Abstract
Nocturnal hypoxemic burden is established as a robust prognostic metric of sleep-disordered breathing (SDB) to predict mortality and treating hypoxemic burden may improve prognosis. The aim of this study was to evaluate improvements in nocturnal hypoxemic burden using transvenous phrenic nerve stimulation (TPNS) to treat patients with central sleep apnea (CSA). The remedē System Pivotal Trial population was examined for nocturnal hypoxemic burden. The minutes of sleep with oxygen saturation < 90% significantly improved in Treatment compared with control (p < .001), with the median improving from 33 min at baseline to 14 min at 6 months. Statistically significant improvements were also observed for average oxygen saturation and lowest oxygen saturation. Hypoxemic burden has been demonstrated to be more predictive for mortality than apnea–hypopnea index (AHI) and should be considered a key metric for therapies used to treat CSA. Transvenous phrenic nerve stimulation is capable of delivering meaningful improvements in nocturnal hypoxemic burden. There is increasing interest in endpoints other than apnea–hypopnea index in sleep-disordered breathing. Nocturnal hypoxemia burden may be more predictive for mortality than apnea–hypopnea index in patients with poor cardiac function. Transvenous phrenic nerve stimulation is capable of improving nocturnal hypoxemic burden.Graphical
Highlights
The apnea–hypopnea index (AHI), defined as the number of apnea and hypopnea events per hour of sleep, has been the most commonly used measure to describe the burden of sleepAssociate Editor Marat Fudim oversaw the review of this article.Ruhr-Universität Bochum, Georgstr. 11, D-32545 Bad Oeynhausen, Germany 4 Advocate Heart Institute, Naperville, IL, USA 5 Respicardia, Inc, Minnetonka, MN, USA apnea [1]
Despite the AHI being easy to measure by a sleep laboratory and easy to understand by clinicians for the diagnosis of sleep apnea, questions persist about whether AHI describes the complete picture of the severity of both central and obstructive sleep apnea [3]
The remedē System Pivotal Trial investigated patients with moderate to severe central sleep apnea (CSA) and the results demonstrated 60% of patients using transvenous phrenic nerve stimulation experienced a 50% or greater reduction in AHI at 6 months [11]
Summary
The apnea–hypopnea index (AHI), defined as the number of apnea and hypopnea events per hour of sleep, has been the most commonly used measure to describe the burden of sleepAssociate Editor Marat Fudim oversaw the review of this article.Ruhr-Universität Bochum, Georgstr. 11, D-32545 Bad Oeynhausen, Germany 4 Advocate Heart Institute, Naperville, IL, USA 5 Respicardia, Inc, Minnetonka, MN, USA apnea [1]. The apnea–hypopnea index (AHI), defined as the number of apnea and hypopnea events per hour of sleep, has been the most commonly used measure to describe the burden of sleep. The AHI was initially developed for use in measuring severity of obstructive sleep apnea (OSA) and was adopted for central sleep apnea (CSA), even though the mechanisms and deleterious impacts of the disorders are very different [2]. CSA does not always result in significant oxygen desaturation as typically seen in OSA, and the AHI does not adequately describe desaturation by its current definition [3]. Reducing CSA severity leads to improvements in AHI that should translate to improved oxygenation during sleep [4, 5]. A therapy may reduce the impact of each event if the depth of the desaturation is lessened or event duration is shortened, even if some apnea
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