{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T22:39:23Z","timestamp":1792190363175,"version":"4.4.0"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      At 6 months, cardiac magnetic resonance imaging demonstrated significant reverse right ventricular remodeling, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction (all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction.<\/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: NCT03983512.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.126.016616","type":"journal-article","created":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T09:00:37Z","timestamp":1781773237000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study"],"prefix":"10.1161","volume":"19","clinical-trial-number":[{"clinical-trial-number":"nct03983512","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3071-2661","authenticated-orcid":true,"given":"Sang-Yun","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Seoul National University Children\u2019s Hospital, Seoul National University School of Medicine, Republic of Korea (S.-Y.L., G.B.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7880-280X","authenticated-orcid":true,"given":"Gi Beom","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Seoul National University Children\u2019s Hospital, Seoul National University School of Medicine, Republic of Korea (S.-Y.L., G.B.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9734-3007","authenticated-orcid":true,"given":"Mario","family":"Carminati","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Dr Siyami Ersek Hospital for Cardiology and Cardiovascular Surgery, Istanbul, T\u00fcrkiye (A.C., I.K.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Giugno","sequence":"additional","affiliation":[{"name":"Pediatric and Adult Congenital Cardiology Center, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milan, Italy (M.C., L.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5490-0296","authenticated-orcid":true,"given":"Ahmet","family":"\u00c7elebi","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Dr Siyami Ersek Hospital for Cardiology and Cardiovascular Surgery, Istanbul, T\u00fcrkiye (A.C., I.K.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilker Kemal","family":"Yucel","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Dr Siyami Ersek Hospital for Cardiology and Cardiovascular Surgery, Istanbul, T\u00fcrkiye (A.C., I.K.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Eicken","sequence":"additional","affiliation":[{"name":"Department of Congenital Heart Defects and Pediatric Cardiology, Technische Universit\u00e4t M\u00fcnchen University Hospital German Heart Center, Technical University of Munich, Germany (A.E., P.E., S.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0253-1190","authenticated-orcid":true,"given":"Peter","family":"Ewert","sequence":"additional","affiliation":[{"name":"Department of Congenital Heart Defects and Pediatric Cardiology, Technische Universit\u00e4t M\u00fcnchen University Hospital German Heart Center, Technical University of Munich, Germany (A.E., P.E., S.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6239-8160","authenticated-orcid":true,"given":"Stanimir","family":"Georgiev","sequence":"additional","affiliation":[{"name":"Department of Congenital Heart Defects and Pediatric Cardiology, Technische Universit\u00e4t M\u00fcnchen University Hospital German Heart Center, Technical University of Munich, Germany (A.E., P.E., S.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1247-6669","authenticated-orcid":true,"given":"Jae Young","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea (J.Y.C., C.S.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1156-6536","authenticated-orcid":true,"given":"Chang Sin","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea (J.Y.C., C.S.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9958-5763","authenticated-orcid":true,"given":"Federico","family":"Guti\u00e9rrez-Larraya","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain (F.G.-L., E.B.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6832-7007","authenticated-orcid":true,"given":"Enrique","family":"Balbacid Domingo","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain (F.G.-L., E.B.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ender","family":"Odemis","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine, Ko\u00e7 University, \u0130stanbul, T\u00fcrkiye (E.O., M.H.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mete Han","family":"Kizilkaya","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine, Ko\u00e7 University, \u0130stanbul, T\u00fcrkiye (E.O., 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