title: SERVE-HF: More Questions Than Answers.
abstract: The recent online publication of the SERVE-HF trial that evaluated the effect of treating central sleep apnea (CSA) with an adaptive servoventilation (ASV) device in patients with heart failure and reduced ejection fraction (HFrEF) has raised serious concerns about the safety of ASV in these patients. Not only was ASV ineffective but post hoc analysis found excess cardiovascular mortality in treated patients. The authors cited as one explanation an unfounded notion that CSA is a compensatory mechanism with a protective effect in HFrEF patients. We believe that there are several possible considerations that are more likely to explain the results of SERVE-HF. In this commentary, we consider methodological issues including the use of a previous-generation ASV device that constrained therapeutic settings to choices that are no longer in wide clinical use. Patient selection, data collection, and treatment adherence as well as group crossovers were not discussed in the trial as potential confounding factors. We have developed alternative reasons that could potentially explain the results and that can be explored by post hoc analysis of the SERVE-HF data. We believe that our analysis is of critical value to the field and of particular importance to clinicians treating these patients.
authors.affiliation: Sleep Laboratory, Bethesda North Hospital, Cincinnati, OH. Electronic address: shahrokhjavaheri@icloud.com.
authors.forename: Shahrokh
authors.initials: S
authors.lastname: Javaheri
authors.affiliation: Departments of Internal Medicine and Electrical and Computer Engineering, University of New Mexico, Albuquerque, NM.
authors.forename: Lee K
authors.initials: LK
authors.lastname: Brown
authors.affiliation: Center of Sleep and Ventilatory Medicine, Bethanien Hospital, University of Cologne, Solingen, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Randerath
authors.affiliation: Sleep Heart Program, the Ohio State University, Columbus, OH.
authors.forename: Rami
authors.initials: R
authors.lastname: Khayat
mesh_terms: D002318:Cardiovascular Diseases / Q000401:mortality; D002639:Cheyne-Stokes Respiration / Q000628:therapy*; D002986:Clinical Trials as Topic; D019983:Guideline Adherence; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006801:Humans; D011175:Positive-Pressure Respiration / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D012121:Respiration, Artificial / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D020182:Sleep Apnea, Central / Q000628:therapy*; D013318:Stroke Volume
keywords: Hunter-Cheyne-Stokes breathing; adaptive servoventilation; cardiac arrhythmia; central sleep apnea; congestive heart failure; noninvasive ventilation; sudden cardiac death