The NCDR® ICD Registry™ Version 2.0: Update and Inclusion of Pediatric ICDs and Implanted Leads

In this article, the authors discuss the new ICD Registry Version 2.0 launch on April 1, 2010. In January 2005 the Centers for Medicare and Medicaid Services (CMS) expanded the covered indications for primary prevention implantable cardioverter defibrillators (ICDs) to incorporate the findings from the recently published Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). As part of this expansion, CMS mandated that a national registry be formed to compile data on Medicare patients implanted with primary prevention ICDs to confirm the appropriateness of ICD utilization in this patient population. Responding to this mandate, a collaborative effort of the Heart Rhythm Society (HRS) and the American College of Cardiology Foundation (ACCF), utilizing the expertise of the National Cardiovascular Data Registry (NCDR®), developed Version 1 of the ICD Registry™. CMS selected the NCDR ICD Registry as the mandated national registry in October 2005 and enrollment opened on January 1, 2006. In April 2006, QNet (the temporary repository that had been accruing data since the initial ruling) was closed and the NCDR’s ICD Registry became the sole repository of ICD implant data on Medicare recipients. The initial registry design, Version 1, contains 159 data elements and is heavily focused on the patient and the procedure. Data is submitted by centers on a quarterly basis and must pass a data quality report (DQR) to ensure accuracy and completeness to be entered into the database. An on-site audit of a sample of records from randomly selected hospitals is also performed to ensure accuracy. As of February 2010, Version 1 of the ICD Registry has accrued about 470,000 records and is adding about 10,000 implants a month. About 77% of the 1,500+ centers implanting ICDs in the U.S. have chosen to enroll all of their ICD implants (Premier Centers), not just Medicare primary prevention cases (CMS Limited Centers). The Premier Centers enroll about 91% of the total number of implants tracked by the registry (Table 1); thus, the data set is broad-based and representative of the larger clinical spectrum of ICD implants beyond just primary prevention in older patients. As such, it provides insights into this clinical arena that were previously impossible. The ICD patient population thus far entered into the data set has a mean age of 68. Three out of four recipients are men, 5 out of 6 are Caucasian, and 2 out of 3 have coronary heart disease. The implants are for primary prevention in over 75%. ICDs are single chamber in about 20%, dual chamber in 40%, and 40% are cardiac resynchronization therapy (CRT) devices (Table 1). About 25% of the devices are replacements. This rich data set has served as the basis for several important abstracts and manuscripts about ICD implants, including the impact of gender on ICD utilization and outcomes,1 and the role of physician training on appropriateness of device use and complications of implants.2 The data collection also fosters utilization of the registry as a quality tool for benchmarking outcomes of hospitals and physicians on both a local and national basis.3 Participating institutions receive detailed quarterly reports on their data comparing it to the national data set, as well as comparable institutions based on implant volumes. These reports can highlight areas for improvements and promote constructive changes in the quality and cost of ICD implantation. Therefore, Version 1 of the ICD Registry has successfully fulfilled its initial mandate and its utility has extended beyond its inaugural vision. Nonetheless, it was recognized that there were omissions in the original data set that left some important information unavailable. The need for a second version was recognized early after release of Version 1. Development of Version 2.0 has been under way over the past 18 months to correct these oversights, clarify some data issues, and delete some rarely used data elements. In addition, the Pediatric and Congenital Electrophysiology Society (PACES) approached the registry with the request that the registry be expanded to include data elements specific to the pediatric population. The potential value of the registry as a powerful tool to track implanted lead technology was also recognized by the FDA. Thus, Version 2.0 also includes a new section on leads utilized in ICD systems. Pediatric ICD implantations are estimated to constitute