Clinical Research
Heart Failure
Randomized Controlled Trial of an Implantable Continuous Hemodynamic Monitor in Patients With Advanced Heart Failure: The COMPASS-HF Study

https://doi.org/10.1016/j.jacc.2007.10.061Get rights and content
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Objectives

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.

Abbreviations and Acronyms

CRT
cardiac resynchronization therapy
EF
ejection fraction
ePAD
estimated pulmonary artery diastolic pressure
HF
heart failure
ICD
implantable cardioverter-defibrillator
ICHM
implantable continuous hemodynamic monitor
NYHA
New York Heart Association

Cited by (0)

This study was supported by Medtronic Inc., Minneapolis, Minnesota.

1

Dr. Bourge received a research grant from, honoraria from, and was a consultant/advisory board member for Medtronic Inc.

2

Dr. Abraham received a research grant from, honoraria from, and was a consultant/advisory board member for Medtronic Inc.

3

Dr. Adamson received research grants from Sigma-Tau, Medtronic Inc., and Cardiomems; honoraria from Medtronic Inc. and Sigma-Tau; and was a consultant/advisory board member for Medtronic Inc., Cardiomems, GlaxoSmithKline, and Sigma-Tau.

4

Dr. Aaron received a research grant from Medtronic Inc., was a Speakers’ Bureau member for GlaxoSmithKline, received honoraria from Medtronic Inc., and was a consultant/advisory board member for Medtronic Inc.

5

Dr. Aranda received honoraria from and was a consultant/advisory board member for Medtronic Inc.

6

Dr. Zile received a research grant from and was a consultant/advisory board member for Medtronic Inc.

7

Dr. Smith was a consultant/advisory board member for Medtronic Inc.

8

Dr. Smart was a Speakers’ Bureau member for Scios and BioSite, and received honoraria from Scios, BioSite, and Thoratec.

9

Dr. Jessup was a Speakers’ Bureau member for Medtronic Inc., GlaxoSmithKline, and AstraZeneca and was a consultant/advisory board member for GlaxoSmithKline, Ventracor, Medtronic Inc., and ACORN.

10

Dr. Sparks has ownership interest in and is employed by Medtronic Inc.

11

Dr. Stevenson received a research grant from, honoraria from, and was a consultant/advisory board member for Medtronic Inc.