{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:44:27Z","timestamp":1761864267527,"version":"3.40.5"},"reference-count":36,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,3,29]],"date-time":"2021-03-29T00:00:00Z","timestamp":1616976000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>We compared 5\u2010year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post\u2010approval study (PAS) and the investigational device exemption (IDE) trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a \u201creal\u2010world\u201d environment. The 5\u2010year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time\u2010related outcomes and valve\u2010related adverse events were compared between the two trials with Kaplan\u2013Meier curves and log\u2010rank testing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>167 patients (median age, 19\u2009years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17\u2009years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.61) or any reintervention (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.74) over time did not differ between trials. Freedom from stent fracture (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.003) and transcatheter reintervention (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.010) were longer in PAS, whereas freedom from explant (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.020) and TPV endocarditis (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.056); the incidence of any particular event was low in both.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Hemodynamic and time\u2010related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real\u2010world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post\u2010approval studies as part of the regulatory process for Class III medical devices.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29657","type":"journal-article","created":{"date-parts":[[2021,3,29]],"date-time":"2021-03-29T10:00:23Z","timestamp":1617012023000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Comparison of the investigational device exemption and post\u2010approval trials of the Melody transcatheter pulmonary valve"],"prefix":"10.1002","volume":"98","author":[{"given":"Jacqueline","family":"Kreutzer","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh  Pittsburgh Pennsylvania 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University School of Medicine\/Saint Louis Children's Hospital  St. Louis Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5865-9591","authenticated-orcid":false,"given":"Jeffrey D.","family":"Zampi","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology University of Michigan Medical School  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allison K.","family":"Cabalka","sequence":"additional","affiliation":[{"name":"Division of Cardiology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander J.","family":"Javois","sequence":"additional","affiliation":[{"name":"Advocate Children's Hospital, Section of Pediatric Cardiology, Advocate Children's Hospital University of Illinois Hospital  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel R.","family":"Turner","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Carman and Ann Adams Department of Pediatrics Children's Hospital of Michigan  Detroit Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8913-0543","authenticated-orcid":false,"given":"Robert G.","family":"Gray","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Pediatric Cardiology University of Utah  Salt Lake City Utah USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1079-1200","authenticated-orcid":false,"given":"John W.","family":"Moore","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology Rady Children's Hospital, UC San Diego  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shicheng","family":"Weng","sequence":"additional","affiliation":[{"name":"Department of Biostatistics 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