Mayra Guerrero1, Dee Dee Wang2, Amit Pursnani3, Michael Salinger4, Hyde M Russell5, Mackram Eleid6, Tarun Chakravarty7, Marvin H Ng2, Susheel K Kodali8, Christopher U Meduri9, Ashish Pershad10, Lowell Satler11, Ron Waksman11, Igor Palacios12, Richard Smalling13, Mark Reisman14, Mary Gegenhuber15, Tatiana Kaptzan16, Brad Lewis17, Carl Tommaso3, Philip Krause3, Jeremy Thaden6, Jae Oh6, Pamela S Douglas18, Rebecca T Hahn8, Saibal Kar19, Raj Makkar7, Martin B Leon8, Ted Feldman20, Charanjit Rihal6, William W O'Neill2. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: mayraguerrero@icloud.com. 2. Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan, USA. 3. Division of Cardiology, NorthShore University HealthSystem, Evanston, Illinois, USA. 4. Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 5. Division of Cardiovascular Surgery, NorthShore University HealthSystem, Evanston, Illinois, USA. 6. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. 7. Department of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California, USA. 8. Division of Cardiology Columbia University Medical Center, New York, New York, USA. 9. Division of Cardiology, Piedmont Hospital, Atlanta, Georgia, USA. 10. Division of Cardiology, Banner University Medical Center, Phoenix, Arizona, USA. 11. Division of Cardiology, Medstar Washington Hospital Center, Washington, DC, USA. 12. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA. 13. Division of Cardiology, Memorial Hermann Heart and Vascular Center, Texas Medical Center, Houston, Texas, USA. 14. Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA. 15. Novartis Gene Therapies, Bannockburn, Illinois, USA. 16. Cardiovascular Research Unit, Mayo Clinic, Rochester, Minnesota, USA. 17. Division of Biostatistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA. 18. Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. 19. Division of Cardiology, Los Robles Regional Medical Center, Thousand Oaks, California, USA. 20. Edwards Lifesciences, Irvine, California, USA.
Abstract
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.
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.
Authors: Vasilis C Babaliaros; Robert J Lederman; Patrick T Gleason; Jaffar M Khan; Keshav Kohli; Anurag Sahu; Toby Rogers; Christopher G Bruce; Gaetono Paone; Joe X Xie; Norihiko Kamioka; Jose F Condado; Isida Byku; Emily Perdoncin; John C Lisko; Adam B Greenbaum Journal: JACC Cardiovasc Interv Date: 2021-10-25 Impact factor: 11.195
Authors: Matti Adam; Elmar Kuhn; Hendrik Wienemann; Victor Mauri; Laurin Ochs; Maria Isabel Körber; Kaveh Eghbalzadeh; Christos Iliadis; Marcel Halbach; Thorsten Wahlers; Stephan Baldus Journal: Clin Res Cardiol Date: 2022-09-15 Impact factor: 6.138
Authors: Angela McInerney; Luis Marroquin-Donday; Gabriela Tirado-Conte; Breda Hennessey; Carolina Espejo; Eduardo Pozo; Alberto de Agustín; Nieves Gonzalo; Pablo Salinas; Iván Núñez-Gil; Antonio Fernández-Ortiz; Hernan Mejía-Rentería; Fernando Macaya; Javier Escaned; Luis Nombela-Franco; Pilar Jiménez-Quevedo Journal: J Clin Med Date: 2022-05-22 Impact factor: 4.964