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Clinical research

The BioSTAR® device versus the CardioSEAL® device in patent foramen ovale closure: comparison of mid-term efficacy and safety

Aims: To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR® device with the non-bioabsorbable CardioSEAL® device for percutaneous patent foramen ovale (PFO) closure.

Methods and results: All 81 consecutive patients who underwent PFO closure with the CardioSEAL® or BioSTAR® 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® device and 37 patients the BioSTAR® device (47.9±10.7 years). There were no significant differences in short-term complications. Two patients who received the BioSTAR® 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® device compared to 28% (17% minimal, 11% moderate) using the BioSTAR® 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® and BioSTAR® device used for PFO closure. However, using the BioSTAR® device tends to be associated with a higher percentage of moderate shunting.

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