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Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea
STUDY OBJECTIVE: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy. METHODS: Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Dr...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802564/ https://www.ncbi.nlm.nih.gov/pubmed/31634407 http://dx.doi.org/10.1093/sleep/zsz158 |
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author | Fox, Henrik Oldenburg, Olaf Javaheri, Shahrokh Ponikowski, Piotr Augostini, Ralph Goldberg, Lee R Stellbrink, Christoph Mckane, Scott Meyer, Timothy E Abraham, William T Costanzo, Maria Rosa |
author_facet | Fox, Henrik Oldenburg, Olaf Javaheri, Shahrokh Ponikowski, Piotr Augostini, Ralph Goldberg, Lee R Stellbrink, Christoph Mckane, Scott Meyer, Timothy E Abraham, William T Costanzo, Maria Rosa |
author_sort | Fox, Henrik |
collection | PubMed |
description | STUDY OBJECTIVE: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy. METHODS: Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided. RESULTS: Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea–hypopnea index 47 events per hour. Sleep metrics (apnea–hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months. CONCLUSION: These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns. TRIAL REGISTRATION: NCT01816776. |
format | Online Article Text |
id | pubmed-6802564 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-68025642019-10-24 Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea Fox, Henrik Oldenburg, Olaf Javaheri, Shahrokh Ponikowski, Piotr Augostini, Ralph Goldberg, Lee R Stellbrink, Christoph Mckane, Scott Meyer, Timothy E Abraham, William T Costanzo, Maria Rosa Sleep Sleep Disordered Breathing STUDY OBJECTIVE: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy. METHODS: Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided. RESULTS: Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea–hypopnea index 47 events per hour. Sleep metrics (apnea–hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months. CONCLUSION: These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns. TRIAL REGISTRATION: NCT01816776. Oxford University Press 2019-07-08 /pmc/articles/PMC6802564/ /pubmed/31634407 http://dx.doi.org/10.1093/sleep/zsz158 Text en © Sleep Research Society 2019. Published by Oxford University Press [on behalf of the Sleep Research Society]. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Sleep Disordered Breathing Fox, Henrik Oldenburg, Olaf Javaheri, Shahrokh Ponikowski, Piotr Augostini, Ralph Goldberg, Lee R Stellbrink, Christoph Mckane, Scott Meyer, Timothy E Abraham, William T Costanzo, Maria Rosa Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title | Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title_full | Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title_fullStr | Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title_full_unstemmed | Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title_short | Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
title_sort | long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea |
topic | Sleep Disordered Breathing |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802564/ https://www.ncbi.nlm.nih.gov/pubmed/31634407 http://dx.doi.org/10.1093/sleep/zsz158 |
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