Mid-term results of Solysafe® septal occluder for percutaneous closure of secundum atrial septal defects.

ABSTRACT

BACKGROUND: In this article, we report mid-term follow-up results of the Solysafe® septal occluder for percutaneous closure of secundum atrial septal defects. METHODS: A total of 25 patients (8 males, 17 females; mean age 8.4±3.6 years; range 5 to 12 years) who underwent percutaneous closure of secundum atrial septal defect between July 2008 and June 2010 were included in this study. RESULTS: The mean follow-up was 6.1±0.5 (range, 5.2 to 7.2) years. The device was successfully implanted in 22 of 25 patients. The mean stretched diameter of the atrial septal defect as assessed by balloon sizing was 13.6±4.4 (range, 8 to 26) mm. Nine 15-mm devices, eight 20-mm devices, six 25-mm devices, and two 35-mm devices were used. A 20-mm and two 35-mm devices were used in three patients and the procedure failed in these patients. Among the remaining 22 patients, no pericardial effusion, endocarditis, hemolysis, electrocardiographic changes, valvular problems, or suspicious echocardiographic findings were observed during or after the procedure. Only in one patient, a wire fraction was seen at six years, while another patient had a residual shunt during a six-year follow-up. Device embolization (n=1) and hemiparesis (n=1) were the early major complications related to the procedure. CONCLUSION: Although percutaneous closure of secundum atrial septal defects is successful, it would be wiser to check the device regularly, at least once a year, as the manufacturing of the device has been discontinued due to wire fractions.