Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes |
| |
| Authors: | 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 Charanjit Rihal |
| |
| Affiliation: | 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA;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. Division of Cardiology, Columbia University Medical Center, New York, New York, USA;7. Department of Surgery, Columbia University Medical Center, New York, New York, USA;8. Division of Cardiology, Medstar Washington Hospital Center, Washington, DC, USA;9. Division of Cardiology, Piedmont Hospital, Atlanta, Georgia, USA;10. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA;11. Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA;12. Division of Cardiovascular Surgery, NorthShore University HealthSystem, Evanston, Illinois, USA;13. Division of Cardiology, Banner University Medical Center, Phoenix, Arizona, USA;14. Division of Cardiology, Los Robles Regional Medical Center, Thousand Oaks, California, USA;15. Department of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California, USA;p. Division of Cardiovascular Surgery, Froedtert Medical College of Wisconsin, Milwaukee, Wisconsin, USA;q. Cardiovascular Research Unit, Mayo Clinic, Rochester, Minnesota, USA;r. Division of Biostatistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA;s. Division of Cardiology, University of Chicago Medical Center, Chicago, Illinois, USA;t. Edwards Lifesciences, Irvine, California, USA |
| |
| Abstract: | ![]()
ObjectivesThe 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.BackgroundThe 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.MethodsHigh-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).ResultsThirty 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+.ConclusionsTransseptal 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. |
| |
| Keywords: | mitral valve-in-valve surgical mitral valve replacement transcatheter mitral valve replacement CT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0030" }," $$" :[{" #name" :" text" ," _" :" computed tomographic IQR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0040" }," $$" :[{" #name" :" text" ," _" :" interquartile range LVOT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" left ventricular outflow tract MAC" },{" #name" :" keyword" ," $" :{" id" :" kwrd0060" }," $$" :[{" #name" :" text" ," _" :" mitral annular calcification MR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" mitral regurgitation MV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" mitral valve MVG" },{" #name" :" keyword" ," $" :{" id" :" kwrd0090" }," $$" :[{" #name" :" text" ," _" :" mitral valve gradient MViV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0100" }," $$" :[{" #name" :" text" ," _" :" mitral valve-in-valve NYHA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0110" }," $$" :[{" #name" :" text" ," _" :" New York Heart Association STS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0120" }," $$" :[{" #name" :" text" ," _" :" Society of Thoracic Surgeons THV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0130" }," $$" :[{" #name" :" text" ," _" :" transcatheter heart valve TMVR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0140" }," $$" :[{" #name" :" text" ," _" :" transcatheter mitral valve replacement |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
