{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T08:34:32Z","timestamp":1740126872545,"version":"3.37.3"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T00:00:00Z","timestamp":1689120000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T00:00:00Z","timestamp":1689120000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100015345","name":"ZOLL Medical Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015345","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sleep Breath"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Little is known about sex differences in the treatment of central sleep apnea (CSA). Our post hoc analysis of the <jats:bold>rem<\/jats:bold>ed\u0113 System Pivotal Trial aimed to determine sex-specific differences in the safety and effectiveness of treating moderate to severe CSA in adults with transvenous phrenic nerve stimulation (TPNS).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Men and women enrolled in the <jats:bold>rem<\/jats:bold>ed\u0113 System Pivotal Trial were included in this post hoc analysis of the effect of TPNS on polysomnographic measures, Epworth Sleepiness Scale, and patient global assessment for quality of life.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Women (<jats:italic>n<\/jats:italic>\u00a0=\u00a016) experienced improvement in CSA metrics that were comparable to the benefits experienced by men (<jats:italic>n<\/jats:italic>\u00a0= 135), with central apneas being practically eliminated post TPNS. Women experienced improvement in sleep quality and architecture that was comparable to men post TPNS. While women had lower baseline apnea hypopnea index than men, their quality of life was worse at baseline. Additionally, women reported a 25-percentage point greater improvement in quality of life compared to men after 12\u00a0months of TPNS therapy. TPNS was found to be safe in women, with no related serious adverse events through 12\u00a0months post-implant, while men had a low rate of 10%.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Although women had less prevalent and less severe CSA than men, they were more likely to report reduced quality of life. Transvenous phrenic nerve stimulation may be a safe and effective tool in the treatment of moderate to severe CSA in women. Larger studies of women with CSA are needed to confirm our findings.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT01816776; March 22, 2013.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11325-023-02882-5","type":"journal-article","created":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T09:02:11Z","timestamp":1689152531000},"page":"165-171","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analysis by sex of safety and effectiveness of transvenous phrenic nerve stimulation"],"prefix":"10.1007","volume":"28","author":[{"given":"Soraya","family":"Samii","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2886-6864","authenticated-orcid":false,"given":"Scott","family":"McKane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy E.","family":"Meyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neomi","family":"Shah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,7,12]]},"reference":[{"key":"2882_CR1","doi-asserted-by":"publisher","first-page":"608","DOI":"10.1164\/ajrccm.163.3.9911064","volume":"163","author":"EO Bixler","year":"2001","unstructured":"Bixler EO, Vgontzas AN et al (2001) Prevalence of sleep-disordered breathing in women: effects of gender. 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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":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Dr. Samii has no conflicts of interest. McKane and Meyer are employees of ZOLL Respicardia, Inc. Dr. Shah is a consultant to ZOLL Respicardia, Inc.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}