{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T14:27:14Z","timestamp":1790951234599,"version":"4.1.0"},"reference-count":33,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T00:00:00Z","timestamp":1739145600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Abbott S.r.l."},{"name":"Eukon S.r.l."},{"name":"Lopez S.p.a."},{"name":"Medstep S.r.l."},{"name":"Sintec S.r.l."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCDD"],"abstract":"<jats:p>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. \u201cTAVI at Home\u201d 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.<\/jats:p>","DOI":"10.3390\/jcdd12020063","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T08:05:42Z","timestamp":1739347542000},"page":"63","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Transfemoral Transcatheter Aortic Valve Implantation at Hospitals Without On-Site Cardiac Surgery (TAVI at Home): A Multicenter Prospective Interventional Study"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3458-8717","authenticated-orcid":false,"given":"Miriam","family":"Compagnone","sequence":"first","affiliation":[{"name":"Interventional and Structural Cardiology Unit Forl\u00ec-Cesena, 47121 Forl\u00ec, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianni","family":"Dall\u2019Ara","sequence":"additional","affiliation":[{"name":"Interventional and Structural Cardiology Unit Forl\u00ec-Cesena, 47121 Forl\u00ec, Italy"},{"name":"Department of Medical and Surgical Sciences\u2014DIMEC\u2014Alma Mater Studiorum, University of Bologna, 40138 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone","family":"Grotti","sequence":"additional","affiliation":[{"name":"Interventional and Structural Cardiology Unit Forl\u00ec-Cesena, 47121 Forl\u00ec, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0359-0871","authenticated-orcid":false,"given":"Greta","family":"Mambelli","sequence":"additional","affiliation":[{"name":"IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) \u201cDino Amadori\u201d, 47014 Meldola, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Fabbri","sequence":"additional","affiliation":[{"name":"U.O. Ricerca Valutativa e Policy dei Servizi Sanitari, AUSL Romagna, 48121 Ravenna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Savini","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences\u2014DIMEC\u2014Alma Mater Studiorum, University of Bologna, 40138 Bologna, Italy"},{"name":"GVM Care & Research Maria Cecilia Hospital, 48033 Cotignola, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Balducelli","sequence":"additional","affiliation":[{"name":"Division of Cardiology, S. 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Maria GVM Care & Research, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[{"name":"Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padova, 35128 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Saia","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, IRCCS University Hospital of Bologna, Policlinico S. Orsola, 40138 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Zingaretti","sequence":"additional","affiliation":[{"name":"IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) \u201cDino Amadori\u201d, 47014 Meldola, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Moretti","sequence":"additional","affiliation":[{"name":"Division of Cardiology, S. 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Heart J."},{"key":"ref_2","first-page":"e28","article-title":"Heart disease and stroke statics\u20142014 update: A report from the American Heart Association","volume":"129","author":"Go","year":"2014","journal-title":"Circulation"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2263","DOI":"10.1016\/j.jacc.2016.02.057","article-title":"Natural history, diagnostic approaches, and therapeutic strategies for patients with asymptomatic severe aortic stenosis","volume":"67","author":"Stone","year":"2016","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_4","first-page":"e72","article-title":"2020 ACC\/AHA Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"143","author":"Otto","year":"2021","journal-title":"Circulation"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1093\/eurheartj\/ehab395","article-title":"2021 ESC\/EACTS Guidelines for the management of valvular heart disease","volume":"43","author":"Vahanian","year":"2022","journal-title":"Eur. Heart J."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1340","DOI":"10.1016\/j.athoracsur.2012.01.084","article-title":"2012 ACCF\/AATS\/SCAI\/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement Developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance","volume":"93","author":"Holmes","year":"2012","journal-title":"Ann. Thorac. Surg."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1597","DOI":"10.1056\/NEJMoa1008232","article-title":"Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery","volume":"363","author":"Leon","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2187","DOI":"10.1056\/NEJMoa1103510","article-title":"Transcatheter versus surgical aortic-valve replacement in high-risk patients","volume":"364","author":"Smith","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1790","DOI":"10.1056\/NEJMoa1400590","article-title":"US CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with self-expanding prosthesis","volume":"370","author":"Adams","year":"2014","journal-title":"N. Eng. J. Med."