As follow-up to the U.S. Food and Drug Administration's (FDA's) Circulatory System Devices Panel meeting last year, a white paper published May 20 in JACC: Cardiovascular Interventions  looks at the current safety and efficacy of atrial septal defect (ASD) devices, including cardiac perforation or erosion, and proposes using the NCDR's IMPACT Registry® for more comprehensive post-market evaluation and monitoring of devices.

Additional Resources Read White Paper ACC Comments on Safety of Atrial Septal Defect Occlusion Devices IMPACT Registry® ACC's Adult Congenital and Pediatric Cardiology Member Section Results of the U.S. Multicenter Pivotal Study of the HELEX Septal Occluder for Percutaneous Closure of Secundum Atrial Septal Defects Comparison Between Transcatheter and Surgical Closure of Secundum Atrial Septal Defect in Children and Adults CardioSmart for Your Patients: About Congenital Heart Defects

To date, the Amplatzer septal occluder (ASO), approved in 2001, and the Helex septal occluder (HSO), approved in 2006, are the only devices approved by the FDA for transcatheter device closure of ASD. According to the white paper authors, post-market approval studies and reports on the ASO and HSO devices have confirmed the safety profiles suggested by their pivotal studies, and "overall risk imposed by device closure of ASD compares favorably with the risk of surgical closure." However, erosion of the ASO device was recently flagged as a fatal complication by the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, a complication that was not encountered during the pivotal study presumably due to the smaller size of the study population. "This event, though rare, is particularly troublesome because it may occur late after device implantation and because it may be catastrophic," the white paper authors note.

In light of the insufficient evidence and lack of consensus around how or if to change clinical practice or labeling of ACS occlusion devices, the FDA's Circulatory System Devices Panel hosted a hearing last year focused on the need to further define the risk factors and incidence of erosion by the ASO. The ACC provided both a written statement and oral testimony  as part of the hearing. Coming out of the hearing, the FDA panel noted that additional clinical trials are unlikely to better define the incidence of erosion. Instead, panel members recommended a case-cohort study design focused on identifying critical risk factors.

According to the white paper authors, the FDA panel's recommendation "has merit only if the cases identified for study have high quality, comprehensive, and longitudinal clinical data and imaging available." According to the authors, the NCDR's IMPACT Registry given its size and sophistication is one tool that might be suitable for this task. The authors note that the number of centers enrolled in IMPACT is growing steadily, with the goal of enrolling the majority of the 200 centers in the U.S. by the end of 2013. While current IMPACT Registry data elements for the ASD occlusion are not sufficient the provide additional information about risk factors, the authors suggest the overarching goal of the Registry to develop longitudinal modules to study longer-term outcomes for select information "is perfectly aligned with the FDA panel recommendations."

Keywords: Incidence, Follow-Up Studies, United States Food and Drug Administration, Heart Septal Defects, Atrial, Risk Factors, Septal Occluder Device

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