Abstract 17197: Closure of Multiple Atrial Septal Defects with the Helex Device

Abstract

Background: The performance of the Helex Septal Occluder (HSO) for closure of fenestrated atrial septum/multiple ASDs (mASDs) has not been evaluated. We sought to review our experience with closure of mASDs with the HSO. Methods: We identified 48 patients with mASDs who underwent percutaneous closure between 6/2001 and 5/2011. Number and size of ASDs, number of implanted HSOs, residual shunt, and complications were recorded. Results: Of 48 patients, 27 had defect closure with ≥ 1 HSO. Indication for closure was RV enlargement (RVE) in 24 (89%) and cryptogenic neurologic event in 3 (11%). Median age was 9.1 (1.9-66.2) years, median weight 30.7 (12.2-99.5) kg. Six patients (22%) weighed < 20 kg. Median number of ASDs was 2 (2-≥5). Median stop-flow diameter in 25/27 patients was 12 (6-24) mm. Two patients had multiple small defects that were not sized. One HSO was implanted in 21 patients (78%), and 2 HSOs in 6 patients (22%). Procedural complications included device embolization in 2 patients, and both were retrieved percutaneously with successful deployment of another HSO. Residual shunt immediately post-closure was absent in 5/27 (19%), trivial in 15/27 (55%), small in 6/27 (22%), and moderate in 1/27 (4%). The median length of follow-up was 2 (0-9) years. Residual shunt at last follow-up was absent in 13/27 (48%), trivial in 8/27 (30%), small in 5/27 (18%), and moderate in 1/27 (4%). No complication occurred during follow-up. Of the 24 patients with RVE before closure, 2 are recent without follow-up and 1 is lost to follow-up. RV size normalized in 20/21 (95%) patients. No patient with a prior neurological event had a recurrence. The patient with moderate residual shunt and RVE had 1 HSO, and placement of a second HSO is planned. Conclusions: We conclude that closure of mASDs with 1 or more HSOs is effective with a low complication rate. The complication observed, embolization, did not significantly affect outcome in this series, as percutaneous retrieval was successful. In addition, the low profile of the HSO may facilitate safe implantation of multiple devices in smaller patients.