783-4 Follow-up Results of Transvenous Occlusion of Patent Ductus Arteriosus with the Adjustable Buttoned Device

Abstract

During a 4-year period ending July 1994, 81 patients underwenttranscatheter occlusion of patent ductus arteriosus (PDA) with the adjustable buttoned device at 22 institutions around the world under an IRB-approved custom-made device protocol. The device is a modified version of the Sideris’ buttoned device for atrial septal defect closure. The patients were 11 mo to 65 years (median. 7.0 years) with weight range of 7.2 to 90 kg (median. 19 kg) The PDAs measured 1 to 15 mm (median, 4 mm) at the narrowest diameter; fifteen were larger than 8 mm and three larger than 10 mm with a Qp:Qs range of 1.3 to 3.2. They were occluded with devices measuring 15 to 35 mm; all but 10 were delivered via #7-French sheaths. Ten devices ≥ 25 mm were delivered to the implantation site via #8-French sheaths. 78 of 81 (96%) were implanted at first attempt. In all three with device dislodgment, the device was retrieved via the sheath and two of these underwent PDA occlusion with larger devices and third patient had elective surgical closure of PDA. Small residual shunts detected by color Doppler were present in 31 (39%) patients. Forty-one patients were followed for 1 to 24 months (8 ± 7 mo) with clinical, chest x-ray and echo-Doppler evaluation. None required repeat intervention. The device was found intact on chest x-ray and echo. No evidence for thromboembolism, endocarditis or hemolysis was found nor was there evidence for descending aortic or left pulmonary artery obstruction. Percent incidence of residual shunt by color Doppler gradually decreased and was 39,21.15.13 and 0% respectively at 1 day. 1.6,12 and 24 months following device implantation. Based on these data it is concluded that 1) transvenous occlusion of PDA is feasible, effective and safe, 2) small-sized sheaths (7-French in most, 8French in some) are adequate for all ductus sizes, 3) all types of PDAs (conical, tubular and short) and both long and short PDAs can be occluded because of the adjustable button loop design of the device. 4) further improvementlminiaturization may eventually result in extending the procedure to neonates and premature infants.