Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.

Abstract

Although outcomes data on transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (Mitraclip) are available via the Transcatheter Valve Therapy (TVT) registry, dissemination of TVT data is often delayed. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) system collects postmarket outcomes data in public medical device reports. We used natural language processing to compare the event rates for TAVR and Mitraclip in the TVT regi