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1056\/NEJMoa1514616","article-title":"Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients","volume":"374","author":"Leon","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1056\/NEJMoa1700456","article-title":"Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients","volume":"376","author":"Reardon","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1695","DOI":"10.1056\/NEJMoa1814052","article-title":"Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients","volume":"380","author":"Mack","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1706","DOI":"10.1056\/NEJMoa1816885","article-title":"Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients","volume":"380","author":"Popma","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"2492","DOI":"10.1016\/j.jacc.2020.09.595","article-title":"STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement","volume":"76","author":"Carrol","year":"2020","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1016\/j.amjcard.2013.02.062","article-title":"Treatment assignment of high-risk symptomatic severe aortic stenosis patients referred for transcatheter AorticValve implantation","volume":"112","author":"Bainey","year":"2013","journal-title":"Am. J. Cardiol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1007\/s12471-011-0224-z","article-title":"Patients with aortic stenosis referred for TAVI: Treatment decision, in-hospital outcome and determinants of survival","volume":"20","author":"Nuis","year":"2012","journal-title":"Neth. Heart J."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1161\/CIRCULATIONAHA.117.033432","article-title":"Temporal Trends and Clinical Consequences of Wait Times for Transcatheter Aortic Valve Replacement: A Population-Based Study","volume":"138","author":"Masih","year":"2018","journal-title":"Circulation"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"2682","DOI":"10.1161\/CIRCULATIONAHA.113.007477","article-title":"Predictors of poor outcomes after transcatheter aortic valve replacement: Results from the PARTNER (Placement of Aortic Transcatheter Valve) trial","volume":"129","author":"Arnold","year":"2014","journal-title":"Circulation"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1868","DOI":"10.1016\/j.jacc.2016.07.762","article-title":"Prediction of Poor Outcome After Transcatheter Aortic Valve Replacement","volume":"68","author":"Arnold","year":"2016","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Arbel, Y., Zivkovic, N., Mehta, D., Radhakrishnan, S., Fremes, S.E., Rezaei, E., Cheema, A.N., Al-Nasser, S., Finkelstein, A., and Wijeysundera, H.C. (2017). Factors associated with length of stay following trans-catheter aortic valve replacement a multicenter study. BMC Cardiovasc. Disord., 17.","DOI":"10.1186\/s12872-017-0573-7"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2173","DOI":"10.1016\/j.jacc.2015.03.034","article-title":"Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements Prospective Data from the GARY registry","volume":"65","author":"Walther","year":"2015","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"975","DOI":"10.4244\/EIJV10I8A165","article-title":"Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): Insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry","volume":"10","author":"Eggebrecht","year":"2014","journal-title":"EuroIntervention"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1123","DOI":"10.1161\/CIRCULATIONAHA.116.025103","article-title":"SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve","volume":"135","author":"Wendler","year":"2017","journal-title":"Circulation"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/j.jacc.2017.04.053","article-title":"Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI","volume":"70","author":"Auffret","year":"2017","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1093\/eurheartj\/ehx713","article-title":"Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): Insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI)","volume":"39","author":"Eggebrecht","year":"2018","journal-title":"Eur. Heart J."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1751","DOI":"10.1016\/j.jcin.2019.04.026","article-title":"Incidence and outcomes of surgical bailout during TAVR: Insights from the STS\/ACC TVT registry","volume":"12","author":"Pineda","year":"2019","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1016\/j.jcin.2024.09.050","article-title":"Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes","volume":"18","author":"Aarts","year":"2025","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"3026","DOI":"10.1016\/j.jcin.2023.09.020","article-title":"Transcatheter Aortic Valve Replacement Without On-Site Cardiac Surgery: Ready for Prime Time?","volume":"16","author":"Compagnone","year":"2023","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"2069","DOI":"10.1001\/jama.2013.282043","article-title":"Outcomes Following Transcatheter Aortic Valve Replacement in the United States","volume":"310","author":"Mack","year":"2013","journal-title":"JAMA"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"2160","DOI":"10.1016\/j.jcin.2018.07.015","article-title":"Austrian TAVI Group. Impact of on-site cardiac surgery on clinical outcomes after transfemoral transcatheter aortic valve replacement","volume":"11","author":"Egger","year":"2018","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"S45","DOI":"10.1093\/ejcts\/ezs533","article-title":"Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document (VARC-2)","volume":"42","author":"Kappetein","year":"2012","journal-title":"Eur. J. Cardiothorac. Surg."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"2717","DOI":"10.1016\/j.jacc.2021.02.038","article-title":"Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research","volume":"77","author":"Genereux","year":"2021","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"340","DOI":"10.1016\/j.jacc.2018.07.002","article-title":"2018 AATS\/ACC\/SCAI\/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons","volume":"73","author":"Bavaria","year":"2019","journal-title":"J. Am. Coll. Cardiol."}],"container-title":["Journal of Cardiovascular Development and Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2308-3425\/12\/2\/63\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:30:13Z","timestamp":1760027413000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2308-3425\/12\/2\/63"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,10]]},"references-count":33,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["jcdd12020063"],"URL":"https:\/\/doi.org\/10.3390\/jcdd12020063","relation":{},"ISSN":["2308-3425"],"issn-type":[{"value":"2308-3425","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,10]]}}}