AIMS: Transcatheter closure of the secundum-type atrial septal defect (ASD) is widely practised. We report complications and efficacy of percutaneous ASD closure in adults using the Amplatzer ASD occluder and the Cardioseal/Starflex device during long-term follow-up. METHODS AND RESULTS: Between 1996 and 2008 percutaneous ASD closure was performed in 133 patients (mean age 46.8 ± 16.9 years; 36 men) by using the Amplatzer(r) device in 104 patients and the Cardioseal/Starflex device in 29. During a mean follow-up of 3.4 ± 2.8 years the occurrence of major complications was higher in patients with the Cardioseal/Starflex compared to patients with the Amplatzer(r) devices (17.2 vs. 2.9%, log rank, P=0.005), due to a higher embolisation rate (13.8 vs. 1.0%, log rank, P=0.002). In univariable analysis, the implantation of a Cardioseal/Starflex device (OR 6.0 (CI 1.4-25.2); P=0.01) and a larger device diameter (OR 1.1 (CI 1.0-1.2); P=0.04) were found to be predictors of the occurrence of major complications. Minor complications occurred in 10.5%, recurrent thrombo-embolism in 2.3% and residual shunting at six months was 13.9% without differences between devices. NYHA class improved from 1.8 ± 0.6 before to 1.2 ± 0.4 after closure (P<0.001) without differences between devices. CONCLUSIONS: During long-term follow-up, percutaneous ASD closure in adults is safe and effective when using the Amplatzer(r) device. Larger Cardioseal/Starflex devices are related to a higher embolisation rate. Randomised trials are needed.
AIMS: Transcatheter closure of the secundum-type atrial septal defect (ASD) is widely practised. We report complications and efficacy of percutaneous ASD closure in adults using the Amplatzer ASD occluder and the Cardioseal/Starflex device during long-term follow-up. METHODS AND RESULTS: Between 1996 and 2008 percutaneous ASD closure was performed in 133 patients (mean age 46.8 ± 16.9 years; 36 men) by using the Amplatzer(r) device in 104 patients and the Cardioseal/Starflex device in 29. During a mean follow-up of 3.4 ± 2.8 years the occurrence of major complications was higher in patients with the Cardioseal/Starflex compared to patients with the Amplatzer(r) devices (17.2 vs. 2.9%, log rank, P=0.005), due to a higher embolisation rate (13.8 vs. 1.0%, log rank, P=0.002). In univariable analysis, the implantation of a Cardioseal/Starflex device (OR 6.0 (CI 1.4-25.2); P=0.01) and a larger device diameter (OR 1.1 (CI 1.0-1.2); P=0.04) were found to be predictors of the occurrence of major complications. Minor complications occurred in 10.5%, recurrent thrombo-embolism in 2.3% and residual shunting at six months was 13.9% without differences between devices. NYHA class improved from 1.8 ± 0.6 before to 1.2 ± 0.4 after closure (P<0.001) without differences between devices. CONCLUSIONS: During long-term follow-up, percutaneous ASD closure in adults is safe and effective when using the Amplatzer(r) device. Larger Cardioseal/Starflex devices are related to a higher embolisation rate. Randomised trials are needed.