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Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial.
J Am Coll Cardiol 2017; 69(12):1577-1587JACC

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).

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28335841

Citation

O'Connor, Christopher M., et al. "Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: the CAT-HF Trial." Journal of the American College of Cardiology, vol. 69, no. 12, 2017, pp. 1577-1587.
O'Connor CM, Whellan DJ, Fiuzat M, et al. Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. J Am Coll Cardiol. 2017;69(12):1577-1587.
O'Connor, C. M., Whellan, D. J., Fiuzat, M., Punjabi, N. M., Tasissa, G., Anstrom, K. J., ... Oldenburg, O. (2017). Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. Journal of the American College of Cardiology, 69(12), pp. 1577-1587. doi:10.1016/j.jacc.2017.01.041.
O'Connor CM, et al. Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: the CAT-HF Trial. J Am Coll Cardiol. 2017 03 28;69(12):1577-1587. PubMed PMID: 28335841.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial. AU - O'Connor,Christopher M, AU - Whellan,David J, AU - Fiuzat,Mona, AU - Punjabi,Naresh M, AU - Tasissa,Gudaye, AU - Anstrom,Kevin J, AU - Benjafield,Adam V, AU - Woehrle,Holger, AU - Blase,Amy B, AU - Lindenfeld,JoAnn, AU - Oldenburg,Olaf, PY - 2016/12/01/received PY - 2016/12/23/revised PY - 2017/01/02/accepted PY - 2017/3/25/entrez PY - 2017/3/25/pubmed PY - 2017/7/14/medline KW - 6-min walk distance KW - HFpEF KW - acute heart failure KW - mortality KW - sleep apnea SP - 1577 EP - 1587 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 69 IS - 12 N2 - 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). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/28335841/Cardiovascular_Outcomes_With_Minute_Ventilation_Targeted_Adaptive_Servo_Ventilation_Therapy_in_Heart_Failure:_The_CAT_HF_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(17)30439-4 DB - PRIME DP - Unbound Medicine ER -