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

Mayra Guerrero, Dee Dee Wang, Amit Pursnani, Michael Salinger, Hyde M. Russell, Mackram Eleid, Tarun Chakravarty, Marvin H. Ng, Susheel K. Kodali, Christopher U. Meduri, Ashish Pershad, Lowell Satler, Ron Waksman, Igor Palacios, Richard Smalling, Mark Reisman, Mary Gegenhuber, Tatiana Kaptzan, Brad Lewis, Carl TommasoPhilip Krause, Jeremy Thaden, Jae Oh, Pamela S. Douglas, Rebecca T. Hahn, Saibal Kar, Raj Makkar, Martin B. Leon, Ted Feldman, Charanjit Rihal, William W. O'Neill

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)846-858
Number of pages13
JournalJACC: Cardiovascular Interventions
Issue number8
StatePublished - Apr 26 2021


  • mitral valve-in-ring
  • surgical mitral valve repair
  • transcatheter mitral valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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