Early Experience With New Transcatheter Mitral Valve Replacement
Vinayak Bapat, Vivek Rajagopal, Christopher Meduri, R Saeid Farivar, Antony Walton, Stephen J Duffy, Robert Gooley, Aubrey Almeida, Michael J Reardon, Neal S Kleiman, Konstantinos Spargias, Stratis Pattakos, Martin K Ng, Michael Wilson, David H Adams, Martin Leon, Michael J Mack, Sharla Chenoweth, Paul Sorajja, Intrepid Global Pilot Study Investigators, Neal S Kleiman, Michael Reardon, Tanvir Bajwa, Daniel O'Hair, Vivek Rajagopal, Christopher Meduri, Mathew Williams, Hasan Jilaihawi, Paul Sorajja, R Saeid Farivar, Antony Walton, Stephen Duffy, Robert Gooley, Aubrey Almeida, Martin Ng, Michael Wilson, Konstantinos Spargias, Stratis Pattakos, Mika Laine, Helena Haenninen, Thomas Modine, Augustin Coisne, David Hildick-Smith, Uday Trivedi, Daniel Blackman, Betsy Evans, Ronak Rajani, Simon Redwood, Vinayak Bapat, Vivek Rajagopal, Christopher Meduri, R Saeid Farivar, Antony Walton, Stephen J Duffy, Robert Gooley, Aubrey Almeida, Michael J Reardon, Neal S Kleiman, Konstantinos Spargias, Stratis Pattakos, Martin K Ng, Michael Wilson, David H Adams, Martin Leon, Michael J Mack, Sharla Chenoweth, Paul Sorajja, Intrepid Global Pilot Study Investigators, Neal S Kleiman, Michael Reardon, Tanvir Bajwa, Daniel O'Hair, Vivek Rajagopal, Christopher Meduri, Mathew Williams, Hasan Jilaihawi, Paul Sorajja, R Saeid Farivar, Antony Walton, Stephen Duffy, Robert Gooley, Aubrey Almeida, Martin Ng, Michael Wilson, Konstantinos Spargias, Stratis Pattakos, Mika Laine, Helena Haenninen, Thomas Modine, Augustin Coisne, David Hildick-Smith, Uday Trivedi, Daniel Blackman, Betsy Evans, Ronak Rajani, Simon Redwood
Abstract
Background: Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.
Objectives: The authors report their early experience with TMVR using a new valve system.
Methods: The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).
Results: Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.
Conclusions: TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid TMVR Pilot Study; NCT02322840).
Keywords: mitral valve regurgitation; prosthesis; transcatheter mitral valve replacement.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed