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This study presented at the ACC Scientific Sessions 2005 explores the use of the implantable hemodynamic monitor system in managing patients with advanced signs and symptoms of heart failure. The results suggest a potential reduction in heart failure-related hospitalizations.
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COMPASS-HF Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Robert C. Bourge
COMPASS-HF 274 patients having class III or IV heart failure (despite treatment with standard medical therapy) and at least one heart failure related hospitalization Randomization was stratified by LVEF < or ≥ 50%. Mean age 58 years. 35% female. Total clinician access Monitored n=134 Blocked clinician access Control n=140 • Endpoints (mean follow-up 6 months): • Primary: Safety (freedom from system-related complications and sensor lead failure) and Efficacy (heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention) • Secondary: Heart failure related hospitalizations Presented at ACC Scientific Sessions 2005
COMPASS-HF Primary Composite Endpoint: heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention p=0.27 • Intravenous intervention was required in 74 patients in the monitored group and 102 patients in the control group, resulting in a 22% non-significant reduction • Groups well balanced, with 85% of patients in New York Heart Association class III heart failure • The main component of the primary endpoint, heart failure hospitalizations, occurred less frequently in the monitored group (RR 0.79, p=0.029) Presented at ACC Scientific Sessions 2005
COMPASS-HF Clinical Composite Score P=0.035 Rate of worsening Rate of improvement • The clinical composite score had a higher rate of improvement in the monitored group (46% vs 35%) and a lower rate of worsening (34% vs 51%) Presented at ACC Scientific Sessions 2005
COMPASS-HF Subgroup Analysis: patients with NYHA class III p=0.03 • In the subgroup analysis of patients with NYHA Class III CHF, the primary composite endpoint was significantly lower in the monitored group than in the control group (RR 0.90, p=0.03) • Additionally, heart failure hospitalization was lower in the monitored group (RR 0.76, p=0.023) Presented at ACC Scientific Sessions 2005
COMPASS-HF • Among patients with NYHA class III or IV heart failure, use of the implantable hemodynamic monitor system for specialized heart failure care management was associated with a non-significant reduction in the primary endpoint of heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention compared with heart failure care management without information from the implantable hemodynamic monitor system. • Use of the monitor was associated with a significant reduction in heart failure hospitalizations. These improvements were observed despite treatment with optimal medical therapy in both groups. • Benefit was particularly evident in patients with NYHA class III heart failure. The reduction in heart failure related hospitalizations associated with the monitored group has the potential to reduce the high cost of therapy for these patients. Presented at ACC Scientific Sessions 2005