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Objective: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. Methods: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. Results: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups (P =.808). Operative time exhibited a significant downward trend (P <.001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P <.001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P <.001). ESS outcomes remained equivalent for those with data through 12-months. Conclusions: Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases. [ABSTRACT FROM AUTHOR]

Objective/hypothesis: The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study Design: Cohort Study.Methods: Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit.Results: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.Conclusions: Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.Level Of Evidence: 2 Laryngoscope, 130:1333-1338, 2020. [ABSTRACT FROM AUTHOR]

Objective: Examine the patient characteristics of those undergoing upper airway stimulation (UAS) for the treatment of continuous positive airway pressure (CPAP)-refractive obstructive sleep apnea (OSA) at a tertiary care medical center to determine objective clinical predictors of success.Methods: Retrospective chart review of the first 25 consecutive patients between August 2015 and December 2016 treated with UAS at a tertiary care academic center. Demographic data, medical and sleep history, pre- and postoperative polysomnography data, and sleep endoscopy findings were collected. Statistical analysis was performed using two-sided t test with bivariate and linear regression analysis.Results: In our cohort of 25 patients, mean age was 67.5 ± 7.6 years, and mean body mass index (BMI) was 28.2 ± 3.8 kg/m2 with 42% female. One patient was excluded from analysis for unmasking of complete central apnea with therapy. AHI decreased by a mean of 33.8 events/hour following treatment (95% confidence interval: 25.8 to 41.7, P < 0.001). Preintervention AHI was associated with therapy response, with each point of preintervention AHI leading to an average decrease of 1.03 points (P < 0.001). Eighty-three percent of patients achieved a treatment AHI < 5, whereas 92% achieved an AHI < 10. Mean device use was 49.5 ± 10.4 hours per week. Ninety-two percent of patients were discharged the day of surgery. No major adverse events occurred.Conclusion: UAS continues to gain popularity for the treatment of CPAP-refractive OSA; therefore, identification of predictors of success is crucial. Our study, although small, suggests that more severe preintervention AHI does not preclude significant therapy response and may expand the inclusion criteria for UAS, meriting further investigation.Level Of Evidence: 4 Laryngoscope, 130:556-560, 2020. [ABSTRACT FROM AUTHOR]

Objective: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation.Study Design: Cohort (retrospective and prospective).Setting: Eleven academic medical centers.Subjects and Methods: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index.Results: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P < .001) and 11.4 ± 12.6 at final follow-up (P < .001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up.Conclusion: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of age on safety, efficacy, and usage of upper airway stimulation (UAS).Study Design: Multicenter observational study.Setting: Thirteen US hospitals and 3 German hospitals.Subjects and Methods: The ADHERE registry is a multicenter database enrolling patients undergoing UAS implantation from October 2016 to April 2018. Outcome measures included the Epworth Sleepiness Scale, apnea-hypopnea index (AHI), therapy usage, and complications. Data were segmented by age (<65 vs ≥65 years).Results: Younger adults (n = 365) were a mean ± SD 52.7 ± 7.9 years old and 82% male, with a body mass index of 29.6 ± 3.8. Older adults (n = 235) were 71.1 ± 4.8 years old and 71% male, with a body mass index of 28.8 ± 3.8. Baseline AHI was similar (younger, 36.2 ± 15.9; older, 36.1 ± 14.8). Both groups had lower AHI at 12 months versus baseline (P < .001), but the older group showed a greater reduction (7.6 ± 6.9 vs 11.9 ± 13.4, P = .01). The Epworth Sleepiness Scale score decreased from 12.3 ± 5.4 to 7.1 ± 4.8 (P < .001) among younger adults and from 10.7 ± 5.7 to 6.3 ± 4.4 (P < .001) among older adults. Usage was slightly higher among older adults (6.0 ± 2.0 vs 5.4 ± 2.1 hours/night, P = .02). Surgical time was similar between younger patients (2.4 ± 0.7 hours) and older patients (2.3 ± 0.7 hours, P = .40), with comparably low complications.Conclusion: AHI reduction and therapy usage were found to be somewhat higher among patients aged ≥65 years who were treated with UAS. Surgical complications were low, in contrast to traditional sleep surgery. [ABSTRACT FROM AUTHOR]

Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients' symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction. [ABSTRACT FROM AUTHOR]

Context.—: Tumor contaminants were incidentally noted in frozen section margins of oropharyngeal squamous cell carcinoma., Objective.—: To estimate the frequency of tumor contaminants in frozen section slides of patients who underwent surgery for pharyngeal cancer, and to characterize the surgical and pathologic context of these incidents., Design.—: A retrospective search was conducted to identify pharyngeal resections from 2016 to 2022. Surgical pathology, operative reports, and frozen section slides were reviewed. Preanalytical phase tumor contaminants were defined as tumor contaminants that occurred in frozen section slides with or without occurrence in permanent slides., Results.—: Eighty-one pharyngeal resections with intraoperative tumor bed margins for squamous cell carcinoma were identified. These included 308 tumor bed margins represented in 641 slides. Preanalytical contaminants occurred among 9 patients (11.1% of all and 21.4% of robotic surgeries) and in 3.8% of the 308 intraoperative tumor bed margins. A statistically significant association was found between contaminants and larger tumor size (Student t test, P = .04) and surgical approach (robotic versus open oropharyngectomy: Fisher exact test, P < .001). All patients with contaminants had intraoperative tumor disruption. Two frozen section deferrals (0.6%) and 2 discrepancies with final diagnosis (0.6%) attributed to contaminants were identified; however, clinical or surgical management was not affected in any patient., Conclusions.—: Preanalytical contaminants may cause confusion in intraoperative margin assessment. They are more likely to occur in margins of nonkeratinizing squamous cell carcinoma resected by transoral robotic surgery if there is intraoperative tumor disruption. Rarely, preanalytical contaminants lead to frozen section deferral or discrepancy with final diagnosis., (© 2024 College of American Pathologists.)

