TRANSCATHETER CLOSURE OF ATRIAL SEPTAL-DEFECT BY BUTTONED DEVICES

During a 21-month period ending in August 1991, 12 patients underwent transcatheter closure of atrial septal defect (ASD) with a "buttoned" device through an 8Fr sheath, using an institutional review board-approved, custom-made device protocol initially, and Food and Drug Administration-approved clinical trials subsequently. Ten children had left-to-right shunts across the ASD and 2 adults had their patent foramen ovale closed to prevent recurrent paradoxical embolism (including cerebrovascular accidents). The device dislodged in 1 of the 4 patients in whom a first-generation device was used, and retrieval of the device, and surgical closure of the ASD were performed without incident. In the remaining 11 patients (age range 7 months to 45 years, weight 3.6 to 64 kg), the device remained intact, and pulmonary-to-systemic flow ratio decreased from 2.1 +/- 0.3 to 1.04 +/- 0.06. Follow-up chest x-ray and echo-Doppler studies were available in all patients 0.5 to 18 months after the procedure. The device was intact in all patients. Small residual shunt detected by color Doppler was seen in 2 children. Right ventricular size decreased (23 +/- 6 to 17 +/- 3 mm; p < 0.01), and paradoxical septal motion disappeared in all patients. There was no recurrence of paradoxical embolism in the 2 adults. No complications occurred during follow-up. It is concluded that transcatheter closure of ASD with the buttoned device is feasible, effective and safe, and can be accomplished with small, 8Fr sheaths (even in infants weighing 3.6 kg), follow-up results are excellent, and clinical trials on a larger number of patients are needed.