{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T20:38:22Z","timestamp":1791491902829,"version":"4.3.4"},"reference-count":29,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T00:00:00Z","timestamp":1648771200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic\/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of \u2265one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III\/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12\/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.<\/jats:p>","DOI":"10.3390\/jcm11071978","type":"journal-article","created":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T21:23:55Z","timestamp":1648848235000},"page":"1978","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6750-5682","authenticated-orcid":false,"given":"Eustaquio Maria","family":"Onorato","sequence":"first","affiliation":[{"name":"Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Alamanni","sequence":"additional","affiliation":[{"name":"Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Muratori","sequence":"additional","affiliation":[{"name":"Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grzegorz","family":"Smolka","sequence":"additional","affiliation":[{"name":"3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3681-5207","authenticated-orcid":false,"given":"Wojtek","family":"Wojakowski","sequence":"additional","affiliation":[{"name":"3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4390-9882","authenticated-orcid":false,"given":"Piotr","family":"Pysz","sequence":"additional","affiliation":[{"name":"3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4283-492X","authenticated-orcid":false,"given":"Aleksejus","family":"Zorinas","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Vilnius University, 01513 Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Zakarkaite","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Vilnius University, 01513 Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Eltchaninoff","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, 76000 Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre-Yves","family":"Litzer","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, 76000 Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Godart","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology and Congenital Heart Disease, University of Lille, 59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Calvert","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge CB2 0AY, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos","family":"Christou","sequence":"additional","affiliation":[{"name":"American Heart Institute, Nicosia 1311, Cyprus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdurashid","family":"Mussayev","sequence":"additional","affiliation":[{"name":"National Research Cardiac Surgery Center, Astana 020000, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bindo","family":"Missiroli","sequence":"additional","affiliation":[{"name":"Gemelli Molise di Campobasso-Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 86100 Campobasso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Buzaev","sequence":"additional","affiliation":[{"name":"Cardiovascular Department, Bashkir State Medical University, 450008 Ufa, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Curello","sequence":"additional","affiliation":[{"name":"USVD Emodinamica, Spedali Civili di Brescia, 25123 Brescia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tullio","family":"Tesorio","sequence":"additional","affiliation":[{"name":"Department of Invasive Cardiology, Clinica Montevergine, 83013 Mercogliano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio Luca","family":"Bartorelli","sequence":"additional","affiliation":[{"name":"Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy"},{"name":"Department of Biomedical and Clinical Sciences \u201cLuigi Sacco\u201d, University of Milan, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"887","DOI":"10.1016\/j.ejcts.2006.09.019","article-title":"Mitral valve periprosthetic leakage: Anatomical observations in 135 patients from a multicentre study","volume":"30","author":"Russo","year":"2006","journal-title":"Eur. 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Imaging"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/7\/1978\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:48:36Z","timestamp":1760136516000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/7\/1978"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,1]]},"references-count":29,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2022,4]]}},"alternative-id":["jcm11071978"],"URL":"https:\/\/doi.org\/10.3390\/jcm11071978","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,1]]}}}