{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:09:14Z","timestamp":1792080554152,"version":"4.4.0"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. Here, 5-year clinical and hemodynamic outcomes for patients in the main cohort and the continued access protocol are reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>The COMPASSION S3 trial was a single-arm, multicenter study enrolling patients with either moderate-to-severe pulmonic regurgitation, a mean RVOT gradient \u226535 mm\u2009Hg, or both. The primary end point was THV dysfunction at 1 year, a nonhierarchical composite of RVOT reintervention, \u2265moderate total pulmonic regurgitation, and mean RVOT gradient &gt;40 mm\u2009Hg. Clinical and echocardiographic outcomes were assessed at baseline, discharge, 30 days, 6 months, 1 year, and then annually to 5 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Between 2016 and 2020, 69 patients were enrolled and successfully implanted with the SAPIEN 3 THV. The mean patient age was 32.1 years, and most patients (70.8%) had a conduit as the most recent prior intervention. At 5 years, the rate of THV dysfunction was 12.0%: 3 patients required reintervention, 2 patients had \u2265moderate pulmonic regurgitation, and 1 patient had a mean gradient &gt;40 mm\u2009Hg. There were 3 cases of device-related endocarditis (4.4%). One death occurred on postoperative day 560 due to cardiogenic shock. No cases of tricuspid valve injury, stent fractures, or valve malposition were reported. Post-transcatheter pulmonic valve replacement, mean gradients were low and stable through 5-year follow-up. Through 5 years, &gt;95% of patients had \u2264mild total pulmonic regurgitation, and 97.9% of patients had none\/trace paravalvular regurgitation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>Five-year results from the COMPASSION S3 trial demonstrate that the SAPIEN 3 THV provides durable RVOT relief with low rates of reintervention or endocarditis, supporting the device as a safe and versatile option for transcatheter pulmonic valve replacement across diverse anatomies and clinical scenarios.<\/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: NCT02744677.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.125.016361","type":"journal-article","created":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T09:00:36Z","timestamp":1774515636000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial"],"prefix":"10.1161","volume":"19","clinical-trial-number":[{"clinical-trial-number":"nct02744677","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Michael R.","family":"Hainstock","sequence":"first","affiliation":[{"name":"University of Virginia, Charlottesville (M.R.H., D.S.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0772-7192","authenticated-orcid":true,"given":"Gregory","family":"Fleming","sequence":"additional","affiliation":[{"name":"Duke University Medical Center, Durham, NC (G.F., R.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Kim","sequence":"additional","affiliation":[{"name":"Emory University, Atlanta, GA (D. Kim, V.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0209-9505","authenticated-orcid":true,"given":"Jamil","family":"Aboulhosn","sequence":"additional","affiliation":[{"name":"University of California, Los Angeles (J.A., D.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9926-8805","authenticated-orcid":true,"given":"Daniel","family":"Levi","sequence":"additional","affiliation":[{"name":"University of California, Los Angeles (J.A., D.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3150-5215","authenticated-orcid":true,"given":"Richard","family":"Krasuski","sequence":"additional","affiliation":[{"name":"Duke University Medical Center, Durham, NC (G.F., R.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9280-6236","authenticated-orcid":true,"given":"Robert","family":"Sommer","sequence":"additional","affiliation":[{"name":"Columbia University Irving Medical Center, New York, NY (R.S., A.J.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2302-4433","authenticated-orcid":true,"given":"Alejandro J.","family":"Torres","sequence":"additional","affiliation":[{"name":"Columbia University Irving Medical Center, New York, NY (R.S., A.J.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Gray","sequence":"additional","affiliation":[{"name":"University of Utah at Primary Children\u2019s Hospital, Salt Lake City (R.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1086-127X","authenticated-orcid":true,"given":"Dean","family":"Kereiakes","sequence":"additional","affiliation":[{"name":"The Christ Hospital and Lindner Research Center, Cincinnati, OH (D. Kereiakes)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Leventhal","sequence":"additional","affiliation":[{"name":"University of Kentucky, Lexington (A.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine, University of Pennsylvania, Philadelphia (M.G., W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilson","family":"Szeto","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine, University of Pennsylvania, Philadelphia (M.G., W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5765-640X","authenticated-orcid":true,"given":"Alan","family":"Zajarias","sequence":"additional","affiliation":[{"name":"Barnes-Jewish Hospital, Washington University, St. Louis, MO (A.Z., S.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1620-9709","authenticated-orcid":true,"given":"Shabana","family":"Shahanavaz","sequence":"additional","affiliation":[{"name":"Barnes-Jewish Hospital, Washington University, St. Louis, MO (A.Z., S.S.)."},{"name":"Cincinnati Children\u2019s Hospital, OH (S.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0008-6484","authenticated-orcid":true,"given":"Zachary L.","family":"Steinberg","sequence":"additional","affiliation":[{"name":"University of Washington Medical Center, Seattle (Z.L.S.)."}],"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":"Seattle Children\u2019s Hospital, WA (T.K.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6354-1873","authenticated-orcid":true,"given":"Vaikom S.","family":"Mahadevan","sequence":"additional","affiliation":[{"name":"University of California, San Francisco (V.S.M., P.M., S.E.)."},{"name":"University of Massachusetts Memorial Medical Center, Worcester (V.S.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip","family":"Moore","sequence":"additional","affiliation":[{"name":"University of California, San Francisco (V.S.M., P.M., S.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8013-8733","authenticated-orcid":true,"given":"Sammy","family":"Elmariah","sequence":"additional","affiliation":[{"name":"University of California, San Francisco (V.S.M., P.M., S.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Girish","family":"Shirali","sequence":"additional","affiliation":[{"name":"Children\u2019s Mercy Hospital, Kansas City, MO (G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenhao","family":"Li","sequence":"additional","affiliation":[{"name":"Edwards Lifesciences, Irvine, CA (W.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9438-0846","authenticated-orcid":true,"given":"Vasilis","family":"Babaliaros","sequence":"additional","affiliation":[{"name":"Emory University, Atlanta, GA (D. 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Scott","family":"Lim","sequence":"additional","affiliation":[{"name":"University of Virginia, Charlottesville (M.R.H., D.S.L.)."},{"name":"University of British Columbia and Vancouver Coastal Health, Canada (D.S.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of COMPASSION 3 Trial Executive Committee and Study Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.06.034"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.121.010852"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.07.040"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2022.12.010"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.10.065"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.echo.2008.11.029"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.10.041"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.27973"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.07.734"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0735-1097(24)03612-x"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.05.044"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.013588"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jjcc.2019.04.007"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2016.12.012"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.3390\/jcm13092683"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.2174\/011573403X324878240903045701"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv526"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.121.011480"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacadv.2025.101599"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.125.015196"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.02.038"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.125.016361","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T18:00:33Z","timestamp":1780509633000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.125.016361"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.125.016361"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.125.016361","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]},"assertion":[{"value":"2025-11-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}