Original Research

DOI: 10.4244/EIJ-D-23-00904

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study

Lenard Conradi1,2, MD; Sebastian Ludwig2,3,4, MD; Paul Sorajja5, MD; Alison Duncan6, MD; Brian Bethea7, MD; Gry Dahle8, MD; Vasilis Babaliaros9, MD; Mayra Guerrero10, MD; Vinod Thourani11, MD; Nicolas Dumonteil12, MD; Thomas Modine13, MD, PhD; Andrea Garatti14, MD; Paolo Denti15, MD; Jonathon Leipsic16, MD; Michael L. Chuang17, MD; Philipp Blanke16, MD; David W. Muller18, MD; Vinay Badhwar19, MD

Abstract

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR.

AIMS: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR.

METHODS: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed.

RESULTS: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement...

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Volume 20 Number 14
Jul 15, 2024
Volume 20 Number 14
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