TY - JOUR
T1 - Initial Feasibility Study of a New Transcatheter Mitral Prosthesis
T2 - The First 100 Patients
AU - Sorajja, Paul
AU - Moat, Neil
AU - Badhwar, Vinay
AU - Walters, Darren
AU - Paone, Gaetano
AU - Bethea, Brian
AU - Bae, Richard
AU - Dahle, Gry
AU - Mumtaz, Mubashir
AU - Grayburn, Paul
AU - Kapadia, Samir
AU - Babaliaros, Vasilis
AU - Guerrero, Mayra
AU - Satler, Lowell
AU - Thourani, Vinod
AU - Bedogni, Francesco
AU - Rizik, David
AU - Denti, Paolo
AU - Dumonteil, Nicolas
AU - Modine, Thomas
AU - Sinhal, Ajay
AU - Chuang, Michael L.
AU - Popma, Jeffrey J.
AU - Blanke, Philipp
AU - Leipsic, Jonathon
AU - Muller, David
N1 - Funding Information:
Dr. Sorajja has served as a consultant for Abbott Structural, Boston Scientific, Medtronic, Edwards, Admedus, and Gore; and has received research grants from Abbott Structural, Boston Scientific, and Medtronic. Dr. Moat has served as a consultant and on the Speakers Bureau for Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr. Badhwar has served as an uncompensated consultant for Abbott Vascular. Dr. Walters has served as a consultant and proctor for Edwards Lifesciences, Boston Scientific, and Abbott Vascular. Dr. Paone has served as a consultant for Edwards Lifesciences. Dr. Bethea has served as a consultant, proctor, and is on the speaker's bureau for Abbott Vascular and Medtronic. Drs. Bae and Dahle have served on the Speakers Bureau for Abbott Vascular. Dr. Mumtaz has served as a consultant for and received grant support from Abbott Vascular, Medtronic, Millipede, Terumo, Atricure, Edwards Lifesciences, Japanese Organization for Medical Device Development, Keystone, and Boston Scientific. Dr. Grayburn has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Neochord; has served as a consultant for Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord; and has received core laboratory support from Edwards Lifesciences and Neochord. Dr. Kapadia has stock options in Navigate. Dr. Babaliaros has served as a consultant and researcher for Edwards Lifesciences and Abbott Vascular. Dr. Guerrero has served as a proctor for and received research support from Edwards Lifesciences; and has served as a consultant and is on the Speakers Bureau for Boston Scientific. Dr. Thourani has served as a consultant for Abbott Vascular. Dr. Bedogni has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Terumo. Dr. Rizik has served on the Advisory Board for Abbott Vascular, Cordis/Cardinal, Biotronik, and Boston Scientific; has received grant or research support from Abbott Vascular and Boston Scientific; and has received licensing fees from Boston Scientific. Dr. Denti has served as a consultant for and received speaker honoraria from Abbott Vascular. Dr. Dumonteil has served as a consultant and proctor for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Sinhal has served as a proctor and consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Popma has received institutional grants from Abbott, Medtronic, Edwards, and Boston Scientific; and has served on the Medical Advisory Board of Boston Scientific. Dr. Blanke has served as a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Edwards Lifesciences, Tendyne, and Neovasc. Dr. Leipsic has served as a consultant for and has stock options in Circle Cardiovascular Imaging and HeartFlow; and has core laboratory agreements with Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr. Muller has served as a consultant for Abbott and Cephea; has received research support from Medtronic, Tendyne, and Cephea; has served as a proctor for Medtronic; and has served on the Advisory Board of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/3/26
Y1 - 2019/3/26
N2 - 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.
AB - 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.
KW - mitral
KW - regurgitation
KW - surgery
KW - transcatheter
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U2 - 10.1016/j.jacc.2018.12.066
DO - 10.1016/j.jacc.2018.12.066
M3 - Article
C2 - 30898200
AN - SCOPUS:85062711394
VL - 73
SP - 1250
EP - 1260
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 11
ER -