Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients

• Published in: Journal of the American College of Cardiology 2019-03, Vol.73 (11), p.1250-1260
• Main Authors: Sorajja, Paul, Moat, Neil, Badhwar, Vinay, Walters, Darren, Paone, Gaetano, Bethea, Brian, Bae, Richard, Dahle, Gry, Mumtaz, Mubashir, Grayburn, Paul, Kapadia, Samir, Babaliaros, Vasilis, Guerrero, Mayra, Satler, Lowell, Thourani, Vinod, Bedogni, Francesco, Rizik, David, Denti, Paolo, Dumonteil, Nicolas, Modine, Thomas, Sinhal, Ajay, Chuang, Michael L, Popma, Jeffrey J, Blanke, Philipp, Leipsic, Jonathon, Muller, David
• Format: Article
• Language: English
• Subjects: Aged; Anticoagulants; Bleeding; Cardiac arrhythmia; Cardiac Catheterization - methods; Cardiology; Cardiomyopathy; Confidence intervals; Congestive heart failure; Endocarditis; Fatalities; Feasibility Studies; Female; Global Health; Heart attacks; Heart failure; Heart surgery; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart valves; Humans; Hypertension; Laboratories; Male; Medical imaging; Medical personnel; Medical prognosis; Mitral valve; Mitral Valve - diagnostic imaging; Mitral Valve - surgery; Mitral Valve Insufficiency - diagnosis; Mitral Valve Insufficiency - physiopathology; Mitral Valve Insufficiency - surgery; Mortality; Ostomy; Outcome Assessment, Health Care; Patients; Postoperative Complications - diagnosis; Postoperative Complications - mortality; Postoperative Complications - psychology; Prostheses; Pulmonary arteries; Quality of Life; Regurgitation; Risk Adjustment - methods; Risk Factors; Signs and symptoms; Stroke; Success; Surgery; Survival; Symptom Assessment - methods; Thorax; Thrombosis; Ventricle; Ventricular Dysfunction, Left - diagnosis
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2018.12.066

Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. 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. 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