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SERVE-HF: More Questions Than Answers
Shahrokh Javaheri1, Lee K Brown2, Winfried Randerath3
1Sleep Laboratory, Bethesda North Hospital, Cincinnati, OH.
Insights
The SERVE-HF trial found adaptive servoventilation (ASV) ineffective for central sleep apnea (CSA) in heart failure patients, raising safety concerns. Alternative explanations for trial results, beyond the authors
Area of Science:
- Cardiology
- Pulmonology
- Sleep Medicine
- Medical Device Technology
Background:
- The SERVE-HF trial investigated adaptive servoventilation (ASV) for central sleep apnea (CSA) in patients with heart failure and reduced ejection fraction (HFrEF).
- Published results indicated ASV was ineffective and associated with increased cardiovascular mortality in treated patients.
- The trial authors suggested CSA might be a compensatory mechanism in HFrEF, explaining the adverse outcomes.
Purpose of the Study:
- To critically evaluate the SERVE-HF trial findings regarding ASV treatment for CSA in HFrEF patients.
- To propose alternative explanations for the trial's safety concerns and ineffectiveness findings.
- To highlight potential methodological limitations and confounding factors not adequately addressed in the original study.
Main Methods:
- Commentary and critical analysis of the SERVE-HF trial data and published results.
- Examination of potential methodological issues, including the ASV device generation and constrained therapeutic settings.
- Consideration of patient selection, data collection, adherence, and group crossovers as potential confounding factors.
Main Results:
- The commentary questions the trial's conclusion that CSA is a protective mechanism in HFrEF.
- Identified potential limitations in the ASV device used, which may not reflect current clinical practice.
- Suggested that methodological shortcomings and unaddressed confounding factors could explain the observed adverse outcomes.
Conclusions:
- The results of the SERVE-HF trial may be influenced by factors beyond the primary hypothesis.
- Further post hoc analysis of the SERVE-HF data is warranted to explore alternative explanations.
- This analysis provides critical insights for clinicians managing HFrEF patients with CSA.
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.
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