CATHETER CLOSURE OF MODERATE-SIZED TO LARGE-SIZED PATENT DUCTUS-ARTERIOSUS USING THE NEW AMPLATZER DUCT OCCLUDER - IMMEDIATE AND SHORT-TERMRESULTS

Objectives. The aim of this study was to assess the immediate and shor t term results of anterograde catheter closure of a moderate-to large- sized patent ductus arteriosus (PDA) using the new self-expandable, re spositionable Amplatzer duct occluder (ADO) device. Background. Transc atheter closure of a PDA using devices or coils is technically challen ging and may be accompanied by a 38% incidence of residual shunts. Met hods. Twenty-four patients (6 male, 18 female) underwent attempted tra nscatheter 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 l ong 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 (foami ng 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 a ll patients, The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 1 3.5 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%) wit h 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 t herapy for patients with a PDA diameter up to 6 mm, Further clinical t rials are underway, (C) 1998 by the American College of Cardiology.