Transfemoral Transcatheter Aortic Valve Implantation at Hospitals Without On-Site Cardiac Surgery (TAVI at Home): A Multicenter Prospective Interventional Study
Year: 2025
Type: article
Abstract: Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. "TAVI at Home" is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.
DOI: 10.3390/jcdd12020063
Authors: Miriam Compagnone, Gianni Dall’Ara, Simone Grotti, Greta Mambelli, Elisabetta Fabbri, Carlo Savini, Marco Balducelli, Andrea Santarelli, Elia Iorio, Beatriz Vaquerizo, Alfredo Marchese, Giuseppe Tarantini, Francesco Saia, Chiara Zingaretti, Carolina Moretti, Caterina Cavazza, Bernadette Vertogen, Filippo Ottani, Andrea Rubboli, Oriana Nanni, Carmine Pizzi, Marcello Galvani, Fabio Felice Tarantino
Institutions: University of Bologna, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Azienda Unità Sanitaria Locale Della Romagna, Maria Cecilia Hospital, Ospedale "Santa Maria delle Croci" di Ravenna, Ospedale “M. Bufalini” di Cesena, Ospedale Generale Regionale Francesco Miulli, Hospital Del Mar, Ospedale Santa Maria, University of Padua, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, Ospedale Infermi di Rimini, Ospedale G.B. Morgagni - L.Pierantoni
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,258
OpenAlex ID: W4407389803