{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:54:56Z","timestamp":1765828496489,"version":"3.44.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000274","name":"British Heart Foundation","doi-asserted-by":"publisher","award":["SP\/15\/5\/31548"],"award-info":[{"award-number":["SP\/15\/5\/31548"]}],"id":[{"id":"10.13039\/501100000274","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institute Health Research invention for innovation product development Award","award":["NIHR203377"],"award-info":[{"award-number":["NIHR203377"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,2]]},"abstract":"Abstract<\/jats:title>\n \n Objectives<\/jats:title>\n To assess the in vivo 6-month safety of styrene-block-ethylene\/butylene-block-styrene (SEBS) block copolymers material used to make cardiac valves.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Research-grade mitral valve prototypes made from SEBS29\/SEBS20 copolymers (n\u2009=\u20097; 3 with heparin-coating) were implanted in juvenile sheep under cardiopulmonary bypass and kept for 6 months. No vitamin K antagonists were used. Anticoagulation included enoxaparin 1 mg\/kg SC twice\/day from day 1 until day 120 along with clopidogrel 300 mg once\/day with food from day 1 until sacrifice. Safety measures included SEBS-related calcification, degradation, haemolysis, cytotoxicity, clinical pathology (biochemistry, complete blood count, coagulation), structural integrity, damage to surrounding tissue, overall animal health, and device embolization and function.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Surgery was feasible in all cases. Four animals reached the final 180\u2009\u00b1\u20095 days timepoint, while 1 needed non-SEBS related sacrifice on day 2, 1 suffered non-SEBS related death on day 81, and 1 needed sacrifice on day 169 due to prototype dysfunction. High-resolution X-ray, spectroscopy and histology showed absence of SEBS calcification, while gel permeation chromatography confirmed no SEBS degradation at 6 months. At histology, there was no SEBS-related calcification, thrombosis, cytotoxic or neoplastic degeneration, and no damage of the cardiac and downwards organs. Blood testing showed no haemolysis, while clinical pathology and animal health remained within normal reference intervals. The function of the research-grade mitral prototypes was clinically acceptable. The use of heparin-coating did not add benefit.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This preclinical in vivo study in juvenile sheep confirms the 6-month safety of SEBS29\/SEBS20 material used to make cardiac valves. A future early feasibility study is warranted to confirm long-term durability, haemocompatibility, and function in humans.<\/jats:p>\n <\/jats:sec>","DOI":"10.1093\/ejcts\/ezaf266","type":"journal-article","created":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T16:15:19Z","timestamp":1754064919000},"source":"Crossref","is-referenced-by-count":1,"title":["Material Safety of Styrene-Block<\/i>-Ethylene\/Butylene-Block<\/i>-Styrene Copolymers Used for Cardiac Valves: 6-Month In Vivo<\/i> Results from a Juvenile Sheep Model"],"prefix":"10.1093","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8045-5619","authenticated-orcid":false,"given":"Raimondo","family":"Ascione","sequence":"first","affiliation":[{"name":"Bristol Medical School and Translational Biomedical Research Centre, Faculty of Health and Life Science, University of Bristol , Bristol BS2 8HW,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanna R","family":"Stasiak","sequence":"additional","affiliation":[{"name":"Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge CB3 0AS,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Baz-Lopez","sequence":"additional","affiliation":[{"name":"Bristol Medical School and Translational Biomedical Research Centre, Faculty of Health and Life Science, University of Bristol , Bristol BS2 8HW,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Serrani","sequence":"additional","affiliation":[{"name":"Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge CB3 0AS,","place":["United Kingdom"]},{"name":"Durham University Department of Engineering, , DH1 3LE, Durham,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geoff D","family":"Moggridge","sequence":"additional","affiliation":[{"name":"Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge CB3 0AS,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,8,1]]},"reference":[{"key":"2025082520072360900_ezaf266-B1","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1016\/j.jacc.2013.05.015","article-title":"Aortic stenosis in the elderly: disease, prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modelling study","volume":"62","author":"Osnabrugge","year":"2013","journal-title":"J Am Coll Cardiol"},{"key":"2025082520072360900_ezaf266-B2","first-page":"68","article-title":"Analysis of prosthetic cardiac devices: a guide for the practicing pathologist","volume":"267","author":"Butany","year":"2018","journal-title":"Int J Cardiol"},{"key":"2025082520072360900_ezaf266-B3","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1016\/S0140-6736(06)69208-8","article-title":"Burden of valvular heart disease: a population-based study","volume":"368","author":"Nkomo","year":"2006","journal-title":"Lancet"},{"key":"2025082520072360900_ezaf266-B4","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1056\/NEJMoa1603693","article-title":"Global, regional and national burden of rheumatic heart disease 1990-2015","volume":"377","author":"Watkins","year":"2017","journal-title":"N Engl J Med"},{"key":"2025082520072360900_ezaf266-B5","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1111\/jocs.13740","article-title":"Evolving trends in aortic valve replacement: a statewide experience","volume":"33","author":"Kim","year":"2018","journal-title":"J Card Surg."},{"key":"2025082520072360900_ezaf266-B6","doi-asserted-by":"crossref","first-page":"1628","DOI":"10.1016\/j.jacc.2018.02.025","article-title":"Interpreting national trends in aortic valve replacement: let the buyer beware","volume":"71","author":"Leon","year":"2018","journal-title":"J Am Coll Cardiol"},{"key":"2025082520072360900_ezaf266-B7","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1016\/j.ijcard.2018.04.042","article-title":"Mechanical prosthetic heart valves: quality of anticoagulation and thromboembolic risk. 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