National ICD Registry’s First-Year Data Show Few Complications, Not all Physicians Formally Trained
Comparative Data Expected To Improve Patient Care

FOR IMMEDIATE RELEASE
Contact: Ann-Marie White
Heart Rhythm Society
202-464-3476
awhite@hrsonline.org

While few complications were found last year with Implantable Cardioverter Defibrillators (ICDs), a number of implanting physicians had no formal training with the medical procedure, according to first-year data from the National ICD Registry published in the September 2007 edition of HeartRhythm, the official journal of the Heart Rhythm Society.

The registry, the nation’s first comprehensive database of detailed information about patients with the implantable medical devices, found that complications at the time of device implantation and prior to hospital discharge occurred at a 3.6 percent rate in the more than 108,000 ICD implantations at 1,117 hospitals. Adverse events included hematomas (1.2 percent), lead dislodgement (1.0 percent) and death (0.02 percent).

The first-year data also showed that 15 percent of the 3,249 physicians who implanted ICDs in 2006 had no formal training in device implantation. Formal training consists of the completion of an EP fellowship and CCEP boards, EP fellowship only, thoracic/cardiac surgery residency, pediatric EP fellowship, or Heart Rhythm Society clinical competency standards for ICD and CRT implantation. These physicians accounted for six percent of all implants captured by the registry last year.

“The good news from this year-one data is that, in general, physicians implanting these lifesaving devices are providing heart patients with reliable, high-quality care,” said Stephen Hammill, MD, FHRS, chair of the ICD Registry™ Steering Committee and past president of the Heart Rhythm Society. “But to continue to ensure patient safety, we need to make sure that specially trained physicians are performing these procedures.”

The Heart Rhythm Society established an alternate training pathway in 2004 consisting of rigorous clinical competency standards for physicians not certified in electrophysiology to help them gain the proper experience and knowledge before implanting ICD and CRT devices.

The first-year data also provided an overview of who is receiving the medical devices. The average patient is 68 years of age, white (83 percent) and male (74 percent). Medicare beneficiaries represented 70 percent of patients last year. Though the registry was established in April 2006 to be the sole repository of ICD implantation data for Medicare patients, about 88 percent of implants are being done in hospitals that are entering data for all patients.

The registry is developing a Longitudinal study to capture device-firing data and will subsequently be combined with Medicare claims data to record complications that may occur after discharge such as infection and lead dislodgement.

“The registry has so far proven to be an ongoing, quality improvement tool that allows a hospital to compare its outcomes from ICD implantation with hospitals of a similar size,” concluded Dr. Hammill. “Access to the data helps hospitals determine if changes need to be made to ensure the best patient care possible.”

About the ICD Registry
The creation of the National ICD Registry™ began in September 2004 with the convening of the National ICD Registry Working Group, an interdisciplinary committee led by the Heart Rhythm Society and consisting of 17 organizations including: physician associations; health insurance providers; government officials; medical device manufacturers and registry experts. This workgroup addressed the lack of information available for determining if ICDs benefited Medicare patients, a patient population that is both older and in some cases less healthy than patients receiving ICDs in the clinical trials. The working group also determined the best approach to develop and implement the registry to collect this information without overburdening hospital participants. As a result, the ICD Registry™, a partnership of the Heart Rhythm Society and the American College of Cardiology Foundation, was created. In October 2005, CMS announced the ICD Registry™ as the official national repository of ICD information. More information about the ICD Registry can be found at www.accncdr.org.