{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T05:06:10Z","timestamp":1777352770124,"version":"3.51.4"},"reference-count":24,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,12,9]],"date-time":"2023-12-09T00:00:00Z","timestamp":1702080000000},"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":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Transcatheter mitral valve replacement (TMVR) has become an alternative for high\u2010risk patients with severe mitral regurgitation (MR). The aim of this study was to evaluate the safety and feasibility of the Mi\u2010thos TMVR system (NewMed Medical) for high\u2010risk patients with severe MR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a prospective, two\u2010center, single\u2010arm early feasibility study. Baseline characteristics, procedural data and 30\u2010day follow\u2010up outcomes were collected and analyzed. The primary endpoint was intraoperative success rate of device implantation. The second endpoints were all\u2010cause mortality and major post\u2010procedural complications. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ten high\u2010risk patients with severe MR were enrolled at two sites from August 2021 to November 2022. The median age was 70.5 years, and 60% of patients were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality was 9.5%. The Mi\u2010thos TMVR system was successfully implanted via transapical access in all patients. There was no pericedural mortality or major postpericedural complications during the 30\u2010day follow\u2010up. All implanted prosthetic valves had no or trace valvular or paravalvular MR, and the median mitral valve gradient at 30 days was 2.0\u2009mmHg (IQR: 2.0\u20133.0\u2009mmHg). There was one mild left ventricular outflow tract obstruction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The favorable short\u2010term outcomes of the Mi\u2010thos TMVR system demonstrated that it might be a feasible and safe therapeutic alternative for high\u2010risk patients with severe MR. Nevertheless, further evaluation of the Mi\u2010thos TMVR system is warranted.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30926","type":"journal-article","created":{"date-parts":[[2023,12,10]],"date-time":"2023-12-10T06:13:33Z","timestamp":1702188813000},"page":"153-159","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Transcatheter mitral valve replacement with Mi\u2010thos system: First\u2010in\u2010human experience"],"prefix":"10.1002","volume":"103","author":[{"given":"Ye","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Surgery, Zhongshan Hospital Fudan University Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4326-0665","authenticated-orcid":false,"given":"Jinmiao","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Zhongshan Hospital Fudan University Shanghai 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