Abstract 19802: Implantable Hemodynamic Monitoring Reduces Heart Failure Hospitalizations Due to Congestion Regardless of Perfusion Status
Introduction: Heart failure (HF) management guided by implantable hemodynamic monitoring systems reduces overall hospitalizations in NYHA Class III patients with a previous HF hospitalization.
Hypothesis: Hemodynamic monitoring may reduce hospitalizations with accompanying low output status, as well as those resulting primarily from congestion.
Methods: The CHAMPION Trial enrolled 550 NYHA Class III patients and randomly assigned them to a treatment group who were managed by hemodynamic monitoring using a permanently implanted pulmonary artery (PA) MEMS-based sensor or to a control group who were managed by standard clinical assessments (MEMS-sensors were implanted, but the uploaded pressures were not available to investigators). The primary endpoints were the comparison of HF hospitalization rates between the treatment and control groups assessed after 6 and 17 months of randomized follow-up. The blinded Clinical Events Committee prospectively adjudicated each HF hospitalization based on documented clinical hemodynamic characteristics: (1) well perfused/congested, (2) poorly perfused/congested or (3) poorly perfused without congestion. Group 3 events were rare and not different between groups.
Results: Patients in the treatment group had fewer hospitalizations overall (182 hospitalizations, rate 0.46/patient/year treatment vs. 279 hospitalizations, rate 0.68/patient/year control; (HR 0.67 CI (0.55-0.80), p<0.001). The majority of hospitalizations fit the perfused/congested profile, and were decreased in the treatment group compared with control (138 vs. 224 hospitalizations, HR 0.62, CI 0.50-0.77, p<0.001). Poorly perfused/congested events were similarly reduced in the treatment group compared with control (29 vs. 44 hospitalizations, HR 0.63, CI 0.39-1.01, p=0.05).
Conclusions: Compared to standard clinical assessments, HF managed with implantable hemodynamic monitoring results in significant reductions in heart failure hospitalization regardless of perfusion status.
Author Disclosures: A.B. Miller: Honoraria; Significant; St. Jude Medical. E.M. Gilbert: Honoraria; Significant; CardioMems, Inc, St. Jude Medical. E.S. Chung: Consultant/Advisory Board; Significant; Medtronic, Inc., Boston Scientific, St. Jude Medical, Otsuka. W.C. Levy: Research Grant; Modest; Thoratec, HeartWare. Honoraria; Modest; St. Jude Medical. Consultant/Advisory Board; Modest; GE Healthcare, HeartWare, Pharmin, Novartis. J.R. Teerlink: Honoraria; Significant; St. Jude Medical, CardioMEMS, Inc, Medtronic, Inc. P. Carson: Consultant/Advisory Board; Modest; St. Jude Medical. P.B. Adamson: Employment; Significant; St. Jude Medical. W.T. Abraham: Speakers Bureau; Significant; St. Jude Medical. Honoraria; Significant; St. Jude Medical.
- © 2015 by American Heart Association, Inc.