Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes.
JACC Cardiovasc Interv
; 17(16): 1936-1945, 2024 Aug 26.
Article
en En
| MEDLINE
| ID: mdl-39197992
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Diseño de Prótesis
/
Válvula Tricúspide
/
Insuficiencia de la Válvula Tricúspide
/
Prótesis Valvulares Cardíacas
/
Cateterismo Cardíaco
/
Sistema de Registros
/
Implantación de Prótesis de Válvulas Cardíacas
/
Recuperación de la Función
/
Ensayos de Uso Compasivo
Límite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Estados Unidos