The BioSTAR(r) device versus the CardioSEAL(r) device in patent foramen ovale closure: comparison of mid-term efficacy and safety.
OBJECTIVE
To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR(r) device with the non-bioabsorbable CardioSEAL(r) device for percutaneous patent foramen ovale (PFO) closure.


RESULTS
All 81 consecutive patients who underwent PFO closure with the CardioSEAL(r) or BioSTAR(r) device between June 2003 and July 2008 were included. The presence of a residual shunt (minimal, moderate or large) was measured in both groups at six months follow-up, using contrast transthoracic echocardiography. Forty-four patients (48.4±11.4 years) received the CardioSEAL(r) device and 37 patients the BioSTAR(r) device (47.9±10.7 years). There were no significant differences in short-term complications. Two patients who received the BioSTAR(r) device developed a recurrent transient cerebral ischaemic event. Overall, atrial arrhythmias occurred in 19%, with no difference between both groups. At six months, a residual shunt was present in 29% (27% minimal, 2% moderate) using the CardioSEAL(r) device compared to 28% (17% minimal, 11% moderate) using the BioSTAR(r) device (p=0.18). A predictor for residual shunt could not be found.


CONCLUSIONS
There is no difference in safety and efficacy at six months between the CardioSEAL(r) and BioSTAR(r) device used for PFO closure. However, using the BioSTAR(r) device tends to be associated with a higher percentage of moderate shunting.
Van den Branden
Ben J
BJ
Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands. b.van.den.branden@antoniusziekenhuis.nl
Luermans
Justin G
JG
Post
Martijn C
MC
Plokker
Herbert W
HW
Ten Berg
Jurriën M
JM
Suttorp
Maarten J
MJ
D020341:Absorbable Implants / Q000009:adverse effects; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005260:Female; D054092:Foramen Ovale, Patent / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055989:Septal Occluder Device / Q000009:adverse effects; D013923:Thromboembolism / Q000209:etiology; D016896:Treatment Outcome