Plasma cell-free DNA methylome profiling in pre- and post-surgery oral cavity squamous cell carcinoma.

Head and neck squamous cell carcinoma (HNSCC), a highly heterogeneous disease that involves multiple anatomic sites, is a leading cause of cancer-related mortality worldwide. Although the utility of noninvasive biomarkers based on circulating cell-free DNA (cfDNA) methylation profiling has been widely recognized, limited studies have been reported so far regarding the dynamics of cfDNA methylome in oral cavity squamous cell carcinoma (OCSCC). It is hypothesized in this study that comparison of methylation profiles in pre- and postsurgery plasma samples will reveal OCSCC-specific prognostic and diagnostic biomarkers. As a strategy to further prioritize tumor-specific targets, top differential methylated regions (DMRs) were called by reanalyzing methylation data from paired tumor and normal tissue collected in the the cancer genome atlas head-neck squamous cell carcinoma (TCGA) head and neck cancer cohort. Matched plasma samples from eight patients with OCSCC were collected at Moffitt Cancer Center before and after surgical resection. Plasma-derived cfDNA was analyzed by cfMBD-seq, which is a high-sensitive methylation profiling assay. Differential methylation analysis was then performed based on the matched samples profiled. In the top 200 HNSCC-specific DMRs detected based on the TCGA data set, a total of 23 regions reached significance in the plasma-based DMR test. The top five validated DMR regions (ranked by the significance in the plasma study) are located in the promoter regions of genes PENK, NXPH1, ZIK1, TBXT, and CDO1, respectively. The genome-wide cfDNA DMR analysis further highlighted candidate biomarkers located in genes SFRP4, SOX1, IRF4, and PCDH17. The prognostic relevance of candidate genes was confirmed by survival analysis using the TCGA data. This study supports the utility of cfDNA-based methylome profiling as a promising noninvasive biomarker source for OCSCC and HNSCC.

Upper-airway stimulation for obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. METHODS: Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial. RESULTS: The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. CONCLUSIONS: In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).

Determining optimal follow-up in the management of human papillomavirus-positive oropharyngeal cancer.

BACKGROUND: Determining the optimal follow-up for patients can help maximize the use of health care resources. This is particularly true in a growing epidemic such as human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+OPSCC). The objective of the current study was to evaluate time to disease recurrence or late toxicity in this cohort of patients to optimize patient management. METHODS: An institutional database identified 232 patients with biopsy-proven, nonmetastatic HPV+OPSCC who were treated with radiotherapy. A retrospective review was conducted in patients who were followed every 3 months for the first year, every 4 months in year 2, and every 6 months in years 3 to 5. Late toxicity (grade ≥ 3; toxicity was scored based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4]), locoregional control, distant control, and overall survival were assessed. RESULTS: The median follow-up was 33 months. Based on Radiation Therapy Oncology Group (RTOG) 0129 study risk groupings, patients were either considered to be at low (162 patients; 70%) or intermediate (70 patients; 30%) risk. Concurrent systemic therapy was used in 85% of patients (196 patients). The 3-year locoregional control, distant control, and overall survival rates were 94%, 91%, and 91%, respectively. Late toxicity occurred in 9% of patients (21 patients). Overall, 64% of toxicity and failure events occurred within the first 6 months of follow-up, with a < 2% event incidence noted at each subsequent follow-up. Only 4 patients experienced their first event after 2 years. CONCLUSIONS: HPV+OPSCC has a low risk of disease recurrence and late toxicity after treatment; approximately two-thirds of events occur within the first 6 months of follow-up. These data suggest that it may be reasonable to reduce follow-up in patients with HPV+OPSCC to every 3 months for the first 6 months, every 6 months for the first 2 years, and annually thereafter.

Radiation Therapy is Associated with Improved Outcomes in Merkel Cell Carcinoma.

