{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T17:09:45Z","timestamp":1768324185647,"version":"3.49.0"},"reference-count":38,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,4,9]],"date-time":"2024-04-09T00:00:00Z","timestamp":1712620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The dry\u2010pericardium Vienna transcatheter aortic valve system is repositionable and retrievable, already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The VIVA first\u2010in\u2010human feasibility study, a prospective, nonrandomized, single\u2010center trial, evaluated the Vienna aortic valve in 10 patients with severe symptomatic aortic stenosis, who were at intermediate or high surgical risk. This study, registered at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link> (NCT04861805), focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1\u2010year follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mean patient age was 79\u2009\u00b1\u20095 years, 60% male. Valve sizes used: 26\u2009mm (10%), 29\u2009mm (30%), 31\u2009mm (60%). Key hemodynamic improvements were significant: mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, aortic valve area (cm<jats:sup>2<\/jats:sup>) increased from 0.75 to 1.91, and maximum jet velocity through the aortic valve (m\/s) decreased from 4.41 to 1.95 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). No moderate\/severe paravalvular leakage was observed, and computed tomography scans revealed no evidence of hypo\u2010attenuated leaflet thickening. The study recorded one life\u2010threatening bleeding event, two cases requiring postprocedural pacemaker implantation, and three ischemic events, with only one causing lasting neurological impairment. Importantly, there were no cases of cardiovascular mortality and only one noncardiovascular death, which was confirmed as unrelated to the device.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The study indicates the Vienna valve as a potential option for severe symptomatic aortic stenosis, designed to streamline the procedure and potentially lower healthcare costs by reducing resource and equipment needs, also procedural errors. Further research is essential to thoroughly evaluate its safety and efficacy.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.31039","type":"journal-article","created":{"date-parts":[[2024,4,9]],"date-time":"2024-04-09T10:40:48Z","timestamp":1712659248000},"page":"1111-1124","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["One\u2010year initial efficacy and safety outcomes of the premounted dry\u2010pericardium Vienna self\u2010expandable transcatheter aortic valve system: A first\u2010in\u2010human VIVA feasibility study"],"prefix":"10.1002","volume":"103","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-1242-0480","authenticated-orcid":false,"given":"Kasparas","family":"Briedis","sequence":"first","affiliation":[{"name":"Department of Cardiology Lithuanian University of Health Sciences Kaunas 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