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.
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.


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.
Mullen
Michael J
MJ
Royal Brompton Hospital, Sydney Street, London, SW3 6NP, England, United Kingdom. m.mullen@rbht.nhs.uk
Hildick-Smith
David
D
De Giovanni
Joseph V
JV
Duke
Christopher
C
Hillis
W Stewart
WS
Morrison
W Lindsay
WL
Jux
Christian
C
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects