1. Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes.
- Author
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Stolz L, Cheung A, Boone R, Fam N, Ong G, Villablanca P, Jabri A, De Backer O, Mølller JE, Tchétché D, Oliva O, Chak-Yu So K, Lam YY, Latib A, Scotti A, Coisne A, Sudre A, Dreyfus J, Nejjari M, Favre PE, Cruz-Gonzalez I, Estévez-Loureiro R, Barreiro-Perez M, Makkar R, Patel D, Leurent G, Donal E, Modine T, and Hausleiter J
- Subjects
- Humans, Female, Male, Retrospective Studies, Aged, Treatment Outcome, Time Factors, Aged, 80 and over, Risk Factors, Hospital Mortality, Postoperative Complications etiology, Jugular Veins, Registries, Heart Valve Prosthesis, Tricuspid Valve surgery, Tricuspid Valve physiopathology, Tricuspid Valve diagnostic imaging, Compassionate Use Trials, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency mortality, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Prosthesis Design, Recovery of Function
- Abstract
Background: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited., Objectives: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned., Methods: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm)., Results: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size., Conclusions: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Cheung has received speaker honoraria from Edwards Lifesciences, Abbott Vascular, and Medtronic; and has served as an eligibility committee member for the TRINITY trial. Dr Boone has served as a consultant for Edwards Lifesciences and Abbott. Dr Fam has served as a consultant for Edwards Lifesciences, Abbott, and Cardiovalve. Dr Villablanca has served as a consultant for Edwards Lifesciences, Medtronic, Angiodynamic, Telflex, and Abiomed. Dr De Backer has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. Dr Tchétché has served as consultant for Abbott, Edwards Lifesciences, Boston Scientific, and Medtronic. Dr So has served as a proctor for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Latib has served on the Advisory Board for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-dyne, and Philips. Dr Scotti has served as a consultant for NeoChord and Edwards Lifesciences. Dr Estévez-Loureiro has served as a consultant to Abbott Vascular, Edwards Lifesciences, Boston Scientific, Venus Medtech, and Jenscare. Dr Leurent has received speaker and proctoring honoraria from Edwards Lifesciences and Abbott Medical. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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