Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry
Michael Mack, John D Carroll, Vinod Thourani, Sreekanth Vemulapalli, John Squiers, Pratik Manandhar, G Michael Deeb, Wayne Batchelor, Howard C Herrmann, David J Cohen, George Hanzel, Thomas Gleason, Ajay Kirtane, Nimesh Desai, Kim Guibone, Karen Hardy, Joan Michaels, J Michael DiMaio, Barbara Christensen, Susan Fitzgerald, Carole Krohn, Ralph G Brindis, Fred Masoudi, Joseph Bavaria, Michael Mack, John D Carroll, Vinod Thourani, Sreekanth Vemulapalli, John Squiers, Pratik Manandhar, G Michael Deeb, Wayne Batchelor, Howard C Herrmann, David J Cohen, George Hanzel, Thomas Gleason, Ajay Kirtane, Nimesh Desai, Kim Guibone, Karen Hardy, Joan Michaels, J Michael DiMaio, Barbara Christensen, Susan Fitzgerald, Carole Krohn, Ralph G Brindis, Fred Masoudi, Joseph Bavaria
Abstract
Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).
Keywords: mitral regurgitation; mitral valve repair; percutaneous; prognosis; treatment.
Conflict of interest statement
Funding Support and Author Disclosures Dr Mack has served as uncompensated co–principal investigator for the Partner 3 Trial by Edwards Lifesciences, study chair for the Apollo Trial by Medtronic, and co–principal investigator for the Coapt Trial by Abbott, receiving only travel expenses for trial-related meetings. Dr Carroll has been a local investigator for Abbott (COAPT, TRILUMINATE, and EXPAND clinical trials), Edwards Lifesciences (PARTNER 2 and CLASP clinical trials), and Medtronic (Low Risk TAVR clinical trial; has been the chair of the data and safety monitoring board for Abbott Tendyne clinical trial; and has been a steering committee member for the Abbott RESPECT clinical trial. Dr Thourani has received consultancy and research grants from Abbott and Edwards Lifesciences. Dr Vemulapalli has received grants/contracts from Abbott, Boston Scientific, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, National Evaluation System for health Technology Coordinating Center (FDA); and has received consulting fees/served on the advisory board/Speakers Bureau for Boston Scientific, Janssen, HeartFlow, and American College of Physicians. Dr Deeb has been an executive committee and investigator for all the Medtronic TAVR Trials; has served on the surgical Advisory Committee for Medtronic; and has served on the data management committee for the Medtronic EV-ICD Trial (no personal reimbursement). Dr Batchelor has served as a consultant for V-Wave, Medtronic, Abbott, Boston Scientific, and Idorsia; and has received research support from Abbott and Boston Scientific. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consultant fees from Edwards Lifesciences and Medtronic; and has equity in Microinterventional Devices. Dr Cohen has received research grant support and consulting income from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Hanzel has served as a local investigator for Abbott (COAPT and Summit clinical trials), Boston Scientific (REPRISE III and REPRISE IV clinical trials), and Edwards Lifesciences (PARTNER 2 and PARNTER 3 clinical trials). Dr Gleason serves on the medical advisory board for Abbott. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical; has received institutional funding, including fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; has received consulting fees from Neurotronic; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Desai has received speaking fees from Medtronic, Gore, and Terumo; and has received research grants from Gore and Medtronic. Dr Brindis serves as Senior Medical Officer, External Affairs, ACC National Cardiovascular Data Registry. Dr Masoudi has a contract with the ACC for his role as Chief Scientific Advisor, National Cardiovascular Data Registry. Dr Bavaria has served as a site principal investigator on clinical trials for Edwards Lifesciences, Medtronic, W.L. Gore, and Abbott; has served as a consultant for Edwards Lifesciences, W.L. Gore, and Abbott; has served on the Speakers Bureau for Medtronic; and has served as data and safety monitoring board chair for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 by The American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Source: PubMed