Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure - COMPASS-HF

Mar 11, 2008
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2005
Date Published:
01/01/2008
Date Updated:
03/11/2008
Original Posted Date:
03/11/2008
References

Description:

The goal of this trial was to evaluate a strategy of heart failure management directed by an implantable continuous hemodynamic monitor (Chronicle device; Medtronic Inc., Minneapolis, MN) compared with optimal medical therapy in patients with advanced heart failure.

Hypothesis:

The use of the implantable Chronicle device will be more effective in reducing heart failure-related events.

Study Design

  • Randomized
  • Blinded
  • Parallel
  • Stratified

Patients Screened: 301
Patients Enrolled: 274
NYHA Class: 84% with class III
Mean Follow Up: 6 months
Mean Patient Age: 58 years
Female: 34%

Patient Populations:

• New York Heart Association class III-IV
• At least 18 years old
• Management in an advanced heart failure program
• Optimal medical therapy for at least 3 months prior to enrollment
• At least one heart failure-related hospitalization in the past 6 months

Exclusions:

• Chronic obstructive pulmonary disease
• Pulmonary arterial hypertension
• Major cardiovascular event within the past 3 months
• Atrial or ventricular septal defect
• Tricuspid or pulmonary valve stenosis
• Mechanical right heart valve
• Noncardiac condition limiting 6-month survival
• Creatinine ≥3.5 mg/dl
• Anticipated heart transplantation within the next 6 months
• Requirement of continuous inotropic therapy
• Had an internal cardiac defibrillator or cardiac resynchronization therapy
• Childbearing age without use of contraceptives

Primary Endpoints:

• Primary safety endpoint was freedom from device-related complications.
• Primary efficacy endpoint was freedom from hospitalizations, emergency department, or heart failure clinic visits that required diuretics.

Drug/Procedures Used:

After successful implantation of the Chronicle device, patients were randomized to management directed by Chronicle data (n = 134) or continued medical management without Chronicle data (n = 140).

Concomitant Medications:

At baseline, the use of diuretics was 93% versus 99%, angiotensin-converting enzyme inhibitor was 85% versus 81%, and beta-blocker was 83% versus 81%, in the Chronicle versus control group, respectively. During follow-up, patients in the Chronicle group had 54% more diuretic changes than the control group.

Principal Findings:

There were a similar number of calls between patient and heart failure clinics (25 calls per patient) in both groups. In the entire study group (n = 274), freedom from device complications was 91.5%. Most of these were related to lead dislodgement. There were no sensor failures. The primary efficacy endpoint (freedom from hospitalizations, emergency department, or heart failure clinic visits that required diuretics) occurred in 44 Chronicle patients (event rate 0.67 per 6 patient-months) and in 60 control patients (event rate 0.85 per 6 patient-months) (p = 0.33).

Interpretation:

Chronicle data resulted in 54% more diuretic changes, compared with the control group. Despite this, the use of the Chronicle device to direct therapy did not reduce the rate of the primary outcome (freedom from hospitalization, emergency department, or clinic visit that required diuretics). This was achieved without an apparent decline in renal function. Freedom from device-related complications was also low.

This trial reinforces the poor prognosis of patients with advanced heart failure and serves as a reminder not to overlook proven life-saving therapies such as angiotensin-converting enzyme inhibitors and beta-blockers. The optimal use of these medical therapies may have limited the ability to detect a difference in the primary outcome. The applicability of this technologically advanced device in the community setting is uncertain. Future studies may need to determine if this device can improve other outcomes such as quality of life.

References:

Bourge RC, Abraham WT, Adamson PB, et al. Randomized Controlled Trial of an Implantable Continuous Hemodynamic Monitor in Patients With Advanced Heart Failure: The COMPASS-HF Study. J Am Coll Cardiol 2008;51:1073-9.

Keywords: Prognosis, Quality of Life, Diuretics, Heart Failure, Hospitalization, Hemodynamics


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