{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T05:40:09Z","timestamp":1794030009126,"version":"4.8.0"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Otolaryngol Head Neck Surg"],"published-print":{"date-parts":[[2023,1,1]]},"abstract":"<jats:sec id=\"ab-ooi220077-4\"><jats:title>Importance<\/jats:title><jats:p>Vagus nerve stimulation (VNS) devices have gained widespread acceptance for treatment of resistant epilepsy and depression. The increasing number of procedures has resulted in an increasing number of iatrogenic injuries to the vagus nerve, which can have a significant effect on vocalization and quality of life.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi220077-5\"><jats:title>Objective<\/jats:title><jats:p>To determine the relative frequency of laryngeal adverse effects reported to the US Food and Drug Administration (FDA) after VNS implantation and to analyze associated VNS device problems.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi220077-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This retrospective cross-sectional analysis queried the FDA Manufacturer and User Facility Device Experience database of adverse events in the US between 1996 and 2020.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi220077-7\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>The primary outcome was the percent of adverse events reported to the FDA that included patients who received VNS with laryngeal adverse effects and the associated proportion of device problems after VNS surgery.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi220077-8\"><jats:title>Results<\/jats:title><jats:p>A total of 12\u202f725 iatrogenic vagus nerve issues were documented after VNS implantation, with apnea (n\u2009=\u2009395; 3.1%) being the most common patient problem. Overall, 187 reports of laryngeal adverse effects associated with VNS devices were identified and represented the eighth most common iatrogenic vagus nerve problem reported to the FDA. Laryngeal adverse effects included 78 reports of voice alteration and 57 reports of paresis\/paralysis. The VNS device problems frequently associated with laryngeal adverse effects were high impedance (n\u2009=\u200915, 8.02%), incorrect frequency delivery (n\u2009=\u200910, 5.35%), and battery problems (n\u2009=\u200911, 5.88%). The number of laryngeal adverse effect reports per year peaked in 2012 with 43 cases.<\/jats:p><\/jats:sec><jats:sec id=\"ab-ooi220077-9\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>This cross-sectional study found that although the literature demonstrates that vocal changes occur with nearly all VNS devices, the FDA receives adverse event reports of voice changes. Our results emphasize a potential need to improve patient counseling prior to VNS surgery to better set patient expectations regarding vocal changes and to prevent unnecessary patient concern. In addition, reports of vocal fold paresis\/paralysis potentially suggest that patients may benefit from preoperative laryngeal assessment to differentiate preexisting vocal fold paralysis from that caused by VNS surgery.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaoto.2022.3699","type":"journal-article","created":{"date-parts":[[2022,11,23]],"date-time":"2022-11-23T16:33:22Z","timestamp":1669221202000},"page":"49","source":"Crossref","is-referenced-by-count":7,"title":["Laryngology Outcomes Following Implantable Vagus Nerve Stimulation"],"prefix":"10.1001","volume":"149","author":[{"given":"Philip R.","family":"Brauer","sequence":"first","affiliation":[{"name":"Case Western Reserve University School of Medicine, Cleveland, Ohio"},{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric D.","family":"Lamarre","sequence":"additional","affiliation":[{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria L.","family":"Gau","sequence":"additional","affiliation":[{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert R.","family":"Lorenz","sequence":"additional","affiliation":[{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon S.","family":"Wu","sequence":"additional","affiliation":[{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"},{"name":"Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul C.","family":"Bryson","sequence":"additional","affiliation":[{"name":"Head and Neck Institute, The Cleveland Clinic, Cleveland, Ohio"},{"name":"Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"2","key":"ooi220077r1","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.nurt.2009.01.010","article-title":"Vagus nerve stimulation in the treatment of refractory epilepsy.","volume":"6","author":"Milby","year":"2009","journal-title":"Neurotherapeutics"},{"issue":"3","key":"ooi220077r2","doi-asserted-by":"publisher","first-page":"327","DOI":"10.1111\/ner.13509","article-title":"Short- and long-term response of vagus nerve stimulation therapy in drug-resistant epilepsy: a systematic review and meta-analysis.","volume":"25","author":"Mao","year":"2022","journal-title":"Neuromodulation"},{"issue":"9","key":"ooi220077r3","doi-asserted-by":"publisher","first-page":"1260","DOI":"10.1111\/ene.2015.22.issue-9","article-title":"Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability.","volume":"22","author":"Ben-Menachem","year":"2015","journal-title":"Eur J Neurol"},{"issue":"2","key":"ooi220077r4","doi-asserted-by":"publisher","first-page":"188","DOI":"10.1111\/ner.12376","article-title":"Automatic vagus nerve stimulation triggered by ictal tachycardia: clinical outcomes and device performance\u2014The U.S. E-37 Trial.","volume":"19","author":"Fisher","year":"2016","journal-title":"Neuromodulation"},{"issue":"3","key":"ooi220077r5","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1111\/ner.13528","article-title":"A comprehensive review of vagus nerve stimulation for depression.","volume":"25","author":"Austelle","year":"2022","journal-title":"Neuromodulation"},{"issue":"7","key":"ooi220077r6","doi-asserted-by":"publisher","first-page":"448","DOI":"10.1212\/WNL.0b013e3182477edc","article-title":"Incidence