Medical Device Daily Executive Editor

DENVER — The big blue bear stands about two stories tall, his forepaws up on the shiny glass of the Colorado Convention Center, peering in as if to inquire, "what's going on in there?"

He won't understand much about the goings-on here this week, since the presentations and conversations in the rooms and hallways of the center deal with the technicalities of cardiac arrhythmia: atrial fibrillation, atrial flutter, cardiac arrest and other rhythm abnormalities, and the drugs and devices used to seek normal heart rhythms.

At least 13,000 and up to more than 14,000 attendees are expected here this week at the annual meeting of the Heart Rhythm Society (HRS; Washington), and they appear keen on soaking up these technicalities.

The conference requires them to have tickets for entry to many of the presentations (the press, happily, able to waltz in without the required ticket, though at most of the sessions they may be as puzzled as the bear). And given the packed-hall look of most of these rooms, the non-ticketed were clearly out of luck.

While rhythm management is a complex topic, the failure of such management is much less complex — and often fatal — for patients. And the problems of implantable cardioverter defibrillators (ICDs) produced some of the biggest headlines in 2005 and 2006 with large recalls of the devices.

Still to be determined is the legal fallout from those recalls: how courts will rule on roughly 1,000 lawsuits, primarily against Guidant (Indianapolis), now the cardiac rhythm management (CRM) business of Boston Scientific (Natick, Massachusetts).

With launch of the conference, HRS and the American College of Cardiology (Washington) reported the release of the National Implantable Cardioverter Defibrillator (ICD) Registry, calling it the nation's first comprehensive database of detailed information about patients receiving these devices, an initiative launched in 2004 by the HRS and then involving, it said, up to 17 organizations.

HRS and the ACC said that the initial ICD Registry includes data provided by 1,450 hospitals, related to nearly 3,900 physicians and for more than 100,000 patients in its first year. The hope is that the registry will provide an improved guide for the use of these devices in patients currently implanted with them and those implanted in the future.

Laurent Lewkowieez, MD, director of clinical cardiac electrophysiology at the University of Colorado Hospital (Denver), called the registry data "invaluable . . . By analyzing patient characteristics and device trends over time, we can determine if changes need to be made to our medical protocols to ensure the best patient care possible."

Stephen Hammill, MD, chair of the ICD Registry steering committee, and a past president of HRS, said in a statement that a key benefit will be in enabling physicians to understand device performance "relative to their peers" and thus improve the quality of care.

However, in an interview with Medical Device Daily, he modified that statement a bit.

A hospital will see data for their individual physicians but not from the physicians at other hospitals, he said. Individual hospitals also will be able to compare their data to, first, other hospitals in their own size category and, second, to the data from the entire national universe of hospitals, but not to the performance of physicians at the other hospitals.

Others receiving data reports from the registry are third-party payers and manufacturers of ICDs.

Hammill said that manufacturers won't be able to use comparisons between their own performance and that of another manufacture, for instance as a promotional tool. They will only see their data compared to the aggregated data of all manufacturers.

Hammill said that moves to create the registry preceded the national headlines concerning ICD failures but was officially launched in September 2004 and then given further boost by the Centers for Medicare and Medicaid Services (CMS) which wanted more information about what it was paying for in its reimbursements of ICDs. The agency then adopted the registry system in 2005.

Hammill acknowledged initial pushback from some hospitals concerning the registry because of the costs involved in implementation, but those objections went away in the face of non-reimbursement from CMS for those not registry-compliant.

Hammill noted that the hospitals were invited to voluntarily submit information on all their patients implanted with ICDs, not just Medicare patients, to develop the registry's "benchmark scores."

About 80% of the hospitals voluntarily supplied information from non-Medicare ICD implantees, he said, and about 46% of the data came from non-Medicare patients.

The data reviews 100 data points, ranging from highly critical aspects of care — such as the rate of infection — to simple reporting of patient ages. To provide clarity to the 100 points of data, the report provides an executive summary highlighting the 10 most critical points for benchmarking simplicity.

Researchers will also receive access to the information, and Hammill predicted the development of up to four abstracts concerning the registry at the next meeting of the American Heart Association (Dallas).

The first registry provides data only concerning the circumstances of original implantation, but Hamill said that future reports will track follow-up data to provide trending information.

And he expressed pride in the registry release as a groundbreaking event.

The ICD registry "will go forever," he told MDD, adding the hope that this initiative will be added to by similar registries covering, for instance, lead implantation, pacemakers and cardiac ablation procedures.

Referring to the inherent nature of clinical trials to be very patient-selective, Hammill said he thought the main benefit of the registry is that it will report "what's happening in real life and real-life populations — of people who are often older, often sicker.

And in the HRS statement he expressed a broader hope concerning registry implementation: "I am confident," Hammill said, "that physicians will thoroughly review their data reports and benchmark scores to learn from their colleagues."