Transcatheter aortic-valve implantation with or

被引：6

作者：

Iannopollo, Gianmarco ^{[1
]}

Cocco, Marta ^{[2
]}

Leone, Alessandro ^{[3
]}

Sacca, Salvatore ^{[4
]}

Mangino, Domenico ^{[5
]}

Picchi, Andrea ^{[6
]}

Reccia, Matteo Rocco ^{[7
]}

Fineschi, Massimo ^{[8
]}

Meliga, Emanuele ^{[9
]}

Audo, Andrea ^{[10
]}

Nobile, Giampiero ^{[1
]}

Tumscitz, Carlo ^{[2
]}

Penzo, Carlo ^{[2
]}

Saia, Francesco ^{[11
]}

Rubboli, Andrea ^{[12
]}

Moretti, Carolina ^{[12
]}

Vignali, Luigi ^{[13
]}

Niccoli, Giampaolo ^{[13
]}

Cimaglia, Paolo ^{[2
]}

Rognoni, Andrea ^{[14
]}

Aschieri, Daniela ^{[15
]}

Iaccarino, Daniele ^{[16
]}

Ottani, Filippo ^{[17
]}

Cavazza, Caterina ^{[17
]}

Varbella, Ferdinando ^{[18
]}

Secco, Gioel Gabrio ^{[19
]}

Bolognese, Leonardo ^{[7
]}

Limbruno, Ugo ^{[6
]}

Guiducci, Vincenzo ^{[20
]}

Campo, Gianluca ^{[2
]}

Casella, Gianni ^{[1
]}

机构：

[1] Osped Maggiore Bologna, Cardiol Unit, Bologna, Italy

[2] Azienda Osped Univ Ferrara, Cardiovasc Inst, Ferrara, Italy

[3] Univ Bologna, S Orsola Hosp, Cardiac Surg Dept, Bologna, Italy

[4] Osped Civile Mirano, Dept Cardiol, Venice, Italy

[5] Osped Angelo, Cardiac Surg Unit, Venice Mestre, Italy

[6] Misericordia Hosp, Azienda USL Toscana Sud Est, Cardiovasc Dept, Grosseto, Italy

[7] San Donato Hosp, Cardiovasc Dept, Arezzo, Italy

[8] Azienda Osped Univ Senese, Intervent Cardiol UOSA, Siena, Italy

[9] Cardinal Massaia Hosp, Dept Cardiol, Asti, Italy

[10] AO SS Antonio & Biagio & Cesare Arrigo, Dept Cardiac Surg, Alessandria, Italy

[11] IRCCS Univ Hosp Bologna, Policlin St Orsola, Div Intervent Cardiol, Bologna, Italy

[12] S Maria Croci Hosp, Div Cardiol, Ravenna, Italy

[13] Parma Univ Hosp, Div Cardiol, Parma, Italy

[14] Osped Inferm Biella, Azienda Sanit Locale Biella, Div Cardiol, Biella, Italy

[15] Guglielmo da Saliceto Hosp, Emergency Dept, Cardiol Unit, Piacenza, Italy

[16] Nuovo Osped S Agostino Estense, Cardiol Dept, Modena, Italy

[17] Infermi Hosp, Cardiovasc Dept, Rimini, Italy

[18] Rivoli Infermi Hosp, Turin, Italy

[19] AO SS Antonio & Biagio & Cesare Arrigo, Dept Cardiol, Alessandria, Italy

[20] Santa Maria Nuova Hosp, Azienda USL IRCCS Reggio Emilia, Cardiol Unit, Reggio Emilia, Italy

来源：

AMERICAN HEART JOURNAL | 2025年 / 280卷

关键词：

SITE CARDIAC-SURGERY; HIGH-RISK; CLINICAL-OUTCOMES; REPLACEMENT; STENOSIS; REGISTRY; IMPACT; TAVI; REGURGITATION; PREDICTORS;

D O I：

10.1016/j.ahj.2024.10.019

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 ([CS) 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 [CS, 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 [CS. 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

引用

页码：7 / 17

页数：11

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