Background and aimHypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.MethodsThis prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea–hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.Results22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m−2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h−1, a mean change of 10.8 events·h−1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h−1, a mean change of 9.3 events·h−1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.ConclusionsBilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.
From an inception cohort of 204 patients with squamous cell carcinoma of the true vocal cord classified as T2N0 and a minimum of 3 years of follow-up, the authors compare the oncological and functional outcomes following vertical partial laryngectomy (group 1; 85 patients) and supracricoid partial laryngectomy (group 2; 119 patients). The 10-year actuarial survival estimate was 46.2% for group 1 and 66.4% for group 2. Survival was statistically more likely to be reduced (p = .019) in group 1 than in group 2. The 10-year actuarial local control estimate was 69.3% for group 1 and 94.6% for group 2. Local recurrence was statistically more likely to occur (p < .0001) in group 1 than in group 2. Salvage treatment resulted in an overall 94.1% local control rate and a 78.1% laryngeal preservation rate for group 1 and an overall 99.2% local control rate and a 94.9% laryngeal preservation rate for group 2. The 10-year actuarial nodal control estimate was 81.7% for group 1 and 93.7% for group 2. Nodal recurrence was statistically more likely to occur (p = .028) in group 1 than in group 2. The 10-year actuarial estimate for patients without distant metastasis was 84.6% for group 1 and 95.1% for group 2. Distant metastasis was statistically more likely to occur (p = .05) in group 1 than in group 2. The hospital mortality rate was 1.2% for group 1 and 0.8% for group 2. The incidence of permanent gastrostomy was 0% for group 1 and 2.4% for group 2. The incidence of permanent tracheostomy was 1.2% for group 1 and 2.4% for group 2. The incidence of completion laryngectomy due to functional problems was 1.2% for group 1 and 0.8% for group 2.
The treatment of drooling by Botox(®) injections into salivary glands is effective. The authors propose ultrasound-guided injection of both submaxillary glands and both parotid glands. These injections can be repeated in the case of recurrence of drooling.
The medical files of 15 patients with local recurrence after supracricoid partial laryngectomy consecutively managed at Laënnec Hospital were reviewed. The clinical symptoms and the laryngeal computed tomography appearance of local recurrence, as well as the salvage treatment performed, are presented. The main presenting symptom was dyspnea. None of the local recurrences was considered to be unresectable. One patient refused any form of salvage treatment. Radiation therapy and salvage total laryngectomy were the options retained for local salvage. A minimum 5-year follow-up was always achieved. In patients who underwent salvage total laryngectomy, perioperative or postoperative death and postoperative pharyngocutaneous fistula were not encountered. The 5-year survival was 33.3%. The local control rate was 66.6%. The percentage of patients who experienced nodal recurrence was 26.6%, and the distant metastasis estimate was 53.3%. The cause of death was distant metastasis in eight patients, local recurrence in two, and intercurrent disease in one. Peristomal recurrence was not encountered. Overall, 80% local control and 6.6% laryngeal preservation rates were achieved.
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