The ACC provided testimony, as well as a written statement, on the safety of atrial septal defect (ASD) closure devices before a Food and Drug Administration (FDA) Circulatory Systems Devices panel meeting on May 24. Atrial septal defects, while recognized as a relatively benign form of cardiac disease, can eventually contribute to significant morbidity and mortality if left untreated. Currently, ASD represents approximately 10 percent of congenital heart defects.
During the testimony, ACC representative John Moore, MD, FACC, a member of the IMPACT Registry™ Steering Committee, urged the FDA to consider two primary recommendations:
- That the FDA require that a prospective study of potential risk factors for erosion in relation to the implantation of ASD occlusion devices, and that the NCDR® provide the infrastructure for that study.
- That the FDA fund a registry study to assess adverse events in patients with implanted devices after discharge to better ascertain if and when problems occur that may not have been identified in the initial studies and what the risk factors for such problems may be.
"The ACC believes that there is insufficient data and no consensus as to whether or how to change clinical practice or alter labeling of ASD occlusion devices," he said. "Given the lack of available data pertaining to the potential risk factors for erosion and frequency of adverse events in patients with ASD occlusion devices, these two recommendations are necessary."
Other stakeholders that presented included representatives from The Society of Thoracic Surgeons, the American Association for Thoracic Surgery and the American Heart Association. Representatives from the two companies that manufacture ASD occlusion devices also presented their analyses of potential safety events.
The panel, chaired by Clyde Yancy, MD, FACC, debated a number of potential recommendations to make to the FDA, emphasizing changes to the device label and prospective studies using registries versus a case cohort.