Mayra Guerrero1, Amit Pursnani2, Akhil Narang3, Michael Salinger4, Dee Dee Wang5, Mackram Eleid6, Susheel K Kodali7, Isaac George8, Lowell Satler9, Ron Waksman9, Christopher U Meduri10, Vivek Rajagopal10, Ignacio Inglessis11, Igor Palacios11, Mark Reisman12, Marvin H Eng5, Hyde M Russell13, Ashish Pershad14, Kenith Fang14, Saibal Kar15, Rajj Makkar16, Jorge Saucedo4, Paul Pearson17, Ujala Bokhary2, Tatiana Kaptzan18, Brad Lewis19, Carl Tommaso2, Philip Krause2, Jeremy Thaden6, Jae Oh6, Roberto M Lang20, Rebecca T Hahn7, Martin B Leon7, William W O'Neill5, Ted Feldman21, Charanjit Rihal6. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: mayraguerrero@icloud.com. 2. Division of Cardiology, NorthShore University HealthSystem, Evanston, Illinois, USA. 3. Division of Cardiology, Northwestern Memorial Hospital, Chicago, Illinois, USA. 4. Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 5. Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan, USA. 6. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. 7. Division of Cardiology, Columbia University Medical Center, New York, New York, USA. 8. Department of Surgery, Columbia University Medical Center, New York, New York, USA. 9. Division of Cardiology, Medstar Washington Hospital Center, Washington, DC, USA. 10. Division of Cardiology, Piedmont Hospital, Atlanta, Georgia, USA. 11. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA. 12. Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA. 13. Division of Cardiovascular Surgery, NorthShore University HealthSystem, Evanston, Illinois, USA. 14. Division of Cardiology, Banner University Medical Center, Phoenix, Arizona, USA. 15. Division of Cardiology, Los Robles Regional Medical Center, Thousand Oaks, California, USA. 16. Department of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California, USA. 17. Division of Cardiovascular Surgery, Froedtert Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 18. Cardiovascular Research Unit, Mayo Clinic, Rochester, Minnesota, USA. 19. Division of Biostatistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA. 20. Division of Cardiology, University of Chicago Medical Center, Chicago, Illinois, USA. 21. Edwards Lifesciences, Irvine, California, USA.
Abstract
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.
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.
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