Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo-Ventilation in Patients With Heart Failure - SERVE-HF

Sep 01, 2015
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Presenter/Author:
Martin R. Cowie, MD, MSc, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
ResMed
Date Presented:
09/01/2015
Original Posted Date:
09/01/2015
References

Description:

The goal of the trial was to evaluate treatment with adaptive servo-ventilation among subjects with heart failure with reduced ejection fraction and central sleep apnea. Adaptive servo-ventilation uses inspiratory pressure support, plus expiratory positive airway pressure.

Contribution to the Literature: The SERVE-HF trial showed that adaptive servo-ventilation was not beneficial, but instead was associated with increased all-cause and cardiovascular mortality.

Study Design

  • Randomized
  • Parallel

Subjects with heart failure and central sleep apnea were randomized to adaptive servo-ventilation (n = 666) versus optimal medical management (n = 659).

Inclusion criteria:

  • Subjects ≥22 years of age with chronic heart failure due to left ventricular ejection fraction ≤45%
  • New York Heart Association (NYHA) class II-IV symptoms
  • Apnea-hypopnea index ≥15 events per hour (majority central events)
  • Total number of enrollees: 1,315
  • Duration of follow-up: Median 31 months
  • Mean patient age: 69 years
  • Percentage female: 9%
  • Percentage diabetics: 39%
  • Mean left ventricular ejection fraction = 33%
  • Antiarrhythmic drug therapy: 19% in the adaptive servo-ventilation group vs. 14% in the control group (p = 0.005)

Principal Findings:

At 12 months, the apnea-hypopnea index was 6.6 events per hour in the adaptive servo-ventilation group.

The primary outcome of all-cause mortality, lifesaving cardiovascular intervention, or hospitalization for heart failure occurred in 54.1% of the adaptive servo-ventilation group versus 50.8% of the control group (p = 0.10).

Secondary outcomes:

  • All-cause mortality: 34.8% vs. 29.3% (p = 0.01), respectively, for ventilation vs. control
  • Cardiovascular mortality: 29.9% vs. 24.0% (p = 0.006), respectively, for ventilation vs. control

Adaptive servo-ventilation was not associated with an improvement in heart failure symptoms or quality of life.

Interpretation:

Among patients with chronic heart failure and predominantly central sleep disordered breathing, adaptive servo-ventilation was not beneficial. This was despite a significant reduction in the apnea-hypopnea index at 12 months. The increase in all-cause and cardiovascular mortality with adaptive servo-ventilation was unexpected and unexplained. The treatment of heart failure patients with obstructive sleep apnea remains continuous positive airway pressure; therefore, it is important that these patients are appropriately studied and delineated from those with central sleep apnea.

References:

Cowie MR, Woehrle H, Wegscheider K, et al. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med 2015;373:1095-105.

Editorial: Magalang UJ, Pack AI. Heart Failure and Sleep-Disordered Breathing — The Plot Thickens. N Engl J Med 2015;373:1166-7.

Presented by Dr. Martin Cowie at the European Society of Cardiology Congress, London, September 1, 2015.

Keywords: Apnea, Continuous Positive Airway Pressure, Heart Failure, Primary Prevention, Respiration, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, ESC Congress


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