Original Investigation
Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial

https://doi.org/10.1016/j.jacc.2016.10.068Get rights and content
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Abstract

Background

Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR.

Objectives

This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery.

Methods

Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes.

Results

Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.

Conclusions

TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514)

Key Words

heart failure
mitral prosthesis
mitral regurgitation
mitral valve implantation
transcatheter

Abbreviations and Acronyms

CT
computed tomography
LV
left ventricular/ventricle
LVEDVI
left ventricular end-diastolic volume index
LVESVI
left ventricular end-systolic volume index
LVOT
left ventricular outflow tract
MR
mitral valve regurgitation
NYHA
New York Heart Association
STS-PROM
Society of Thoracic Surgeons Predicted Risk of Mortality
TEE
transesophageal echocardiography
TMVR
transcatheter mitral valve replacement
TTE
transthoracic echocardiography

Cited by (0)

Source of funding for this study was Tendyne Holdings LLC, Roseville, Minnesota. Dr. Muller is an advisory board member and consultant to Medtronic, Boston Scientific, and Edwards Lifesciences; has received research grant support from Tendyne Holdings, Abbott Vascular, and Medtronic; and is a proctor for Medtronic and Abbott Vascular. Dr. Farivar is a medical advisory board member and consultant to Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr. Walters is an advisory board member for Edwards Lifesciences and Boston Scientific; a proctor for Abbott Vascular and Edwards Lifesciences; a consultant for Abbott Vascular; and has received research funding from Abbott Vascular. Dr. Grayburn is a consultant to Abbott Vascular, Edwards Lifesciences, Tendyne Holdings, Valtech Cardio, and NeoChord; has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Valtech Cardio, Tendyne Holdings, and NeoChord; and has provided echocardiography core lab support for NeoChord and Valtech. Dr. Stoler is an advisory board member and proctor for Medtronic and Boston Scientific. Dr. Guerrero is a proctor for and has received research grant support from Edwards Lifesciences; and is a consultant to Tendyne Holdings, and Edwards Lifesciences. Dr. Gillinov is a consultant to Abbott, Edwards Lifesciences, Medtronic, AtriCure, and CryoLife. Dr. Popma has received institutional grant support from Medtronic, Boston Scientific, Abbott Vascular, and Direct Flow Medical; is on the medical advisory board of Boston Scientific; and has equity in Direct Flow Medical. Dr. Blanke has received institutional grant support from Neovasc; and is a consultant for Tendyne Holdings, Edwards Lifesciences, and Circle Cardiovascular Imaging. Dr. Leipsic has received institutional grant support from Neovasc; is a consultant for Edwards Lifesciences and Circle Cardiovascular Imaging; and through the University of British Columbia, provides core laboratory support for Tendyne Holdings, Edwards Lifesciences, Neovasc, and Medtronic. Dr. Sorajja is a consultant to Abbott Vascular, Medtronic, Boston Scientific, and Lake Regions Medical; and has received institutional grant support from Abbott Vascular.

Listen to this manuscript's audio summary by JACC Editor-in-Chief Dr. Valentin Fuster.

© 2017 by the American College of Cardiology Foundation. Published by Elsevier.