Closure of defects of the atrial septum in adults using the amplatzer device:100 consecutive patients in a single center

BACKGROUND: Transcatheter device closure of atrial septal defects (ASD) is an alternative to surgery, but experience is limited in adults, especially in those with large (> 26 mm) defects. HYPOTHESIS: We investigated the safety, efficacy, and learning curve for closure of ASD and patent foramen ovale (PFO) using the Amplatzer device. METHODS: In all, 101 procedures were carried out in 100 consecutive adult patients in a single cardiac center between July 1998 and August 2002. RESULTS: Preprocedure diagnosis was ASD and PFO in 50 patients each. A device was deployed in 94 of 101 attempts (93%) in 94 of 100 patients (94%). Atrial septal defect device sizes were 10-38 mm, median 24 mm, and 40% were > 26 mm. Major complications occurred in 2 of 100 patients (2%). One ASD device displaced requiring surgery within 24 h and one patient with PFO experienced pericardial tamponade; there were no deaths. Local vascular complications occurred in 4 of 100 (4%) and late complications in 4 of 100 (4%) patients. Patent foramen ovale closure was quicker (p<0.001), required less radiation (p=0.04), and was associated with fewer local vascular complications than ASD closure (p=0.04). Deployment of ASD devices > 26 mm was not associated with increased complications, length of procedure, or radiation compared with devices < or = 26 mm (all p>0.05). Complications in the first 35 patients were more frequent than in subsequent patients: 7 of 35 (20%) versus 3 of 65 (4.6%) (p=0.04); procedure and fluoroscopy times (both p<0.001) and radiation doses (p=0.001) were also higher. CONCLUSION: The Amplatzer device is an effective method for transcatheter closure of interatrial defects in adults, including large ASDs up to 38 mm. Major complications are uncommon. A learning curve of approximately 35 cases was suggested by the decline of complications, procedure times, and radiation exposure.