HF monitoring did not improve disease management in minorities, women

The Alere system did not improve clinical outcomes for certain elderly patients with HF.

WASHINGTON — The results of a trial evaluating the Alere Day Link Heart Failure Monitoring System suggested that certain patients who use the system experience no significant benefits compared with patients undergoing standard HF care.

Z. Ozlem Soran, MD, associate professor of medicine, associate professor of epidemiology/research at the University of Pittsburgh School of Medicine and director of Enhanced External Counter Pulsation Research Lab at the University of Pittsburgh Medical Center, presented the results of the Heart Failure Home Care trial at the Heart Failure Society of America’s 11th Annual Scientific Meeting.

“There is a paucity of information regarding the use of disease management programs in outpatients, the elderly, women and [nonwhite] males,” Soran said at the meeting. “Thus, the present study was undertaken to assess the efficacy of a unique home monitoring system in a group of elderly patients enriched for both women and non-white males.”

Alere system and Day Link

The researchers randomly assigned 315 Medicare beneficiaries in the multicenter, controlled clinical HFHC trial to either the standard care group (n=155) or the Alere group (n=160). Average patient age was 76 years in the standard care group and 77 in the Alere group. More than 60% of participants in both groups were women, nearly 30% in each group were Hispanic, and 47% were black in the standard care group (vs. 58% in the Alere group). Standard care included evidence-based optimal medical treatment, a digital scale and management by a primary care physician.

The Alere system included an electronic scale with a response mechanism called the Day Link Monitoring System that activated itself when the patient stepped onto it. The scale sent a signal to a remote computerized database monitored by trained nurses who would monitor the patients and instruct by phone on how to comply with the daily measurement routine.

The nurses contacted the patient’s primary physician if the patient condition or weight changed. The patients were followed-up at 30 days via phone, at three months and at six months, and primary endpoints were designated as treatment failure up to cardiovascular death or HF hospitalization.

Insignificant differences

Compliance with the Alere system was 97%, and 839 alerts were sent to the primary care physicians using the system.

The incidence of the primary outcome, six-month cardiac mortality or rehospitalizations for HF was somewhat higher in the standard-care arm (28.8% vs. 21.2%, P=.15); however, the difference was not statistically different. Six-month mortality was 11.2% in the standard-care arm and 7% in the Alere arm (P=.24).

The results suggested that the differences between the two treatment arms were too small to conclude that the Alere system was more effective at helping certain minority populations and women manage HF.

“Our study results suggest that the development of an infrastructure of trained heart failure specialists who actually manage care is as important as a home monitoring device reporting to busy clinicians without a heart failure management infrastructure,” Soran said in a press release. “Heart failure management programs hold tremendous promise for patients not receiving comprehensive care, but that does not mean it’s universally effective. Limitations of disease management programs need to be addressed and overcome so that care of patients with heart failure can be successful.” – by Eric Raible

For more information:

• Soran, O. Randomized clinical trial of the clinical effects of enhanced HF monitoring using a computer-based telephonic monitoring system in older minorities and women. Recent and late breaking trials. Presented at: Heart Failure Society of America Annual Scientific Meeting; Sept. 16-19, 2007; Washington