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Randomized Controlled Trial
. 2021 Jul;110(7):983-992.
doi: 10.1007/s00392-020-01701-1. Epub 2020 Jul 10.

Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction

Henrik Fox #  1   2 , Thomas Bitter #  3 , Odile Sauzet  4 , Volker Rudolph  5   3 , Olaf Oldenburg  3   6
Affiliations
Randomized Controlled Trial

Automatic positive airway pressure for obstructive sleep apnea in heart failure with reduced ejection fraction

Henrik Fox et al. Clin Res Cardiol. 2021 Jul.

Abstract

Background: Moderate-to-severe obstructive sleep apnea (OSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HFrEF), and is associated with worsening cardiac function and increased mortality.

Objectives: The automatic positive airway pressure (APAP) trial tested the impact of APAP treatment on changes for the pre-specified endpoints: changes in peak oxygen uptake (peak VO2), percent-predicted peak VO2 and oxygen uptake at anaerobic threshold (VO2-AT).

Methods: This randomized, controlled pilot study included patients with chronic, stable HFrEF who had moderate-to-severe OSA. Patients were randomized 1:1 to either APAP (AutoSet™, ResMed) or nasal strips (control) for 6 months.

Results: 76 patients have been randomized and 58 had complete data for final analysis. There was a statistically significant change in the APAP intervention arm for the primary endpoint percent-predicted peak VO2 in comparison to control (67 ± 17 to 73 ± 19%; p = 0.01). Additional primary endpoints peak VO2 and VO2-AT showed a trend in increase in the APAP group. Moreover, there were significant improvements within the APAP group for hypoxemia, left ventricular function and quality of life from baseline to 6 months, but not within the control group (p = 0.001 and p = 0.037, respectively).

Conclusion: APAP intervention was shown to significantly improve outcome compared to control group, represented in percent-predicted peak VO2, an established surrogate marker for cardiovascular prognosis in HFrEF. APAP has additional beneficial effects on hypoxemia, cardiac function and quality of life.

Keywords: Heart failure with reduced ejection fraction; Obstructive sleep apnea; Positive airway pressure; Sleep-disordered breathing.

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Conflict of interest statement

All authors state that they have no conflicts of interest to declare regarding the content of this study.

Figures

Fig. 1
Fig. 1
Study design and key finding. Intervention through APAP therapy for 6 months significantly improved primary endpoint percent-predicted peak VO2 in HFrEF patients with confirmed moderate-to-severe obstructive sleep apnea. APAP automatic positive airway pressure, HFrEF heart failure with reduced ejection fraction, OSA obstructive sleep apnea, Peak VO2 peak oxygen consumption
Fig. 2
Fig. 2
Patient flow. APAP automatic positive airway pressure, CPX cardiopulmonary exercise testing, HFrEF heart failure with reduced ejection fraction, OSA obstructive sleep apnea, PSG polysomnography, SDB sleep-disordered breathing. Exclusion criteria were: cardiac resynchronization therapy within the last 12 weeks, significant chronic obstructive pulmonary disease (forced expiratory volume in 1 s/vital capacity < 70%), respiratory insufficiency requiring home oxygen therapy, hypercapnia (pCO2 > 45 mmHg), current treatment with any kind of positive airway pressure therapy, relevant treatment-emergent central sleep apnea (complex sleep apnea), restless legs syndrome (untreated or non-treatable), any cardiac surgery and/or percutaneous coronary intervention within the last 12 weeks, myocardial infarction (STEMI and non-STEMI), unstable angina or any kind of stroke within the last 12 weeks, acute myocarditis within the last 12 weeks, pregnancy or breast feeding
See this image and copyright information in PMC

References

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