Abstract
BackgroundsTo explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices).MethodsThe OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups (k-means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer’s software for 6 months.ResultsOne hundred seventy-seven patients (87.57% male) were analysed with a median (IQ25–75) initial Apnea-Hypopnea-Index of 50 (38–62)/h, an ASV-treatment duration of 2.88 (1.76–4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k-means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 (p = 0.029) and C4 (p = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 (p = 0.006) and C2 (p < 0.001). MV differences between ASV-F (p = 0.002) and ASV-V (p < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type.ConclusionsReal-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety.Trial registrationThe OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986). 1 April 2015.
Highlights
Adaptive Servo-Ventilation (ASV) is a non-invasive ventilatory therapy that provides positive expiratory airway pressure and inspiratory pressure support based on servo-controlled-flow or -volume monitoring [1,2,3,4]
SDB groups did not differ in ASV settings, MV or therapeutic pressures
Real-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful
Summary
Adaptive Servo-Ventilation (ASV) is a non-invasive ventilatory therapy that provides positive expiratory airway pressure and inspiratory pressure support based on servo-controlled-flow or -volume monitoring [1,2,3,4]. Unlike preliminary data demonstating short term benefits in terms of symptoms and physiology [6], the randomized SERVE-HF study reported an unexpected increase in cardiovascular mortality with ASV-treatment [7] To explain these conflicting results, it was hypothesized that the high-pressure ASV default settings used in the SERVE-HF study could lead to an inappropriate ventilation with cascading negative consequences (i.e. pro-arrythmogenic effects through alkalosis and hypocapnia related to hyperventilation, and a direct lower cardiac output through ASV-pressurization) [8,9,10]. The potential for cardiac output worsening due to specific pressure levels is not always counterbalanced by the neurovegetative response [19, 20, 22] and at-risk patients are likely those with a low pulmonary capillary wedge pressure [18] and a right ventricular dysfunction [19]
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