Transcatheter occlusion of persistent arterial duct. Report of The European Registry.

Rashkind's "double umbrella" technique for percutaneous transcatheter occlusion of patent arterial duct (ductus arteriosus) has been used successfully in several centres. To assess its feasibility, safety, and efficacy in routine clinical practice, a European registry was established. In 642 of 686 patients entered into the study, the device was successfully implanted at the first attempt, and in a further 9 at a subsequent attempt. 491 patients (71% of all patients entered) had doppler-echocardiographic evidence of complete occlusion with a single device at the latest follow-up. Kaplan-Meier survival estimates indicated a complete occlusion rate of 82.5% (95% Cl 79.4 to 85.8) at one year after implantation of a single device. A second device was implanted in 41 patients with residual flow, and 37 of these had complete occlusion, giving an overall latest follow-up occlusion rate of 77% and an actuarial complete occlusion rate for one or two devices of 94.8% (95% Cl 92.9 to 96.7) at 30 months after implantation of the first device. 2 early deaths occurred (0.3%), both in patients with associated ventricular septal defect. Complications included embolisation of the device in 18 patients (2.4%), of whom 6 underwent catheter-retrieval of the device. Mechanical haemolysis occurred in a further 4 patients (0.5%). Transcatheter occlusion of the arterial duct is a safe and effective alternative to surgical closure. A second device is sometimes needed to achieve complete occlusion.