TY  - BOOK
AU  - Satler, Lowell F
AU  - Waksman, Ron
TI  - Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes
SN  - 1936-8798
PY  - 2021///
KW  - *Heart Valve Prosthesis
KW  - *Heart Valve Prosthesis Implantation
KW  - *Mitral Valve Annuloplasty
KW  - *Mitral Valve Insufficiency
KW  - Aged
KW  - Cardiac Catheterization/ae [Adverse Effects]
KW  - Female
KW  - Heart Valve Prosthesis Implantation/ae [Adverse Effects]
KW  - Humans
KW  - Male
KW  - Mitral Valve Annuloplasty/ae [Adverse Effects]
KW  - Mitral Valve Insufficiency/dg [Diagnostic Imaging]
KW  - Mitral Valve Insufficiency/su [Surgery]
KW  - Mitral Valve/dg [Diagnostic Imaging]
KW  - Mitral Valve/su [Surgery]
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N2  - 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; 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. Copyright (c) 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved; 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); 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); 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
UR  - https://dx.doi.org/10.1016/j.jcin.2021.01.051
ER  -