Crippling costs

Heart failure represents a significant health care challenge in the US due to its high prevalence, morbidity, mortality and treatment cost. The number of heart failure patients is increasing dramatically, from 5.1 million in 2012 to an estimated 8.0 million by 2030. These patients consume 34% of the total Medicare budget with costs of $30.7 billion in 2012 and an expected $67.7 billion in 2030. The transition in health
care from a fee-for-service to a fee-for-value payment structure creates tremendous motivation for healthcare providers to reduce the disproportionate treatment costs associated with heart failure management.

Frequent hospital admissions

Nearly 80% of heart failure expenditures are related to hospital admissions to treat clinical decompensation due to volume overload. Greater than 1 million heart failure patients are hospitalized each year, with the average cost of each admission totaling $16,770 for Medicare and $30,104 for commercial payers. Rehospitalization rates for heart failure are among the highest across diagnoses, with approximately 20% of patients readmitted within 30 days and >50% readmitted within 6 months of discharge. In FY 2015, the US Centers for Healthcare and Medicare Services Hospital Readmission Reduction Program (HRRP) imposed $420 million in penalties due to excessive readmission rates. Given the concentration of treatment costs on hospital admissions and appreciable Medicare penalties, there exists a significant opportunity for any product that can cost-effectively reduce heart failure-related hospital admissions.

inadequate solutions

Recent attempts to reduce hospital admissions have been either unsuccessful or cost prohibitive. The primary cause of heart failure-related hospitalizations is fluid overload. Classic symptoms of fluid overload, such as difficulty breathing, swelling, fatigue, and weight gain occur too late in the pathophysiologic sequence of decompensation to permit effective intervention, and numerous studies have shown that monitoring late indicators has no effect on hospital admission rates.  Monitoring based on early indicators can be successful, and early warning systems sensitive to hemodynamic congestion have been shown to reduce admissions by nearly 40%. However, current systems are expensive, invasive and surgically implanted.  Although these devices have demonstrated that proactive intervention can reduce heart failure-related hospitalizations, their costs do not adequately address the needs of the healthcare system.