TY - JOUR
T1 - Adaptive servo-ventilation for central sleep apnoea in systolic heart failure
T2 - results of the major substudy of SERVE-HF
AU - Cowie, Martin R.
AU - Woehrle, Holger
AU - Wegscheider, Karl
AU - Vettorazzi, Eik
AU - Lezius, Susanne
AU - Koenig, Wolfgang
AU - Weidemann, Frank
AU - Smith, Gillian
AU - Angermann, Christiane
AU - d'Ortho, Marie Pia
AU - Erdmann, Erland
AU - Levy, Patrick
AU - Simonds, Anita K.
AU - Somers, Virend K.
AU - Zannad, Faiez
AU - Teschler, Helmut
N1 - Funding Information:
The authors thank the CRI (Clinical Research Institute) for their expertise in overseeing the SERVE-HF trial. Medical writing support was provided by Nicola Ryan, independent medical writer, and statistical calculations were supported by Anika Buchholz, Christine Eulenburg, and Anna Suling, funded by ResMed. M.R.C. and A.K.S.’s salaries are supported by the National Institute for Health Research Cardiovascular and Respiratory Biomedical Research Units, respectively, at the Royal Brompton Hospital, London, UK.
Funding Information:
This work was supported by ResMed. Representatives and scientists from the ResMed participated in the study including design, data collation, data analysis, and critical review of the paper. Conflicts of interest: M.R.C. reports receiving consulting fees from Servier, Novartis, Pfizer, St. Jude Medical, Boston Scientific, Respicardia, and Medtronic and grant support through his institution from Bayer. H.W. was employed by ResMed during the conduct of the study, and reports receiving lecture fees from Vital Air, Boehringer Ingelheim and ResMed, and research support from ResMed. K.W. receiving grant support from ResMed and personal fees from Biotronik. E.V. receiving grant support from ResMed. S.L. receiving grant support from ResMed. W.K. receiving personal fees from AstraZeneca, Novartis, MSD, Amgen, Actavis, Novartis, Pfizer, The Medicines Company, GSK and Sanderling Ventures, grants and non-financial support from Abbott, Roche Diagnostics, Beckmann and Singulex. F.W. receiving lecture fees from ResMed. G.S. receiving lecture fees from ResMed. C.A. receiving grants, personal fees and non-financial support from ResMed, grants from Novartis, personal fees from Servier, grants and non-financial support from Thermo Fisher, grants and personal fees from Boehringer, Lundbeck, and Vifor. M-P.d'O. receiving fees for serving on advisory boards from ResMed and IP Sant?, lecture fees from ResMed, Philips, IP Sant?, and VitalAire, grant support from Fisher and Paykel Healthcare, ResMed, Philips, ADEP Assistance, and IP Sant?, and small material donations from VitalAire. E.E., P.L. and A.K. report no potential conflicts of interest outside the submitted work. V.S. receiving consulting fees from PriceWaterhouseCoopers, Sorin, 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 apnoea. F.Z. receiving personal fees from ResMed, Janssen, Bayer, Pfizer, Novartis, Boston Scientific, Takeda, Amgen and CVRx. H.T. receiving consulting fees, grant support, and hardware and software for the development of devices from ResMed. The majority of these conflicts of interest is outside the submitted work. The authors thank the CRI (Clinical Research Institute) for their expertise in overseeing the SERVE-HF trial. Medical writing support was provided by Nicola Ryan, independent medical writer, and statistical calculations were supported by Anika Buchholz, Christine Eulenburg, and Anna Suling, funded by ResMed.
Publisher Copyright:
© 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology
PY - 2018/3
Y1 - 2018/3
N2 - Aims: The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. Methods and results: In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. Conclusion: In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.
AB - Aims: The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. Methods and results: In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. Conclusion: In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.
KW - Adaptive servo-ventilation
KW - Biomarkers
KW - Cardiac function
KW - Central sleep apnoea
KW - Heart failure
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U2 - 10.1002/ejhf.1048
DO - 10.1002/ejhf.1048
M3 - Article
C2 - 29193576
AN - SCOPUS:85029923106
SN - 1388-9842
VL - 20
SP - 536
EP - 544
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 3
ER -