BACKGROUND: Following wide excision of Merkel cell carcinoma (MCC), postoperative radiation therapy (RT) is typically recommended. Controversy remains as to whether RT can be avoided in selected cases, such as those with negative margins. Additionally, there is evidence that RT can influence survival. METHODS: We included 171 patients treated for non-metastatic MCC from 1994 through 2012 at a single institution. Patients without pathologic nodal evaluation (clinical N0 disease) were excluded to reflect modern treatment practice. The endpoints included local control (LC), locoregional control (LRC), disease-free survival (DFS), overall survival (OS), and disease-specific survival (DSS). RESULTS: Median follow-up was 33 months. Treatment with RT was associated with improved 3-year LC (91.2 vs. 76.9 %, respectively; p = 0.01), LRC (79.5 vs. 59.1 %; p = 0.004), DFS (57.0 vs. 30.2 %; p < 0.001), and OS (73 vs. 66 %; p = 0.02), and was associated with improved 3-year DSS among node-positive patients (76.2 vs. 48.1 %; p = 0.035), but not node-negative patients (90.1 vs. 80.8 %; p = 0.79). On multivariate analysis, RT was associated with improved LC [hazard ratio (HR) 0.18, 95 % confidence interval (CI) 0.07-0.46; p < 0.001], LRC (HR 0.28, 95 % CI 0.14-0.56; p < 0.001), DFS (HR 0.42, 95 % CI 0.26-0.70; p = 0.001), OS (HR 0.53, 95 % CI 0.31-0.93; p = 0.03), and DSS (HR 0.42, 95 % CI 0.26-0.70; p = 0.001). Patients with negative margins had significant improvements in 3-year LC (90.1 vs. 75.4 %; p < 0.001) with RT. Deaths not attributable to MCC were relatively evenly distributed between the RT and no RT groups (28.5 and 29.3 % of patients, respectively). CONCLUSIONS: RT for MCC was associated with improved LRC and survival. RT appeared to be beneficial regardless of margin status.

Multidisciplinary Management of Salivary Gland Cancers.

BACKGROUND: Salivary carcinomas are a rare group of biologically diverse neoplasms affecting the head and neck. The wide array of different histological entities and clinical presentations has historically limited attempts to establish well-defined treatment algorithms. In general, low-risk lesions can be managed with a single treatment modality, whereas advanced lesions require a more complex, multidisciplinary approach. METHODS: The relevant literature was reviewed, focusing on diagnostic and treatment algorithms for salivary malignancies. RESULTS: Salivary carcinomas with high-risk features require an aggressive treatment approach with complete surgical resection, neck dissection to appropriate cervical lymph-node basins, and postoperative radiotherapy. CONCLUSIONS: The heterogeneity of salivary neoplasms represents a unique clinical challenge. Despite the multidisciplinary management paradigm detailed in this review, outcomes for advanced disease are unsatisfactory. Future progress will likely require the addition of novel systemic therapeutic strategies.

Lingual traction to facilitate fiber-optic intubation of difficult airways: a single-anesthesiologist randomized trial.

PURPOSE: Flexible fiber-optic bronchoscope-guided orotracheal intubation is a valuable technique with demonstrated benefits in the management of difficult airways. Despite its popularity with anesthesia providers, the technique is not fail-safe and airway-related complications secondary to failed intubation attempts remain an important problem. We sought to determine the effect of incorporating lingual traction on the success rate of fiber-optic bronchoscope-guided intubation in patients with anticipated difficult airways. METHODS: In this prospective, randomized, cohort study, we enrolled 91 adult patients with anticipated difficult airways scheduled for elective surgery to undergo fiber-optic bronchoscope-guided orotracheal intubation alone or with lingual traction by an individual anesthesiologist after induction of general anesthesia and neuromuscular blockade. A total of 78 patients were randomized: 39 patients to the fiber-optic bronchoscope-guided intubation with lingual traction group and 39 patients to the fiber-optic bronchoscope-guided intubation alone group. The primary endpoint was the rate of successful first attempt intubations. The secondary outcome was sore throat grade on post-operative day 1. RESULTS: Fiber-optic intubation with lingual traction compared to fiber-optic intubation alone resulted in a higher success rate (92.3 vs. 74.4 %, χ (2) = 4.523, p = 0.033) and greater odds for successful first attempt intubation (OR 4.138, 95 % CI 1.041-16.444, p = 0.044). Sore throat severity on post-operative day 1 was not significantly different but trended towards worsening grades with lingual traction. CONCLUSIONS: In this study, lingual traction was shown to be a valuable maneuver for facilitating fiber-optic bronchoscope-guided intubation in the management of patients with anticipated difficult airways.

Cutaneous angiosarcoma: a single-institution experience.

