July 2nd, 2012
Eroding Confidence in ASD Occlusion Devices
The FDA has identified more than 100 cases of cardiac erosion following atrial septal defect occlusion (ASO) device implantation. All were associated with implantation of the AMPLATZER (AGA Medical/St. Jude Medical) or related cribriform ASO devices; none have been reported thus far with the GORE HELEX (Gore Medical) ASO device.
Although the estimated occurrence of cardiac erosion is 0.1% to 0.3%, the precise incidence is unknown, because ASO manufacturers aren’t required to register or report device implantations, and the reporting of device-associated complications in the FDA Manufacturer and User Facility Device Experience (MAUDE) database is sporadic.
Cardiac erosion has been observed as early as within 24 hours of device implantation and as late as 8.6 years after implantation, with ≈50% occurring in the first week, 61% in the first month, and 87% in the first year after device placement. The erosions typically occur at the domes of the atria near the aortic root and cause immediate hemodynamic compromise due to pericardial effusion, tamponade, or both; patients typically present with pericarditis, hypotension, or even sudden death. Occasionally, the process is chronic; fibrosis develops as erosion progresses, and an atrial-to-aortic fistula develops. These individuals typically present with heart failure or a new-onset murmur. Regardless of the manner of presentation, prompt recognition and surgical intervention are indicated.
Except for ASO device type, the risk factors that predispose to device-related erosions are unknown. A deficient anterosuperior atrial rim (<5 mm) seems to be a risk factor, but the FDA Circulatory Device Advisory Panel determined that the data supporting this association were inconclusive and made the uncharacteristic recommendation that St. Jude remove deficient anterosuperior rim — which occurs in ≈40% of patients with a secundum ASD — as a contraindication to ASO device closure.
Limitations in our understanding of this life-threatening complication highlight the fact that a device registry is needed. In the meantime, patients considering ASO device implantation should be informed of this potential complication and its symptoms, so they can decide whether to proceed with percutaneous ASD closure or, alternatively, to undergo surgical repair.
Will these reports of cardiac erosions following ASD occlusion device implantation affect your recommendations regarding their use?