Paul Sorajja1, Neil Moat2, Vinay Badhwar3, Darren Walters4, Gaetano Paone5, Brian Bethea6, Richard Bae7, Gry Dahle8, Mubashir Mumtaz9, Paul Grayburn10, Samir Kapadia11, Vasilis Babaliaros12, Mayra Guerrero13, Lowell Satler14, Vinod Thourani14, Francesco Bedogni15, David Rizik16, Paolo Denti17, Nicolas Dumonteil18, Thomas Modine19, Ajay Sinhal20, Michael L Chuang21, Jeffrey J Popma21, Philipp Blanke22, Jonathon Leipsic22, David Muller23. 1. Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com. 2. Royal Brompton Hospital, London, United Kingdom. 3. West Virginia University Heart and Vascular Institute, Morgantown, West Virginia. 4. Prince Charles Hospital, Brisbane, Australia. 5. Henry Ford Hospital, Detroit, Michigan. 6. Delray Medical Center, Delray Beach, Florida. 7. Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota. 8. Oslo University Hospital, Oslo, Norway. 9. University of Pittsburg Medical Center Pinnacle, Harrisburg, Pennsylvania. 10. Baylor University Medical Center, Dallas, Texas. 11. Cleveland Clinic Foundation, Cleveland, Ohio. 12. Emory University Hospital, Atlanta, Georgia. 13. Mayo Clinic, Rochester, Minnesota. 14. Medstar Washington Hospital Center, Washington, DC. 15. Policlinico San Donato, Milan, Italy. 16. Honor Health, Scottsdale, Arizona. 17. Ospedale San Raffaele, Milan, Italy. 18. Clinique Pasteur, Toulouse, France. 19. CHRU Lille, Lille, France. 20. Flinders University Hospital, Adelaide, Australia. 21. Beth Israel Deaconess Medical Center, Boston, Massachusetts. 22. St Paul's Hospital, Vancouver, British Columbia, Canada. 23. St. Vincent's Hospital, Sydney, Australia.
Abstract
BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. OBJECTIVES: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. METHODS: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. RESULTS: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. CONCLUSIONS: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. OBJECTIVES: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. METHODS: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. RESULTS: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. CONCLUSIONS: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
Authors: Thilo Noack; Philipp Kiefer; Christian Besler; Philipp Lurz; Sergey Leontyev; Mohamed Abdel-Wahab; David Michael Holzhey; Joerg Seeburger Journal: Indian J Thorac Cardiovasc Surg Date: 2019-09-10
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