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

Oct 03, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
St Jude Medical Inc.
Date Published:
10/02/2017
Date Updated:
10/03/2017
Original Posted Date:
01/04/2016
References

Contribution To Literature:

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

Description:

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

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.

Among 456 patients with heart failure due to reduced ejection fraction, hospitalization for heart failure occurred at a rate of 0.49 events per patient per year in the treatment group vs. 0.69 events per patient per year in the treatment group (p = 0.0013).

Interpretation:

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

References:

Givertz MM, Stevenson LW, Costanzo MR, et al., on behalf of the CHAMPION Trial Investigators. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol 2017;70:1875-86.

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 2016;387:453-61.

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


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