Atrial septal defect and patent foramen ovale closure- complication profile of approved Gore Occluders.

Background: Patent foramen ovale and atrial septal defect are among the most common congenital heart diseases. When they are symptomatic, either pharmacologic or percutaneous/surgical treatment should be considered. The aim of this study was to investigate the post-approval complication profiles of the Gore Cardioform and Gore Helex devices based on the Manufacturer and User Facility Device Experience database.

Methods: A search of the Manufacturer and User Facility Device Experience Database was performed to identify reports of complications following the closure of atrial septal defects with Gore devices. 401 reports met inclusion criteria, including 204 patients with Gore Cardioform Septal Occluder, 146 patients with Gore Cardioform ASD Occluder, and 51 patients with Gore Helex Septal Occluder.

Results: The number of adverse events related to device problems contributed to 51.4 % of reported complications (n = 206), which mostly consisted of embolism of the device (n = 140). There were 3 reported cases of death, with 2 linked to device embolization. Most reports concerned devices sized 25 and 30 mm although only 313 reports (78.1 %) had information about size available. 54 cases of pericardial effusion and 14 cases of perforation were reported. Multiple postoperative arrhythmias were reported (n = 80), with the majority of them being atrial fibrillation (n = 39) or heart block (n = 18).

Conclusions: No cardiac erosions linked to Gore devices were found throughout our analysis, supporting earlier literature findings. The investigated devices and their sizes varied in terms of complication profiles.