Each year approximately 500,000 new cases of heart failure (HF) are diagnosed in the United States. HF currently accounts for > 3% of hospital discharges and > 20% of discharges for cardiovascular disease (CVD) each year. The burden of HF on the health care system will rise dramatically as the baby-boomer generation enters their seventh and eighth decades. We tested the benefits of a home-based telemonitoring system with a nurse-staffed call center providing disease management compared to standard care on survival and rates of ER visits and/or hospitalizations. Secondary end points included performance on the 6-Minute Walk Test. A total of 284 patients with NYHA Class II-IV HF were enrolled at sites in Pennsylvania, New York, Montana, Indiana, and Kentucky and randomized to one of three treatment arms: (1) standard care, (2) home monitoring with disease management for 6 months followed by 6 months of standard care, and (3) home monitoring with disease management for 12 months. Home monitoring utilized the Alere DayLink Monitor that transmits daily to a nurse-staffed call-center data on the patient's weight and responses to questions regarding HF symptoms. In the event that a patient's weight gain or loss in a 24-hour to 7-day period exceeded his/her physician defined limits or if serious HF symptoms occurred, the call center nurse informed the patient's physician who might intervene. Analysis by intention to treat failed to show a significant effect (p < .05) of either 6- or 12-month monitoring on all-cause, CVD-, or HF-related mortality or on ER visits or hospitalizations. However, several important lessons were learned. First, simple incidence rates or time to failure do not capture the complex clinical course of HF patients. But analysis of the cumulative incidence shows highly significant effects of home monitoring with disease management. Specifically, 12 months of monitoring reduced all-cause ER visits or hospitalizations by 26%, CVD admissions by 37%, and HF admissions by 41% (all p < .05). But the group monitored for 6 months experienced the primary outcomes at rates consistently between those of the standard therapy group and the 12-month monitored group (all p > .05). We also note that patients with HF but normal LVEF had a better clinical course than patients with LVEF < 35% and that performance on the 6-Minute Walk test is a potent predictor of the clinical course of HF patients. We conclude that home monitoring with disease management for a period > 6 months can improve the clinical course of Class II-IV HF patients.
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