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Res."],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 remed\u0113 System Pivotal Trial population was examined for nocturnal hypoxemic burden. The minutes of sleep with oxygen saturation\u2009&lt;\u200990% significantly improved in Treatment compared with control (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001), with the median improving from 33\u00a0min at baseline to 14\u00a0min at 6\u00a0months. 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\u2013hypopnea 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\u2013hypopnea index in sleep-disordered breathing. Nocturnal hypoxemia burden may be more predictive for mortality than apnea\u2013hypopnea index in patients with poor cardiac function. Transvenous phrenic nerve stimulation is capable of improving nocturnal hypoxemic burden.<\/jats:p>","DOI":"10.1007\/s12265-020-10061-0","type":"journal-article","created":{"date-parts":[[2020,8,12]],"date-time":"2020-08-12T17:03:59Z","timestamp":1597251839000},"page":"377-385","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Improving Nocturnal Hypoxemic Burden with Transvenous Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea"],"prefix":"10.1007","volume":"14","author":[{"given":"Olaf","family":"Oldenburg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rosa","family":"Costanzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Germany","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"McKane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy E.","family":"Meyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2187-8715","authenticated-orcid":false,"given":"Henrik","family":"Fox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,8,12]]},"reference":[{"key":"10061_CR1","doi-asserted-by":"publisher","unstructured":"Berry, R. 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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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee and with the 1964 Helsinki declaration and its later amendments.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval for this Research Involving Human Participants"}},{"value":"Written informed consent was obtained from all individual participants included in this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and ISO-14155:2011 and registered at  (Identifier: NCT01816776). All patients provided written informed consent. The protocol was approved by the following local ethics or institutional review boards: Quorum Review IRB, Western Institutional Review Board, Cleveland Clinic Institutional Review Board, The Cooper Health System Institutional Review Board, University of Pennsylvania Office of Regulatory Affairs, Office of Human Subjects Research Institutional Review Board Johns Hopkins University, Lancaster General Hospital Institutional Review Board, Marshfield Clinic Research Foundation, Methodist Healthcare Institutional Review Board, Schulman IRB, Presbyterian Healthcare Institutional Review Board, Spectrum Health Human Research Protection Program, University of Maryland-Baltimore Institutional Review Board, University of Southern California Health Sciences Campus Institutional Review Board, Washington University St. Louis Institutional Review Board, Henry Ford Health System Research Administration, Christ Hospital Institutional Review Board, Baptist Institutional Review Board, Forsyth Medical Center Institutional Review Board, Edward Hospital & Health Services Institutional Review Board, Komisja Bioetyczna przy Dolno\u015blaskiej Izbie Lekarskiej, and Vorsitzender Ethikkommission Der Medizinischen Fakult\u00e4t Der Ruhr-Universit\u00e4t Bochum Sitz Bad Oeynhausen.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human Subjects\/Informed Consent"}}]}}