{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T18:34:34Z","timestamp":1791916474969,"version":"4.3.4"},"reference-count":36,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"18","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2006,10,31]]},"abstract":"<jats:p>\n                    <jats:bold>\n                      <jats:italic>Background\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    The use of permanent synthetic implants to close atrial septal defects (ASD) and patent foramen ovale (PFO) has a number of limitations, including late complications and the limiting of transeptal access to the left heart should it be required for the later treatment of acquired heart disease. BioSTAR is a novel, bioabsorbable, atrial septal repair implant. This phase I pilot study evaluates the feasibility, safety, and effectiveness of BioSTAR for the first time in humans.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>\n                      <jats:italic>Methods and Results\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    We conducted a prospective, open-label, multicenter clinical study in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively. There was no evidence of a clinically significant response to the device. Transient atrial arrhythmia occurred in 5 patients after implantation. No major safety issues were observed.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>\n                      <jats:italic>Conclusions\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    This study demonstrates the feasibility, safety, and effectiveness of BioSTAR for the closure of ASD and PFO in humans with a high rate of early and complete shunt closure. BioSTAR is a novel septal repair implant designed to provide biological closure of atrial-level defects using the patient\u2019s natural healing response. Because 90% to 95% of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved.\n                  <\/jats:p>","DOI":"10.1161\/circulationaha.106.664672","type":"journal-article","created":{"date-parts":[[2006,10,24]],"date-time":"2006-10-24T23:10:02Z","timestamp":1161731402000},"page":"1962-1967","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":134,"title":["BioSTAR Evaluation STudy (BEST)"],"prefix":"10.1161","volume":"114","author":[{"given":"Michael J.","family":"Mullen","sequence":"first","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Hildick-Smith","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph V.","family":"De Giovanni","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Duke","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. Stewart","family":"Hillis","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. Lindsay","family":"Morrison","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Jux","sequence":"additional","affiliation":[{"name":"From Royal Brompton Hospital (M.J.M.), London, United Kingdom; Royal Sussex County Hospital (D.H.-S.), Brighton, United Kingdom; University Hospital (J.V.D.G.), Birmingham, United Kingdom; Glenfield Hospital (C.D.), Leicester, United Kingdom; Western Infirmary (W.S.H.), Glasgow, United Kingdom; Cardiothoracic Centre (W.L.M.), Liverpool, United Kingdom; and Georg-August University (C.J.), Goettingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_1_2","unstructured":"Fyler DC ed. Nadas\u2019 Pediatric Cardiology. Philadelphia Pa: Hanley & Belfus; 1992."},{"key":"e_1_3_2_2_2","unstructured":"Perloff JK Child JS eds. Congenital Heart Disease in Adults. Philadelphia Pa: WB Saunders; 1991."},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.03.049"},{"key":"e_1_3_2_4_2","first-page":"465","volume":"1","year":"2006","unstructured":"Billinger K, Ostermayer S, Carminati M, DeGiovanni J, Ewert P, Hess J, Maymone-Martins F, Qureshi S, Salmon A, Schneider M, Wilson N, Sievert H. HELEX septal occluder for transcatheter closure of patent foramen ovale: multicentre experience. EuroIntervention. 2006; 1: 465\u2013471.","journal-title":"EuroIntervention"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2006.00154.x"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/clc.4960270907"},{"key":"e_1_3_2_7_2","first-page":"22","volume":"1","year":"2005","unstructured":"Meier JM, Berger A, Delabays A, Girod G, Graf D, Lyon X, Roguelov C, Vogt P, Stauffer JC, Eeckhout E. Percutaneous closure of patent foramen ovale: head-to-head comparison of two different devices. EuroIntervention. 2005; 1: 22\u201326.","journal-title":"EuroIntervention"},{"key":"e_1_3_2_8_2","first-page":"365","volume":"18","year":"2006","unstructured":"Alaeddini J, Feghali G, Jenkins S, Ramee S, White C, Abi-Samra F. Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. J Invasive Cardiol. 2006; 18: 365\u2013368.","journal-title":"J Invasive Cardiol"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1009852312907"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.20722"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.2143\/AC.60.5.2004973"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.20211"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.12.072"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0003-4975(03)00901-9"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.20220"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.20497"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2005.12.017"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","unstructured":"Sigler M Jux C. Biocompatibility of septal defect closure devices. Heart. October 11 2006. DOI: 10.1136\/hrt.2006.098103. Available at: http:\/\/heart.bmjjournals.com. Accessed October 15 2006.","DOI":"10.1136\/hrt.2006.098103"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(99)00515-9"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2001.tb00715.x"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2001.tb00339.x"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.02.057"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1540-8183.2003.08027.x"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1161\/str.31.2.398"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1080\/14628840410030432"},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.trim.2003.12.016"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.820290809"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1177\/155335060501200307"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.1038\/15062"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-4636(20000905)51:3<442::AID-JBM19>3.0.CO;2-4"},{"key":"e_1_3_2_31_2","first-page":"675","volume":"49","year":"1996","unstructured":"Hardin-Young J, Carr R, Downing G, Condon K, Termin P. Modification of native collagen reduces antigenicity but preserves cell compatibility. Biotechnol Bioeng. 1996; 49: 675\u2013682.","journal-title":"Biotechnol Bioeng"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-4636(200107)56:1<101::AID-JBM1074>3.0.CO;2-6"},{"key":"e_1_3_2_33_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.1183"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.10603"},{"key":"e_1_3_2_35_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10029-004-0208-7"},{"key":"e_1_3_2_36_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2005.01.042"}],"container-title":["Circulation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCULATIONAHA.106.664672","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T00:51:43Z","timestamp":1715561503000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCULATIONAHA.106.664672"}},"subtitle":["A Prospective, Multicenter, Phase I Clinical Trial to Evaluate the Feasibility, Efficacy, and Safety of the BioSTAR Bioabsorbable Septal Repair Implant for the Closure of Atrial-Level Shunts"],"short-title":[],"issued":{"date-parts":[[2006,10,31]]},"references-count":36,"journal-issue":{"issue":"18","published-print":{"date-parts":[[2006,10,31]]}},"alternative-id":["10.1161\/CIRCULATIONAHA.106.664672"],"URL":"https:\/\/doi.org\/10.1161\/circulationaha.106.664672","relation":{},"ISSN":["0009-7322","1524-4539"],"issn-type":[{"value":"0009-7322","type":"print"},{"value":"1524-4539","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,10,31]]},"assertion":[{"value":"2006-10-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}