Pediatric Cardiovascular Device Registries—The Need for Such Data And The Potential Impact

Abstract

The use of devices to treat disorders and diseases affecting pediatric patients has increased significantly since the 1980s, particularly in the field of pediatric cardiology where interventional procedures have become viable alternatives to open heart surgery for many conditions [1, 2]. Yet as the treatment of congenital heart disease (CHD) with cardiac catheterization and device placement has evolved, there remains a lack of devices on the market that are designed for, studied in, and specifically labeled for pediatric patients and evidence-based data to guide decision making in treating these patients remains scarce. Treatment strategies instead are derived largely from expert opinion— which may not be consistent across locales or widely accessible—and off-label use is not uncommon [3]. With the emphasis on evidence-based practice in medicine today, it is important that pediatrics not be left behind. If the present situation is to change, and the quality and consistency of information about catheter-based device treatment for pediatric cardiology patients is to improve, a method of collecting, analyzing, and widely distributing procedural data becomes essential. The development of more comprehensive pediatric device registries would thus seem a critical part of the progression and of utmost importance to the public health. Registries provide opportunities to collect data from a broader population of patients and physicians than current surveillance mechanisms and could be used to monitor actual practices and practice bias for both onand off-label use of devices used in children—better defining the current clinical landscape so that unmet needs and supportive regulatory initiatives can be more easily and quickly identified. Also, collection of long-term, longitudinal data on significant events, functionality, and quality of care that are so essential to optimizing pediatric care could be attained. The limited numbers of patients with any given congenital cardiac anomaly, and the heterogeneous subpopulations, makes pediatric cardiology an especially challenging area to obtain valid and generalizable data. Thus, it is one in which high-quality registry data would be particularly suitable.