First experiences with the GORE(®) Septal Occluder in children and adults with atrial septal defects.

OBJECTIVES

In this study, we report the first experiences with the GORE(®) Septal Occluder in transcatheter treatment of patients with atrial septal defects (ASD).

METHODS

Twenty-two patients with secundum ASD were selected for GORE(®) Septal Occluder device closure. Mean age was 25.8 ± 4.6 years (range 4-60), 10 were children below the age of 15. Closure was guided by transeosophageal or intracardiac echocardiography and transthoracic echocardiography was used at follow-up (median time 3 months). All defects were balloon sized and device size was chosen according to an occluder/defect size ratio ≥2.

RESULTS

The mean ASD size was 11.4 ± 0.5 mm (range 6-15). All GORE(®) Septal Occluder sizes (15, 20, 25 and 30 mm) were used. Six patients had additional defects. The aortic rim was deficient in twelve patients and four patients had a septal aneurysm. Symptoms were seen in 17 patients and 19 had dilated right ventricles. Implantation was successful in all patients with no complications. Delivery was easy and intuitive by the new delivery system. None of the patients had residual shunts at follow-up. Mean procedure time was 38 ± 5 min (range 20-120). All patients had resolution or improvement in symptoms. There were no new onset arrhythmias or AV valve regurgitation and right ventricular dimensions were normalized.

CONCLUSIONS

The GORE(®) Septal Occluder is an efficient device for closing ASDs up to 15 mm. It is feasible for defects with different anatomy including a deficient aortic rim, septal aneurysm and multiple fenestrations and due to its compliance and conformability it has a presumed low risk of erosion.