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.