Results that demonstrate commitment
Publications & Abstracts
We are committed to the continued publication of clinical data supporting the benefit of transvenous phrenic nerve stimulation for the treatment of central sleep apnea.
Peer-Reviewed Publications from the remedē System Pivotal Trial
Costanzo MR, Javaheri S, Ponikowski P, et al. Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. Nat Sci Sleep. 2021;13:515-526
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Fox H, Oldenburg O, Javaheri S, et al. remedē® System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea. Sleep doi.org/10.1093/sleep/zsz158.
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Costanzo MR, Ponikowski P, Javaheri S, Augostini R, Goldberg LR, Holcomb R, Kao A, Khayat RN, Oldenburg O, Stellbrink C, Abraham WT, remedē System Pivotal Trial Study Group. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
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Costanzo MR, Ponikowski P, Javaheri S, et al. Randomised Controlled Trial of Transvenous Neurostimulation for Central Sleep Apnoea. The Lancet 2016;388:974–82
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Costanzo MR, Augostini R, Goldberg LR, et al. Design of the remedē® System Pivotal Trial: A Prospective, Randomized Study in the Use of Respiratory Rhythm Management to Treat Central Sleep Apnea. J Card Fail 2015;21:892-902.
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Other Peer-Reviewed Publications
William T. Abraham, Olaf Oldenburg, Mitja Lainscak, Rami Khayat, Jerryll Asin, Piotr Ponikowski, Robin Germany, Scott McKane, Maria Rosa Costanzo. Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure. 10/18/2024; https://doi.org/10.1002/ehf2.15074
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Pépin J-L, Schwartz AR, Khayat R, Germany R, McKane S, Warde M, Ngo V, Baillieul S, Bailly S, Tamisier S. (2024). Multidimensional phenotyping to distinguish among central (CSA), obstructive (OSA) and co-existing central and obstructive sleep apnea (CSA-OSA) phenotypes in real-world data. Sleep Medicine.124:426-433
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Voigt J, Emani S, Gupta S, et al. Meta-Analysis Comparing Outcomes of Therapies for Patients With Central Sleep Apnea and Heart Failure With Reduced Ejection Fraction. Am J Cardiol 2020; https://doi.org/10.1016/j.amjcard.2020.04.011
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Schwartz AR, Sgambati FP, James KJ, et al. Novel phrenic nerve stimulator treats Cheyne-Stokes respiration: polysomnographic insights. J Clin Sleep Med. 2020;16(5):817–820.
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Fudim M, Spector AR, Costanzo M-R, Pokorney SD, Mentz RJ, Jagielski D, Augostini R, Abraham WT, Ponikowski PP, McKane SW, Piccini JP. Phrenic nerve stimulation for the treatment of central sleep apnea: a pooled cohort analysis. J Clin Sleep Med. 2019;15(12):1747–1755.
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Costanzo MR, Ponikowski P, et al. Phrenic Nerve Stimulation to Treat Patients with Central Sleep Apnea and Heart Failure. European Journal of Heart Failure 2018; doi:10.1002/ejhf.1312.
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Jagielski D, Ponikowski P, Augostini R, et al. Long-Term Safety and Efficacy of Transvenous Stimulation of the Phrenic Nerve for the Treatment of Central Sleep Apnea: Experience with the remedē® System. Eur J Heart Fail 2016 DOI: 10.1002/ejhf.593.
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Joseph S, Costanzo MR. A novel therapeutic approach for central sleep apnea: Phrenic nerve stimulation by the remedē® System. International Journal of Cardiology 2016;206:S28–S34.
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Zhang XL, Ding N, Ni B, et al. Safety and feasibility of chronic transvenous phrenic nerve stimulation for treatment of central sleep apnea in heart failure patients. Clin Respir J 2015; DOI:10.1111/crj. 12320.
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Abraham WT, Jagielski D, Oldenburg O, et al. Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea. JCHF 2015;5:360-369.
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Ponikowski P, Javaheri S, Michalkiewicz D, et al. Transvenous phrenic nerve stimulation for the treatment of central sleep apnoea in heart failure. Eur Heart J 2012;33:889-894.
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Abstracts
Costanzo MR, Javaheri S, Augostini R, et al. Effects of Phrenic Nerve Stimulation on Central Sleep Apnea in Heart Failure Patients. Presented ESC 2017.
Goldberg L, Ponikowski P, Javaheri S, et al. In heart failure patients with central sleep apnea, transvenous stimulation of the phrenic nerve improves sleep and quality of life. Presented HFSA 2017.
Costanzo MR, Augostini R, Ponikowski P, et al. Improvement in Central Sleep Apnea with Transvenous Phrenic Nerve Stimulation is Sustained at 12 Months: Data from the remedē System Pivotal Trial. Presented HRS 2017.
Costanzo MR, Javaheri S, Ponikowski P, Augostini R, Goldberg L, Holcomb R, Kao A, Oldenburg O, Stellbrink C, Abraham WT. Tranvenous stimulation of the phrenic nerve to treat central sleep apnea: results of a randomized trial. SLEEP 2016 Late-breaking clinical trials.
Costanzo MR, Javaheri S, Ponikowski P, Augostini R, Goldberg L, Holcomb R, Kao A, Oldenburg O, Stellbrink C, Abraham WT. Pivotal Trial of Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea. ESC-HFA 2016 Late-breaking clinical trials.
Javaheri, S, Cameron N, Abraham W, Germany R, Ponikowski P. Central Sleep Apnea in Heart Failure Worsens Throughout the Night Chest 2015;148 (4_MeetingAbstracts) :1047A. doi:10.1378/chest.2264874.
Pleister A, Hasan A, Khayat R, James K, Abraham WT. Changes in Thoracic Impedance Measured via the Azygos Vein with the remedē® System Indicate Worsening Heart Failure. Journal of Cardiac Failure 2014;20:S111-112.
Ponikowski P, Krueger S, Oldenburg O, Germany R, Abraham WT. Prevalence of Central Sleep Apnea in Patients Screened During the remedē® System Pilot Study. J Cardiac Failure 2014;20:S117-118.
Abraham WT, Oldenburg O, Jagielski D, Augostin R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Ponikowski P, on Behalf of the remedē® System Pilot Study Investigators. The Long Term Effects of the remede System in the Treatment of Central Sleep Apnea. European Journal of Heart Failure 2014.
Oldenburg O, Abraham WT, Krueger S, Bourn D, Ponikowski P on Behalf of the remedē® System Pilot Study Investigators. Significant Chronic Improvements in Sleep Quality Shown in Central Sleep Apnea in Patients when Treated with a Respiratory Rhythm Management System. European Journal of Heart Failure 2014; P230.