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h -1 , median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response., Competing Interests: Conflict of interest: C. Heiser reports grants and personal fees from Inspire Medical Systems (Maple Grove, MN, USA), during the conduct of the study; and grants and personal fees for consultancy from Inspire Medical Systems, outside the submitted work. Conflict of interest: A. Steffen has received reimbursement of conference fees and travel and accommodation expenses, fees for preparing scientific continuing professional development or other events, funding for research he himself initiated, and fees for conducting clinical studies on related subjects from Inspire Medical Systems. Conflict of interest: M. Boon reports grants from Inspire Medical Systems, during the conduct of the study; and grants and personal fees for consultancy from Inspire Medical Systems, outside the submitted work. Conflict of interest: B. Hofauer reports personal fees from Inspire Medical Systems, during the conduct of the study. Conflict of interest: K. Doghramji reports grants from Inspire Medical Systems, during the conduct of the study; and grants and personal fees from Inspire Medical Systems, outside the submitted work. Conflict of interest: J.T. Maurer reports grants and personal fees for lectures, surgical training and consulting from Inspire Medical Systems, during the conduct of the study; and grants and personal fees for surgical training from Imthera and Revent, grants and personal fees for consultancy from Philipps and Nyxoah, and personal fees for lecturing from GlaxoSmithKline, Heinen und Löwenstein, Weinmann, Sissel Novacare, ResMed, Olympus, Neuwirth Medical and Medtronic, outside the submitted work. Conflict of interest: J.U. Sommer reports grants, personal fees and non-financial support from Inspire Medical Systems, ImThera, Regis Medical, Nyxoah, Phillips, MedEl, and personal fees from Neucomed, during the conduct of the study. Conflict of interest: R. Soose was a consultant and study investigator for Inspire Medical Systems, during the conduct of the study; and carried out advisory board and consultancy work for Galvani Bioelectronics, and was a consultant for Invicta Medical, outside the submitted work. Conflict of interest: P.J. Strollo Jr reports grants and personal fees for consultancy from Inspire Medical Systems and Jazz Pharmaceuticals, and personal fees for consultancy from Philips-Respironics and Itamar Medical, outside the submitted work. Conflict of interest: R. Schwab reports grants from Inspire Medical Systems, during the conduct of the study. Conflict of interest: E. Thaler is a consultant for Inspire Medical Systems, outside the submitted work. Conflict of interest: K. Withrow has nothing to disclose. Conflict of interest: A. Kominsky has nothing to disclose. Conflict of interest: C. Larsen has nothing to disclose. Conflict of interest: E.J. Kezirian reports grants from Inspire Medical Systems, during the conduct of the study; and equity from Nyxoah, Pillar Palatal, Cognitive Life Science, Split Rock Scientific, Gerard Scientific, Berendo Scientific and ReVENT Medical, and grants from Autonomic Technologies, outside the submitted work; and in addition, has a patent Magnap issued, a patent Endoscopic Device and System issued, a patent Head and Neck Exercise Methods pending, and a patent Airway and Airflow Factors issued. Conflict of interest: J. Hsia has nothing to disclose. Conflict of interest: S. Chia has nothing to disclose. Conflict of interest: J. Harwick has nothing to disclose. Conflict of interest: K. Strohl reports grants (as site PI for post-approval studies) from Inspire Medical Systems, during the conduct of the study; and was consultant to Sommetrics and advisor to Galvani Bioelectronics, outside the submitted work. Conflict of interest: R. Mehra reports grants (to institution, to support efforts to collect data for the ADHERE registry) from Inspire Medical Systems, during the conduct of the study; and grants from NIH, equipment for research from Philips Respironics and Resmed, personal fees from American Academy of Sleep Medicine, and royalties from Up to Date, outside the submitted work., (Copyright ©ERS 2019.)

Parathyromatosis is an uncommon cause of hypercalcemia. We describe a case of parathyromatosis and hypercalcemia in a 38-year-old man with a history of end-stage renal disease and subtotal parathyroidectomy in which a previous parathyroid operation was implicated. The results of fine-needle aspiration and histologic examination demonstrated a neck mass consistent with parathyromatosis. We discuss parathyromatosis as a rare cause of recurrent hypercalcemia in patients with end-stage renal disease and in those who have undergone previous parathyroid operations. We also characterize the iatrogenic and the embryologic pathogenetic factors involved.