{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T02:34:14Z","timestamp":1792118054155,"version":"4.4.0"},"reference-count":31,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,7,6]],"date-time":"2021-07-06T00:00:00Z","timestamp":1625529600000},"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":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study sought to investigate patient intermediate\u2010term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short\u2010term follow\u2010up has been reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve\u2010reintervention and freedom from infective endocarditis at last follow\u2010up, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The primary efficacy outcome was met for 87.1% patients after a mean follow\u2010up of 4.6\u2009\u00b1\u20091.8\u2009years, corresponding to a freedom of reintervention at 5\u2009years of 89% (95% CI 74.8\u201395.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient\u2010year (95% CI 0.01\u20132.00%). At 5\u2009years, freedom from infective endocarditis was 98.4% (95% CI 89.1\u201399.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube\u2010graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study documents the mid\u2010term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit\u2013risk balance.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29862","type":"journal-article","created":{"date-parts":[[2021,7,6]],"date-time":"2021-07-06T09:58:29Z","timestamp":1625565509000},"page":"990-999","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5\u2010year follow\u2010up in a French Registry"],"prefix":"10.1002","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8964-6611","authenticated-orcid":false,"given":"Robin","family":"Le Ruz","sequence":"first","affiliation":[{"name":"Centre Hospitalier Universitaire de Nantes, Institut du Thorax, F\u00e9d\u00e9ration des Cardiopathies Cong\u00e9nitales Service de Cardiologie  Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Plessis","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Nantes, Institut du Thorax, F\u00e9d\u00e9ration des Cardiopathies Cong\u00e9nitales Service de Cardiologie  Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Houeijeh","sequence":"additional","affiliation":[{"name":"Centre Hospitalier R\u00e9gional Universitaire de Lille Service de Cardiologie Infantile et Cong\u00e9nitale  Nantes France"},{"name":"H\u00f4pital Marie Lannelongue, Pole de Chirurgie des 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