Key result
Hemodynamic monitor-guided care fails to reduce HF-related events compared with medical management alone.
Why the study?
Patients with HF experience frequent decompensations requiring hospitalization despite intensive treatment and follow-up. Whether an HF management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity was unknown.
Does a heart failure management strategy guided by an implantable continuous hemodynamic monitor reduce heart failure-related events compared with optimal medical management alone in patients with NYHA class III or IV heart failure?
RCT (n=274)
Single-blind
parallel-controlled
Yes
Does a heart failure management strategy guided by an implantable continuous hemodynamic monitor reduce heart failure-related events compared with optimal medical management alone in patients with NYHA class III or IV heart failure?
Answers are grounded in this paper and cite their sources.
Continuous intracardiac pressure monitor-guided care was safe but did not significantly reduce total heart failure-related events compared with optimal medical therapy alone in patients with advanced heart failure, though a retrospective analysis suggested a 36% reduction in time to first HF hospitalization.
Objectives The purpose of this study was to determine whether a heart failure (HF) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity. Background Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up. Methods The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study was a prospective, multicenter, randomized, single-blind, parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor. Patients were randomized to a Chronicle (Medtronic Inc., Minneapolis, Minnesota) (n = 134) or control (n = 140) group. All patients received optimal medical therapy, but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group. Primary end points included freedom from system-related complications, freedom from pressure-sensor failure, and reduction in the rate of HF-related events (hospitalizations and emergency or urgent care visits requiring intravenous therapy). Results The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8% of the 277 patients who underwent implantation (all but 4 complications were successfully resolved). The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21% lower rate of all HF-related events compared with the control group (p = 0.33). A retrospective analysis of the time to first HF hospitalization showed a 36% reduction (p = 0.03) in the relative risk of a HF-related hospitalization in the Chronicle group. Conclusions The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management. Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF.
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Bourge et al. (2008) conducted an RCT in Advanced heart failure (NYHA class III or IV) (n=274). Implantable continuous hemodynamic monitor-guided management (Chronicle) vs. Optimal medical therapy without hemodynamic monitor-guided management was evaluated on Freedom from system-related complications, freedom from pressure-sensor failure, and reduction in the rate of HF-related events (hospitalizations and emergency or urgent care visits requiring intravenous therapy) (21% lower rate, p=0.33). Implantable continuous hemodynamic monitor-guided care did not reduce total HF-related events compared with optimal medical management.
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