With the positive initial results of the CREST trial released in February, more facilities will begin exploring the idea of implementing a carotid artery stenting (CAS) program and weigh the challenges—including turf battles—and benefits, such as multidisciplinary cooperation.
Complementary, not competitive
Reimbursement for CAS in the U.S. is approximately $2,000 per procedure and it is restricted to symptomatic patients at high risk for stroke and surgery with at least 70 percent stenosis. The procedure also must include embolic protection. In the CREST trial, however, CAS in patients with a “standard risk” showed similar rates of stroke, MI and death as patients in the carotid endarterectomy (CEA) arm. While these data need to be studied further, stenting proponents say the trial’s results could help expand the indications, making the possibility of adding a carotid stenting program to a facility’s service line all the more attractive. But there are turf issues to consider.
CEA is the most common procedure for U.S. vascular surgeons, who perform almost 200,000 of them per year, “so they may try to block interventional cardiologists from performing CAS,” says Donna Marchant, MD, an interventional cardiologist at North Shore University Hospital in Manhasset, N.Y. Marchant and colleagues have been performing CAS since 1999, but it took some time for them to iron out the turf issues. They had to prove to hospital administrators that CAS was a safe alternative to CEA, and that they were well trained to perform it. “The more training you have, the easier it will be for administrators to support you,” she says.
Cardiologists at Ochsner Medical Center in New Orleans faced similar problems, says Stephen Ramee, MD, head of interventional cardiology and director of the cardiac cath lab. “When you have progress, something has to die for its replacement to fill in,” says Ramee, adding that vascular surgeons are lobbying the FDA to recognize that there are not enough data to support CAS. “There are some politics involved. It’s not always about the science and, unfortunately, this has stifled the growth of CAS procedures.”
W. Charles Sternbergh, III, MD, head of the department of vascular and endovascular surgery at Ochsner, says that medical therapy, CEA and CAS are complementary and proper patient selection is key to achieving success in any treatment plan. CREST clearly showed that certain subgroups are better served with stenting, while others are more suited for surgery. “Carotid stenting now is widespread,” says Sternbergh. “It worries me that groups may be thinking about starting a carotid stenting program just because it’s reimbursed.”
Gary S. Roubin, MD, PhD, chairman of the department of interventional cardiology at Lenox Hill Hospital in New York City and a CREST investigator, predicts that the positive results of CREST will influence CMS to change its reimbursement scheme within the next six to 12 months. In the meantime, Roubin and colleagues are not marketing their CAS program. Patients come from referrals. If CMS widens the indications to include standard risk and/or asymptomatic patients, Lenox Hill will market its CAS service, and will include outcomes data in any marketing push, says Roubin.
Regulatory & societal caveats
CMS requires facilities that are approved to perform CAS to be recertified every two years. To do so, the facility must turn over specific data elements to CMS including physician training standards, device inventory and outcomes data. Facilities also must have a high-quality digital imaging system, advanced physiologic monitoring, emergency management equipment and an oversight committee to evaluate interventionalists and the overall quality of the CAS program. CMS suggests that an internal analysis of the data occur no less than every six months.
It’s incumbent upon each institution to determine written competency standards for physicians. The consensus statement issued by the Society of Cardiovascular Angiography and Interventions (SCAI), in conjunction with the Society of Vascular Medicine and Biology and the Society for Vascular Surgery, suggests a minimum of 30 diagnostic cerebrovascular angiograms (15 as the primary interventionalist) and 25 CAS procedures to demonstrate competency. Some other societies suggest higher minimum numbers. Ultimately, it’s up to the facility to decide.
The SCAI consensus statement suggests two physician training pathways: One during fellowship