BACKGROUND: Cutaneous angiosarcoma (CAS) is a rare, aggressive vascular sarcoma with a poor prognosis, historically associated with 5-year overall survival (OS) rates between 10 and 30 %. METHODS: This is a single-institution retrospective review of patients treated for CAS from 1999-2011. Demographics, primary tumor characteristics, treatment, and outcomes were analyzed. RESULTS: A total of 88 patients were identified (median age 70 years and 57 % female). Median tumor size was 3 cm. Median follow-up was 22 months. The 5-year OS and recurrence-free survival (RFS) were 35.2 and 32.3 %, respectively; median was 22.1 months. Also, 36 patients (41 %) received surgery alone, 7 (8 %) received XRT alone, and 41 (47 %) received surgery and XRT. Of the 67 of 88 patients who were disease-free after treatment, 33 (50 %) recurred (median of 12.3 months). Surgery alone had the highest 5-year OS (46.9 %) and RFS (39.9 %) (p = ns). Four presentation groups were identified: (1) XRT-induced, n = 30 (34 %), 26 of 30 occurred in females with a prior breast cancer, (2) sporadic CAS on head and neck (H/N), n = 38, (3) sporadic CAS on trunk/extremities, n = 13, and (4) Stewart-Treves n = 7. Those with trunk/extremity CAS had the highest 5-year OS (64.8 %), with H/N CAS having the worst 5-year OS (21.5 %). On MV analysis, only tumor size <5 cm correlated with improved OS (p = 0.014). DISCUSSION: In this large series, there appears to be a better overall prognosis than historically reported, especially in Stewart-Treves and CAS on trunk or extremities. While surgery alone was associated with better OS and RFS compared with other treatment modalities, this was not statistically significant. Tumor size was a significant prognostic factor for OS.

Rare treatment of radiation induced carotid pseudoaneurysm and ensuing carotid blowout syndrome with placement of multiple contiguous endovascular stents: a case report.

Cervical radiotherapy for treatment of head and neck cancer can result in the delayed carotid vasculopathy. Surgical management for an ensuing hemorrhage is challenging due to the associated high mortality and morbidity. We present a case of a relative rapid formation of common carotid pseudoaneurysm formation with subsequent carotid blowout syndrome in previously irradiated neck. Successful treatment in our patient is highlighted by the fact that multiple, contiguous endovascular stents were placed emergently to obtain control of pseudoaneurysm rupture.

Telehealth Interventions in Head and Neck Cancer Patients: A Systematic Review.

BACKGROUND: Head and neck cancer (HNC) and its treatments often result in adverse effects that impair a patient's quality of life. Although intensive rehabilitative strategies can be used, their applicability can be limited due to patient-specific and socioeconomic barriers. Telehealth interventions represent a possible novel approach to increase access to these services and improve posttreatment quality of life in the HNC population. OBJECTIVE: The objective of this systematic review was to identify studies investigating telemedicine-based interventions for HNC patients to determine whether there is a consensus concerning the cost-effectiveness, clinical utility, and accessibility of this model for rehabilitation. METHODS: PubMed, EMBASE, Web of Science, and CINAHL were used to identify literature without time limit for publication. A critical appraisal of individual sources was conducted by 2 reviewers. Sixteen studies met inclusion criteria. RESULTS: Studies related to telehealth interventions in the HNC population are limited. Salient themes included feasibility of telehealth as an intervention, effects on self-management and knowledge, impact on quality of life, physical and psychiatric symptoms, and cost. CONCLUSION: Although the current literature presents promising data, indicating that telehealth interventions may be both effective and cost-efficient in the management of HNC patients, more research is needed to definitively elucidate their role in management. IMPLICATIONS FOR PRACTICE: Telehealth interventions are valuable for clinicians as an alternative to expand access to care across the cancer continuum, to strengthen patients' knowledge and consequently their self-management, and to provide continuity of services as well as for remote monitoring of symptoms and response to treatment.

Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories.

STUDY OBJECTIVES: Data on adherence and outcome of upper airway stimulation (UAS) for patients with obstructive sleep apnea (OSA) are collected in an international registry (ADHERE). Previous publications report significant improvement in self-reported and objective OSA outcomes, durable effectiveness, and high adherence. Debate remains whether the effectiveness of UAS is influenced by preoperative OSA severity; therefore, we aimed to evaluate this using data from the ADHERE Registry. METHODS: ADHERE is a postmarket, ongoing, international multicenter registry. Adult patients were included if they had undergone UAS implantation and had at least 1 follow-up visit recorded in the database on June 8, 2021. We divided the patients into 5 subgroups, based on OSA severity at baseline (AHI in events/h): subgroup 1 (0-15), 2 (15-30), 3 (≥ 30-50), 4 (> 50-65), and 5 (> 65). We compared results regarding objective and self-reported treatment outcomes. RESULTS: A total of 1,963 patients were included. Twelve months after implantation, there was a significant (P < .0001) improvement in objective sleep parameters in all subgroups with an AHI above 15 events/h. Patients in subgroup 1 had the lowest AHI at the final visit and the AHI reduction in patients in subgroup 5 was the largest (P < .0001). No significant difference was found between the subgroups in overall treatment success (66.6%) and improvement in self-reported outcomes. CONCLUSIONS: Our results suggest that UAS is an effective treatment for patients with an AHI ≥ 15 events/h, independent of preoperative OSA severity. Self-reported outcomes and treatment success did not differ significantly between the 5 subgroups. These results clearly support that the indication of UAS could be broadened for patients with an AHI above 65 events/h, which, to date, is not common practice. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry (ADHERE Registry); Identifier: NCT02907398; URL: https://www.clinicaltrials.gov/ct2/show/NCT02907398. CITATION: Bosschieter PFN, de Vries N, Mehra R, et al. Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories. J Clin Sleep Med. 2022;18(6):1657-1665.

