Atrial septal occluders (AGA and NMT devices) showed erosion/perforation rates of 0.3% and 0.05%, respectively, though MAUDE data suggests higher major complication rates than published literature.
What are the major complications associated with transcatheter atrial septal occluder implantation in patients receiving percutaneous closure of atrial septal communications?
Postmarketing surveillance via the MAUDE database reveals a higher estimated major complication rate for atrial septal occluders than reported in the medical literature, highlighting the importance of vigilant postmarketing reporting.
OBJECTIVE: To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. DESIGN: The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. OUTCOME: The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.
Delaney et al. (Sun,) conducted a review in Atrial septal communications. Transcatheter atrial septal occluder implantation was evaluated on Major complications. Atrial septal occluders (AGA and NMT devices) showed erosion/perforation rates of 0.3% and 0.05%, respectively, though MAUDE data suggests higher major complication rates than published literature.