Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure.

Abstract

BACKGROUND:

Central sleep apnea is associated with poor prognosis and death in patients with heart failure. Adaptive servo-ventilation is a therapy that uses a noninvasive ventilator to treat central sleep apnea by delivering servo-controlled inspiratory pressure support on top of expiratory positive airway pressure. We investigated the effects of adaptive servo-ventilation in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea.

METHODS:

We randomly assigned 1325 patients with a left ventricular ejection fraction of 45% or less, an apnea-hypopnea index (AHI) of 15 or more events (occurrences of apnea or hypopnea) per hour, and a predominance of central events to receive guideline-based medical treatment with adaptive servo-ventilation or guideline-based medical treatment alone (control). The primary end point in the time-to-event analysis was the first event of death from any cause, lifesaving cardiovascular intervention (cardiac transplantation, implantation of a ventricular assist device, resuscitation after sudden cardiac arrest, or appropriate lifesaving shock), or unplanned hospitalization for worsening heart failure.

RESULTS:

In the adaptive servo-ventilation group, the mean AHI at 12 months was 6.6 events per hour. The incidence of the primary end point did not differ significantly between the adaptive servo-ventilation group and the control group (54.1% and 50.8%, respectively; hazard ratio, 1.13; 95% confidence interval [CI], 0.97 to 1.31; P=0.10). All-cause mortality and cardiovascular mortality were significantly higher in the adaptive servo-ventilation group than in the control group (hazard ratio for death from any cause, 1.28; 95% CI, 1.06 to 1.55; P=0.01; and hazard ratio for cardiovascular death, 1.34; 95% CI, 1.09 to 1.65; P=0.006).

CONCLUSIONS:

Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea, but all-cause and cardiovascular mortality were both increased with this therapy. (Funded by ResMed and others; SERVE-HF ClinicalTrials.gov number, NCT00733343.).

• Authors: Martin R Cowie, Holger Woehrle, Karl Wegscheider, Christiane Angermann, Marie-Pia d'Ortho, Erland Erdmann, Patrick Levy, Anita K Simonds, Virend K Somers, Faiez Zannad, Helmut Teschler
• Journal: The New England journal of medicine (N Engl J Med) Vol. 373 Issue 12 Pg. 1095-105 (Sep 17 2015) ISSN: 1533-4406 [Electronic] United States
• PMID: 26323938 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Cardiovascular Diseases (etiology, mortality)
• Female
• Heart Failure, Systolic (complications, physiopathology, therapy)
• Hospitalization
• Humans
• Intention to Treat Analysis
• Male
• Middle Aged
• Positive-Pressure Respiration (adverse effects, methods)
• Sleep Apnea, Central (complications, therapy)
• Stroke Volume
• Treatment Failure