TY - JOUR
T1 - The BioSTAR® device versus the CardioSEAL® device in patent foramen ovale closure
T2 - Comparison of mid-term efficacy and safety
AU - Van Den Branden, Ben J.
AU - Luermans, Justin G.
AU - Post, Martijn C.
AU - Plokker, Herbert W.
AU - Ten Berg, Jurriën M.
AU - Suttorp, Maarten J.
PY - 2010/1/1
Y1 - 2010/1/1
N2 - Aims: To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR® device with the nonbioabsorbable 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.
AB - Aims: To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR® device with the nonbioabsorbable 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.
KW - Patent foramen ovale
KW - Residual shunt
KW - Transcatheter closure
UR - http://www.scopus.com/inward/record.url?scp=79952192860&partnerID=8YFLogxK
U2 - 10.4244/EIJ30V6I4A83
DO - 10.4244/EIJ30V6I4A83
M3 - Article
C2 - 20884438
AN - SCOPUS:79952192860
SN - 1774-024X
VL - 6
SP - 498
EP - 504
JO - EuroIntervention
JF - EuroIntervention
IS - 4
ER -