Objectives To compare early outcomes between Direct Flow Medical (DFM) and 1st-generation transcatheter aortic valve replacement (TAVR) devices. Background The effectiveness of new-generation TAVR devices compared with earlier generations is unclear. Methods and Results Overall, 496 patients treated between November 2007 and March 2014 were included: 44 (8.7%) treated with DFM, 179 (36.9%) with Medtronic CoreValve (MCV) and 273 (54.4%) with Edwards Sapien / Sapien XT (SXT) valve. Because of differences in baseline characteristics, propensity-score matching among patients treated in the same time span (March 2012-March 2014) was performed. The primary objective was the VARC-2 device success composite endpoint. Propensity-score matching identified 41 patients in each group. A higher device success composite endpoint was observed in DFM (DFM 97.6% vs. MCV 65.9% vs. SXT 92.7%; P <0.001). This was attributed to a significantly lower incidence of moderate-to-severe post-procedural aortic regurgitation (AR; 2.4% vs. 22% vs. 7.3%; P <0.001), lower rate of valve embolization (0% vs. 7.3% vs. 0%; 0.041) and need for a 2nd valve implantation (0% vs. 7.3% vs. 0%; P = 0.041). Conclusions DFM was associated with higher rates of device success and a lower incidence of post-procedural AR. New generation devices appear to address several of the limitations of earlier generation devices.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Radiology Nuclear Medicine and imaging