{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T03:51:32Z","timestamp":1773028292887,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T00:00:00Z","timestamp":1731283200000},"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":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The Hydra CE study revealed 1\u2010year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>We evaluated the 3\u2010year clinical and hemodynamic outcomes of Hydra self\u2010expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Hydra CE study was a prospective, multicenter, single\u2010arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long\u2010term follow\u2010up at recruitment, with a planned 5\u2010year follow\u2010up period. The primary endpoint was all\u2010cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 54 patients, the average age was 81.0\u2009\u00b1\u20094.1 years. The mean STS score was 3.2\u2009\u00b1\u20092.0%. At 3 years, all\u2010cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device\u2010related deaths. There was a progressive enhancement in EOA that is, 0.68\u2009\u00b1\u20090.15\u2009cm<jats:sup>2<\/jats:sup> at baseline to 1.97\u2009\u00b1\u20090.52\u2009cm<jats:sup>2<\/jats:sup> at 3 years (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4\u2009\u00b1\u200914.24\u2009mmHg at baseline to 8.6\u2009\u00b1\u20092.80\u2009mmHg at 3 years (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). New permanent pacemaker implantation rates up to 3\u2010year follow\u2010up was 12.9%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The 3\u2010year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.31285","type":"journal-article","created":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T15:59:49Z","timestamp":1731340789000},"page":"292-300","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Three\u2010Year Clinical and Hemodynamic Evaluation of the Hydra Self\u2010Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis"],"prefix":"10.1002","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0917-1442","authenticated-orcid":false,"given":"Vilhelmas","family":"Bajoras","sequence":"first","affiliation":[{"name":"Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine Vilnius University Vilnius Lithuania"},{"name":"Division of Cardiology and Vascular Diseases Vilnius University Hospital Santaros Clinics Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maciej","family":"Dabrowski","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology &amp; Angiology National Institute of Cardiology Warsaw Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giedrius","family":"Davidavicius","sequence":"additional","affiliation":[{"name":"Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine Vilnius University Vilnius Lithuania"},{"name":"Division of Cardiology and Vascular Diseases Vilnius University Hospital Santaros Clinics Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7254-4099","authenticated-orcid":false,"given":"Sigitas","family":"Cesna","sequence":"additional","affiliation":[{"name":"Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine Vilnius University Vilnius Lithuania"},{"name":"Division of Cardiology and Vascular Diseases Vilnius University Hospital Santaros Clinics Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dovile","family":"Peciuraite","sequence":"additional","affiliation":[{"name":"Division of Cardiology and Vascular Diseases Vilnius University Hospital Santaros Clinics Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanna J.","family":"Wykrzykowska","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, University Medical Center Groningen University of Groningen Groningen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3514-2047","authenticated-orcid":false,"given":"Adam","family":"Witkowski","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology &amp; Angiology National Institute of Cardiology Warsaw Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrycjusz","family":"Stoklosa","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology &amp; Angiology National Institute of Cardiology Warsaw Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krishnankutty","family":"Sudhir","sequence":"additional","affiliation":[{"name":"Sahajanand Medical Technologies Limited Surat India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Audrius","family":"Aidietis","sequence":"additional","affiliation":[{"name":"Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine Vilnius University Vilnius Lithuania"},{"name":"Division of Cardiology and Vascular Diseases Vilnius University Hospital Santaros Clinics Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,11,11]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.28999"},{"key":"e_1_2_12_3_1","first-page":"234","volume-title":"Transcatheter Aortic Valve Implantation","author":"Laborde J.\u2010C.","year":"2010"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-1-201301010-00007"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehy244"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.29889"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.122.062481"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.02.017"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700456"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1514616"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000503"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.shj.2023.100166"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.02.038"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2021.09.004"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2012.09.002"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehx303"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000047200.36165.B8"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1816885"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.03.014"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1814052"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.123.012873"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1400590"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2018.04.010"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.10.033"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12872-023-03397-3"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.31285","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T10:58:33Z","timestamp":1738580313000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.31285"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,11]]},"references-count":24,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1002\/ccd.31285"],"URL":"https:\/\/doi.org\/10.1002\/ccd.31285","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,11]]},"assertion":[{"value":"2024-07-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}