COMPASS-HF: Management with remote system effective

ORLANDO – Patients with heart failure managed with a remote hemodynamic monitoring system had significantly fewer hospitalizations and a lower rate of worsening heart failure.

Robert Bourge, MD, University of Alabama at Birmingham, presented results of the COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) trial at the American College of Cardiology Scientific Session 2005.

COMPASS-HF tested a remote hemodynamic monitoring system (Chronicle, Medtronic) among patients with heart failure who were already on best available therapy. “Our ability to correctly assess increased filling pressures by symptoms and physical signs has been shown to be somewhat limited,” Bourge said.

The Chronicle system comprises an implanted pacemaker-size monitor and a pressure-sensing lead placed in the right ventricular outflow track. Intercardiac pressures are measured continuously and stored in the device for eventual transmission to a treating clinician from a patient’s home or hospital room.

Randomized trial

COMPASS-HF researchers implanted Chronicle devices in 274 patients and randomized them to either open monitoring or a control group where physicians could not access the Chronicle information. All patients transmitted data at least once weekly from remote monitoring, and follow-up occurred for six months. Each time a patient was assessed, they were classified as hypervolemic, optivolemic or hypovolemic. The optivolemic state is defined as the filling pressure required to minimize congestive symptoms and signs and symptoms of low cardiac output. If patients were determined to be less than optivolemic, care was applied based on established guidelines. Bourge said these guidelines were followed 96% of the time.

The mean age of the patients in COMPASS-HF was 58, and 35% were women. Half the group was white. About 85% had NYHA Class III heart failure, and the mean number of previous events was 2.3. Nearly all the patients were assigned diuretics, 80% to 83% were assigned ACE or ARB, 80% were assigned beta-blockers and 40% were being treated with some sort of concomitant device.

No sensor failures were reported with the device, and complications were low at 8.4%.

At six months, researchers assessed the rate of heart failure hospitalizations, emergency department visits and urgent clinic visits. These events occurred 74 times in the monitored group compared to 102 times in the control group, a 22% reduction that was not statistically significant (P=.27).

However, 86% of the events were heart failure hospitalizations. When this outcome was measured separately, researchers found a significant 21% reduction (P=.029) in favor of the monitored group.

Monitored patients also reported improvements in the secondary outcome of the clinical composite score. Overall, 31% of the monitored patients had an improved score, while 33% of the control patients had a worsened score.

In a subgroup analysis that included only those patients with NYHA Class III heart failure, 85% of the overall population, there was a significant 41% reduction in the rate of the primary composite outcome.

In a comment period following the presentation, Jamie B. Conti, MD, University of Florida, said while the primary outcome of the trial was negative, the reduction in heart failure hospitalizations could result in significantly reduced costs.

Conti said if one assumed 500,000 heart failure hospitalizations per year, at a total cost of $3 billion, a 41% reduction would save $1.2 billion. “This unique technology allows the physician to monitor a patient’s intracardiac pressures during activities of daily living, instead of while hospitalized, thus allowing a broader picture,” Conti said. – by Jeremy Moore

For more information:

• Bourge RC, Abraham WT, Aaron MF, et al. The Chronicle offers management to patients with advanced signs and symptoms of heart failure (COMPASS-HF) study: ambulatory acquired hemodynamic guided management of heart failure. Presented at the American College of Cardiology Scientific Session 2005. March 6-9, 2005. Orlando.