{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T17:39:53Z","timestamp":1778521193045,"version":"3.51.4"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"15","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              ACURATE\n              <jats:italic>neo2<\/jats:italic>\n              is a transcatheter aortic valve implantation system consisting of a self\u2010expanding bioprosthetic valve with supra\u2010annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real\u2010life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE\n              <jats:italic>neo2<\/jats:italic>\n              . Data were collected from 554 consecutive patients treated with ACURATE\n              <jats:italic>neo2<\/jats:italic>\n              at 12 European sites (mean age, 82\u2009years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%\u00b13.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in\u2010hospital) paravalvular regurgitation grade \u22652, in\u2010hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30\u2010day death, and 30\u2010day stroke. The primary end point occurred in 12.6% of patients. The 30\u2010day rates for all\u2010cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory\u2013adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6\u00b13.3\u2009mm\u2009Hg, and 2.8% of patients exhibited paravalvular regurgitation grade \u22652.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              In this report of postmarket use of the ACURATE\n              <jats:italic>neo2<\/jats:italic>\n              valve in a real\u2010world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.122.029464","type":"journal-article","created":{"date-parts":[[2023,7,25]],"date-time":"2023-07-25T11:36:33Z","timestamp":1690284993000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE\n            <i>neo2<\/i>\n            in a European Population"],"prefix":"10.1161","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2920-6574","authenticated-orcid":false,"given":"Andreas","family":"R\u00fcck","sequence":"first","affiliation":[{"name":"Department of Cardiology Karolinska University Hospital Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0799-7478","authenticated-orcid":false,"given":"Won\u2010Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiac Surgery Kerckhoff Heart and Lung Centre Bad Nauheim Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9596-558X","authenticated-orcid":false,"given":"Mohamed","family":"Abdel\u2010Wahab","sequence":"additional","affiliation":[{"name":"Department of Cardiology Heart Center Leipzig at University of Leipzig Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0169-998X","authenticated-orcid":false,"given":"Holger","family":"Thiele","sequence":"additional","affiliation":[{"name":"Department of Cardiology Heart Center Leipzig at University of Leipzig Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8839-7476","authenticated-orcid":false,"given":"Tanja K.","family":"Rudolph","sequence":"additional","affiliation":[{"name":"Heart and Diabetes Center Bad Oeynhausen, Department of General and Interventional Cardiology\/Angiology Bad Oeynhausen, 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