Catheter closure of moderate- to large-sized patent ductus arteriosus using the new Amplatzer duct occluder: Immediate and short-term results

Objectives. The aim of this study was to assess the immediate and short term results of anterograde catheter closure of a moderate-to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder (ADO) device. Background. Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts. Methods. Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7 +/- 1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure. Results. Twenty three of the 24 patients had successful device placement, Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients, The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day, There were no complications, Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure. Conclusions. Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm, Further clinical trials are underway, (C) 1998 by the American College of Cardiology.