This article is reprinted from "The Gray Sheet" – April 7, 2008
Some cardiologists doubt the value of the national registry for implantable cardioverter defibrillators that was created to satisfy CMS coverage requirements, even as the registry is about to expand.
Brian Olshansky, University of Iowa, is among ICD implanters who question whether the National Cardiovascular Data Registry data will be used in a scientifically valid way.
"The information is going to be used for political purposes by CMS to limit implantation of devices," Olshansky said at the American College of Cardiology's annual meeting in Chicago March 30.
"It's not going to be for the benefit of the patients, and it's not going to be for the benefit of the profession."
The ACC and the Heart Rhythm Society created the registry in 2005 when CMS made participation in a registry a condition of Medicare coverage for primary-prevention ICD implants (1"The Gray Sheet" July 17, 2006, p. 5).
The national registry also collects information far beyond CMS' requirements. Close to 1,500 hospitals are enrolled, and over 250,000 patient records are in the database so far.
But Olshansky calls the data "retrospective, post-hoc, uncarefully evaluated" and "useless."
Bradley Knight, an electrophysiologist at the University of Chicago, pointed to specific weaknesses, including the difficulty in interpreting the significance of adverse events entered into the system.
He also noted that variability can be introduced because different people fill out the form differently. Data entry may be done by a nurse, the implanting physician or an administrative staffer, depending on the hospital, he explained.
Heart Rhythm Society President Bruce Lindsay, M.D., University of Washington in St. Louis, acknowledged potential problems with the quality of the data and agreed that the data must be audited, but the audit process is already a year or two behind in getting started, he said.
Registry Participation Burdens Physicians
Physicians also complain about the time and money needed to enroll in the registry. In the past, the hospital registration fee has been subsidized by ICD manufacturers and some private payers, but physicians are not compensated for their participation.
"We really need to be specific about the purpose of this and try to make it as minimally burdensome as possible," Knight said. "I'm just afraid that it's going to continue to get expanded and expanded, and there are no resources provided to do this work."
The three-page registry form includes roughly 150 fields on patient characteristics and the device implanted. The guide explaining how to fill it out runs 41 pages.
Lindsay said additional fields are being added to the registry form to track specific leads implanted with the device.
"If they start seeing a lot of replacements, it could be a tripwire to industry. ... It might allow us to identify problems earlier," he said.
For example, the malfunctions leading to the recent recall of Medtronic's Sprint Fidelis probably could not have been detected in pre-market trials, even if they had been more robust, Lindsay argued (2"The Gray Sheet" Oct. 22, 2007, p. 3).
The ICD registry, as well as the remote monitoring systems maintained by ICD manufacturers, have the potential to help with post-market surveillance, Lindsay said.
Expanded Longitudinal Registry Could Satisfy CMS
Meanwhile, administrators of the registry hope to secure funding within the next six months to begin a longitudinal five-year prospective registry of 3,500 Medicare patients, Lindsay said.
The study will track the rate of appropriate ICD shocks, delivery of pacing therapy and mortality rates in a primary-prevention population.
Approximately 350 implanting physicians will be randomly selected to help collect device data over three years for the study. Five-year rates of survival and re-hospitalization will be assessed through Medicare claims data.
Full analysis of the longitudinal registry data could take eight years from start-up to complete, the Heart Rhythm Society estimates.
CMS asked for the longitudinal registry as part of its 2005 ICD coverage policy in addition to the implant registry that is already operational.
The agency says the resulting data could lead to expanded ICD coverage and a lifting of the data collection requirement, but funding remains an obstacle.
The $3.6 million longitudinal project is partially funded but is still short $1.1 million, according to Stephen Hammill, Mayo Clinic, the chair of the ICD Registry Steering Committee and a past president of the Heart Rhythm Society.
ICD manufacturers have committed $1.5 million, and America's Health Insurance Plans, which represents private payers, will commit $1 million if full funding comes together, Hammill told "The Gray Sheet" April 3.
Investigators are pursuing federal funding from the Agency for Healthcare Research and Quality and the National Heart, Lung and Blood Institute to complete the financing.
- Chloe Taft
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