tortuosity of iliac arteries, and proximal common carotid tortuosity.

Thus, it would seem to me that the only indications for carotid stenting would be in patients who clearly need some sort of invasive treatment and who have a real contraindication to a carotid endarterectomy such as anatomical inaccessibility or a neck that is hostile or unsuitable for open surgery. I welcome other opinions on this controversial topic.

Rip Pfeiffer, M.D.
Mobile, Ala.