Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes.

Objectives: The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve-in-ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV).
Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings.
Methods: Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.S. sites. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year).
Results: Thirty patients were enrolled between January 2016 and October 2017 (median age 71.5 years [interquartile range: 67.0 to 76.8 years], 36.7% women, median Society of Thoracic Surgeons score 7.6% [interquartile range: 5.1% to 11.8%], 76.7% in New York Heart Association functional class III or IV). Technical success was 66.7% (driven primarily by need for a second valve in 6 patients). There was no intraprocedural mortality or conversion to surgery. The primary performance endpoint was achieved in 85.7% of survivors at 30 days (24 of 28) and 89.5% of patients alive at 1 year with echocardiographic data available (17 of 19). All-cause mortality at 30 days was 6.7% and at 1 year was 23.3%. Among survivors at 1-year follow-up, 84.2% were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.0 mm Hg (interquartile range: 4.7 to 7.3 mm Hg), and all had ≤1+ MR.
Conclusions: Transseptal MViR was associated with a 30-day mortality rate lower than predicted by the Society of Thoracic Surgeons score. At 1 year, transseptal MViR was associated with symptom improvement and stable THV performance.
Competing Interests: Funding Support and Author Disclosures This study was supported by an unrestricted research grant from Edwards Lifesciences. The authors had absolute control of the study design, data collection, analysis and interpretation of data, writing of this paper, and take full responsibility for this report. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, Materialise, and HighLife Medical; and has received grant support from Boston Scientific. Dr. Salinger has served as a proctor for Boston Scientific and Edwards Lifesciences. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Microinterventional Devices, and Supira Medical. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Reisman has served as consultant for Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, W.L. Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Feldman is an employee of Edwards Lifesciences. Dr. O’Neill has served as consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)