Author + information
- Sanjeet Hegde, MD, PhD and
- John Moore, MD, MPH∗ ()
- ↵∗Rady Childrens Hospital, San Diego, Section of Pediatric Cardiology, University of California, San Diego, 3020 Children's Way MC 5004, San Diego, California 92123
We thank Dr. Santini and colleagues for their interest in our paper (1). Santini and colleagues discuss a hypothetical cause of erosion based on an anecdotal report stemming from 1 patient who had a device-related cardiac perforation following a period of intense isometric exercise. We did not reference the report by Santini et al. (2), but we acknowledge that a period of intense exercise could potentially bring about hemodynamic changes that may alter the relationship between the device and surrounding structures and, thereby, increase the risk for erosion. However, this hypothesis is based on a single case report. As alluded to in our review, erosions are rare, with the overall incidence of erosions ranging from 0.1% to 0.3% and with mortality from erosion being around 0.05%, which is lower than the overall surgical mortality of 0.13% (1). The causation of erosion, based on review of reports available, is still unclear, and we proposed a few possible risk factors for erosion in our paper. To further define individual risk factors for erosion with the Amplatzer septal occluder (St. Jude Medical, St. Paul, Minnesota), a very large, detailed, longitudinal dataset will be required. The IMPACT (Improving Pediatric and Adult Congenital Treatments) registry, although currently not suitable for longitudinal studies, could be adapted to evaluate device closures of atrial septal defect across nearly 100 centers in the United States and Canada (1). A similar registry would be needed to gather data on patients outside of the United States to further our understanding of this subject.
We need to gather more data before making any radical changes to current post–device-closure surveillance practices. The interim recommendations proposed by the U.S. Food and Drug Administration panel could be modified as more data becomes available to include recommendations such as stress echocardiography and restriction of physical activity, as proposed by Santini et al. (2). The rarity of the event, lack of adequate high-quality data, and the unpredictability of the timeline to erosion make it very difficult to propose definitive recommendations for now.
Please note: Dr. Moore was a proctor for Amplatzer devices until 2008. Dr. Hegde has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation