Transvenous closure of patent ductus arteriosus with Ivalon plugs. Multicenter experience with a new technique.

Rationale and Objective: The authors assess the clinical efficacy of transvenous closure of patent ductus arteriosus (PDA) with a new plug consisting of Ivalon foam and a platinum/iridium frame with four aortic and two pulmonary nitinol struts. The most widely used devices for transcatheter treatment of PDA (Porstmann plug, Rashkind umbrella, Botallo occluder, coils) have specific limitations inherent to their design (e.g., transarterial approach, residual shunts, limited retrieval).
Methods: Between 1994 and 1997, PDA closure was attempted in 33 children and 67 adolescents and adults in 7 clinical centers; PDA diameter was 2 to 11 mm. Plug diameter was 6 to 20 mm, and 8 to 16 F venous sheaths were used for insertion.
Results: Placement was successful in 98% (with a single plug in 88%, and a second or third plug in 10%) and unsuccessful in 2%. Plugs were retrieved after malpositioning in 12 of 12 patients and after pulmonary embolization in 2 of 3 patients. One patient underwent surgery for removal of an embolized plug. Complete PDA closure was proved by aortography and color Doppler echocardiography in 85% (40 of 43 patients with a PDA 2-3.9 mm, 30 of 36 patients with a PDA 4-5.9 mm, and 15 of 21 patients with a PDA 6-11 mm). During a median follow-up interval of 16 months, there were no complications (infection, hemolysis, fracture, embolization).
Conclusion: The new plug device can be used successfully in patients with a PDA diameter up to 11 mm. Further investigations are underway to determine the definite clinical value of this technique.