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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
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
COMPASS-HF
Presented at ACC Scientific Sessions 2005
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.
Blocked clinician access
Control
n=140
Total clinician access
Monitored
n=134
Presented at ACC Scientific Sessions 2005
Primary Composite Endpoint: heart failure related hospitalizations, emergency department and urgent clinic visits requiring intravenous intervention
COMPASS-HF
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)
p=0.27
Presented at ACC Scientific Sessions 2005
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%)
Rate of improvement
Rate of worsening
COMPASS-HF
Clinical Composite Score
P=0.035
Presented at ACC Scientific Sessions 2005
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)
COMPASS-HF
Subgroup Analysis: patients with NYHA class III
p=0.03
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
COMPASS-HF