Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

BACKGROUND AND AIM: Hypoglossal 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. METHODS: This 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. RESULTS: 22 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. CONCLUSIONS: Bilateral 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.

Advanced age does not increase morbidity after total thyroidectomy. Result of a prospective study.

BACKGROUND: It is well known that total thyroidectomy is feasible on elderly patients but is linked to complications because of their underlying comorbidities. In this study we analyzed the specific risks linked to surgery, hypoparathyroidism and recurrent nerve palsy. METHODS: materials-methods:Prospective, multicentre trial conducted at 13 hospital sites. The primary endpoint was the percentage of patients with postoperative hypocalcaemia (albumin-corrected serum calcium level <2 mmol/L at day 2). Secondary endpoints included recurrent nerve palsy rate at day 2, the percentage of patients with hypocalcaemia (serum calcium level <2 mmol/L) and recurrent nerve palsy at month 6, operating durations and postoperative pain. Patients were separated in two groups: <70 years and ≥70 years old. RESULTS: In total, 1329 patients who underwent total thyroidectomy were included (median age 51.17 years [18.10; 80.90], 80% women, and hyperthyroidism in 20%, 101 ≥ 70 years old). Rates of hypocalcaemia at day 2 and month 6 were 20.02% and 1.98% respectively. Nasofibroscopy showed postoperative abnormal vocal cord motility in 9.92% cases (hypo-motility 5.76% - immobility 4.16%) and 0.95% at month 6 (hypo-motility 0.48%, immobility 0.48%). Patients ≥70 years had a lower (but non-significant) postoperative and definitive hypocalcaemia rate than patients < 70 years: 14.85% vs 20.44% at day 2 (p = 0.1773) and 0% vs 2.15% at month 6 respectively (p = 0.2557). Abnormal vocal cord motility rate was 12.00% in patients ≥70 years vs 9.75% in patients <70 years at day 2 (p = 0.4702), and 2.06% in patients ≥70 years vs 0.86% at month 6 (p = 0.2340). CONCLUSIONS: Total thyroidectomy in patients ≥70 years is feasible and safe. Age does not increase the morbidity. The study is registered with ClinicalTrials.gov number NCT01551914.

Impact of body mass index on post-thyroidectomy morbidity.

BACKGROUND: The impact of obesity on total thyroidectomy (TT) morbidity (recurrent laryngeal nerve palsy and hypocalcaemia) remains largely unknown. METHODS: In a prospective study (NCT01551914), patients were divided into five groups according to their body mass index (BMI): underweight, normal weight, overweight, obese, and severely obese. Preoperative and postoperative serum calcium was measured. Recurrent laryngeal nerve (RLN) function was evaluated before discharge, and if abnormal, at 6 months. RESULTS: In total 1310 patients were included. Baseline characteristics were similar across BMI groups except for age and sex. Postoperative hypocalcaemia was more frequent in underweight compared to obese patients but the difference was not statistically significant in multivariate analysis. There was no difference between groups in terms of definitive hypocalcaemia, transient and definitive RLN palsy, and postoperative pain. CONCLUSION: Obesity does not increase intraoperative and postoperative morbidity of TT, despite a longer duration of the procedure.

Does intraoperative neuromonitoring of recurrent nerves have an impact on the postoperative palsy rate? Results of a prospective multicenter study.

