{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T00:16:59Z","timestamp":1780705019803,"version":"3.54.1"},"reference-count":23,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,1,18]],"date-time":"2025-01-18T00:00:00Z","timestamp":1737158400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Ministry of Health within the call \u201cRicerca Finalizzata 2016\u201d","award":["PE-2016-02364619"],"award-info":[{"award-number":["PE-2016-02364619"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Paravalvular leak (PVL) was initially recognized as one of the most common complications after transcatheter aortic valve implantation (TAVI) and has been linked to adverse clinical outcomes, including mortality. This study aims to assess the long-term clinical effects of PVL in patients undergoing TAVI with the latest generation of transcatheter aortic valves, as part of the national observational prospective multicenter study OBSERVANT II. Methods: OBSERVANT II included all consecutive patients with severe aortic stenosis who underwent TAVI across 28 Italian centers from December 2016 to September 2018. A total of 2125 patients were included in this analysis and stratified according to the presence of moderate-to-severe PVL (significant PVL, n = 155) versus no\/trace-to-mild PVL (no significant PVL, n = 1970). The primary endpoint was 5-year major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, myocardial infarction, and coronary revascularization. Five-year all cause death and re-hospitalization for heart failure (HF) were the secondary endpoints. Results: In our cohort, the incidence of moderate-to-severe PVL was 7%. Age, aortic anulus perimeter, and self-expandable valves were determinants of PVL. The risk of MACCE, all-cause death, and re-hospitalization for HF at the 5-year follow-up were not different between the study groups [HR = 1.07 (95% CI: 0.85\u20131.34) p = 0.571; HR = 1.10 (95% CI: 0.87\u20131.39) p = 0.435; HR = 1.20 (95% CI: 0.88\u20131.62) p = 0.245, respectively]. Conclusions: In this analysis of the OBSERVANT II study, moderate\/severe PVL was not associated with a higher incidence of MACCE and re-hospitalization for heart failure at the 5-year follow-up.<\/jats:p>","DOI":"10.3390\/jcm14020605","type":"journal-article","created":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T10:32:15Z","timestamp":1737369135000},"page":"605","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Long-Term Clinical Impact of Paravalvular Leak Following Transcatheter Aortic Valve Implantation"],"prefix":"10.3390","volume":"14","author":[{"given":"Cristina","family":"Aurigemma","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Science CUORE Fondazione Policlinico Universitario, IRCCS, A. Gemelli, 00168 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9777-013X","authenticated-orcid":false,"given":"Carlo","family":"Trani","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Science CUORE Fondazione Policlinico Universitario, IRCCS, A. Gemelli, 00168 Rome, Italy"},{"name":"Universit\u00e0 Cattolica del Sacro Cuore, 00168 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"D\u2019Errigo","sequence":"additional","affiliation":[{"name":"National Center for Global Health, Istituto Superiore di Sanit\u00e1, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4903-5437","authenticated-orcid":false,"given":"Marco","family":"Barbanti","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Surgery, Universit\u00e0 degli Studi di Enna \u201cKore\u201d, 94100 Enna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5028-8186","authenticated-orcid":false,"given":"Fausto","family":"Biancari","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35122 Padova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8849-3097","authenticated-orcid":false,"given":"Gian Paolo","family":"Ussia","sequence":"additional","affiliation":[{"name":"Department of Cardiology Science, Universit\u00e0 Campus Bio-Medico, 00128 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4915-3572","authenticated-orcid":false,"given":"Marco","family":"Ranucci","sequence":"additional","affiliation":[{"name":"Anesthesia and Cardiovascular Intensive Care Unit, IRCCS Policlinico San Donato, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0562-4923","authenticated-orcid":false,"given":"Gabriella","family":"Badoni","sequence":"additional","affiliation":[{"name":"National Center for Global Health, Istituto Superiore di Sanit\u00e1, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8313-794X","authenticated-orcid":false,"given":"Giovanni","family":"Baglio","sequence":"additional","affiliation":[{"name":"Italian National Agency for Regional Healthcare Services, 00187 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6690-5537","authenticated-orcid":false,"given":"Stefano","family":"Rosato","sequence":"additional","affiliation":[{"name":"National Center for Global Health, Istituto Superiore di Sanit\u00e1, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1093\/eurheartj\/ehab395","article-title":"ESC\/EACTS Scientific Document Group. 2021 ESC\/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). 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