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Multicenter USA Amplatzer patent ductus arteriosus occlusion device trial: initial and one-year results
Robert H Pass1, Ziyad Hijazi, Daphne T Hsu
1Department of Pediatrics, Children's Hospital of New York, Presbyterian Hospital, Columbia University, New York, New York 10032, USA. Pediheart@aol.com
Insights
The Amplatzer ductal occluder (ADO) device safely and effectively closes moderate to large patent ductus arteriosus (PDA) in patients. Initial and one-year follow-up show excellent closure rates, reducing the need for coils or surgery.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pediatric Cardiology
Background:
- Transcatheter closure of moderate to large patent ductus arteriosus (PDA) presents challenges with conventional methods.
- The Amplatzer ductal occluder (ADO) is designed to close PDAs up to 12 mm in diameter.
Purpose of the Study:
- To evaluate the initial and one-year efficacy and safety of the Amplatzer ductal occluder (ADO) device in a multicenter trial.
- To assess the device's performance in closing moderate to large PDAs.
Main Methods:
- A multicenter trial involving 484 patients enrolled between September 1999 and June 2002.
- ADO device implantation was attempted in 439 patients; 45 were excluded due to PDA size or pulmonary resistance.
- Data collected included patient demographics, PDA size, pulmonary artery pressure, and procedural outcomes.
Main Results:
- Successful ADO implantation in 99% (435/439) of eligible patients.
- High occlusion rates: 76% initially, 89% by post-catheterization day 1, and 99.7% at one year.
- Overall PDA closure documented in 98% of patients, with minimal complications such as partial pulmonary artery occlusion (2 cases).
Conclusions:
- The ADO device provides effective and safe closure for moderate to large PDAs.
- Excellent initial and one-year outcomes support the ADO as a primary treatment option.
- The ADO device may eliminate the need for multiple coils or surgical intervention for PDA closure.
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.
