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

Publication ,  Journal Article
Guerrero, M; Wang, DD; Pursnani, A; Salinger, M; Russell, HM; Eleid, M; Chakravarty, T; Ng, MH; Kodali, SK; Meduri, CU; Pershad, A; Satler, L ...
Published in: JACC Cardiovasc Interv
April 26, 2021

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.

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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

April 26, 2021

Volume

14

Issue

8

Start / End Page

846 / 858

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prosthesis Design
  • Prospective Studies
  • Mitral Valve Insufficiency
  • Mitral Valve Annuloplasty
  • Mitral Valve
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis
 

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Guerrero, M., Wang, D. D., Pursnani, A., Salinger, M., Russell, H. M., Eleid, M., … O’Neill, W. W. (2021). Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes. JACC Cardiovasc Interv, 14(8), 846–858. https://doi.org/10.1016/j.jcin.2021.01.051
Guerrero, Mayra, Dee Dee Wang, Amit Pursnani, Michael Salinger, Hyde M. Russell, Mackram Eleid, Tarun Chakravarty, et al. “Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes.JACC Cardiovasc Interv 14, no. 8 (April 26, 2021): 846–58. https://doi.org/10.1016/j.jcin.2021.01.051.
Guerrero M, Wang DD, Pursnani A, Salinger M, Russell HM, Eleid M, et al. Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes. JACC Cardiovasc Interv. 2021 Apr 26;14(8):846–58.
Guerrero, Mayra, et al. “Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes.JACC Cardiovasc Interv, vol. 14, no. 8, Apr. 2021, pp. 846–58. Pubmed, doi:10.1016/j.jcin.2021.01.051.
Guerrero M, Wang DD, Pursnani A, Salinger M, Russell HM, Eleid M, Chakravarty T, Ng MH, Kodali SK, Meduri CU, Pershad A, Satler L, Waksman R, Palacios I, Smalling R, Reisman M, Gegenhuber M, Kaptzan T, Lewis B, Tommaso C, Krause P, Thaden J, Oh J, Douglas PS, Hahn RT, Kar S, Makkar R, Leon MB, Feldman T, Rihal C, O’Neill WW. Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes. JACC Cardiovasc Interv. 2021 Apr 26;14(8):846–858.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

April 26, 2021

Volume

14

Issue

8

Start / End Page

846 / 858

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prosthesis Design
  • Prospective Studies
  • Mitral Valve Insufficiency
  • Mitral Valve Annuloplasty
  • Mitral Valve
  • Male
  • Humans
  • Heart Valve Prosthesis Implantation
  • Heart Valve Prosthesis