Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder

OBJECTIVE The aim of this study was to report further experience with trans catheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). BACKGROUND The design of previously used devices is not ideal for this purp ose, and their use has been associated with several drawbacks, especially i n large PDAs. METHODS Forty-three patients, aged 0.3 to 33 years (mean 6.4 +/- 6.7 years) , with a moderate to large, type A to E PDA, underwent attempted transcathe ter closure using the ADO. The device is a plug-shaped repositionable occlu der made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9 +/- 1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follo w-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter. RESULTS The mean ADO diameter was 6.1 +/- 1.4 mm (range 4 to 10 mm). Comple te angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial an giographic shunt through the ADO, At 24 h, color flow mapping revealed no s hunt in all patients. A 9F long sheath was required for repositioning of a misplaced X-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9 +/- 1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was no ted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered. CONCLUSIONS Transcatheter closure using the ADO is an effective and safe th erapy for the majority of patients with patency of the arterial duct. Furth er studies are required to establish long-term results in a larger patient population. (C) 2000 by the American College of Cardiology.