Published Online
on October 24, 2006

A more recent version of this article appeared on October 31, 2006

This Article Free upon publication Full Text (PDF) All Versions of this Article: 114/18/1962    most recent CIRCULATIONAHA.106.664672v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mullen, M. J. Articles by Jux, C. Search for Related Content PubMed PubMed Citation Articles by Mullen, M. J. Articles by Jux, C. Related Collections Catheter-based coronary and valvular interventions: other Pediatric and congenital heart disease, including cardiovascular surgery Other Stroke Treatment - Surgical Transient Ischemic Attacks

Submitted on September 16, 2006
Revised on September 30, 2006
Accepted on October 3, 2006

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, and 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.

^* To whom correspondence should be addressed. E-mail: m.mullen{at}rbht.nhs.uk.

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.

Key words: heart septal defects • heart defects, congenital • pediatrics • stroke

This article has been cited by other articles:

				A Wahl and B Meier Patent foramen ovale and ventricular septal defect closure Heart, January 1, 2009; 95(1): 70 - 82. [Abstract] [Full Text] [PDF]

				Z. M. Hijazi and S. M. Awad Pediatric Cardiac Interventions J. Am. Coll. Cardiol. Intv., December 1, 2008; 1(6): 603 - 611. [Abstract] [Full Text] [PDF]

				T. P. Graham Jr The Year in Congenital Heart Disease J. Am. Coll. Cardiol., July 24, 2007; 50(4): 368 - 377. [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., July 17, 2007; 50(3): 270 - 285. [Full Text] [PDF]