Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Apr;14(2):377-385.
doi: 10.1007/s12265-020-10061-0. Epub 2020 Aug 12.

Improving Nocturnal Hypoxemic Burden with Transvenous Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea

Olaf Oldenburg  1   2   3 , Maria Rosa Costanzo  4 , Robin Germany  5 , Scott McKane  5 , Timothy E Meyer  5 , Henrik Fox  6   7
Affiliations
Randomized Controlled Trial

Improving Nocturnal Hypoxemic Burden with Transvenous Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea

Olaf Oldenburg et al. J Cardiovasc Transl Res. 2021 Apr.

Erratum in

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 Abstract.

Trial registration: ClinicalTrials.gov NCT01816776.

Keywords: Central sleep apnea; Hypoxemic burden; Phrenic nerve stimulation.

PubMed Disclaimer

Conflict of interest statement

The authors have the following conflicts of interest to declare: Fox: no conflict of interest to declare regarding this manuscript. Oldenburg: no conflict of interest to declare regarding this manuscript. Costanzo: was the Primary Investigator for the trial. Germany, McKane and Meyer: Employees of Respicardia.

Figures

None
Graphical Abstract
Fig. 1
Fig. 1
CONSORT Diagram, Composition of the per protocol population with sleep study results through the 6-month visit, PSG = polysomnogram
Fig. 2
Fig. 2
Central Apnea Index Percentage Reduction from baseline to 6 Months for each subject, each vertical bar represents the percentage reduction (improvement) in the central apnea index from baseline to 6 months for a subject. The green bars (> 0%) represent reduction and red (< 0%) represent increase. Actual percentage increase for control subject results beyond the scale are noted at the bottom of the bars, CAI = central apnea index
Fig. 3
Fig. 3
Median (interquartile range) of minutes with oxygen saturation < 90%, median (and interquartile range) minutes with oxygen saturation < 90% at baseline and 6 months for the full per protocol population (A) and the subgroup with heart failure and ejection fraction ≤ 45% (B). P value from Mann–Whitney test for difference in change from baseline between groups (2-sided)
Fig. 4
Fig. 4
Oxygen saturation < 90% improvement from baseline to 6 months for each subject. Each vertical bar represents the reduction (improvement) in minutes of sleep with oxygen saturation < 90% from baseline to 6 months for a subject. The green bars (> 0%) represent reduction and red (< 0%) represent increase. Actual percentage increase for control subject results beyond the scale are noted at the bottom of the bars, Min = minutes; T90 = minutes of sleep with oxygen saturation < 90%
See this image and copyright information in PMC

References

    1. Berry, R. B., Budhiraja, R., Gottlieb, D. J., Gozal, D., Iber, C., Kapur, V. K., Marcus, C. L., Mehra, R., Parthasarathy, S., Quan, S. F., Redline, S., Strohl, K. P., Davidson Ward, S. L., Tangredi, M. M., & M American Academy of Sleep. (2012). Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 10.5664/jcsm.2172. - PMC - PubMed
    1. Khayat, R., Jarjoura, D., Porter, K., Sow, A., Wannemacher, J., Dohar, R., Pleister, A., & Abraham, W. T. (2015). Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. European Heart Journal. 10.1093/eurheartj/ehu522. - PMC - PubMed
    1. Oldenburg, O., Wellmann, B., Buchholz, A., Bitter, T., Fox, H., Thiem, U., Horstkotte, D., & Wegscheider, K. (2016). Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. European Heart Journal. 10.1093/eurheartj/ehv624. - PubMed
    1. Javaheri, S., Barbe, F., Campos-Rodriguez, F., Dempsey, J. A., Khayat, R., Javaheri, S., Malhotra, A., Martinez-Garcia, M. A., Mehra, R., Pack, A. I., Polotsky, V. Y., Redline, S., & Somers, V. K. (2017). Sleep apnea: types, mechanisms, and clinical cardiovascular consequences. Journal of the American College of Cardiology. 10.1016/j.jacc.2016.11.069. - PMC - PubMed
    1. Spiesshoefer, J., Linz, D., Skobel, E., Arzt, M., Stadler, S., Schoebel, C., Fietze, I., Penzel, T., Sinha, A. M., Fox, H., Oldenburg, O., & EVO On Behalf Of The German Cardiac Society Working Group On Sleep Disordered Breathing Ag-Deutsche Gesellschaft Fur Kardiologie Herz Und Kreislaufforschung. (2019). Sleep—the yet underappreciated player in cardiovascular diseases: a clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. European Journal of Preventive Cardiology. 10.1177/2047487319879526. - PubMed

Publication types

MeSH terms

Associated data

LinkOut - more resources