{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T23:08:39Z","timestamp":1788908919448,"version":"build-2803163510"},"reference-count":8,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2025,5,11]],"date-time":"2025-05-11T00:00:00Z","timestamp":1746921600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,5,11]],"date-time":"2025-05-11T00:00:00Z","timestamp":1746921600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["grant number JP17he1302009"],"award-info":[{"award-number":["grant number JP17he1302009"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Teijin Limited"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Gen Thorac Cardiovasc Surg"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Patients with congenital heart defects, such as tetralogy of Fallot (TOF) or right ventricular outflow tract stenosis or atresia, often require pulmonary valve replacement (PVR) decades after the primary repair. The purpose of this study was to assess the safety and efficacy of a novel synthetic hybrid fabric (SHF) for PVR in adult congenital heart disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>SHF, consisting of bio-absorbable and non-absorbable yarns coated with cross-linked gelatin, was used in a prospective, multicenter, single-arm pivotal clinical trial involving subjects with an age range of 0\u201359\u00a0years. The overall study was registered in the Japan Registry of Clinical Trials (jRCT1080224691). This paper specifically presents a subgroup analysis focusing on five adult patients (aged 18\u201342\u00a0years) from the multicenter trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The procedures were performed similarly to those using existing products, with no SHF-specific complications observed. The SHF material allowed surgeons to clearly observe the bioprosthetic valve annulus during suturing. None of the patients required blood transfusion or developed adverse events. At a mean follow-up of 4.5 years (range 4.0\u20134.9 years), no re-interventions or reoperations were needed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>SHF shows promise as a patch material for PVR, offering significant benefits such as clear visualization during surgery, which facilitates precise valve placement. This transparency is crucial for adults with repaired TOF, as it helps reduce surgery time and complication risks. This study suggests that SHF could be a valuable material for adult PVR, extending its potential applications beyond pediatric cardiology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11748-025-02154-x","type":"journal-article","created":{"date-parts":[[2025,5,11]],"date-time":"2025-05-11T09:15:27Z","timestamp":1746954927000},"page":"806-810","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Novel transparent patch as an adjunct to adult pulmonary valve replacement"],"prefix":"10.1007","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0858-1017","authenticated-orcid":false,"given":"Hajime","family":"Ichikawa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigemitsu","family":"Iwai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasumi","family":"Nishiwaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kousuke","family":"Kikuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,11]]},"reference":[{"issue":"6","key":"2154_CR1","doi-asserted-by":"publisher","first-page":"563","DOI":"10.1093\/eurheartj\/ehaa554","volume":"42","author":"H Baumgartner","year":"2021","unstructured":"Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, et al. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021;42(6):563\u2013645.","journal-title":"Eur Heart J"},{"issue":"4","key":"2154_CR2","first-page":"660","volume":"103","author":"W Pan","year":"2024","unstructured":"Pan W, Zhou D, Hijazi ZM, Qureshi SA, Promphan W, Feng Y, et al. 2024 Statement from Asia expert operators on transcatheter pulmonary valve replacement. Catheter Cardiovasc Interv. 2024;103(4):660\u20139.","journal-title":"Catheter Cardiovasc Interv"},{"issue":"6","key":"2154_CR3","doi-asserted-by":"publisher","first-page":"754","DOI":"10.21037\/cdt.2018.10.06","volume":"8","author":"J H\u00f6rer","year":"2018","unstructured":"H\u00f6rer J. Current spectrum, challenges and new developments in the surgical care of adults with congenital heart disease. Cardiovasc Diagn Ther. 2018;8(6):754\u201364.","journal-title":"Cardiovasc Diagn Ther"},{"key":"2154_CR4","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcchd.2022.100394","author":"K Kubota","year":"2022","unstructured":"Kubota K, Diller G-P, Kempny A, Hoschtitzky A, Imai Y, Kawada M, et al. Surgical pulmonary valve replacement at a tertiary adult congenital heart centre in the current era. Int J Cardiol Congenit Heart Dis. 2022. https:\/\/doi.org\/10.1016\/j.ijcchd.2022.100394.","journal-title":"Int J Cardiol Congenit Heart Dis"},{"issue":"2","key":"2154_CR5","doi-asserted-by":"publisher","first-page":"318","DOI":"10.1093\/ejcts\/ezy045","volume":"54","author":"S Nemoto","year":"2018","unstructured":"Nemoto S, Konishi H, Shimada R, Suzuki T, Katsumata T, Yamada H, et al. In situ tissue regeneration using a warp-knitted fabric in the canine aorta and inferior vena cava. Eur J Cardiothorac Surg. 2018;54(2):318\u201327.","journal-title":"Eur J Cardiothorac Surg"},{"issue":"2","key":"2154_CR6","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1093\/icvts\/ivab064","volume":"33","author":"S Nemoto","year":"2021","unstructured":"Nemoto S, Konishi H, Suzuki T, Shimada R, Katsumata T, Osawa S, et al. Long-term viability and extensibility of an in situ regenerated canine aortic wall using hybrid warp-knitted fabric. Interact CardioVasc Thorac Surg. 2021;33(2):165\u201372.","journal-title":"Interact CardioVasc Thorac Surg"},{"key":"2154_CR7","doi-asserted-by":"publisher","first-page":"A10935","DOI":"10.1161\/circ.146.suppl_1.10935","volume":"146","author":"S Nemoto","year":"2022","unstructured":"Nemoto S, Konishi H, Suzuki T, Suzuki A, Katsumata T, Yamaguchi A, et al. Long-term maturity and extensibility of an in situ regenerated aortic wall induced by a novel synthetic hybrid knit. Circulation. 2022;146:A10935.","journal-title":"Circulation"},{"issue":"4","key":"2154_CR8","doi-asserted-by":"publisher","first-page":"804","DOI":"10.1016\/j.atssr.2024.04.020","volume":"2","author":"S Kasahara","year":"2024","unstructured":"Kasahara S, Yoshimura Y, Ichikawa H, Hirata Y, Murayama H, Nakano T, et al. Early clinical results for a new self-organizing hybrid fabric in congenital cardiac surgery. Ann Thorac Surg Short Rep. 2024;2(4):804\u20139.","journal-title":"Ann Thorac Surg Short Rep"}],"container-title":["General Thoracic and Cardiovascular Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11748-025-02154-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11748-025-02154-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11748-025-02154-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T15:23:27Z","timestamp":1761233007000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11748-025-02154-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,11]]},"references-count":8,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["2154"],"URL":"https:\/\/doi.org\/10.1007\/s11748-025-02154-x","relation":{},"ISSN":["1863-6705","1863-6713"],"issn-type":[{"value":"1863-6705","type":"print"},{"value":"1863-6713","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,11]]},"assertion":[{"value":"6 March 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 April 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 May 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Hajime Ichikawa reports a relationship with Teijin Medical Technologies Co., Ltd that includes consulting or advisory and speaking and lecture fees. Shigemitsu Iwai reports a relationship with Teijin Medical Technologies Co., Ltd that includes speaking and lecture fees. Yasumi Nishiwaki and Kousuke Kikuchi are employees of Teijin Limited.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The authors are accountable for all aspects of the work and for ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (revised in 2013). The multicenter study was registered in the Japan Registry of Clinical Trials (jRCT1080224691). Subjects provided written informed consent before enrollment. The protocol for this study was approved by the National Cerebral and Cardiovascular Center IRB (#1103) in 2019.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}