Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction

Circ Heart Fail. 2014 Nov;7(6):935-44. doi: 10.1161/CIRCHEARTFAILURE.113.001229. Epub 2014 Oct 6.


Background: No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF).

Methods and results: The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a prospective, single-blinded, randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization. Of the 550 patients enrolled in the study, 119 had left ventricular EF ≥40% (average, 50.6%), 430 patients had low left ventricular EF (<40%; average, 23.3%), and 1 patient had no documented left ventricular EF. A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization. After implant, subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring, and pressures were uploaded but not available for investigator use. The primary efficacy end point of HF hospitalization rate >6 months for preserved EF patients was 46% lower in the treatment group compared with control (incidence rate ratio, 0.54; 95% confidence interval, 0.38-0.70; P<0.0001). After an average of 17.6 months of blinded follow-up, the hospitalization rate was 50% lower (incidence rate ratio, 0.50; 95% confidence interval, 0.35-0.70; P<0.0001). In response to pulmonary artery pressure information, more changes in diuretic and vasodilator therapies were made in the treatment group.

Conclusions: Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00531661.

Keywords: heart failure with preserved ejection fraction; hemodynamic monitoring; hospitalization.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Pressure Monitoring, Ambulatory / instrumentation*
  • Blood Pressure Monitoring, Ambulatory / methods
  • Comorbidity
  • Heart Failure / drug therapy
  • Heart Failure / epidemiology
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Hospitalization / statistics & numerical data
  • Humans
  • Pulmonary Wedge Pressure / physiology*
  • Remote Sensing Technology / instrumentation*
  • Remote Sensing Technology / methods
  • Stroke Volume
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00531661