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(Circulation. 2006;114:1962-1967.)
© 2006 American Heart Association, Inc.

Interventional Cardiology

BioSTAR Evaluation STudy (BEST)

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

Michael J. Mullen, MB, BS, MRCP, MD; David Hildick-Smith, MD, MRCP; Joseph V. De Giovanni, MD, FRCP, FRCPCH, MOM; Christopher Duke, MB, ChB, MA, MRCP; W. Stewart Hillis, MB, ChB, FRCP, FRCS; W. Lindsay Morrison, MD, FRCP; Christian Jux, MD

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.

Correspondence to Dr Michael J. Mullen, Consultant Cardiologist, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, England. E-mail m.mullen{at}rbht.nhs.uk

Received September 16, 2006; revision received September 30, 2006; accepted October 3, 2006.

Background— 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.

Methods and Results— 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.

Conclusions— 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’s 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.

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CLINICAL PERSPECTIVE

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