Early Outcomes From a Multicenter Transcatheter Self-Expanding Pulmonary Valve Replacement Registry.
J Am Coll Cardiol
; 83(14): 1310-1321, 2024 Apr 09.
Article
en En
| MEDLINE
| ID: mdl-38569760
ABSTRACT
BACKGROUND:
Transcatheter pulmonary valve replacement (TPVR) with the self-expanding Harmony valve (Medtronic) is an emerging treatment for patients with native or surgically repaired right ventricular outflow tract (RVOT) pulmonary regurgitation (PR). Limited data are available since U.S. Food and Drug Administration approval in 2021.OBJECTIVES:
In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience.METHODS:
This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S. CENTERS The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.RESULTS:
A total of 243 patients underwent TPVR at a median age of 31 years (Q1-Q3 19-45 years). Cardiac diagnoses were tetralogy of Fallot (71%), valvular pulmonary stenosis (21%), and other (8%). Acute technical success was achieved in all but 1 case. Procedural serious adverse events occurred in 4% of cases, with no device embolization or death. Hospital length of stay was 1 day in 86% of patients. Ventricular arrhythmia prompting treatment occurred in 19% of cases. At a median follow-up of 13 months (Q1-Q3 8-19 months), 98% of patients had acceptable hemodynamic function. Estimated freedom from the composite clinical outcome was 99% at 1 year and 96% at 2 years. Freedom from TPVR-related endocarditis was 98% at 1 year. Five patients died from COVID-19 (n = 1), unknown causes (n = 2), and bloodstream infection (n = 2).CONCLUSIONS:
In this large multicenter real-world experience, short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent. Ongoing follow-up of this cohort will provide important insights into long-term outcomes.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Válvula Pulmonar
/
Insuficiencia de la Válvula Pulmonar
/
Prótesis Valvulares Cardíacas
/
Implantación de Prótesis de Válvulas Cardíacas
Límite:
Adult
/
Humans
Idioma:
En
Revista:
J Am Coll Cardiol
Año:
2024
Tipo del documento:
Article