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 registry and from MAUDE data. We identified all medical device reports related to TAVR and Mitraclip from December 2011 through December 2014. Our primary objective was to demonstrate that event rates in TVT and MAUDE were not significantly different. We also compared TVT event rates for TAVRs performed in 2014 to MAUDE-derived event rates for the Sapien XT and CoreValve devices, both Food and Drug Administration-approved in 2014. Regression analysis demonstrated close correlation between TVT and MAUDE rates for both TAVR and Mitraclip, with R2 values of 0.86 and 0.77, respectively. The rates for all events except bleeding were not statistically significantly different. We demonstrated similar increased rates of permanent pacemaker implantation in the 2014 TVT and MAUDE data sets consistent with approval of the CoreValve. We demonstrated that natural language processing technology sorted through raw MAUDE data, allowing identification of the most common events associated with TAVR and Mitraclip procedures, and that MAUDE-derived event rates were not statistically significantly different from TVT event rates. This technology has important public health implications because it improves postmarket surveillance of implantable devices and permits rapid and early dissemination of vital information.