Expanded ICD registry corrects previous limitations, offers data on leads
The annual report announces Version 2.0 of the National ICD Registry, an expanded and improved database available in the second quarter of 2010. The new registry will correct limitations from earlier reported data by eliminating confusing data elements and including lead data and information pertaining to pediatric ICD procedures.
The revised registry will include new data on atrial, ventricular, defibrillation, left heart and epicardial leads placed at the time of ICD implant and whenever existing leads are repositioned, replaced, extracted or abandoned. The information will assist the FDA with surveillance of lead performance, according to the authors.
As of June, the registry has collected data from more than 380,000 implants in the U.S., a rate of 10,000 ICD implants per month, with 88 percent of implants in the registry being performed in hospitals that enter all patients regardless of device indication or patient age. The data included in the registry represents more than 90 percent of all ICDs implanted in the U.S. from 1,432 participating hospitals and 4,563 implanting physicians.
The data collected is used in reports that allow hospitals to compare their data with similar hospitals – based on procedure volume – and against the national aggregate. These reports are designed to improve patient care, detect inefficiencies, increase resource utilization and provide information needed for hospital quality assessment and improvement.
Key findings from the ICD Registry Annual Report include:
- Devices were placed for primary prevention in 78 percent of patients, two-thirds with coronary artery disease;
- Total complications for new implants have decreased over time from 3.78 percent in 2006 to 3 percent in 2008;
- Among physicians that provided information about their training, 57 percent completed an electrophysiology fellowship, accounting for 83 percent of ICD implants;
- Of patients receiving an ICD for primary prevention of sudden death, 79 percent were shown to meet published national guideline;
- Of patients receiving cardiac resynchronization therapy with defibrillation (CRT-D), 70 percent met published guideline; and
- Medicare beneficiaries accounted for 68 percent of patients in the registry.