Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry.

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.

A ratiometric threshold for determining presence of cancer during fluorescence-guided surgery.

BACKGROUND AND OBJECTIVE: Fluorescence-guided imaging to assist in identification of malignant margins has the potential to dramatically improve oncologic surgery. However, a standardized method for quantitative assessment of disease-specific fluorescence has not been investigated. Introduced here is a ratiometric threshold derived from mean fluorescent tissue intensity that can be used to semi-quantitatively delineate tumor from normal tissue. METHODS: Open-field and a closed-field imaging devices were used to quantify fluorescence in punch biopsy tissues sampled from primary tumors collected during a phase 1 trial evaluating the safety of cetuximab-IRDye800 in patients (n = 11) undergoing surgical intervention for head and neck cancer. Fluorescence ratios were calculated using mean fluorescence intensity (MFI) from punch biopsy normalized by MFI of patient-matched tissues. Ratios were compared to pathological assessment and a ratiometric threshold was established to predict presence of cancer. RESULTS: During open-field imaging using an intraoperative device, the threshold for muscle normalized tumor fluorescence was found to be 2.7, which produced a sensitivity of 90.5% and specificity of 78.6% for delineating disease tissue. The skin-normalized threshold generated greater sensitivity (92.9%) and specificity (81.0%). CONCLUSION: Successful implementation of a semi-quantitative threshold can provide a scientific methodology for delineating disease from normal tissue during fluorescence-guided resection of cancer.

Early Voice and Swallowing Disturbance Incidence and Risk Factors After Revision Anterior Cervical Discectomy and Fusion Using a Multidisciplinary Surgical Approach: A Retrospective Cohort Evaluation of a Prospective Database.

BACKGROUND AND OBJECTIVES: Dysphagia and vocal cord palsy (VCP) are common otolaryngological complications after revision anterior cervical discectomy and fusion (rACDF) procedures. Our objective was to determine the early incidence and risk factors of VCP and dysphagia after rACDF using a 2-team approach. METHODS: Single-institution, retrospective analysis of a prospectively collected database of patients undergoing rACDF was enrolled from September 2010 to July 2021. Of 222 patients enrolled, 109 patients were included in the final analysis. All patients had prior ACDF surgery with planned revision using a single otolaryngologist and single neurosurgeon. MD Anderson Dysphagia Inventory and fiberoptic endoscopic evaluation of swallowing (FEES) were used to assess dysphagia. VCP was assessed using videolaryngostroboscopy. RESULTS: Seven patients (6.7%) developed new postoperative VCP after rACDF. Most cases of VCP resolved by 3 months postoperatively (mean time-to-resolution 79 ± 17.6 days). One patient maintained a permanent deficit. Forty-one patients (37.6%) reached minimum clinically important difference (MCID) in their MD Anderson Dysphagia Inventory composite scores at the 2-week follow-up (MCID decline of ≥6), indicating new clinically relevant swallowing disturbance. Forty-nine patients (45.0%) had functional FEES Performance Score decline. On univariate analysis, there was an association between new VCPs and the number of cervical levels treated at revision ( P = .020) with long-segment rACDF (≥4 levels) being an independent risk factor ( P = .010). On linear regression, there was an association between the number of levels treated previously and at revision for FEES Performance Score decline ( P = .045 and P = .002, respectively). However, on univariate analysis, sex, age, body mass index, operative time, alcohol use, smoking, and individual levels revised were not risk factors for reaching FEES Performance Score decline nor MCID at 2 weeks postoperatively. CONCLUSION: VCP is more likely to occur in long-segment rACDF but is often temporary. Clinically relevant and functional rates of dysphagia approach 37% and 45%, respectively, at 2 weeks postoperatively after rACDF.

Preanalytical Phase Tumor Contaminants in Intraoperative Margins From Transoral Robotic Surgeries.

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.

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation.

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.

Increasing preoperative apnea severity improves upper airway stimulation response in OSA treatment.

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.

Tracheotomy in the SARS-CoV-2 pandemic.

The severe acute respiratory syndrome (SARS)-CoV-2 pandemic continues to produce a large number of patients with chronic respiratory failure and ventilator dependence. As such, surgeons will be called upon to perform tracheotomy for a subset of these chronically intubated patients. As seen during the SARS and the SARS-CoV-2 outbreaks, aerosol-generating procedures (AGP) have been associated with higher rates of infection of medical personnel and potential acceleration of viral dissemination throughout the medical center. Therefore, a thoughtful approach to tracheotomy (and other AGPs) is imperative and maintaining traditional management norms may be unsuitable or even potentially harmful. We sought to review the existing evidence informing best practices and then develop straightforward guidelines for tracheotomy during the SARS-CoV-2 pandemic. This communication is the product of those efforts and is based on national and international experience with the current SARS-CoV-2 pandemic and the SARS epidemic of 2002/2003.

