The Centers for Medicare and Medicaid Services has granted approval to about 500 facilities to perform carotid artery stenting with embolic protection. The CMS extended Medicare coverage in March to include high-risk patients outside the trial setting.
The move to limit the procedure to approved facilities is aimed at reducing the risk of stroke, said Dr. Kieran Murphy, director of interventional neuroradiology at Johns Hopkins University.
"The issue is who should do the procedure and how safely it can be done. The rule specifically says that surgeons need to decide whether patients can safely undergo endarterectomy. If that's not the case, stenting should be applied," Murphy said.
The CMS decision allows only one practitioner application for carotid stenting per institution. It requires institutional patient selection criteria, a preintervention surgical review to ensure that the patient is at high surgical risk, and a risk assessment in terms of comorbidities identified by CMS.
CMS's rule also demands proper privileging and credentialing, patient follow-up performed by neurologists, a monthly morbidity and mortality conference, and a semiannual report of individual and hospital complications, Murphy said.
Each facility should establish an oversight committee to identify the minimum case volume for an interventionalist to maintain privileges. The committee would also clarify the risk-adjusted threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation.
The government suggested that hospitals adopt published standards and clinical competence guidelines from national specialty societies such as the American Society of Neuroradiology and the American College of Cardiology.
While all major vascular interventional groups support the expanded coverage, those closely allied with radiology wanted more stringent guidelines with respect to provider familiarity and experience with cerebrovascular interventions. The Society of Interventional Radiology, American Society of Interventional and Therapeutic Neuroradiology, and ASNR were pitted against the Society for Vascular Medicine and Biology, Society for Cardiovascular Angiography and Interventions, Society for Vascular Surgery, and ACC.
Only the Acculink stent and embolic protection system by Guidant is FDA-approved. Other companies with devices currently undergoing trials include Cordis, Medtronic, EndoTex Interventional Systems, Boston Scientific, and ev3.
Dr. Robert Safian and colleagues reported on the Carotid Revascularization with ev3 Arterial Technology Evolution (CREATE) Trial at the SIR meeting in April. The prospective multicenter trial evaluated the Protege stent and Spider embolic device in 419 high-risk patients. Results were better than those of the Acculink trial, Safian said. He anticipates approval for the Protege later this year when the FDA reviews the one-year data.
