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

Paul Sorajja, Neil Moat, Vinay Badhwar, Darren Walters, Gaetano Paone, Brian Bethea, Richard Bae, Gry Dahle, Mubashir Mumtaz, Paul Grayburn, Samir Kapadia, Vasilis Babaliaros, Mayra Guerrero, Lowell Satler, Vinod Thourani, Francesco Bedogni, David Rizik, Paolo Denti, Nicolas Dumonteil, Thomas ModineAjay Sinhal, Michael L. Chuang, Jeffrey J. Popma, Philipp Blanke, Jonathon Leipsic, David Muller

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1250-1260
Number of pages11
JournalJournal of the American College of Cardiology
Volume73
Issue number11
DOIs
StatePublished - Mar 26 2019

Fingerprint

Feasibility Studies
Mitral Valve
Prostheses and Implants
Mitral Valve Insufficiency
Survivors
Mortality
Survival
Left Ventricular Dysfunction
Cardiopulmonary Bypass
Cardiomyopathies
Heart Failure
Stroke
Quality of Life
Confidence Intervals
Hemorrhage
Morbidity
Safety
Therapeutics

Keywords

  • mitral
  • regurgitation
  • surgery
  • transcatheter

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Sorajja, P., Moat, N., Badhwar, V., Walters, D., Paone, G., Bethea, B., ... Muller, D. (2019). Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. Journal of the American College of Cardiology, 73(11), 1250-1260. https://doi.org/10.1016/j.jacc.2018.12.066

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

In: Journal of the American College of Cardiology, Vol. 73, No. 11, 26.03.2019, p. 1250-1260.

Research output: Contribution to journalArticle

Sorajja, P, Moat, N, Badhwar, V, Walters, D, Paone, G, Bethea, B, Bae, R, Dahle, G, Mumtaz, M, Grayburn, P, Kapadia, S, Babaliaros, V, Guerrero, M, Satler, L, Thourani, V, Bedogni, F, Rizik, D, Denti, P, Dumonteil, N, Modine, T, Sinhal, A, Chuang, ML, Popma, JJ, Blanke, P, Leipsic, J & Muller, D 2019, 'Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients', Journal of the American College of Cardiology, vol. 73, no. 11, pp. 1250-1260. https://doi.org/10.1016/j.jacc.2018.12.066
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. / Initial Feasibility Study of a New Transcatheter Mitral Prosthesis : The First 100 Patients. In: Journal of the American College of Cardiology. 2019 ; Vol. 73, No. 11. pp. 1250-1260.
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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

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.

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