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. 2021 Apr 26;14(8):859-872.
doi: 10.1016/j.jcin.2021.02.027.

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

Mayra Guerrero  1 , Amit Pursnani  2 , Akhil Narang  3 , Michael Salinger  4 , Dee Dee Wang  5 , Mackram Eleid  6 , Susheel K Kodali  7 , Isaac George  8 , Lowell Satler  9 , Ron Waksman  9 , Christopher U Meduri  10 , Vivek Rajagopal  10 , Ignacio Inglessis  11 , Igor Palacios  11 , Mark Reisman  12 , Marvin H Eng  5 , Hyde M Russell  13 , Ashish Pershad  14 , Kenith Fang  14 , Saibal Kar  15 , Rajj Makkar  16 , Jorge Saucedo  4 , Paul Pearson  17 , Ujala Bokhary  2 , Tatiana Kaptzan  18 , Brad Lewis  19 , Carl Tommaso  2 , Philip Krause  2 , Jeremy Thaden  6 , Jae Oh  6 , Roberto M Lang  20 , Rebecca T Hahn  7 , Martin B Leon  7 , William W O'Neill  5 , Ted Feldman  21 , Charanjit Rihal  6
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Free article

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes

Mayra Guerrero et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.

Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.

Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. 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 July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+.

Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

Keywords: mitral valve-in-valve; surgical mitral valve replacement; transcatheter mitral valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific assigned to her employer, Henry Ford Health; and holds equity in Encompass Technologies. 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, Micro Interventional Devices, and Supira Medical. Dr. George has served as consultant for Cardiomech, VDyne, MitreMedical, and Neptune 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, 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. O’Neill has served as a consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. Dr. Feldman is an employee of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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