Dallas, TX - Primary-prevention implantable cardioverter-defibrillator (ICD) therapy in chronic heart failure can be considered cost-effective by today's standards relative to medical therapy alone, a prospectively planned analysis of data from a major randomized trial recently concluded [1].

Use of a "conservatively programmed, single-lead ICD," as in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), "is an economically efficient way to increase health benefits in this population, assuming that the observed benefits of ICD therapy in SCD-HeFT persist for at least eight years," according to the authors, Dr Daniel B Mark (Duke University, Durham, NC) and colleagues. Their report was posted online July 3, 2006 in Circulation and published in the journal's July 11, 2006 issue.

The devices' value appeared to be concentrated in HF patients initially in NYHA functional class 2, who had also gained the most clinical benefit relative to those in NYHA class 3 in the trial's primary analysis [2]. The group used cost standards, described as typical, in which <$50 000 per life-year saved (LYS) is considered a "good value" and >$100 000/LYS is an "inadequate value."

An accompanying editorial from Dr Lynne Warner Stevenson (Brigham and Women's Hospital, Boston, MA) in the journal's July 11, 2006 issue lauded the group's analysis but provided a different take on its interpretation. Among other things, she proposes that other HF therapies that, unlike ICDs, improve hospitalization rates may still be more cost effective than the devices in actual clinical practice as compared with randomized trials.

The current cost, multiplied by the prevalence of heart failure deemed high risk, threatens to make this one enterprise the highest-priced intervention for the Medicare population.

As reported in the literature last year, the 2521-patient SCD-HeFT's primary finding was a 23% drop in the relative five-year all-cause mortality risk among ICD recipients compared with controls. Mark reported and heartwire had covered the preliminary results of the cost analysis at the American Heart Association 2004 Scientific Sessions.

In the current report, he and his colleagues determined that the lifetime cost-effectiveness ratio for ICDs in SCD-HeFT was as low as $38 389/LYS and about $3000 more on a quality-adjusted LYS basis. But the ratio varied significantly according how long the "lifetime" exceeded the five-year follow-up period represented by the trial's actual data. The cost per LYS reached $127 503 at five years, $88 657 at eight years, and $58 510 at 12 years.

The lifetime cost/LYS also was seen to vary from about $32 000 to about $59 000 with adjustments to some underlying assumptions, including initial costs, projected late-complication rates, and battery longevity. SCD-HeFT was notable for having used single-chamber ICDs programmed to treat with shocks only—less sophisticated and therefore likely cheaper than typically used devices.

The "elegant" SCD-HeFT cost analysis provides "exemplary insight" into the challenges of using a formidable yet costly therapy in the many patients likely eligible for it, according to Stevenson's editorial. "The current cost, multiplied by the prevalence of heart failure deemed high risk," she writes, "threatens to make this one enterprise the highest-priced intervention for the Medicare population."

ICDs for primary prevention of sudden death . . . may be less cost-effective than other recommended heart failure therapies, which are prescribed to modify disease progression and symptoms.

And in contrast to Mark et al's "favorable conclusions" to the cost analysis, Stevenson writes, "ICDs for primary prevention of sudden death in the heart-failure population may be less cost effective than other recommended heart-failure therapies, which are prescribed to modify disease progression and symptoms, decreasing costly hospitalizations as well as mortality."

That interpretation is based on "back-of-the-envelope" estimates and considerations with potential influence over ICD-related costs and outcomes in the HF population, she writes. For example, ICDs can prolong life but do not alter the disease course or prevent costly HF hospitalizations and may actually increase them. And "there remains some concern that the device firings themselves, even if inappropriate, may have adverse effects on survival."

Possibly more cost-effective than ICDs, according to the editorial, might be strategies that, besides improving survival, also cut hospitalization risk. That might include biventricular resynchronization pacemakers, which "could easily" cost <$40 000 per adjusted life-year "when selected high-responder populations are chosen," Stevenson speculates.

Also, she writes, "Meta-analyses of heart-failure management programs delivered by specialized multidisciplinary teams . . . show consistent decreases in hospitalizations and improvements in quality of life and are cost neutral or cost saving. It may be necessary to introduce these programs into device clinics for optimal implementation of medical therapies known to be effective to decrease the heart-failure disease progression that currently limits the duration of ICD benefit."