{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:33:56Z","timestamp":1761863636057,"version":"3.41.2"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2016,10,26]]},"abstract":"\n Background<\/jats:title>\n \n The safety and effectiveness of the fully repositionable\n LOTUS<\/jats:styled-content>\n valve system as compared with the balloon\u2010expandable Edwards\n SAPIEN<\/jats:styled-content>\n 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n All patients undergoing transcatheter aortic valve implantation with the Edwards\n SAPIEN<\/jats:styled-content>\n 3 or the\n LOTUS<\/jats:styled-content>\n valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium\u20102 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the\n LOTUS<\/jats:styled-content>\n and the Edwards\n SAPIEN<\/jats:styled-content>\n 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with\n LOTUS<\/jats:styled-content>\n (14.3%) and those treated with Edwards\n SAPIEN<\/jats:styled-content>\n 3 (14.6%) (crude hazard ratio, 0.97; 95%\n CI<\/jats:styled-content>\n , 0.61\u20131.56 [\n P<\/jats:italic>\n =0.915]; adjusted hazard ratio, 1.03; 95%\n CI<\/jats:styled-content>\n , 0.64\u20131.67 [\n P<\/jats:italic>\n =0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with\n LOTUS<\/jats:styled-content>\n and 14.1% of patients treated with Edwards\n SAPIEN<\/jats:styled-content>\n 3 required a permanent pacemaker (\n HR<\/jats:styled-content>\n , 2.76; 95%\n CI<\/jats:styled-content>\n , 1.97\u20133.87 [\n P<\/jats:italic>\n <0.001]).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n The repositionable\n LOTUS<\/jats:styled-content>\n valve system and the balloon\u2010expandable Edwards\n SAPIEN<\/jats:styled-content>\n 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium\u20102 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the\n LOTUS<\/jats:styled-content>\n valve.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.116.004088","type":"journal-article","created":{"date-parts":[[2016,11,18]],"date-time":"2016-11-18T03:15:21Z","timestamp":1479438921000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Repositionable Versus Balloon\u2010Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis"],"prefix":"10.1161","volume":"5","author":[{"given":"Thomas","family":"Pilgrim","sequence":"first","affiliation":[{"name":"Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Stortecky","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabian","family":"Nietlispach","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dik","family":"Heg","sequence":"additional","affiliation":[{"name":"Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Tueller","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Triemlispital, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Toggweiler","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Kantonsspital, Luzern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Enrico","family":"Ferrari","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Hospital, Lausanne, Switzerland"},{"name":"Cardiac Surgery Unit, Cardiocentro Ticino Foundation, Lugano, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"St\u00e9phane","family":"Noble","sequence":"additional","affiliation":[{"name":"Division of Cardiology, University Hospital, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Maisano","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raban","family":"Jeger","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Hospital, Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Roffi","sequence":"additional","affiliation":[{"name":"Division of Cardiology, University Hospital, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrg","family":"Gr\u00fcnenfelder","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Hirslanden Klinik, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Huber","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Wenaweser","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland"},{"name":"Department of Cardiology, Klinik im Park, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2016.01.004"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.05.067"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.12.012"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.10.024"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV10I8A166"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV10SUA13"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.09.001"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1200384"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.013947"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.11.011"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.115.002653"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.03.054"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2015-307666"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.07.022"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2012.11.115"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.03.034"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.282043"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.1474"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30073-3"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2015.07.013"},{"key":"e_1_3_4_22_2","article-title":"Meta\u2010analysis 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Meta\u2010analysis of the effectiveness and safety of transcatheter aortic valve implantation without balloon predilation. Am J Cardiol. 2016. Available at: http:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S000291491630296X. 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