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. 2024 Jul 15;20(14):e887-e897.
doi: 10.4244/EIJ-D-23-00904.

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

Lenard Conradi  1   2 , Sebastian Ludwig  2   3   4 , Paul Sorajja  5 , Alison Duncan  6 , Brian Bethea  7 , Gry Dahle  8 , Vasilis Babaliaros  9 , Mayra Guerrero  10 , Vinod Thourani  11 , Nicolas Dumonteil  12 , Thomas Modine  13 , Andrea Garatti  14 , Paolo Denti  15 , Jonathon Leipsic  16 , Michael L Chuang  17 , Philipp Blanke  16 , David W Muller  18 , Vinay Badhwar  19
Affiliations

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

Lenard Conradi et al. EuroIntervention. .

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 of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047).

Conclusions: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

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Conflict of interest statement

L. Conradi has been an advisory board member for Abbott, Medtronic and JenaValve; and has received personal fees from Boston Scientific, Edwards Lifesciences, Micro Interventional Devices, MicroPort, Neovasc, Pi-Cardia, and Venus Medtech. S. Ludwig has received a grant from the German Heart Foundation (DHS); speaker honoraria from Abbott; travel compensation from Edwards Lifesciences; advisory fees from Bayer; and is a consultant to NVT. D.W. Muller has served as a consultant for Medtronic, Abbott, and Edwards Lifesciences; and has received research grant support from Abbott and Medtronic. P. Sorajja has served as a consultant for 4C Medical, Abbott, Adona, Boston Scientific, Cultiv8, Edwards Lifesciences, Foldax, GE HealthCare, GLG, Laza Medical, Medtronic, Philips, W.L. Gore & Associates, VDyne, and xDot. A. Duncan has served as a proctor and consultant for Abbott, Edwards Lifesciences, Medtronic, and Neochord. B. Bethea has served as a consultant for Abbott. G. Dahle has been proctor/speaker for Abbott; and speaker for Edwards Lifesciences. V. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott; and has equity in Transmural Systems. M. Guerrero has served as a consultant for Edwards Lifesciences and Abbott; and has received research grant support from Edwards Lifesciences. V. Thourani has served as a consultant for and received research grant support from Abbott. N. Dumonteil has been a consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. T. Modine has served as a proctor and consultant for Abbott, Edwards Lifesciences, and Medtronic. A. Garatti has served as a proctor for Abbott. P. Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant for Approxima, HVR, InnovHeart, and Pi-Cardia. J. Leipsic has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Pi-Cardia, and Neovasc, without direct personal compensation. P. Blanke has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Pi-Cardia, and Neovasc, without direct personal compensation; and has been a consultant to Edwards Lifesciences. V. Badhwar has served as an uncompensated consultant for Abbott. M.L. Chuang has no conflicts of interest to declare relevant to the contents of this paper.

Figures

Figure 1
Figure 1. Study flowchart.
Figure 2
Figure 2. Kaplan-Meier analysis for all-cause mortality up to 2 years.
A) Kaplan-Meier analysis for 2-year all-cause mortality. B) Three-month landmark analysis for 2-year all-cause mortality.
Figure 3
Figure 3. Baseline and follow-up symptom evaluation and quality of life assessments.
A) Mitral regurgitation; B) NYHA Functional Classification; C) 6MWD; D) KCCQ. MR severity was assessed by TTE at baseline, 30-day, 1- and 2-year follow-up and adjudicated by an independent echocardiography core lab. Heart failure symptoms and functional capacity were assessed at baseline, 30-day, 1- and 2-year follow-up. 6MWD: six-minute walk distance; F/u: follow-up; KCCQ: Kansas City Cardiomyopathy Questionnaire; MR: mitral regurgitation; NYHA: New York Heart Association; TTE: transthoracic echocardiography
See this image and copyright information in PMC

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