BACKGROUND: The impact of intraoperative neuromonitoring on recurrent laryngeal nerve palsy remains debated. Our aim was to evaluate the potential protective effect of intraoperative neuromonitoring on recurrent laryngeal nerve during total thyroidectomy. METHODS: This was a prospective, multicenter French national study. The use of intraoperative neuromonitoring was left at the surgeons' choice. Postoperative laryngoscopy was performed systematically at day 1 to 2 after operation and at 6 months in case of postoperative recurrent laryngeal nerve palsy. Univariate and multivariate analyses and propensity score (sensitivity analysis) were performed to compare recurrent laryngeal nerve palsy rates between patients operated with or without intraoperative neuromonitoring. RESULTS: Among 1,328 patients included (females 79.9%, median age 51.2 years, median body mass index 25.6 kg/m2), 807 (60.8%) underwent intraoperative neuromonitoring. Postoperative abnormal vocal cord mobility was diagnosed in 131 patients (9.92%), including 69 (8.6%) and 62 (12.1%) in the intraoperative neuromonitoring and nonintraoperative neuromonitoring groups, respectively. Intraoperative neuromonitoring was associated with a lesser rate of recurrent laryngeal nerve palsy in univariate analysis (odds ratio = 0.68, 95% confidence interval, 0.47; 0.98, P = .04) but not in multivariate analysis (oddsratio = 0.74, 95% confidence interval, 0.47; 1.17, P = .19), or when using a propensity score (odds ratio = 0.76, 95% confidence interval, 0.53; 1.07, P = .11). There was no difference in the rates of definitive recurrent laryngeal nerve palsy (0.8% and 1.3% in intraoperative neuromonitoring and non-intraoperative neuromonitoring groups respectively, P = .39). The sensitivity, specificity, and positive and negative predictive values of intraoperative neuromonitoring for detecting abnormal postoperative vocal cord mobility were 29%, 98%, 61%, and 94%, respectively. CONCLUSION: The use of intraoperative neuromonitoring does not decrease postoperative recurrent laryngeal nerve palsy rate. Due to its high specificity, however, intraoperative neuromonitoring is useful to predict normal vocal cord mobility. From the CHU de Nantes,a Clinique de Chirurgie Digestive et Endocrinienne, Nantes, France; CHU Lille, Université de Lille,b Chirurgie Générale et Endocrinienne, Lille, France; CHU Nancy-Hôpital de Brabois,c Service de Chirurgie Digestive, Hépato-Biliaire, et Endocrinienne, Nancy, France; CHU Angers,d Chirurgie Digestive et Endocrinienne, Angers, France; CHU de Toulouse-Hôpital Larrey,e Chirurgie Thoracique, Pôle Voies Respiratoires, Toulouse; CHU Saint-Etienne-Hôpital Nord,f ORL et Chirurgie Cervico-Faciale et Plastique, Saint-Etienne, France; CHU de Limoges-Hôpital Dupuytren,g Chirurgie Digestive, Générale et Endocrinienne, Limoges, France; CHU de Besançon-Hôpital Jean Minjoz,h Chirurgie Digestive, Besançon, France; Centre Hospitalier du Mans,i Service ORL et Chirurgie Cervico-Faciale, Le Mans, France; Centre Hospitalier Lyon-Sud,j Chirurgie Générale, Endocrinienne, Digestive et Thoracique, Pierre Bénite, France; AP-HM-Hôpital de La Conception,k Chirurgie Générale, Marseille, France; CHU de Rennes-Hôpital Pontchaillou,l Service ORL et Chirurgie Maxillo-Faciale, Rennes, France; CHU de Caen,m ORL et Chirurgie Cervico-Faciale, Caen, France; CHU d'Angers,n ORL et Chirurgie Cervico-Faciale, Angers, France; CHU de Nantes,o Service ORL, Nantes, France; AP HP URCEco île-de-France,p hôpital de l'Hôtel-Dieu, Paris, France; DRCI, département Promotion,q Nantes, France.

An elevated level of TSH might be predictive of differentiated thyroid cancer.

Suppression therapy of thyreostimulin (TSH) using thyroid hormones improves survival of subjects operated for differentiated thyroid cancer. The TSH level might be different depending on the type of nodule. The objective of this study was to compare retrospectively the TSH level between two groups of subjects who underwent total thyroidectomy for a nodule, matched on sex, ethnicity, age and biological method of TSH measurement, one whose final histology was benign and one malignant. There was no significant difference between the two groups in terms of age, sex, family history of thyroid disease or thyroid autoimmunity. The subjects, whose final histology was malignant, had a mean TSH level significantly higher than subjects with benign disease (1.55 mU/l versus 0.96 mU/l, P=0.003). Cancer risk was greater when the TSH was in the upper tertile of normal range. There was no correlation between the risk of thyroid cancer and age, sex, family history of thyroid disease, or menopausal status. The relative risk of having thyroid carcinoma was higher when the margins of nodules were blurred or in the presence of microcalcifications. These data confirm a trend toward baseline values of TSH higher in subjects with a thyroid-differentiated cancer. However, we could not define a preoperative threshold that would reliably determine the malignant or benign nature of the nodule.