Utility of Expanding the ICD Registry Evaluated
The Gray Sheet reports some dispute, particularly among cardiologists, as to whether or not the ICD registry, the National Cardiovascular Data Registry, should be expanded. Use of the data collected therein was discussed at the recent annual meeting of the American College of Cardiology (ACC).
The registry was initially created to comply with requirements from the Centers for Medicare and Medicaid Services (CMS). The original mandate necessitated participation in the registry in order to be eligible for implantation of ICDs used for primary prevention.
It was originally created by the Heart Rhythm Society and the ACC in 2005. The registry actually collects a broader array of data than was initially required by CMS. Over 1,500 hospitals are actively participating in the registry. To date, information is included from over 250,000 patients.
Some clinicians, however, argued at the ACC meeting that this data will be utilized by CMS to limit the number of persons eligible to receive the implanted devices. They do not see benefits for either patients or clinicians. In addition, clinicians note that participation in the registry is time consuming for staff, who are not reimbursed for these efforts.
The clinicians argue that the system is not well-designed for scientific evaluation purposes, in part because the data is retrospectively entered. This creates challenges in determining the significance of adverse events that are noted. Complications are also introduced by the variability in data entry, as information is often completed by a variety of different healthcare workers.
Some suggest that the registry requires the introduction of efforts to assure data quality, including auditing. A program for auditing is planned, but will not commence for another two years.
Other clinicians note the potential benefits of the system. One distinct advantage is the ability to capture problems with devices sooner if, for example, there is an increase in the number of devices that are replaced. The registry could also serve as a tool to support post-marketing surveillance.
In fact, plans for a study are underway to use the registry to create a five year prospective registry. 3,500 patients will be recruited to participate from the practices of 350 physicians, who will be chosen randomly. This study will take at least eight years to complete full analysis of all the longitudinal data collected.
April 14, 2008 Related topics: Ethics & Scandals