"The mortality rates even among the most experienced Medicare operators in the study by Nallamothu et al were substantially higher than those in CREST and postapproval studies," Halm wrote. "Relatively high complication rates in real-world practice would substantially reduce and perhaps completely eliminate any long-term expected benefit of revascularization, especially among asymptomatic patients who have much less to gain from the procedure."
The mortality rates caused by clinicians' learning curve, Halm wrote, place policy makers "at a fundamental crossroads regarding carotid artery stenting (CAS)."
"Without careful policies to ensure appropriate use and dissemination of CAS, the procedure may be misused and overused, as was seen in early in the diffusion of CEA (carotid endartarectomy) and percutaneous coronary interventions."
Halm also called for the Centers for Medicare & Medicaid Services to restrict reimbursements and impose requirements for credentialing operators and facilities, and mandatory reporting of audited 30-day death and stroke rates. He also suggested that the new Patient-Centered Outcomes Research Institute take on the procedure to "clarify the indications, appropriateness, and outcomes of CAS in both ideal and real-world practice."