National ICD Registry Reports Few Complications with Implantation of Internal Defibrillators

National ICD Registry Reports Few Complications with Implantation of Internal Defibrillators

Some Implanting Physicians Lack Formal Training

September 7, 2007­–WASHINGTON–First the good news: First year data from the National ICD Registry indicates few complications with Implantable Cardioverter Defibrillators (ICDs). Now the bad news: A number of implanting physicians had no formal training with the medical procedure. The report will be published in the September 2007 edition of Heart Rhythm 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.

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