Medical Device Daily National Editor

Researchers at the University of Pennsylvania School of Medicine (Philadelphia) have concluded that the cost of implantable cardioverter defibrillators (ICDs) for prevention of sudden cardiac arrest (SCA) and death in elderly patients, though considerable, nonetheless provides "real value" to the U.S. healthcare system.

Lead researcher Peter Groeneveld, MD, said that aside from the initial substantial costs of implantation of the devices, the healthcare costs associated with ICD recipients after six months were "almost identical" to non-recipients of similar demographics.

Sudden cardiac arrest is a leading cause of death in the U.S., ending the life of about 350,000 Americans each year. And ICDs have been shown to be effective in preventing death from cardiac arrest.

In 2005, Medicare and other payers expanded coverage of the devices for primary prevention purposes that is, for patients with heart disease at greater risk of sudden death, but who have not yet experienced heart stoppage.

The Pennsylvania researchers examined healthcare data from a nationally representative sample of 14,250 Medicare beneficiaries over age 66 who were treated for congestive heart failure at more than 2,000 academic and community hospitals nationwide.

The study was among the first to analyze the health outcomes and costs associated with primary prevention ICDs for patients outside of a clinical trial setting.

The research was supported by an unrestricted grant from the Institute for Health Technology Studies (InHealth; Washington), a non-profit organization that supports research and analysis of the economic, social and health effects of patient access to medical technology innovation.

Groeneveld, assistant professor of general internal medicine at Penn, and his co-authors reported their findings in the April issue of Heart Rhythm, the journal of the Heart Rhythm Society (Washington).

They found that, on average, patients receiving ICDs for primary prevention had a 38% lower mortality rate than patients who did not. Some 13% of patients who received ICDs died in the first year after implantation, compared with 23% of patients who did not receive ICDs.

During the second year, the gap widened further, as 17% of ICD recipients died, compared with 29% who did not receive such a device.

The study indicated that the average cost for ICD recipients in the first 30 days after initial hospitalization was about $42,000 more than for patients who received other treatments for CHF, which is comparable to cost estimates from previous clinical studies.

Excluding the costs of implantation, after six months the total healthcare costs for ICD recipients were roughly $1,700 higher than for patients who did not receive an ICD. But after six months, the costs associated with both patient groups were almost identical.

In a podcast discussion with Martyn Howgill, MD, executive director of InHealth, Groeneveld said that the study subjects were carefully selected to reflect similar demographics between ICD recipient and non-recipient groups, and represented Medicare patients in all 50 states and the District of Columbia.

Saying the study population was followed to see what happened to them clinically and in terms of cost utilization, Groeneveld noted that ICDs offered "a definite survival benefit," and that once the roughly $42,000 in implantation costs were accounted for, the ICD group's healthcare costs averaged about $1,700 higher in the first six months after implantation, then were essentially comparable with costs in the non-implant group thereafter.

He said the clinical benefits provided were "exceptional," adding the observation that ICDs are "a good deal for healthcare in this country," providing "real value at this cost."

Groeneveld told Howgill that, "even through these devices have been approved [by the Centers for Medicare & Medicaid Services] for primary prevention use for over three years, much less than 50% of the eligible Medicare population has received them.

"This study confirms, through real-world experience among thousands of patients, what clinical trials among hundreds of patients found, which is that ICDs enable patients to live longer, at a reasonable cost to society."

Groeneveld said that expanding the use of ICDs to a larger number of recipients offers "a tremendous opportunity to provide substantial benefits, and . . . in a manner which is economically acceptable."

Groeneveld said expansion of the implantation of ICDs in eligible patients would be "a good investment for [this] country in terms of healthcare."

He said the findings "show that the overall economic value delivered by the ICD is acceptable by U.S. standards for healthcare expenditures, further substantiating Medicare's decision to expand coverage of ICDs for primary prevention patients. This is particularly relevant to policymakers, healthcare providers and payers who face difficult decisions about the use of innovative medical technology in the face of rising healthcare costs."

In addition to the InHealth grant, Groeneveld was supported by a Research Career Development Award from the Health Services Research and Development Service of the Department of Veterans Affairs.

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