Title

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

Authors

Daniel O'Hair
Vivek Rajagopal
Axel Linke
Dean Kereiakes
Ron Waksman
Vinod H. Thourani
Nicolas Dumonteil
Robert W. Hodson, Providence Valve Center, St. Vincent Medical Center, Portland, Oregon, USAFollow
Jeffrey Southard
John Harrison
Samir Kapadia
Dominic Allocco
Ian Meredith
Michael Reardon
Ted Feldman

Files

Publication Date

3-2018

Keywords

cards

Disciplines

Cardiology

Description

Background

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.

Methods

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.

Results

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

Conclusion

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.

Clinical Institute

Cardiovascular (Heart)

Department

Center for Cardiovascular Analytics, Research + Data Science (CARDS)

Department

Cardiology

Conference / Event Name

American College of Cardiology Annual Scientific Session & Expo

Location

Orlando, FL

Book / Chapter Details

Journal of the American College of Cardiology

Volume 71, Issue 11 Supplement, March 2018

DOI

DOI: 10.1016/S0735-1097(18)31966-1

Recommended Citation

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.
https://digitalcommons.providence.org/other_pubs/95