Impact and Predictors of Paravalvular Regurgitation Following Implantation of the Fully Repostionable and Retrievable Lotus Transcatheter Aortic Valve: Results From the Reprise III Randomized Controlled Trial
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Paravalvular leak (PVL) following TAVR has been associated with worse long-term outcomes including an increased risk of mortality. REPRISE III was a large randomized trial comparing 2 contemporary TAVR devices: Lotus and CoreValve (CV). Lotus incorporates an adaptive seal designed to minimize PVL. In this analysis, we evaluated the predictors of PVL and its impact on clinical outcomes.
Patients with high/extreme surgical risk and severe, symptomatic aortic stenosis underwent randomization to Lotus or CV. Multivariate modeling to assess predictors of PVL and outcomes stratified by PVL at 30 days were evaluated.
We randomized 912 patients (2 Lotus:1 CV), age 83±7 years, 51% female, and Society of Thoracic Surgeons predicted risk of mortality 6.8%±4.0%. Lotus was superior to CV for the secondary endpoint of ≥moderate PVL at 1 year (Lotus 0.9%, CV 6.9%; p
Rates of PVL with the Lotus valve were lower than with CV. Calcium was a strong predictor of PVL. Overall, outcomes were similar between groups at 1 year though longer-term follow-up is needed.
Center for Cardiovascular Analytics, Research + Data Science (CARDS)
Conference / Event Name
American College of Cardiology Annual Scientific Session & Expo
Book / Chapter Details
Journal of the American College of Cardiology
Volume 71, Issue 11 Supplement, March 2018
O'Hair, Daniel; Rajagopal, Vivek; Linke, Axel; Kereiakes, Dean; Waksman, Ron; Thourani, Vinod H.; Dumonteil, Nicolas; Hodson, Robert W.; Southard, Jeffrey; Harrison, John; Kapadia, Samir; Allocco, Dominic; Meredith, Ian; Reardon, Michael; and Feldman, Ted, "Impact and Predictors of Paravalvular Regurgitation Following Implantation of the Fully Repostionable and Retrievable Lotus Transcatheter Aortic Valve: Results From the Reprise III Randomized Controlled Trial" (2018). Books, Presentations, Posters, Etc.. 95.