{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T22:40:03Z","timestamp":1792190403628,"version":"4.4.0"},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract. Early outcomes after TPV replacement with the Harmony valve have been positive, but longer-term data are limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>The study included patients who received a commercially available TPV22 or TPV25 device as part of the nonrandomized, prospective Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study. Patients completed at least 3 years of follow-up, and outcomes to 5 years were reported when available.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Eighty-nine patients were catheterized, and 86 were successfully implanted with a Harmony TPV. Median duration of follow-up was 5 (range 0\u20136) years in the TPV22 group and 3 (1\u20134) years in the TPV25 group. At 3 years, all patients with a TPV22 and 96% of those with a TPV25 had \u2264mild pulmonary regurgitation. By magnetic resonance imaging, significant improvements from preimplant to 2 years were observed in RV end-diastolic volume index, RV to left ventricular end-diastolic volume ratio, and effective RV stroke volume (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). SF-36 quality-of-life scores improved after Harmony implantation and were sustained over 3 years. Early cases of ventricular tachycardia resolved, and there were no new arrhythmias. Adverse events up to 5 years included 3 deaths unrelated to the device or procedure, 2 cases of endocarditis that were treated (1 medically, 1 transcatheter debulking of a vegetation) and resolved, 6 patients with RV outflow tract obstruction or thrombosis resulting in valve-in valve procedures, and 1 major stent fracture resulting in surgical explant.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life. Continued monitoring is needed to assess long-term outcomes and valve performance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT01762124; NCT02979587.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.125.015196","type":"journal-article","created":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T09:00:09Z","timestamp":1752656409000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients"],"prefix":"10.1161","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct02979587","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01762124","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7587-7518","authenticated-orcid":true,"given":"Brian H.","family":"Morray","sequence":"first","affiliation":[{"name":"Division of Pediatric Cardiology, Seattle Children\u2019s Hospital, WA (B.H.M., T.K.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Children\u2019s Hospital of Philadelphia, PA (M.J.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0294-4622","authenticated-orcid":true,"given":"John P.","family":"Cheatham","sequence":"additional","affiliation":[{"name":"Pediatrics and Cardiology, The Ohio State University, Columbus (J.P.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9632-4725","authenticated-orcid":true,"given":"Arash","family":"Salavitabar","sequence":"additional","affiliation":[{"name":"Nationwide Children\u2019s Hospital, Columbus, OH (A.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Stanford University, Lucile Packard Children\u2019s Hospital, Palo Alto, CA (L.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4038-1210","authenticated-orcid":true,"given":"Thomas K.","family":"Jones","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, Seattle Children\u2019s Hospital, WA (B.H.M., T.K.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9926-8805","authenticated-orcid":true,"given":"Daniel S.","family":"Levi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, David Geffen School of Medicine at UCLA, Ahmanson\/UCLA Adult Congenital Heart Disease Center, Los Angeles, CA (D.S.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert G.","family":"Gray","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, University of Utah at Primary Children\u2019s Hospital, Salt Lake City (R.G.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8634-7675","authenticated-orcid":true,"given":"Jeremy","family":"Asnes","sequence":"additional","affiliation":[{"name":"Section of Pediatric Cardiology, Yale University, New Haven, CT (J.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3711-0003","authenticated-orcid":true,"given":"Allison K.","family":"Cabalka","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology\/Structural Heart Disease, Mayo Clinic, Rochester, MN (A.K.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6511-2976","authenticated-orcid":true,"given":"Kazuto","family":"Fujimoto","sequence":"additional","affiliation":[{"name":"National Cerebral and Cardiovascular Center, Osaka, Japan (K.F.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5992-568X","authenticated-orcid":true,"given":"Athar M.","family":"Qureshi","sequence":"additional","affiliation":[{"name":"Section of Cardiology, Texas Children\u2019s Hospital\/Baylor College of Medicine, Houston, TX (A.M.Q.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Bergersen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Boston Children\u2019s Hospital, MA 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