and prevalence of epilepsy among older U.S. Medicare beneficiaries.","volume":"78","author":"Faught","year":"2012","journal-title":"Neurology"},{"issue":"9","key":"ooi220077r7","doi-asserted-by":"publisher","first-page":"870","DOI":"10.1212\/WNL.0000000000003662","article-title":"Predictors of incident epilepsy in older adults: The Cardiovascular Health Study.","volume":"88","author":"Choi","year":"2017","journal-title":"Neurology"},{"issue":"4","key":"ooi220077r8","doi-asserted-by":"publisher","first-page":"336","DOI":"10.1001\/jamapsychiatry.2017.4602","article-title":"Epidemiology of adult DSM-5 major depressive disorder and its specifiers in the United States.","volume":"75","author":"Hasin","year":"2018","journal-title":"JAMA Psychiatry"},{"issue":"4","key":"ooi220077r9","doi-asserted-by":"publisher","first-page":"401","DOI":"10.5664\/JCSM.1204","article-title":"Obstructive sleep apnea and respiratory complications associated with vagus nerve stimulators.","volume":"7","author":"Parhizgar","year":"2011","journal-title":"J Clin Sleep Med"},{"issue":"10","key":"ooi220077r10","doi-asserted-by":"publisher","first-page":"827","DOI":"10.1016\/j.seizure.2013.06.011","article-title":"Complications of vagal nerve stimulation for drug-resistant epilepsy: a single center longitudinal study of 143 patients.","volume":"22","author":"Kahlow","year":"2013","journal-title":"Seizure"},{"issue":"1","key":"ooi220077r11","doi-asserted-by":"publisher","first-page":"97","DOI":"10.3171\/2016.1.PEDS15534","article-title":"Complications and safety of vagus nerve stimulation: 25 years of experience at a single center.","volume":"18","author":"R\u00e9v\u00e9sz","year":"2016","journal-title":"J Neurosurg Pediatr"},{"issue":"3","key":"ooi220077r12","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1067\/mhn.2001.117714","article-title":"Quality-of-life assessment in patients with unilateral vocal cord paralysis.","volume":"125","author":"Spector","year":"2001","journal-title":"Otolaryngol Head Neck Surg"},{"issue":"2","key":"ooi220077r13","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1111\/epi.12888","article-title":"Mortality and SUDEP in epilepsy patients treated with vagus nerve stimulation.","volume":"56","author":"Granbichler","year":"2015","journal-title":"Epilepsia"},{"issue":"11 Pt 1","key":"ooi220077r14","doi-asserted-by":"publisher","first-page":"2028","DOI":"10.1097\/00005537-200111000-00030","article-title":"The effect of vagal nerve stimulation on voice.","volume":"111","author":"Charous","year":"2001","journal-title":"Laryngoscope"},{"issue":"4","key":"ooi220077r16","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1093\/bja\/aer040","article-title":"Dyspnoea: underlying mechanisms and treatment.","volume":"106","author":"Nishino","year":"2011","journal-title":"Br J Anaesth"},{"issue":"1 Pt 1","key":"ooi220077r17","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1177\/000348940511400103","article-title":"Vagal nerve stimulation: clinical and electrophysiological effects on vocal fold function.","volume":"114","author":"Shaffer","year":"2005","journal-title":"Ann Otol Rhinol Laryngol"},{"issue":"6","key":"ooi220077r18","doi-asserted-by":"publisher","first-page":"777.e9","DOI":"10.1016\/j.jvoice.2015.01.010","article-title":"Impact of vagal nerve stimulation on objective vocal quality, a pilot study.","volume":"29","author":"Van Lierde","year":"2015","journal-title":"J Voice"},{"issue":"2","key":"ooi220077r19","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1212\/WNL.45.2.224","article-title":"A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures.","volume":"45","author":"The Vagus Nerve Stimulation Study Group","year":"1995","journal-title":"Neurology"},{"issue":"9","key":"ooi220077r20","doi-asserted-by":"publisher","first-page":"2593","DOI":"10.1002\/hed.v42.9","article-title":"Cost-effectiveness of fiberoptic laryngoscopy prior to total thyroidectomy for low-risk thyroid cancer patients.","volume":"42","author":"Walgama","year":"2020","journal-title":"Head Neck"},{"issue":"3","key":"ooi220077r21","doi-asserted-by":"publisher","first-page":"e331","DOI":"10.1055\/s-0039-1688457","article-title":"Laryngeal and vocal characterization of asymptomatic adults with sulcus vocalis.","volume":"23","author":"Soares","year":"2019","journal-title":"Int Arch Otorhinolaryngol"},{"issue":"3","key":"ooi220077r22","doi-asserted-by":"publisher","first-page":"e21","DOI":"10.1097\/SLA.0000000000003580","article-title":"The American Association of Endocrine Surgeons guidelines for the definitive surgical management of thyroid disease in adults.","volume":"271","author":"Patel","year":"2020","journal-title":"Ann Surg"},{"issue":"3","key":"ooi220077r23","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1016\/j.surg.2005.08.009","article-title":"The importance of preoperative laryngoscopy in patients undergoing thyroidectomy: voice, vocal cord function, and the preoperative detection of invasive thyroid malignancy.","volume":"139","author":"Randolph","year":"2006","journal-title":"Surgery"},{"key":"ooi220077r15","unstructured":"MAUDE - Manufacturer and User Facility Device Experience. U.S. Food and Drug Administration. Accessed June 12, 2021. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm"}],"container-title":["JAMA Otolaryngology\u2013Head &amp; Neck Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamaotolaryngology\/articlepdf\/2799059\/jamaotolaryngology_brauer_2022_oi_220077_1672856035.98997.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T16:34:59Z","timestamp":1673541299000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamaotolaryngology\/fullarticle\/2799059"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,1]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamaoto.2022.3699","relation":{},"ISSN":["2168-6181"],"issn-type":[{"value":"2168-6181","type":"print"}],"subject":[],"published":{"date-parts":[[2023,1,1]]}}}