For carotid procedures, registry-level data are not enough, and randomized trials of CAS and CAE “need to be completed,” said Dr. Steve Phurrough, director of the Coverage and Analysis Group at CMS, in an interview. “With ICDs, we had lots of good-quality, high-volume data—with CAS we don't.”
Still, he said, registries are an important part of it all, especially because “comparing [and] risk-adjusting are better done in larger databases.”
The collection of data as a condition of coverage “will become more and more prevalent, especially [in light of recent cases in which] the risks of drugs and devices weren't known until a few years out,” he said.
Dr. Rosenfield said he believed the ACC registry is “a bit more robust” than the SVS registry, particularly with respect to preprocedural history, including neurologic history, and neurologic end points.
Dr. Ralph G. Brindis, chairman and chief medical officer of the ACC-NCDR, said the new registry would benefit from the NCDR's multifaceted strategy for auditing registry data to ensure it is complete and accurate.
“The biggest Achilles' heel [for registries] is the ability of [outsiders] to feel comfortable with the validity of the data,” he said.