1. Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.
- Author
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Fam NP, von Bardeleben RS, Hensey M, Kodali SK, Smith RL, Hausleiter J, Ong G, Boone R, Ruf T, George I, Szerlip M, Näbauer M, Ali FM, Moss R, Bapat V, Schnitzler K, Kreidel F, Ye J, Deva DP, Mack MJ, Grayburn PA, Peterson MD, Leon MB, Hahn RT, and Webb JG
- Subjects
- Aged, Cardiac Catheterization adverse effects, Female, Humans, Male, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes., Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population., Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up., Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis., Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr. Fam has received speaker honoraria from Abbott Vascular; and is a consultant to Edwards Lifesciences. Dr. von Bardeleben received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Ye is a consultant to Edwards Lifesciences, JC Medical, and CryoLife. Dr. Moss is a consultant to Edwards Lifesciences. Dr. Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences; and is a consultant to Abbott Vascular and Edwards Lifesciences. Dr. George is consultant to VDyne, CardioMech, Atricure, MitreMedical, Neptune Medical, and W.L. Gore. Dr. Nabauer has received speaker honoraria from Abbott Vascular. Dr. Mack is co–principal investigator of the PARTNER (Placement of Aortic Transcatheter Valves) 3 trial for Edwards Lifesciences; is co–principal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial for Abbott; and is study chair of the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial for Medtronic (all uncompensated). Dr. Hahn has received speaker fees from Edwards Lifesciences; is a consultant for Abbott Vascular, Boston Scientific, Gore & Associates, and Medtronic; holds equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Becton Dickinson, and ViVitro Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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