The Future of Transcatheter Closure of Patent Ductus Arteriosus: Long-Term Study of 368 Procedures

Abstract

Gross and Hubbard performed the first successful surgical closure of patent ductus arteriosus (PDA) in 1938. In 1967, Porstmann pioneered nonsurgical catheter closure of the ductus. Rashkind developed a new collapsible umbrella for this purpose in 1979. Since then, the devices used experimentally in animals and, rarely, in humans for transcatheter closure of PDA have been an occluder-counter-occluder buttoned device, by Sideris; a double-balloon detachable silicone device, by Warnecke; a nylon sack filled with silicone coated guidewires, by Magal; occluding spring coils, by Gianturco; and a shape-memory polymer, polynorbornene, by Echigo. The most long-term experience worldwide has been with a double-disk Rashkind umbrella device. We attempted PDA closure in 368 infants, children, and young adults between December 1987 and November 1993. The male-to-female ratio was 1:2.4; patient age ranged from 11 months to 45 years (median age, 5 years) and 56 patients were less than 2 years old; patient weight was 7.4 to 69 kg (mean, 18.2 ± 9.5). Successful device implantation was achieved in 98% of cases (358/368); 10 technical failures occurred. Complications included 8 embolizations to a pulmonary artery, 3 self-limited episodes of hemolysis, and 2 episodes of induced supraventricular tachy-cardia. The device was retrieved by grabber in 4 patients and by surgery in 4 patients. Follow-up included echocardiography and Doppler studies with color flow mapping. At 6 months follow-up, 23% of the patients (72/319) had a small residual shunt. The incidence was 17% (46/276) in ductus with the narrowest diameter less than 6 mm and 60% (26/43) in ductus greater than 6 mm in diameter. Successful implantation of a second occluder device was achieved in 49 patients. A third device was implanted in 2 patients who had a residual shunt with a continuous murmur at 7 months follow-up. Overall, closure occured in 90% of patients seen 6 months after initial or repeated implantation. One patient developed bacterial endarteritis and septicemia 2.5 years after deployment of a second device and died of this complication. Follow-up ranged from 9 to 75 months with a mean of 48 months with no complications. This study confirms the efficacy of PDA closure with a Rashkind occluder, especially in patients with ductal diameter of less than 6 mm. Catheter closure with the Rashkind umbrella device is a viable alternative to surgical closure of PDA in selected infants, children, and young adults.