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy.

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.

Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment-Refractory Obstructive Sleep Apnea.

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.Methods: A parallel-arm experimental study design was used to compare objective sleep apnea measures and patient-reported outcomes in those who received upper airway stimulation approval versus denial in a multinational prospective study (NCT02907398). Wilcoxon rank-sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent upper airway stimulation versus no treatment comparators.Results: A greater reduction in apnea-hypopnea index was observed in those who underwent upper airway stimulation (n = 230, follow-up: 360 ± 171 d) versus no treatment (n = 100, follow-up: 272 ± 278 d), that is, -19.1 ± 15.8 versus -8.1 ± 20.9, respectively, P < 0.001, with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing upper airway stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs. 1.8 ± 3.7, respectively, P < 0.001) and overall sleep-related patient-reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively).Conclusions: Objective and subjective sleep apnea burden was more improved in those receiving upper airway stimulation versus not. Results underscore the need to optimize clinical care pathways focused on effective treatment of patients with obstructive sleep apnea who are not upper airway stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities.

Upper Airway Stimulation Response in Older Adults with Moderate to Severe Obstructive Sleep Apnea.

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.

Previous Surgery and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.

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.

Early feasibility of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices and continuous positive airway pressure-intolerant severe obstructive sleep apnea.

BACKGROUND: Implantable hypoglossal nerve upper airway stimulation (HNS) is a novel strategy approved by the US Food and Drug Administration for the management of moderate-to-severe obstructive sleep apnea (OSA) in patients with continuous positive airway pressure therapy intolerance or failure. Because of the proximity of a cardiac implantable electronic device (CIED) to this stimulator, interaction between these devices is theoretically possible. OBJECTIVE: The purpose of this study was to assess interactions between an implantable HNS device and a CIED. METHODS: We retrospectively analyzed 14 ad hoc patients with continuous positive airway pressure-intolerant, moderate-to-severe OSA and pre-existing transvenous CIEDs undergoing HNS implantation (Inspire II, Inspire Medical Systems). We assessed these devices for their pre and postimplant OSA outcomes and for possible device-device interaction. All patients were followed up for 1 year. RESULTS: Of the 14 patients, 9 had a pacemaker (8 dual-chamber, 1 single-chamber), 4 had an implantable cardioverter-defibrillator (2 dual-chamber, 1 single-chamber), and 1 had a cardiac resynchronization therapy device. All the HNS devices were implanted on the opposite side of the CIED. All CIEDs were programmed bipolar. HNS were programmed either unipolar or bipolar. During implant, intraoperative testing was performed to confirm that bipolar and unipolar HNS stimulation did not impact CIED sensing. During the follow-up period, no oversensing episodes were noted on the CIEDs. CONCLUSION: In this early experience, simultaneous use of a novel hypoglossal nerve upper airway stimulation device with transvenous CIEDs seems to be safe, effective, and without any device-device interactions.

Upper Airway Stimulation for Obstructive Sleep Apnea: Results from the ADHERE Registry.

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.

Free tissue transfer to manage salvage laryngectomy defects after organ preservation failure.

OBJECTIVE: Salvage laryngectomy to treat organ preservation failures results in significantly higher local wound complications. Even in the absence of extralaryngeal disease, primary closure of laryngeal defects can result in protracted wound care problems. We hypothesize that even when sufficient mucosa is present to close the defect primarily, introduction of vascularized tissue to close the defect may improve outcomes. DESIGN: Retrospective case-control study. SETTING: Two academic tertiary care centers. PATIENTS AND METHODS: Patients undergoing salvage surgery for laryngeal squamous cell carcinoma between 2000 to 2006 were considered for this study. Patients requiring total laryngopharyngectomy or partial pharyngectomy were excluded. There were 37 patients who met study criteria: 17 patients underwent free flap reconstruction (16 radial forearm flaps and 1 rectus flap), and 20 patients underwent primary closure. The median follow-up was 12 (range, 4-60) months. Previous treatment consisted of chemoradiation for 41% of the reconstruction group and 35% of the primary closure group; the remainder were treated with primary radiation alone. MAIN OUTCOME MEASURES: Pharyngocutaneous fistula, stricture, length of hospitalization, feeding tube dependence. RESULTS: The free flap reconstruction group had a lower rate of fistula (18%) compared with the primary closure group (50%). A lower rate of stricture formation (18% vs. 25%) and feeding tube dependence (23% vs. 45%) was observed in the free flap reconstruction group compared with the primary closure group. The development of a fistula in either group resulted in a prolonged hospital stay (mean, 19 vs. 7 days) and additional procedures. CONCLUSION: Planned reconstruction of salvage laryngectomy defects with vascularized tissue is associated with a lower fistula rate and may improve outcomes.

