{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T17:06:08Z","timestamp":1790615168664,"version":"4.1.0"},"reference-count":12,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,11,5]],"date-time":"2023-11-05T00:00:00Z","timestamp":1699142400000},"content-version":"vor","delay-in-days":4,"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":[[2023,11]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>The Harmony TPV25 transcatheter pulmonary valve (Medtronic Inc.) is constructed with a self\u2010expanding stent frame comprising six zigged nitinol wires sewn together and covered with knitted polyester fabric, with flared inflow and outflow ends and a porcine pericardial valve sutured to the central portion of the device. It was approved for treatment of pulmonary regurgitation after prior right ventricular outflow tract repair in 2021. Early outcomes of this procedure have been excellent, but little is known about valve durability or ultimate mechanisms of dysfunction.<\/jats:p><\/jats:sec>Methods<\/jats:title>We collected data on patients who underwent reintervention for TPV25 dysfunction and described findings related to distortion of the stent frame and tissue accumulation.<\/jats:p><\/jats:sec>Results<\/jats:title>We describe six patients who underwent valve\u2010in\u2010valve implant for TPV25 obstruction (peak catheterization gradient peak 28\u201373\u2009mmHg) 10\u201328 months after implant. In all cases, there was tissue accumulation within the inflow and valve\u2010housing segments of the device and deformation of the self\u2010expanding valve frame characterized by variable circumferential narrowing at the junction between the valve housing and the inflow and outflow portions of the device, with additional geometric changes in all segments. All six patients underwent valve\u2010in\u2010valve implant that results in a final peak gradient \u226410\u2009mmHg and no regurgitation.<\/jats:p><\/jats:sec>Discussion<\/jats:title>The occurrence of short\u2010term Harmony TPV25 dysfunction in multiple patients with a similar appearance of frame distortion and tissue accumulation within the inflow and valve housing portions of the device suggests that this may be an important failure mechanism for this valve. Potential causes of the observed findings are discussed. It is possible to treat this mechanism of TPV25 dysfunction with valve\u2010in\u2010valve implant using balloon expandable transcatheter valves.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30901","type":"journal-article","created":{"date-parts":[[2023,11,5]],"date-time":"2023-11-05T09:23:32Z","timestamp":1699176212000},"page":"1078-1087","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Right ventricular outflow tract obstruction associated with neointimal tissue accumulation and distortion of the Harmony TPV25 stent frame: Potential mechanisms and treatment"],"prefix":"10.1002","volume":"102","author":[{"given":"Zachary L.","family":"Steinberg","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of Washington Medical Center Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison K.","family":"Cabalka","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Mayo Clinic Rochester Minnesota USA"},{"name":"Division of Structural Heart Diseases Mayo Clinic Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Balzer","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Washington University School of Medicine St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8634-7675","authenticated-orcid":false,"given":"Jeremy D.","family":"Asnes","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology Yale New Haven Hospital, Yale School of Medicine New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7587-7518","authenticated-orcid":false,"given":"Brian H.","family":"Morray","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Seattle Children's Hospital Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology University of Pennsylvania School of Medicine and The Children's Hospital of Philadelphia Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7242-0934","authenticated-orcid":false,"given":"Doff B.","family":"McElhinney","sequence":"additional","affiliation":[{"name":"Departments of Cardiothoracic Surgery and Pediatrics (Cardiology) Stanford University School of Medicine Palo Alto California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,5]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.07.715"},{"issue":"12","key":"e_1_2_8_3_1","first-page":"1007","article-title":"Platelets","volume":"6","author":"Sellers SL","year":"2021","journal-title":"J Am Coll Cardiol"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.21037\/acs-2021-tviv-85"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.10.031"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.03.002"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.119.008320"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2021.12.042"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2013.07.013"},{"issue":"2","key":"e_1_2_8_10_1","first-page":"172","article-title":"The durability of porcine xenograft valves and conduits in children","volume":"66","author":"Miller DC","year":"1982","journal-title":"Circulation"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5223(19)39113-5"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5223(19)37248-4"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pcbi.1010902"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.30901","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T14:41:21Z","timestamp":1700145681000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.30901"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":12,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1002\/ccd.30901"],"URL":"https:\/\/doi.org\/10.1002\/ccd.30901","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]},"assertion":[{"value":"2023-06-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-05","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}