Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA). Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA. Design, Setting, and Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023. Intervention: Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively. Main Outcomes and Measures: Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale). Results: Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol. Conclusions and Relevance: This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI. Trial Registration: ClinicalTrials.gov Identifier: NCT02263859.

Management of neck metastasis with carotid artery involvement.

OBJECTIVES: To demonstrate aggressive management of neck metastasis adherent to the internal or common carotid artery using sound oncologic principles while minimizing the significant risk of complications. STUDY DESIGN: Our 13 year experience of treating patients with recurrent or residual neck metastasis adherent to the internal or common carotid artery was retrospectively reviewed. METHODS: Angiography was used in patients who demonstrated fixation of the carotid artery on examination or imaging, followed by balloon test occlusion and single photon emission computer tomography (SPECT) scanning. The majority of carotid resections were reconstructed with a vein graft, especially if there was insufficient collateral cerebral circulation. Radical resection of the soft tissue including the carotid artery was performed followed by 15 to 20 Gray of electron beam delivered directly to the deep tissue. More recently, the carotid has been permanently occluded preoperatively, if possible. The assessment of the cerebral circulation and management of the carotid artery were analyzed as was survival, site of recurrence, and complications. RESULTS: Fifty-eight charts were reviewed. The majority of patients (41) had their carotid artery reconstructed at time of resection, and the remaining had either the artery ligated or permanently occluded preoperatively. Strokes occurred in 11 patients. The median disease-specific survival was 12 months, with 24% of patients dying from distant metastasis. CONCLUSIONS: The high risk of complications, loss of life's quality, and mortality must be balanced against the natural history of the disease if left untreated. The decision is a heavy burden for the patient, family, and head and neck surgeon.