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

Publication ,  Journal Article
Sorajja, P; Moat, N; Badhwar, V; Walters, D; Paone, G; Bethea, B; Bae, R; Dahle, G; Mumtaz, M; Grayburn, P; Kapadia, S; Babaliaros, V ...
Published in: J Am Coll Cardiol
March 26, 2019

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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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 26, 2019

Volume

73

Issue

11

Start / End Page

1250 / 1260

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Symptom Assessment
  • Risk Factors
  • Risk Adjustment
  • Quality of Life
  • Postoperative Complications
  • Outcome Assessment, Health Care
  • Mortality
  • Mitral Valve Insufficiency
  • Mitral Valve
 

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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. J Am Coll Cardiol, 73(11), 1250–1260. https://doi.org/10.1016/j.jacc.2018.12.066
Sorajja, Paul, Neil Moat, Vinay Badhwar, Darren Walters, Gaetano Paone, Brian Bethea, Richard Bae, et al. “Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients.J Am Coll Cardiol 73, no. 11 (March 26, 2019): 1250–60. https://doi.org/10.1016/j.jacc.2018.12.066.
Sorajja P, Moat N, Badhwar V, Walters D, Paone G, Bethea B, et al. Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. J Am Coll Cardiol. 2019 Mar 26;73(11):1250–60.
Sorajja, Paul, et al. “Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients.J Am Coll Cardiol, vol. 73, no. 11, Mar. 2019, pp. 1250–60. Pubmed, doi:10.1016/j.jacc.2018.12.066.
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. Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. J Am Coll Cardiol. 2019 Mar 26;73(11):1250–1260.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 26, 2019

Volume

73

Issue

11

Start / End Page

1250 / 1260

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Symptom Assessment
  • Risk Factors
  • Risk Adjustment
  • Quality of Life
  • Postoperative Complications
  • Outcome Assessment, Health Care
  • Mortality
  • Mitral Valve Insufficiency
  • Mitral Valve