Multicenter USA Amplatzer patent ductus arteriosus occlusion device trial: initial and one-year results.

OBJECTIVES

We sought to review and report initial and one-year efficacy and safety results of the multicenter USA Amplatzer ductal occluder (ADO) device trial.

BACKGROUND

Transcatheter closure of a moderate to large patent ductus arteriosus (PDA) using conventional techniques is challenging. The ADO can close a PDA up to 12 mm in diameter.

METHODS

From September 1999 to June 2002, 484 patients were enrolled in 25 U.S. centers. Forty-five (9%) of 484 patients did not have ADO implantation, because the PDA was too small or because of elevated pulmonary resistance. The median age of the patients at catheterization was 1.8 years (range 0.2 to 70.7 years), and weight was 11 kg (range 4.5 to 164.5 kg).

RESULTS

The median PDA minimal diameter was 2.6 mm (range 0.9 to 11.2 mm); 76 (17%) of 439 were larger than 4.0 mm. Median pulmonary artery mean pressure was 20 mm Hg (range 7 to 80 mm Hg). The ADO was implanted successfully in 435 (99%) of 439 patients, with a median fluoroscopy time of 7.1 min (range 2.9 to 138.4 min). Angiographic demonstration of occlusion was seen in 329 (76%) of 435. This increased to 384 (89%) of 433 on post-catheterization day 1, with occlusion documented in 359 (99.7%) of 360 at one year. At the last evaluation in all patients at any time, PDA closure was documented in 428 (98%) of 435 patients. There have been two cases of partial left pulmonary artery occlusion after ADO implantation and no cases of significant aortic obstruction.

CONCLUSIONS

Moderate to large PDAs can be effectively and safely closed using the ADO device, with excellent initial and one-year results. This device should obviate the need for multiple coils or surgical intervention for these defects.