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

Mayra Guerrero, Amit Pursnani, Akhil Narang, Michael Salinger, Dee Dee Wang, Mackram Eleid, Susheel K. Kodali, Isaac George, Lowell Satler, Ron Waksman, Christopher U. Meduri, Vivek Rajagopal, Ignacio Inglessis, Igor Palacios, Mark Reisman, Marvin H. Eng, Hyde M. Russell, Ashish Pershad, Kenith Fang, Saibal KarRajj Makkar, Jorge Saucedo, Paul Pearson, Ujala Bokhary, Tatiana Kaptzan, Brad Lewis, Carl Tommaso, Philip Krause, Jeremy Thaden, Jae Oh, Roberto M. Lang, Rebecca T. Hahn, Martin B. Leon, William W. O'Neill, Ted Feldman, Charanjit Rihal

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)859-872
Number of pages14
JournalJACC: Cardiovascular Interventions
Issue number8
StatePublished - Apr 26 2021


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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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