{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T18:25:09Z","timestamp":1778610309358,"version":"3.51.4"},"reference-count":31,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"22","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,11,19]]},"abstract":"<jats:sec xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Cardiosphere\u2010derived cell (CDC) infusion was associated with better clinical outcomes at 2\u2009years in patients with single ventricle heart disease. The current study investigates time\u2010to\u2010event outcomes at 8\u2009years.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              This cohort enrolled patients with single ventricles who underwent stage 2 or stage 3 palliation from January 2011 to January 2015 at 8 centers in Japan. The primary outcomes were time\u2010dependent CDC treatment effects on death and late complications during 8\u2009years of follow\u2010up, assessed by restricted mean survival time. Among 93 patients enrolled (mean age, 2.3\u00b11.3\u2009years; 56% men), 40 received CDC infusion. Overall survival for CDC\u2010treated versus control patients did not differ at 8\u2009years (hazard ratio [HR], 0.60 [95% CI, 0.21\u20131.77];\n              <jats:italic>P<\/jats:italic>\n              =0.35). Treatment effect had nonproportional hazards for death favoring CDCs at 4\u2009years (restricted mean survival time difference +0.33\u2009years [95% CI, 0.01\u20130.66];\n              <jats:italic>P<\/jats:italic>\n              =0.043). In patients with heart failure with reduced ejection fraction, CDC treatment effect on survival was greater over 8\u2009years (restricted mean survival time difference +1.58\u2009years [95% CI, 0.05\u20133.12];\n              <jats:italic>P<\/jats:italic>\n              =0.043). Compared with control participants, CDC\u2010treated patients showed lower incidences of late failure (HR, 0.45 [95% CI, 0.21\u20130.93];\n              <jats:italic>P<\/jats:italic>\n              =0.027) and adverse events (subdistribution HR, 0.50 [95% CI, 0.27\u20130.94];\n              <jats:italic>P<\/jats:italic>\n              =0.036) at 8\u2009years.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">By 8\u2009years, CDC infusion was associated with lower hazards of late failure and adverse events in single ventricle heart disease. CDC treatment effect on survival was notable by 4\u2009years and showed a durable clinical benefit in patients with heart failure with reduced ejection fraction over 8\u2009years.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Registration<\/jats:title>\n            <jats:p xml:lang=\"en\">\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 identifiers: NCT01273857 and NCT01829750.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.124.038137","type":"journal-article","created":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T10:52:39Z","timestamp":1731322359000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Eight\u2010Year Outcomes of Cardiosphere\u2010Derived Cells in Single Ventricle Congenital Heart Disease"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0299-7791","authenticated-orcid":false,"given":"Kenta","family":"Hirai","sequence":"first","affiliation":[{"name":"Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan"},{"name":"Department of Regenerative Medicine, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5355-1204","authenticated-orcid":false,"given":"Ryusuke","family":"Sawada","sequence":"additional","affiliation":[{"name":"Department of Pharmacology Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Kurashiki Central Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toru","family":"Araki","sequence":"additional","affiliation":[{"name":"Department of Pediatrics National Hospital Organization Fukuyama Medical Center Hiroshima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6357-7582","authenticated-orcid":false,"given":"Naomi","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maiko","family":"Kondo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan"},{"name":"Department of Pediatrics Kochi Health Sciences Center Kochi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8379-769X","authenticated-orcid":false,"given":"Kenji","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Shimane University Faculty of Medicine Izumo Shimane Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8857-9607","authenticated-orcid":false,"given":"Takuya","family":"Hirata","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Kyoto University Graduate School of Medicine Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoyuki","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Jichi Medical University Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2054-7483","authenticated-orcid":false,"given":"Yuki","family":"Nakatsuka","sequence":"additional","affiliation":[{"name":"Department of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9463-9424","authenticated-orcid":false,"given":"Michihiro","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3698-4836","authenticated-orcid":false,"given":"Shingo","family":"Kasahara","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2716-5185","authenticated-orcid":false,"given":"Kenji","family":"Baba","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9643-6073","authenticated-orcid":false,"given":"Hidemasa","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Regenerative Medicine, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the TICAP\/PERSEUS Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.116.022816"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.017202"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.122.025978"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12265-018-9786-0"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029375"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab826"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2019.5459"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.98.4.330"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.abb3336"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.117.309697"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00395-022-00913-y"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab419"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2020.06.154"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.116.304671"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.116.310253"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.117.312311"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2015.06.076"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.9495"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2021.02.019"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyad127"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.117.311206"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw113"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1038\/ng.3870"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.08.1034"},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.006191"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.07.065"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.118.313251"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00012-5"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.09.019"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029343"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw304"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.124.038137","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T12:33:32Z","timestamp":1732019612000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.124.038137"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,19]]},"references-count":31,"journal-issue":{"issue":"22","published-print":{"date-parts":[[2024,11,19]]}},"alternative-id":["10.1161\/JAHA.124.038137"],"URL":"https:\/\/doi.org\/10.1161\/jaha.124.038137","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,19]]},"assertion":[{"value":"2024-08-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e038137"}}