Endoscopic repair of Zenker's diverticulum by harmonic scalpel.

PURPOSE: Although endoscopic staple-assisted esophagodiverticulostomy (ESED) has become the initial treatment of choice for most patients with Zenker's diverticulum (ZD), anatomical restraints prevent its use in all cases. We describe an endoscopic approach for treating ZD using the harmonic scalpel, which can be used in certain cases where diverticulum anatomy precludes ESED. MATERIALS AND METHODS: Medical records of 7 consecutive patients who underwent endoscopic repair of ZD using the harmonic scalpel (Harmonic Ace, Ethicon Endo-Surgery, Inc, Cincinnati, OH) were reviewed. Data collected included demographics, symptoms, surgical details, complications, and postoperative outcomes. Main outcome measures were time to resumption of oral diet, symptom resolution, and complications. RESULTS: All patients (N = 7) who underwent endoscopic repair of ZD using the harmonic scalpel resumed an oral diet at initial follow-up visit after surgery (mean, 7 days; range, 4-9 days) and rated their symptoms as being completely resolved at subsequent follow-up (mean, 4 months; range, 1.5-8 months). There were no complications. CONCLUSIONS: Endoscopic repair of ZD using the ultrasonic cutting shears is a safe and efficacious procedure that allows for endoscopic treatment in certain cases that cannot be treated by ESED. Further study is warranted in larger series to determine efficacy and safety compared with established endoscopic techniques.

Management of Non-High-Risk Salivary Gland Carcinomas With Surgery Alone.

Background Risk stratification and appropriate treatment selection are essential for the management of head and neck malignancies, in order to optimize long-term outcomes. Salivary gland carcinomas (SGCs) pose a particular challenge due to their extensive biologic heterogeneity. Primary surgical resection remains the mainstay of treatment; however, outcomes with single modality therapy for 'non-high-risk' lesions are less elucidated in the literature present on the subject. We present our experience with non-high-risk salivary gland malignancies treated by surgery alone.  Methods A retrospective analysis of SGCs from 1998-2011 was completed after receiving Institutional Review Board approval. Patient demographic, tumor, treatment, and outcome data were obtained from chart review. The primary outcomes of interest were overall survival (OS) and recurrence-free survival (RFS). Results Of the 62 patients identified, 49 patients underwent resection of the primary tumor alone, while an ipsilateral selective neck dissection was included for 13 patients. The median follow-up was 5.05 years. Of the tumors, 79% were low-intermediate grade, 3% high grade, and 17% poorly classified. The OS and RFS were 91% and 87% at five years and 80% and 79% at 10 years, respectively. The combined failure rate of local, regional, and distance was 13%. Conclusion Surgery alone is an appropriate treatment strategy for patients with non-high-risk salivary gland malignancy, affording a high likelihood of long-term RFS and OS.

Medical Cannabis as Adjunctive Therapy for Head and Neck Cancer Patients.

The goal of this systematic review was to define a consensus within the current literature regarding the impact/effect of cannabis or cannabinoids on the treatment of patients with head and neck cancer. We conducted a review of PubMed, Embase, and Web of Science databases, using a comprehensive search strategy, focusing on articles relating to head & neck cancer and cannabis/cannabinoids without a time limit for publication. Two, independent reviewers screened articles based on title/abstract and included the ones selected by both. We then conducted a full-text review and excluded all articles which did not meet inclusion criteria. A single reviewer then assessed studies for methodological quality and extracted relevant data using a premade data collection tool. We identified five studies that met inclusion criteria. Studies were of varying quality and the majority investigated recreational cannabis use with only one study reporting dosing across participants. Lack of standardized cannabis exposure presents a wide array of potential confounding variables across the remaining studies. Meta-analysis was not attempted due to variability in reported outcomes. It is impossible to draw any conclusions regarding the benefit or adverse effects of current medical cannabis products in this patient population. The literature regarding the effect of cannabis/cannabinoids on head & neck cancer patients is limited. However, the current lack of evidence does not definitively disprove the efficacy of cannabis. High-quality studies are necessary for physicians to provide advice to patients who are either using or interested in cannabis as an adjunctive treatment.

