Chest
CommentarySERVE-HF: More Questions Than Answers
Section snippets
Population Characterization and Protocol Adherence
A critical inclusion criterion was the requirement that enrolled subjects have a documented left ventricular ejection fraction (LVEF) ≤ 45%. However, a range of LVEF values from 9.0% to 71.0% in the control arm and 10.0% to 54.0% in the ASV arm are noted in Table 1 in the article.1 Therefore, a number of patients did not meet the inclusion criteria and had heart failure with preserved ejection fraction (HFpEF). We have been informed, however, that only a small number of patients had HFpEF (oral
Intervention Methodology and Adaptive Servoventilation Issues
The particular ASV device used in SERVE-HF was a first-generation model no longer manufactured by the sponsor. This technology may have applied pressures that were too low for some patients and excessive for others, with adverse cardiovascular consequences. As detailed in a recent publication,7 later generations of ASV devices have incorporated important advances in technology that might have affected the ultimate results had they been used in this trial.
First, the ASV device used in SERVE-HF
Analysis
The study was designed to detect a difference in primary and secondary composite end points that included mortality and readmissions. The statistical design relied on a closed testing method, in which there was no type 1 error control for any outcomes other than the composite primary end point. There was no preplanned analysis or hypothesis testing strategy for mortality in the trial design as was stated in the trial’s design paper6 and the final published trial.1 Consequently, examination of
Acknowledgments
Financial/nonfinancial disclosures: The authors have reported to CHEST the following: S. J. has received honoraria for presentations from Philips Respironics and ResMed Corporation. He is also consultant to Respicardia. L. K. B. serves on the Polysomnography Practice Advisory Committee of the New Mexico Medical Board and chairs the New Mexico Respiratory Care Advisory Board. He has served on a focus group for Koninklijke Philips N.V/Philips Respironics and is a consultant for Considine and
References (27)
- et al.
Positive airway pressure therapy with adaptive servoventilation: part 1: operational algorithms
Chest
(2014) - et al.
Clinical significance of acid-base balance in an emergency setting in patients with acute heart failure
J Cardiol
(2012) - et al.
Association of smoking, sleep apnea, and plasma alkalosis with nocturnal ventricular arrhythmias in men with systolic heart failure
Chest
(2012) - et al.
Relationship of current and past smoking to mortality and morbidity in patients with left ventricular dysfunction
J Am Coll Cardiol
(2001) - et al.
Adaptive servo-ventilation for central sleep apnea in systolic heart failure
N Engl J Med
(2015) - et al.
Clinical applications of positive airway pressure therapy with adaptive servo-ventilation: part 2
Chest
(2014) - et al.
Adaptive servo-ventilation for the treatment of central sleep apnea in congestive heart failure: What have we learned?
Curr Opin Pulm Med
(2014) - et al.
Sleep disordered breathing and post-discharge mortality in patients with acute heart failure
Eur Heart J
(2015) - et al.
Suppression of central sleep apnea by continuous positive airway pressure and transplant-free survival in heart failure: a post hoc analysis of the Canadian Continuous Positive Airway Pressure for Patients with Central Sleep Apnea and Heart Failure Trial (CANPAP)
Circulation
(2007) - et al.
Rationale and design of the SERVE-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure
Eur J Heart Fail
(2013)