{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:21:53Z","timestamp":1790716913784,"version":"4.1.0"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,3,4]],"date-time":"2021-03-04T00:00:00Z","timestamp":1614816000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>We investigated the durability of tricuspid regurgitation (TR) reduction and the clinical outcomes through 12\u2009months after transcatheter tricuspid valve repair (TTVr) with the PASCAL Transcatheter Valve Repair System.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>TTVr has rapidly developed and demonstrated favorable acute outcomes, but longer follow\u2010up data are needed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Overall, 30 patients (age 77\u2009\u00b1\u20096\u2009years; 57% female) received PASCAL implantation from September 2017 to May 2019 and completed a clinical follow\u2010up at 12\u2009months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The TR etiology was functional in 25 patients (83%), degenerative in three (10%), and mixed in two (7%). All patients had TR severe or greater (massive or torrential in 80%) and heart failure symptoms (90% in NYHA III or IV) under optimal medical treatment. Single\u2010leaflet device attachment occurred in two patients. Moderate or less TR was achieved in 23\/28 patients (82%) at 30\u2009days, which was sustained at 12\u2009months (86%). Two patients underwent repeat TTVr due to residual torrential TR (day 173) and recurrence of severe TR (day 280), respectively.<\/jats:p><jats:p>One\u2010year survival rate was 93%; 6 patients required rehospitalization due to acute heart failure. NYHA functional class I or II was achieved in 90% and 6\u2010minute walk distance improved from 275\u2009\u00b1\u2009122\u2009m at baseline to 347\u2009\u00b1\u2009112\u2009m at 12\u2010month (+72\u2009\u00b1\u200982\u2009m, <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.01). There was no stroke, endocarditis, or device embolization during the follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Twelve\u2010month outcomes from this multicenter compassionate use experience with the PASCAL System demonstrated high procedural success, acceptable safety, and significant clinical improvement.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29583","type":"journal-article","created":{"date-parts":[[2021,3,4]],"date-time":"2021-03-04T10:01:58Z","timestamp":1614852118000},"page":"1281-1289","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["12\u2010Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation"],"prefix":"10.1002","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7573-7176","authenticated-orcid":false,"given":"Mitsunobu","family":"Kitamura","sequence":"first","affiliation":[{"name":"Department of Internal Medicine\/Cardiology Heart Center Leipzig at University of Leipzig  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil P.","family":"Fam","sequence":"additional","affiliation":[{"name":"Division of Cardiology St. Michael's Hospital, University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6355-3222","authenticated-orcid":false,"given":"Daniel","family":"Braun","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik I Klinikum der Universit\u00e4t M\u00fcnchen  Munich 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A.","family":"Connelly","sequence":"additional","affiliation":[{"name":"Division of Cardiology St. Michael's Hospital, University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin","family":"Ho","sequence":"additional","affiliation":[{"name":"Division of Cardiology St. Michael's Hospital, University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Nabauer","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik I Klinikum der Universit\u00e4t M\u00fcnchen  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Hausleiter","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik I Klinikum der Universit\u00e4t M\u00fcnchen  Munich 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