Strategies for assessing community challenges and strengths for cancer disparities participatory research and outreach.

Interventions involving community-academic partnerships must be driven by a participatory approach that is informed by a comprehensive understanding of the perspectives of communities or focus populations. Often research agendas of academics are different from perceived priority needs of community members. Successful and sustainable interventions are made possible with initial open dialogue among all collaborators so that roles are clearly defined and concerns are addressed. This article describes approaches used in the development of a participatory assessment of health and social issues as defined by community and academic partners, current findings, and lessons learned. The assessment is one initial activity of the Tampa Bay Community Cancer Network (TBCCN) to guide network directions through 2010. The TBCCN is one of 25 programs nationwide addressing cancer disparities through sustainable community-based participatory research, outreach, and screening activities.

A Community-Oriented Approach to Questionnaire Development for Assessment of Oral Cancer Awareness Among Hispanic Migrant Farmworkers.

While disparities in the incidence, treatment, and mortality of oral cancer have been investigated in underrepresented groups, the Hispanic migrant farmworker population is understudied. A questionnaire was designed to assess oral cancer knowledge, awareness, and care-seeking behavior in this population. We aim to review this survey and outline its development.

Head and neck cutaneous metastasis of testicular choriocarcinoma.

Testicular choriocarcinoma (CC) is a malignant germ cell tumour which most frequently presents with disseminated metastasis, often involving the lungs, brain and liver. Metastatic are characterised by extensive vascularity, often causing patients to present emergently with potentially life-threatening haemorrhagic complications. We report a patient with disseminated testicular CC, presenting with haemorrhage from a dermal metastatic focus involving the lower lip and mentum, requiring surgical intervention. This unique case illustrates the potential utility of palliative surgery, for the management of symptomatic metastatic disease, such as those caused by testicular CC.

Diabetes mellitus in major head and neck cancer surgery: Systematic review and meta-analysis.

BACKGROUND: Diabetes mellitus (DM) is a risk factor for surgical complications and a common comorbidity in the setting of head and neck (H&N) cancer. Our objective was to determine if DM is associated with increased rates of H&N cancer surgery complications. METHODS: We conducted a search of Pubmed, Embase, and the national clinical trials database focusing on H&N cancer surgery or free flap reconstruction and diabetes. Two reviewers screened studies by title/abstract and then full text. We then collected data using a pre-made template. Meta-analysis was performed using Revman 5.3. RESULTS: Of the 272 results from Pubmed and 559 from Embase, we selected 16 studies for inclusion. Meta-analysis revealed DM was associated with increased rates of flap failure (risk ratio [RR] = 1.83 95% confidence interval [CI], 1.18-2.85; P = .007) and local complications (RR = 1.87 95% CI, 1.24-2.80; P < .00001). CONCLUSION: Although DM is associated with increased risk of flap failure and local H&N cancer surgery complications, further research is required to optimize care in this population.

Management of delayed esophageal perforations after anterior cervical spinal surgery.

OBJECT: Delayed esophageal perforation is an uncommon but well-known complication after anterior cervical spine surgery. To the authors' knowledge there is no consensus to the optimal management of these patients in the literature. METHODS: The authors performed a retrospective review of 5 cases involving patients who were referred to their institution for the management of delayed esophageal perforations after undergoing anterior cervical spine surgery for a variety of reasons. RESULTS: The primary presenting symptom in all 5 patients was dysphagia. All patients initially underwent primary closure of the perforation with a sternocleidomastoid muscle flap. One patient required multiple surgeries to correct the perforation and ultimately required a free flap. CONCLUSIONS: The authors recommend a multidisciplinary approach that involves otolaryngological surgeons as well as spine surgeons. They recommend removal of all anterior hardware and believe that it is essential to the treatment of esophageal perforations. If the patient does not have evidence of fusion at the time of presentation, then posterior cervical instrumentation is a viable alternative.

Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes.

Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

Thyroid cancer in pregnancy.

We report a case of papillary thyroid cancer in pregnancy and discuss the various diagnostic and therapeutic challenges inherent to this condition. Several case series are reviewed. In addition, we examine the effect of pregnancy on the development and progression of thyroid malignancy.