title: Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study.
abstract: OBJECTIVE
  The purpose of this study was to determine whether a heart failure (HF) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity.
  
  
  BACKGROUND
  Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up.
  
  
  METHODS
  The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study was a prospective, multicenter, randomized, single-blind, parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor. Patients were randomized to a Chronicle (Medtronic Inc., Minneapolis, Minnesota) (n = 134) or control (n = 140) group. All patients received optimal medical therapy, but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group. Primary end points included freedom from system-related complications, freedom from pressure-sensor failure, and reduction in the rate of HF-related events (hospitalizations and emergency or urgent care visits requiring intravenous therapy).
  
  
  RESULTS
  The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8% of the 277 patients who underwent implantation (all but 4 complications were successfully resolved). The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21% lower rate of all HF-related events compared with the control group (p = 0.33). A retrospective analysis of the time to first HF hospitalization showed a 36% reduction (p = 0.03) in the relative risk of a HF-related hospitalization in the Chronicle group.
  
  
  CONCLUSIONS
  The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management. Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF.
authors.affiliation: Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama 35294, USA. bbourge@uab.edu
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bourge
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Philip B
authors.initials: PB
authors.lastname: Adamson
authors.forename: Mark F
authors.initials: MF
authors.lastname: Aaron
authors.forename: Juan M
authors.initials: JM
authors.lastname: Aranda
authors.forename: Anthony
authors.initials: A
authors.lastname: Magalski
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Smith
authors.forename: Frank W
authors.initials: FW
authors.lastname: Smart
authors.forename: Mark A
authors.initials: MA
authors.lastname: O'Shaughnessy
authors.forename: Mariell L
authors.initials: ML
authors.lastname: Jessup
authors.forename: Brandon
authors.initials: B
authors.lastname: Sparks
authors.forename: David L
authors.initials: DL
authors.lastname: Naftel
authors.forename: Lynne Warner
authors.initials: LW
authors.lastname: Stevenson
mesh_terms: D000328:Adult; D000368:Aged; D001795:Blood Pressure Determination / Q000295:instrumentation*; D015924:Blood Pressure Monitors; D005260:Female; D006333:Heart Failure / Q000175:diagnosis* / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D019736:Prostheses and Implants; D012720:Severity of Illness Index; D016037:Single-Blind Method; D017725:Ventricular Pressure