Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial

Christopher M O'Connor; David J Whellan; Mona Fiuzat; Naresh M Punjabi; Gudaye Tasissa; Kevin J Anstrom; Adam V Benjafield; Holger Woehrle; Amy B Blase; JoAnn Lindenfeld; Olaf Oldenburg

doi:10.1016/j.jacc.2017.01.041

Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial

J Am Coll Cardiol. 2017 Mar 28;69(12):1577-1587. doi: 10.1016/j.jacc.2017.01.041.

Authors

Affiliations

¹ Duke University and Duke Clinical Research Institute, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia. Electronic address: christopher.oconnor@inova.org.
² Thomas Jefferson University, Philadelphia, Pennsylvania.
³ Duke University and Duke Clinical Research Institute, Durham, North Carolina.
⁴ Johns Hopkins University, Baltimore, Maryland.
⁵ ResMed Science Center, ResMed Corp, San Diego, California.
⁶ ResMed Science Center, Martinsried, Germany; Sleep and Ventilation Center Blaubeuren, Respiratory Center Ulm, Ulm, Germany.
⁷ Vanderbilt University, Nashville, Tennessee.
⁸ Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.

PMID: 28335841
DOI: 10.1016/j.jacc.2017.01.041

Abstract

Background: Sleep apnea is common in hospitalized heart failure (HF) patients and is associated with increased morbidity and mortality.

Objectives: The CAT-HF (Cardiovascular Improvements With MV-ASV Therapy in Heart Failure) trial investigated whether minute ventilation (MV) adaptive servo-ventilation (ASV) improved cardiovascular outcomes in hospitalized HF patients with moderate-to-severe sleep apnea.

Methods: Eligible patients hospitalized with HF and moderate-to-severe sleep apnea were randomized to ASV plus optimized medical therapy (OMT) or OMT alone (control). The primary endpoint was a composite global rank score (hierarchy of death, cardiovascular hospitalizations, and percent changes in 6-min walk distance) at 6 months.

Results: 126 of 215 planned patients were randomized; enrollment was stopped early following release of the SERVE-HF (Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure) trial results. Average device usage was 2.7 h/night. Mean number of events measured by the apnea-hypopnea index decreased from 35.7/h to 2.1/h at 6 months in the ASV group versus 35.1/h to 19.0/h in the control group (p < 0.0001). The primary endpoint did not differ significantly between the ASV and control groups (p = 0.92 Wilcoxon). Changes in composite endpoint components were not significantly different between ASV and control. There was no significant interaction between treatment and ejection fraction (p = 0.10 Cox model); however, pre-specified subgroup analysis suggested a positive effect of ASV in patients with HF with preserved ejection fraction (p = 0.036).

Conclusions: In hospitalized HF patients with moderate-to-severe sleep apnea, adding ASV to OMT did not improve 6-month cardiovascular outcomes. Study power was limited for detection of safety signals and identifying differential effects of ASV in patients with HF with preserved ejection fraction, but additional studies are warranted in this population. (Cardiovascular Improvements With MV ASV Therapy in Heart Failure [CAT-HF]; NCT01953874).

Keywords: 6-min walk distance; HFpEF; acute heart failure; mortality; sleep apnea.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Aged
Female
Heart Failure / complications*
Heart Failure / mortality
Humans
Inpatients / statistics & numerical data
Male
Middle Aged
Positive-Pressure Respiration / methods*
Sleep Apnea Syndromes / complications
Sleep Apnea Syndromes / therapy*
United States / epidemiology

Associated data

ClinicalTrials.gov/NCT01953874