{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T15:11:03Z","timestamp":1773414663786,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T00:00:00Z","timestamp":1618876800000},"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":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self\u2010expanding system with supra\u2010annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27\u2009mm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The GENESIS trial was a prospective, multi\u2010center, single\u2010arm, 6\u2009month follow\u2010up study conducted in India. The primary performance endpoint was device success defined as per VARC\u2010II criteria at 30\u2009days. The primary safety endpoint was all\u2010cause mortality at 30\u2009days. All endpoints were adjudicated by an independent clinical events committee.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty high\u2010risk patients (74.5\u2009\u00b1\u20096.7\u2009years, 60% men; STS Score:5.6\u2009\u00b1\u20094.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7\u2009\u00b1\u20090.2 to 2.3\u2009\u00b1\u20090.6\u00a0cm<jats:sup>2<\/jats:sup> at 30\u2009days and to 2.2\u2009\u00b1\u20090.7\u00a0cm<jats:sup>2<\/jats:sup> at 6\u00a0months (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001). Mean aortic valve gradient decreased from 53.5\u2009\u00b1\u200918.1 to 8.9\u2009\u00b1\u20094.9\u2009mmHg at 30\u2009days and to 7.6\u2009\u00b1\u20092.7\u2009mmHg at 6\u00a0months (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001). The rate of new permanent pacemaker implantation was 7.5% at 30\u2009days, and no patient had more than mild paravalvular leak at 6\u00a0months. The 30\u2009days and 6\u00a0month all\u2010cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device\u2010related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6\u00a0months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The GENESIS trial demonstrated high efficacy of the self\u2010expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29733","type":"journal-article","created":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T19:44:12Z","timestamp":1618947852000},"page":"371-379","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical evaluation of the Hydra self\u2010expanding transcatheter aortic valve: 6\u00a0month results from the GENESIS trial"],"prefix":"10.1002","volume":"98","author":[{"given":"Praveen","family":"Chandra","sequence":"first","affiliation":[{"name":"Department of cardiology Medanta Medicity Hospital  Gurgaon 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Kozhikode India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1930-8502","authenticated-orcid":false,"given":"Chandrashekhar N.","family":"Makhale","sequence":"additional","affiliation":[{"name":"Department of cardiology Ruby Hall Clinic  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharad","family":"Chandra","sequence":"additional","affiliation":[{"name":"Department of cardiology King George's Medical University  Lucknow India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ranjan","family":"Shetty","sequence":"additional","affiliation":[{"name":"Department of cardiology Manipal Hospital  Bengaluru India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandeep","family":"Mohanan","sequence":"additional","affiliation":[{"name":"Department of cardiology KMCT Medical College  Kozhikode India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John 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