WASHINGTON, DC — The ICD Registry™, a repository of ICD implantation data developed through a partnership of the Heart Rhythm Society and the American College of Cardiology Foundation, has released the ICD Registry Annual Report 2008. This is the third annual review of the Registry and is published in the September edition of the HeartRhythm Journal , the official journal of the Heart Rhythm Society.
The annual report announces Version 2.0 of the 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. This information will assist the U.S. Food and Drug Administration with surveillance of lead performance.
As of June 2009 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 information 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.
Key Findings from the ICD Registry Annual Report:
The information 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.
- 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 3.01 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 guidelines.
- Of patients receiving cardiac resynchronization therapy with defibrillation backup (CRT-D), 70 percent met published guidelines. Medicare beneficiaries accounted for 68 percent of patients in the Registry.
“The ICD Registry is vital in the ongoing assessment of ICD therapy and offers hospitals and physicians a tool to track and evaluate implant performance and better care for ICD patients,” said Richard L. Page, MD, FHRS, president of the Heart Rhythm Society. “As the Registry continues to grow and more data becomes available, analysis will provide a more accurate depiction of ICD therapy outcomes as well as overall physician performance.”