Author + information
- Received September 10, 2018
- Revision received November 14, 2018
- Accepted December 10, 2018
- Published online March 18, 2019.
- John G. Webb, MD∗ (, )@CHVI85209027,
- Dale J. Murdoch, MBBS,
- Robert H. Boone, MD,
- Robert Moss, MBBS,
- Adrian Attinger-Toller, MD,
- Philipp Blanke, MD,
- Anson Cheung, MD,
- Mark Hensey, MB, BCh, BAO,
- Jonathon Leipsic, MD,
- Kevin Ong, MD,
- Janarthanan Sathananthan, MBChB,
- David A. Wood, MD,
- Jian Ye, MD and
- Paolo Tartara, MD
- Centre for Heart Valve Innovation, St Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- ↵∗Address for correspondence:
Dr. John G. Webb, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Background Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option.
Objectives The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system.
Methods This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days.
Results Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died.
Conclusions Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted.
Drs. Webb, Blanke, Leipsic, Wood, and Ye are consultants to and have received research support from Edwards Lifesciences. Dr. Moss has received consultancy payments and travel assistance from Edwards Lifesciences. Dr. Blanke has served as a consultant for Neovasc, Tendyne, and Circle Cardiovascular Imaging. Dr. Cheung is a consultant to Abbott and Medtronic. Dr. Leipsic has received support through his institutional core laboratory from Edwards, Medtronic, Abbott, and Neovasc; and has served as a consultant for and has stock options in CIRCL CVI and Heartflow. Dr. Tartara is an employee of and has stock ownership in Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received September 10, 2018.
- Revision received November 14, 2018.
- Accepted December 10, 2018.
- 2019 American College of Cardiology Foundation
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