Gianmarco Iannopollo, Marta Cocco, Alessandro Leone, Salvatore Saccà, Domenico Mangino, Andrea Picchi, Matteo Rocco Reccia, Massimo Fineschi, Emanuele Meliga, Andrea Audo, Giampiero Nobile, Carlo Tumscitz, Carlo Penzo, Francesco Saia, Andrea Rubboli, Carolina Moretti, Luigi Vignali, Giampaolo Niccoli, Paolo Cimaglia, Andrea Rognoni, Daniela Aschieri, Daniele Iaccarino, Filippo Ottani, Caterina Cavazza, Ferdinando Varbella, Gioel Gabrio Secco, Leonardo Bolognese, Ugo Limbruno, Vincenzo Guiducci, Gianluca Campo, Gianni Casella
{"title":"TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery: the TRACS trial: TAVI in centers without on-site cardiac surgery.","authors":"Gianmarco Iannopollo, Marta Cocco, Alessandro Leone, Salvatore Saccà, Domenico Mangino, Andrea Picchi, Matteo Rocco Reccia, Massimo Fineschi, Emanuele Meliga, Andrea Audo, Giampiero Nobile, Carlo Tumscitz, Carlo Penzo, Francesco Saia, Andrea Rubboli, Carolina Moretti, Luigi Vignali, Giampaolo Niccoli, Paolo Cimaglia, Andrea Rognoni, Daniela Aschieri, Daniele Iaccarino, Filippo Ottani, Caterina Cavazza, Ferdinando Varbella, Gioel Gabrio Secco, Leonardo Bolognese, Ugo Limbruno, Vincenzo Guiducci, Gianluca Campo, Gianni Casella","doi":"10.1016/j.ahj.2024.10.019","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods and design: </strong>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 one 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.</p><p><strong>Implications: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05751577.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ahj.2024.10.019","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
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 one 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.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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