title: Application of implantable hemodynamic monitoring in the management of patients with diastolic heart failure: a subgroup analysis of the COMPASS-HF trial.
abstract: BACKGROUND
  Nearly half of all patients with chronic heart failure (HF) have a normal ejection fraction (EF), and abnormal diastolic function (ie, diastolic heart failure [DHF]). However, appropriate management of DHF patients remains a difficult and uncertain challenge.
  
  
  RESULTS
  The Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial was designed to evaluate whether an implantable hemodynamic monitor (IHM) was safe and effective in reducing the number of heart failure-related events (HFRE) in patients with chronic HF. The current study presents data on a prespecified and planned subgroup analysis from the COMPASS-HF trial: 70 patients with an EF > or =50% (ie, DHF). As such, this represents a subgroup analysis of the COMPASS-HF Trial. DHF patients were randomized to IHM-guided care (treatment) vs. standard care (control) for 6 months. All 70 patients received optimal medical therapy, but the hemodynamic information from the IHM was used to guide patient management only in the treatment group. The HFRE rate in DHF patients randomized to treatment was 0.58 events/6 months compared with DHF patients randomized to control, which was 0.73 events/6 months; this represented a 20% nonsignificant reduction in the overall HFRE rate in the treatment group (95% CI = -46, 56, P = .66). There was a 29% nonsignificant reduction in the relative risk of a HF hospitalization in the DHF patients randomized to treatment compared with DHF patients randomized to control (95% CI = -69, 70, P = .43).
  
  
  CONCLUSIONS
  The IHM was shown to be safe and was associated with a very low system-related and procedure-related complication rate in DHF patients. However, in this subgroup analysis limited to 70 DHF patients, the addition IHM-guided care did not significantly lower the rate of HFR events. The results of this subgroup analysis in DHF patients, for whom there are currently no proven, effective management strategies, will be used to design future studies defining the effects of IHM-guided care in patients with DHF.
authors.affiliation: Division of Cardiology, Departmentof Medicine, Medical University of South Carolina and RHJ Department of Veterans Affairs Medical Center, Charleston, SC 29425, USA. zilem@musc.edu
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bourge
authors.forename: Tom D
authors.initials: TD
authors.lastname: Bennett
authors.forename: Lynne Warner
authors.initials: LW
authors.lastname: Stevenson
authors.forename: Yong K
authors.initials: YK
authors.lastname: Cho
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: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Frank W
authors.initials: FW
authors.lastname: Smart
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Kueffer
mesh_terms: D000368:Aged; D015331:Cohort Studies; D019468:Disease Management; D005260:Female; D054144:Heart Failure, Diastolic / Q000175:diagnosis / Q000503:physiopathology* / Q000628:therapy*; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation* / Q000379:methods*; D019736:Prostheses and Implants