Key result
The BioSTAR device showed no significant difference in residual shunt at six months compared to the CardioSEAL device for patent foramen ovale closure (28% vs 29%, p=0.18).
Why the study?
Does the BioSTAR device reduce residual shunt at six months compared to the CardioSEAL device in patients undergoing percutaneous PFO closure?
Cohort (n=81)
Does the BioSTAR device reduce residual shunt at six months compared to the CardioSEAL device in patients undergoing percutaneous PFO closure?
Absolute Event Rate: 28% vs 29%
p-value: p=0.18
The bioabsorbable BioSTAR device demonstrates similar mid-term efficacy and safety to the non-bioabsorbable CardioSEAL device for PFO closure, though it may be associated with a higher percentage of moderate shunting.
Similar residual shunt rates between devices; leaves open optimal PFO closure device selection pending randomized data.
AIMS: 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. METHODS AND 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.
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Branden et al. (2010) conducted a cohort in patent foramen ovale (n=81). BioSTAR device vs. CardioSEAL device was evaluated on presence of a residual shunt (minimal, moderate or large) (p=0.18). The BioSTAR device showed no significant difference in residual shunt at six months compared to the CardioSEAL device for patent foramen ovale closure (28% vs 29%, p=0.18).
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