Transcatheter closure of atrial septal defect with the Figulla(®) ASD Occluder: a comparative study with the Amplatzer(®) Septal Occluder.

BACKGROUND: Single-centre experience in transcatheter closure of atrial septal defect (ASD) using the Figulla(®) ASD Occluder (FSO; Occlutech GmbH, Jena, Germany) and the Amplatzer(®) Septal Occluder (ASO; Saint-Jude Medical, Zaventem, Belgium) has been reported.

AIM: To perform a retrospective comparison of the two occluders.

METHODS: From September 2009 to December 2012, 131 consecutive patients underwent percutaneous ASD occlusion: One hundred with the ASO device; 31 with the FSO device.

RESULTS: There were no significant differences between the two groups regarding patient characteristics, stretched diameter, age and device size. In the ASO group, implantation succeeded in all but two patients because of deficient rim. Another patient had device embolization in the aorta retrieved percutaneously. During follow-up, 86 patients had no residual shunt and nine patients had a residual shunt (small in seven; moderate in two). Two other patients had persistent interatrial small shunt caused by an adjacent ASD close to the device. In the FSO group, implantation succeeded in all but two patients: one because of deficient posterior rim; and one because of complete atrioventricular block that resolved after device extraction. During follow-up, no shunt was observed in all but one patient. At late follow-up (up to 36months), full occlusion was observed in 88 (88.0%) patients in the ASO group and 28 (90.3%) patients in the FSO group (with no significant difference between groups).

CONCLUSION: Transcatheter closure of ASD with the FSO is feasible and safe. FSO results compare favorably with ASO results. However, additional long-term studies that include more patients are mandatory.