CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients - CHAMPION

Description:

The goal of the trial was to evaluate an implantable pulmonary artery pressure monitor among patients with recent hospitalization for heart failure.

Contribution to the Literature: The CHAMPION trial demonstrated a reduction in hospitalization for heart failure with the use of an implantable pulmonary artery pressure monitor.

Study Design

  • Randomized
  • Parallel

Patients with New York Heart Association (NYHA) class III heart failure symptoms and recent hospitalization for heart failure were implanted with a pulmonary artery pressure monitor. Patients were then randomized so that providers received daily pulmonary artery pressure information for 6 months (n = 270) versus control in which daily hemodynamic information was not made available for 6 months (n = 280).

After 6 months, all providers received pulmonary artery pressure information for an additional 13 months.

Inclusion criteria:

  • NYHA class III heart failure symptoms and recent hospitalization for heart failure
  • Total number of enrollees: 550
  • Duration of follow-up: 18 months
  • Mean patient age: 61 years
  • Percentage female: 28%
  • Percentage diabetics: 48%

Principal Findings:

The primary outcome, hospitalization for heart failure, occurred at a rate of 0.32 events per patient per 6 months in the treatment group vs. 0.44 events per patient per 6 months in the treatment group (p = 0.0002).

During the randomization period, there were more medication changes in the treatment group compared with the control group. Patients in the control group during the open access period experienced a 48% reduction in hospitalization for heart failure compared with patients in the control group during the randomization period (p < 0.0001).  Eight device or system-related complications were observed within 6 months.

Interpretation:

Among individuals with recent hospitalization for heart failure, the use of an implantable device to provide daily pulmonary artery hemodynamic information was beneficial. This device resulted in more medication changes and a reduction in hospitalization for heart failure. This treatment effect was durable over time.

References:

Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB, on behalf of the CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 2015;Nov 6:[Epub ahead of print].

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure

Keywords: Monitoring, Ambulatory, Heart Failure, Hemodynamics, Pulmonary Wedge Pressure, Secondary Prevention


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