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Randomized Controlled Trial
. 2022 Dec;31(6):e13694.
doi: 10.1111/jsr.13694. Epub 2022 Jul 15.

Effect of adaptive servo ventilation on central sleep apnea and sleep structure in systolic heart failure patients: polysomnography data from the SERVE-HF major sub study

Renaud Tamisier  1 , Jean-Louis Pepin  1 , Martin R Cowie  2 , Karl Wegscheider  3 , Eik Vettorazzi  3 , Anna Suling  3 , Christiane Angermann  4 , Marie-Pia d'Ortho  5 , Erland Erdmann  6 , Anita K Simonds  7 , Virend K Somers  8 , Helmut Teschler  9 , Patrick Lévy  2 , Holger Woehrle  10
Affiliations
Randomized Controlled Trial

Effect of adaptive servo ventilation on central sleep apnea and sleep structure in systolic heart failure patients: polysomnography data from the SERVE-HF major sub study

Renaud Tamisier et al. J Sleep Res. 2022 Dec.

Erratum in

Abstract

This SERVE-HF (Treatment of Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure) sub study analysis evaluated polysomnography (PSG) data in patients with heart failure with reduced ejection fraction (HFrEF) and predominant central sleep apnea (CSA) randomised to guideline-based medical therapy, with or without adaptive servo ventilation (ASV). Patients underwent full overnight PSG at baseline and at 12 months. All PSG recordings were analysed by a core laboratory. Only data for patients with baseline and 3- or 12-month values were included. The sub study included 312 patients; the number with available PSG data differed for each variable (94-103 in the control group, 77-99 in the ASV group). After 12 months, baseline-adjusted respiratory measures were significantly better in the ASV group versus control. Although some between-group differences in sleep measures were seen at 12 months (e.g., better sleep efficiency in the ASV group), these were unlikely to be clinically significant. The number of periodic leg movements during sleep (PLMS) increased in the ASV group (p = 0.039). At 12 months, the respiratory arousal index was significantly lower in the ASV versus control group (p < 0.001), whilst the PLMS-related arousal index was significantly higher in the ASV group (p = 0.04 versus control). ASV attenuated the respiratory variables characterising sleep apnea in patients with HFrEF and predominant CSA in SERVE-HF. Sleep quality improvements during ASV therapy were small and unlikely to be clinically significant. The increase in PLMS and PLMS-related arousals during ASV warrants further investigation, particularly relating to their potential association with increased cardiovascular risk.

Keywords: adaptive servo ventilation; central sleep apnea; periodic leg movements during sleep; polysomnography; systolic heart failure.

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Conflict of interest statement

Renaud Tamisier is supported by the French National Research Agency in the framework of the “Investissements d'avenir” program (ANR‐15‐IDEX‐02), and reports grants from ResMed, during the conduct of the study, grants and personal fees from ResMed, and grants from Agiradom; Jean‐Louis Pepin is supported by the French National Research Agency in the framework of the “Investissements d'avenir” program (ANR‐15‐IDEX‐02), and reports grants from ResMed, during the conduct of the study; grants and personal fees from ResMed, grants and personal fees from Philips, grants from Fisher and Paykel, grants and personal fees from Sefam, grants from Astra‐Zeneca, grants and personal fees from Agiradom, personal fees from Elivie, grants and personal fees from Vitalaire, and personal fees from Boehringer, outside the submitted work; Martin R. Cowie reports receiving consulting fees from Servier, Bayer, Novartis, Pfizer, Abbott, Boston Scientific and Medtronic, and grant support through his institution from Bayer, ResMed and Boston Scientific; Karl Wegscheider reports grant support from ResMed and personal fees from Biotronik; Eik Vettorazzi reports grant support from ResMed; Anna Suling reports grant support from ResMed; Christiane Angermann reports grants, personal fees and non‐financial support from ResMed, grants from Novartis, personal fees from Servier, Medtronics and SJM/Abbott, grants and non‐financial support from ThermoFisher, grants and personal fees from Boehringer, and grants and personal fees from Vifor; Marie‐Pia d'Ortho reports advisory board fees from ResMed and IP Santé, lecture fees from ResMed, Philips, IP Santé and VitalAire, grant support from Fisher and Paykel Healthcare, ResMed, Philips, ADEP Assistance and IP Santé, and small material donations from VitalAire; Virend K. Somers reports consulting fees from Bayer, GlaxoSmithKline, Respicardia, uHealth, Ronda Grey, Dane Garvin, Philips, Biosense Webster, Philips Respironics and ResMed, working with Mayo Medical Ventures on intellectual property related to sleep and cardiovascular disease, and having a pending patent (12/680073) related to biomarkers of sleep apnea; Helmut Teschler reports consulting fees, grant support, and hardware and software for the development of devices from ResMed; and H.W. was employed by ResMed during the conduct of the SERVE‐HF study and has received lecture/consulting fees from Vital Air, Inspire Medical, Allergopharma, Boehringer Ingelheim, GSK, Astra Zeneca and ResMed, and research support from ResMed. Erland Erdmann, Patrick Lévy and Anita K. Simonds report no potential conflicts of interest outside the submitted work.

Figures

FIGURE 1
FIGURE 1
Arousal index (events/h) in the control (a) and adaptive servo ventilation (ASV) (b) groups (intention‐to‐treat analysis)
FIGURE 2
FIGURE 2
Periodic leg movement during sleep (PLMS) index (events/h) in the control and adaptive servo ventilation (ASV) groups (intention‐to‐treat analysis)
See this image and copyright information in PMC

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