Assessment of indocyanine green-labeled cetuximab to detect xenografted head and neck cancer cell lines.

OBJECTIVE: The aim of this study is to determine the efficacy of indocyanine green (ICG) conjugated to antiepidermal growth factor receptor antibody (cetuximab) to image head and neck cancer. STUDY DESIGN: Mice (n = 3) were injected with unconjugated ICG and imaged at 100-second intervals for a total of 1000 seconds to assess imaging characteristics. Mice (n = 10) xenografted with SCC-1 cells were then systemically injected with cetuximab conjugated to indocyanine green and imaged over a 72-hour period. To assess the sensitivity and specificity, xenografted tumors underwent subtotal resections and then were assessed for residual disease by fluorescence stereomicroscopy and confirmed by histology. RESULTS: Tumors demonstrated excellent fluorescence 24 hours after injection of cetuximab-ICG. There was a direct relationship between fluorescence and the given dose of cetuximab-ICG. Following subtotal resection, we found fluorescence correlated with a sensitivity of 78.4% and specificity of 96%. CONCLUSIONS: This study provides evidence that supports further preclinical investigation of cetuximab in the evaluation of surgical margins, but linkage to ICG lacks the sensitivity for use in a clinical setting.

Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.

The purpose of this study was to assess the potential of U.S. Food and Drug Administration-cleared devices designed for indocyanine green-based perfusion imaging to identify cancer-specific bioconjugates with overlapping excitation and emission wavelengths. Recent clinical trials have demonstrated potential for fluorescence-guided surgery, but the time and cost of the approval process may impede clinical translation. To expedite this translation, we explored the feasibility of repurposing existing optical imaging devices for fluorescence-guided surgery. METHODS: Consenting patients (n = 15) scheduled for curative resection were enrolled in a clinical trial evaluating the safety and specificity of cetuximab-IRDye800 (NCT01987375). Open-field fluorescence imaging was performed preoperatively and during the surgical resection. Fluorescence intensity was quantified using integrated instrument software, and the tumor-to-background ratio characterized fluorescence contrast. RESULTS: In the preoperative clinic, the open-field device demonstrated potential to guide preoperative mapping of tumor borders, optimize the day of surgery, and identify occult lesions. Intraoperatively, the device demonstrated robust potential to guide surgical resections, as all peak tumor-to-background ratios were greater than 2 (range, 2.2-14.1). Postresection wound bed fluorescence was significantly less than preresection tumor fluorescence (P < 0.001). The repurposed device also successfully identified positive margins. CONCLUSION: The open-field imaging device was successfully repurposed to distinguish cancer from normal tissue in the preoperative clinic and throughout surgical resection. This study illuminated the potential for existing open-field optical imaging devices with overlapping excitation and emission spectra to be used for fluorescence-guided surgery.

Parathyromatosis and recurrent hyperparathyroidism.

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.

Outcomes of Holmium Laser-Assisted Lithotripsy with Sialendoscopy in Treatment of Sialolithiasis.

OBJECTIVES: The purpose of the current study was to compare outcomes and complication rates of sialolithiasis treated with intracorporeal holmium laser lithotripsy in conjunction with salivary endoscopy with those treated with simple basket retrieval or a combined endoscopic/open procedure. STUDY DESIGN: Case-comparison study. SETTING: Tertiary hospital. METHODS: Review of prospectively collected data of patients who underwent treatment for sialolithiasis by the senior author during 2011 to 2013. Patient demographics, operative techniques, surgical findings, clinical outcomes, and complications were recorded. Additional information regarding symptoms and satisfaction with treatment was obtained via standardized telephone questionnaire at the time of the data analysis. RESULTS: Thirty-one patients were treated for sialolithiasis. Sialoliths averaged 5.9 mm in size (range, 2-20 mm) and were comparable between both groups. Sixty-eight percent were in the submandibular gland (n = 21), with the remaining 32% in the parotid gland (n = 10). Fifty-two percent of patients (n = 16) were treated endoscopically with intracorporeal holmium laser lithotripsy, while the remaining 48% (n = 15) were treated with salivary endoscopy techniques other than laser lithotripsy. Successful stone removal without additional maneuvers occurred in 81% of the laser cases and 93% of the nonlaser group. Patients in the laser group reported an average improvement of symptoms of 95% compared with 90% of the nonlaser group when adjusted for outliers. Complications in all patients included ductal stenosis (n = 2) and salivary fistula (n = 1). CONCLUSION: The results of our series show favorable results with the use of intracorporeal holmium laser lithotripsy for the endoscopic management of sialolithiasis with minimal adverse events.