There is a trend toward a decrease in complications for new implantable cardioverter-defibrillators (ICDs), and Medicare patients make up the vast majority of ICD recipients, based on the 2009 National ICD Registry Annual Report, published in this month’s Heart Rhythm Journal.
The National ICD Registry, a repository of ICD implantation data developed through a partnership of the Heart Rhythm Society (HRS) and the American College of Cardiology Foundation, is accruing ICD implants at the rate of 10,000 per month, with 79 percent of implants in the registry being performed in hospitals that enter all data on patients regardless of device indication or patient age. Thus, approximately 90 percent of all ICD implants performed in the U.S. are entered into the registry.
According to HRS, the collected data are used to determine best practices for ICD therapy in the general population, including gender differences in procedural-related adverse events, racial and ethnic differences in cardiac resynchronization therapy and the association of physician certifications and outcomes.
Based on the registry, which has collected data on 486,025 ICD implants from 2006 to 2009, the demographics of ICD recipients are mainly male (73.8 percent), approximately 68 years of age, Caucasian (82.8 percent), high rates of hypertension (75.3 percent) and relatively low rates of diabetes (36.7 percent).
Some key findings from the 2009 registry include:
- Total complications for new implants (including death in the laboratory) have decreased over time from 3.77 percent in 2006 to 2.87 percent in 2009.
- Medicare beneficiaries accounted for 67.7 percent of patients.
- The device was placed for primary prevention in 78 percent of patients, two-thirds with coronary artery disease, the average left ventricular ejection fraction was 29 percent, and 82 percent were NYHA Class II-III.
- Among 5,246 physicians who implanted ICDs between 2006 and 2009, only 438 physicians provided information about their training. Among those 438 physicians, 56 percent completed an electrophysiology fellowship, accounting for 83 percent of ICD implants.
- Of patients receiving cardiac resynchronization therapy with defibrillation, 68 percent were shown to meet published national guidelines.
- Of patients receiving an ICD for primary prevention of sudden death, 78 percent met published national guidelines.
“Gathering data for inclusion within the National ICD Registry is critical for us to better understand the application of ICD therapy and, more importantly, to improve patient care,” said Douglas L. Packer, MD, president of the HRS. “The ICD Registry is an extensive reporting measure that continues to evolve and enhance its data to offer physicians better insight into device procedures and offer rich data for continued and more effective research.”
As of December 2009, this fourth annual report includes data from 486,025 ICD implantations from 1,434 participating hospitals and 5,246 implanting physicians, representing an increase of participating hospitals and implanting physicians from the 2008 Annual Report.
In April, version 2.0 of the registry was initiated and began collecting data on leads associated with ICD implantation, and also pediatric ICD implants. The ICD Registry working group and the Pediatric and Congenital Electrophysiology Society (PACES) are collaborating to provide data on pediatric and congenital patients and clinical issues affecting pediatric patients receiving an ICD.
The registry also now includes 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 .