Transcatheter aortic-valve implantation with or without on-site cardiac surgery: The TRACS trial. in American heart journal / Am Heart J. 2025 Feb;280:7-17. doi: 10.1016/j.ahj.2024.10.019. Epub 2024 Nov 4.

2025
ASL Asti
AOU Alessandria
ASL Torino 3

Tipo pubblicazione

Journal Article

Autori/Collaboratori (31)Vedi tutti...

Campo G
Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy. Electronic address: cmpglc@unife.it.
Guiducci V
Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy.
Bolognese L
Cardiovascular Department, San Donato Hospital, Arezzo, Italy.

et alii...

Abstract

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as an effective and safe treatment for patients with symptomatic aortic stenosis. The indication to TAVI should be agreed upon by a Heart Team, and the procedure should be performed in centers with on-site cardiac surgery. However, TAVI complications requiring emergent cardiac surgery (ECS) have become very rare. Concurrently, access disparities and prolonged waiting times are pressing issues due to increasing clinical demand of TAVI. Many solutions have been proposed and one of them is the possibility of performing TAVI in centers without on-site cardiac surgery. METHODS AND DESIGN: The Transcatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with symptomatic severe aortic stenosis and deemed inoperable, at high surgical risk, or presenting with at least 1 clinical factor compromising the benefit/risk ratio for ECS, will be randomized to undergo TAVI either in centers with or without on-site cardiac surgery. The primary endpoint will be the composite occurrence of all-cause death, stroke, and hospital readmission for cardiovascular causes at one year. The safety endpoint will include death attributable to periprocedural complications actionable by ECS. The study aims to enroll 566 patients. IMPLICATIONS: The TRACS trial aims to address critical gaps in knowledge regarding the safety and efficacy of TAVI procedures performed in centers without on-site cardiac surgery, potentially improving access and outcomes for high-risk patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05751577.

Accesso banca dati bibliografica

PMID : 39505122

DOI : 10.1016/j.ahj.2024.10.019

Keywords

Stroke/etiology; Transcatheter Aortic Valve Replacement/methods; Prospective Studies; Postoperative Complications/epidemiology; Patient Readmission/statistics & numerical data; Cardiac Surgical Procedures/methods; Aortic Valve Stenosis/surgery; Male; Humans; Female; Aged; Treatment Outcome;