{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T21:13:14Z","timestamp":1776287594968,"version":"3.50.1"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,8,30]],"date-time":"2022-08-30T00:00:00Z","timestamp":1661817600000},"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":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Midterm data comparing clinical outcomes after successful implantation of self\u2010expanding and balloon\u2010expandable transcatheter heart valves (THV) are limited. We aimed to compare 2\u2010year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon\u2010expandable or the Medtronic self\u2010expanding THV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Two\u2010year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all\u2010cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep\u2010vein thrombosis, or pulmonary embolism.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self\u2010expanding and 757 patients received a balloon\u2010expandable THV. Patients treated with a self\u2010expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve\u2010in\u2010valve procedures than those with a balloon\u2010expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self\u2010expanding versus balloon\u2010expandable THV: MACCE (17.0% vs. 13.4%, adjusted\u2010hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82\u22121.69); all\u2010cause death (11.4% vs. 9.3%, adjusted\u2010HR 1.26; 95% CI: 0.78\u22122.05); cardiovascular death (8.5% vs. 4.0%, adjusted\u2010HR 1.53; 95% CI: 0.82\u22122.86), any stroke (5.1% vs. 3.7%, adjusted\u2010HR 0.86; 95% CI: 0.43\u22121.73); major or life\u2010threatening bleeding (5.9% vs. 6.8%, adjusted\u2010HR 0.93; 95% CI: 0.53\u22121.63). Clinical Trial Registration: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>. NCT02556203.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Two\u2010year follow\u2010up data from the GALILEO trial indicate that successful TAVI either with self\u2010expanding or balloon\u2010expandable THVs according to physician discretion did not show difference in rates of MACCE.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30370","type":"journal-article","created":{"date-parts":[[2022,8,30]],"date-time":"2022-08-30T19:28:11Z","timestamp":1661887691000},"page":"636-645","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Two\u2010year clinical outcomes after successful transcatheter aortic valve implantation with balloon\u2010expandable versus self\u2010expanding valves: A subanalysis of the GALILEO trial"],"prefix":"10.1002","volume":"100","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7831-2934","authenticated-orcid":false,"given":"Taishi","family":"Okuno","sequence":"first","affiliation":[{"name":"Department of Cardiology Inselspital, Bern University Hospital Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7502-8049","authenticated-orcid":false,"given":"George D.","family":"Dangas","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai The Zena and Michael A. Wiener Cardiovascular Institute New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8284-2994","authenticated-orcid":false,"given":"Christian","family":"Hengstenberg","sequence":"additional","affiliation":[{"name":"Department of Cardiology Medical University of Vienna Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0618-9409","authenticated-orcid":false,"given":"Samantha","family":"Sartori","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai The Zena and Michael A. Wiener Cardiovascular Institute New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3322-9568","authenticated-orcid":false,"given":"Howard C.","family":"Herrmann","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"de Winter","sequence":"additional","affiliation":[{"name":"Department of Cardiology University of Amsterdam Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martine","family":"Gilard","sequence":"additional","affiliation":[{"name":"Department of Cardiology Brest University Hospital Brest France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Didier","family":"Tch\u00e9tch\u00e9","sequence":"additional","affiliation":[{"name":"Department of Cardiology Groupe CardioVasculaire Interventional, Clinique Pasteur Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helge","family":"M\u00f6llmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I St. \u2010Johannes\u2010Hospital Dortmund Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raj R.","family":"Makkar","sequence":"additional","affiliation":[{"name":"Cedars\u2010Sinai Medical Center Smidt Heart Institute Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8259-1737","authenticated-orcid":false,"given":"Stephan","family":"Baldus","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Heart Center University Hospital Cologne Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9674-0278","authenticated-orcid":false,"given":"Ole","family":"De Backer","sequence":"additional","affiliation":[{"name":"Department of Cardiology Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bj\u00f8rn","family":"Bendz","sequence":"additional","affiliation":[{"name":"Department of Cardiology Oslo University Hospital Rikshospitalet, Oslo, and University of Oslo  Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7189-3307","authenticated-orcid":false,"given":"Annapoorna","family":"Kini","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai The Zena and Michael A. Wiener Cardiovascular Institute New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9996-6128","authenticated-orcid":false,"given":"Dirk","family":"von Lewinski","sequence":"additional","affiliation":[{"name":"Department of Cardiology Medical University of Graz Graz Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Mack","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Baylor Scott &amp; White The Heart Hospital Plano Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0717-1174","authenticated-orcid":false,"given":"Ra\u00fal","family":"Moreno","sequence":"additional","affiliation":[{"name":"Department of Cardiology La Paz University Hospital Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulrich","family":"Sch\u00e4fer","sequence":"additional","affiliation":[{"name":"Department of Cardiology Bundeswehrzentralkrankenhaus Koblenz Koblenz Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jochen","family":"W\u00f6hrle","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medical Campus Lake Constance Friedrichshafen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3392-4931","authenticated-orcid":false,"given":"Julia","family":"Seeger","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medical Campus Lake Constance Friedrichshafen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clayton","family":"Snyder","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai The Zena and Michael A. 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