Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes
Recommended Citation
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. Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes. JACC Cardiovasc Interv 2024; 17(16):1936-1945.
Document Type
Article
Publication Date
8-26-2024
Publication Title
JACC Cardiovasc Interv
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 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.
Medical Subject Headings
Humans; Female; Male; Retrospective Studies; Aged; Treatment Outcome; Time Factors; Registries; Aged, 80 and over; Heart Valve Prosthesis; Tricuspid Valve; Compassionate Use Trials; Tricuspid Valve Insufficiency; Heart Valve Prosthesis Implantation; Cardiac Catheterization; Prosthesis Design; Risk Factors; Recovery of Function; Hospital Mortality; Postoperative Complications; Jugular Veins
PubMed ID
39197992
Volume
17
Issue
16
First Page
1936
Last Page
1945
