Some Researchers Call for National Registry of Cardiac Devices To Track Effectiveness, Reliability

A study released this week that found the Sprint Fidelis defibrillator lead, manufactured by Medtronic, might fail at a rate significantly higher than previously thought, has led to a debate among researchers "who want to understand the discrepancies and the implications for patient care" and has prompted some to renew calls for a national registry of patients who receive cardiac devices, the New York Times reports. However, according to the Times, "setting up such registries in this country has proved difficult so far."

In 2004, Medicare required the creation of a national registry of patients who receive defibrillators as a condition of approval of payments for the devices. The registry, which is administered by the American College of Cardiology and the Heart Rhythm Society and includes data on more than 340,000 patients, sought to determine the number of new patients who would benefit from defibrillators, which can cost $25,000 or more.

Despite the requirement, Medicare has spent a limited amount of funds to support the registry, according to Stephen Hammill, a cardiologist at the Mayo Clinic who has led the effort. In addition, medical device companies, which helped cover the $3 million annual operating cost in the first year, have since reduced their support. Hospitals currently finance the registry in exchange for reports that compare the short-term complication rates of their patients with those of patients nationwide.

According to the Times, the limited financial support, as well as "technical problems that make it hard to merge registry information with Medicare records, have undermined the registry's utility." Researchers, for example, cannot use the registry to collect data on longer-term outcomes for patients, information needed to determine the effectiveness and reliability of defibrillators.

Hammill said that researchers have begun to revise the registry to allow collection of such data, and FDA last year asked for an expansion of the registry to track the effectiveness and reliability of defibrillator leads (Meier, New York Times, 2/27).