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Multicenter Study
. 2022 Dec 6;80(23):2171-2183.
doi: 10.1016/j.jacc.2022.09.037.

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Annular Calcification, Rings, and Bioprostheses

Mackram F Eleid  1 , Dee Dee Wang  2 , Amit Pursnani  3 , Susheel K Kodali  4 , Issac George  5 , Igor Palacios  6 , Hyde Russell  7 , Raj R Makkar  8 , Saibal Kar  9 , Lowell F Satler  10 , Vivek Rajagopal  11 , George Dangas  12 , Gilbert H L Tang  13 , James M McCabe  14 , Brian K Whisenant  15 , Kenith Fang  16 , Tatiana Kaptzan  17 , Bradley Lewis  18 , Pamela Douglas  19 , Rebecca Hahn  4 , Jeremy Thaden  1 , Jae K Oh  1 , Martin Leon  4 , William O'Neill  2 , Charanjit S Rihal  1 , Mayra E Guerrero  20
Affiliations
Free article
Multicenter Study

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Annular Calcification, Rings, and Bioprostheses

Mackram F Eleid et al. J Am Coll Cardiol. .
Free article

Abstract

Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described.

Objectives: This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial.

Methods: This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites.

Results: Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline.

Conclusions: Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups.

Keywords: annuloplasty ring; mitral annular calcification; mitral bioprosthesis; mitral valve disease; transcatheter mitral valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures This study was supported by an unrestricted research grant from Edwards Lifesciences. Dr Wang has served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Materialise, and NeoChord; and has received research grant support from Boston Scientific assigned to her employer Henry Ford Hospital. Dr Tang has served as a physician proctor and consultant for Medtronic; has served as a consultant and physician advisory board member for Abbott Structural Heart; and has served as a consultant for NeoChord. Dr McCabe has received honoraria from Boston Scientific, CSI, Edwards, and Medtronic. Dr Whisenant has received consulting and speaker fees from Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has stock options with Navigate; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Dr Guerrero has received institutional research grant support from Edwards Lifesciences; and has served as a consultant for Abbott Structural Heart and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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