Key result
TAVI without on-site cardiac surgery appears safe in observational data pending randomized trials.
Why the study?
Increasing demand for TAVI prolongs waiting times and access disparities at traditional centres, but whether structural interventions like TAVI can be routinely performed at centres without on-site cardiac surgery remains debated.
Can TAVI be safely performed in centers without on-site cardiac surgery compared to centers with on-site surgery?
Can TAVI be safely performed in centers without on-site cardiac surgery compared to centers with on-site surgery?
Highlights the growing need and rationale for evaluating the safety of performing TAVI in centers without on-site cardiac surgery through a Hub-and-Spoke model to address increasing demand and access disparities.
TRACS RCT will test TAVI safety without on-site surgery; may update guidelines and expand access if noninferior.
Traditionally, structural heart interventions have been performed at heart valve centres with on-site heart surgery to maximize expertise and deal with complications requiring emergent cardiac surgery (ECS). However, at present, only transcatheter aortic-valve implantation (TAVI) must be performed at centres with on-site heart surgery according to current guidelines, while mitral transcatheter edge-to-edge repair, or left appendage atrial occlusion could be performed also in centres without on-site cardiac surgery. Today, ageing of the population and improved results of TAVI have increased the need for such procedures posing strong pressure to traditional heart valve centres, prolonging waiting times for TAVI and increasing access disparities. Fortunately, TAVI procedures have a very low rate of complications, including those necessitating ECS, and observational data suggest that TAVI can be safely performed in centres without on-site cardiac surgery. However, guideline recommendations need randomized clinical trials like the TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial to be updated. The TRACS trial randomizes high-risk symptomatic aortic stenosis patients to treatment by the same operators either at centres with or without on-site cardiac surgery and compares 1-year follow-up. Key issues for structural interventions, in particular TAVI, at centres without on-site surgery are shared indications through heart team evaluation, consistent experiences and competences of non-surgical centres, and strong networking with the Hub centre. The increasing demand for structural heart interventions highlights the need for innovative care models and the careful introduction of a 'Hub-and-Spoke' approach for high-volume heart valve networks could be a study option.
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Iannopollo et al. (2025) conducted a review in Symptomatic aortic stenosis. Transcatheter aortic-valve implantation (TAVI) without on-site cardiac surgery vs. TAVI with on-site cardiac surgery was evaluated. Observational data suggest TAVI can be safely performed in centers without on-site cardiac surgery, but randomized trials like TRACS are needed to update guideline recommendations.
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