Money,Turf,and Carotid Stenting

At the completion of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study, a 6 to 5 vote by the 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. Is it any wonder that the six cardiologists voted for stenting and the two vascular surgeons, two interventional radiologists and one neurologist voted against? How did vascular surgeons place themselves in a token position as it relates to the treatment of carotid stenting? Ten of the 15 SAPPHIRE authors were paid company consultants.

Having been an early proponent of vascular surgeons using interventional techniques (1984), as well as being certified in carotid stenting, I can state that this is not about the old turf giving away to the new turf. I encouraged vascular surgeons to perform interventional techniques 25 years ago, long before it was 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? If a vascular surgeon was involved, it must have been only on a token basis. Almost each and every one of these “high-risk” criteria have been eliminated, by careful data gathering and analysis by vascular surgeons. Under what mantra 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? Age over 80 years, recurrent carotid stenosis, radiation-induced stenosis, and almost every one of the “high–surgical risk” categories have been rejected by the vascular surgery community. It has even been well documented that “cardiac clearance” for any elective vascular surgery patients is of no benefit to the patient except under special circumstances.

What corporate attorney dreamed of the notion that carotid stenting had only to be shown that it was not inferior to carotid endarterectomy (CEA)? This is like saying that something is not necessarily a lie even if it did not necessarily happen. If a vascular surgeon were to submit an article to demonstrate that a new surgical procedure was not inferior to another well-established procedure, it would not get past the first peer review.

The criterion 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 or undertaken by physicians with a financial interest in a company or product. Seventy percent of the patients in SAPPHIRE were asymptomatic. With the advent of statin drugs, β-blockers, better diabetes management, and better antiplatelet drugs, it is unclear that any manipulative therapy (whether carotid stenting or CEA) is indicated in most 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 is 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 are about the tremendous amount of money invested by several 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. The only indications that I can foresee in the future for carotid stenting will be in anatomically inaccessible lesions or other special locally hostile conditions for open surgery. If a patient is a very high risk for anesthesia, then it would seem to be 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 after carotid stenting. With the almost universal use of patching with CEA, modern follow-up studies indicate a long-term recurrent stenosis rate of less than 5% after this procedure.

There are currently at least 15 relative or absolute contradictions to carotid stenting:

Age greater than 80 years

Ulcerated carotid plaque

Proximal calcified atherosclerosis

Uncooperative patient

Distal carotid tortuosity

Proximal innominate tortuosity

> 98% carotid stenosis

Presence of a clot

Patient cannot take clopidogrel (Plavix) or aspirin

Unable to deploy a distal protection device

Tandem carotid lesions

Long carotid stenosis

Unable to access a carotid artery

Severe tortuosity of iliac arteries

Proximal common carotid tortuosity

Thus, despite the flawed SAPPHIRE trial, it would seem 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 CEA, such as anatomic inaccessibility or a neck that is hostile or unsuitable for open surgery. I welcome other opinions on this controversial topic.