Frailty does not worsen postoperative outcomes in sinonasal squamous cell carcinoma.

PURPOSE: Sinonasal squamous cell carcinoma (SCC) is an aggressive malignancy frequently requiring surgical resection and adjuvant treatment. Frailty is a metric that attempts to estimate a patient's ability to tolerate the physiologic stress of treatment. There is limited work describing frailty in patients with sinonasal cancer. We sought to determine the impact of frailty on postoperative outcomes in patients undergoing treatment for sinonasal SCC. MATERIALS AND METHODS: Cases of patients undergoing surgical resection of sinonasal SCC at two tertiary medical centers were queried. Demographic, treatment, and survival data were recorded. Frailty was calculated using validated indexes, including the American Society of Anesthesiologists (ASA) classification, modified 5-item frailty index (mFI-5), and the Charlson Comorbidity Index (CCI). Primary outcomes included medical and surgical complications, readmission, and length of stay (LOS). RESULTS: 38 patients were included. There were 23 (60.5 %) men and 15 (39.5 %) women with an average age of 59.6 ± 12.1 years. MFI-5 was 0.76 ± 0.54 and CCI was 5.71 ± 2.64. No significant association was noted between frailty measures and postoperative outcomes including 30-day medical complications, 30-day surgical complications, any 30-day complication, and readmission. Increased ASA was noted to be predictive of increased length of stay (Incidence Rate Ratio: 1.80, 95 % confidence interval [CI]: 1.16-2.83, p = 0.009). CONCLUSIONS: We found no association between frailty metrics and worsening surgical or medical postoperative outcomes. This suggests that frailty metrics may not be as relevant for sinonasal surgery even for advanced pathologies, given the more limited physiologic impact of minimally invasive surgery.

Postoperative Pain and Opioid Use after Facial Feminization Surgery.

The objective of this study is to characterize surgical pain after facial feminization surgery (FFS) and delineate postoperative opioid usage. It is a retrospective cohort study. It was performed in a multicenter integrated health care system. Electronic medical records were reviewed for patient demographic characteristics, medical history, pain medication prescriptions, and responses to a postoperative pain survey. Student's t-test and the Mann-Whitney U-test were used for bivariate analysis. Fisher's exact tests were used for categorical data. Seventy-four patients who underwent FFS were included. The mean (standard deviation) reported "average" postoperative pain score was 4.3 (2.3) out of 10. A total of 58% of patients reported pain lasting 5 or fewer days after surgery. The severity and duration of postoperative pain was similar between patients who underwent partial-FFS or full-FFS. A total of 68% of patients required fewer than 15 opioid tablets. There were no significant differences in the quantity of opioids prescribed or used between patients who underwent partial-FFS or full-FFS. Older age and premorbid mood disorder did not correlate with greater severity/duration of pain or number of opioids used after surgery. Most patients required fewer than 15 opioid tablets after surgery and experienced less than a week of postoperative pain. Patients undergoing full-FFS did not appear to experience significantly greater pain than those undergoing fewer procedures. Older age and premorbid mood disorder were not predictors of worse pain outcomes or greater opioid utilization.

Electrosurgery Turbinate Reduction Revisited: Can Comparable Volumetric Heating be Achieved Without Feedback Control?

BACKGROUND AND OBJECTIVES: Temperature-controlled radiofrequency inferior turbinate ablation (TCRFA) uses a feedback system to control thermal injury and achieve precise volumetric heating to induce specific scar formation. However, it requires costly single-use proprietary consumables. Comparable volumetric tissue heating may be achieved for a fraction of the cost by adjusting the power settings on traditional monopolar electrosurgery devices that use low-cost needle tips. This pre-clinical study aims to determine the optimized power parameters to achieve electrosurgical coagulum volume similar to that of TCRFA. STUDY DESIGN/MATERIALS AND METHODS: An electrosurgery submucosal diathermy (SMD) system (cut mode, 4-32 W, 5-120 seconds) and a temperature-controlled radiofrequency ablation system (standard clinical parameters for treating inferior turbinate hypertrophy) were used to coagulate egg white and chicken breast. Coagulum major and minor axis were measured, and lesion volume was approximated as prolate spheroid. RESULTS: No significant difference in volume was found between the temperature-controlled system and the electrosurgery system at 8 W for 30 seconds, 8 W for 60 seconds, 16 W for 30 seconds, 32 W for 5 seconds, and 32 W for 15 seconds. The time to achieve equivalent lesion size was significantly less in the SMD system when compared to the temperature-controlled system (P < 0.05). CONCLUSION: Electrosurgery handpieces may achieve similar lesion volume effects as the temperature feedback-controlled, single-use handpieces when set to the optimized parameters. SMD handpieces are significantly more cost and time effective than proprietary devices, and they are easily used in the office. SMD devices may be a more affordable alternative to temperature-controlled systems with comparable lesion volume effect and may be valuable for office-based therapy. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

The efficacy of surgery for upper airway resistance syndrome: A systematic review, meta-analysis and case series.

PURPOSE: Upper airway resistance syndrome (UARS) is a sleep related breathing disorder that was first described in 1993. This goal of this study is to determine the efficacy of surgical intervention for UARS. MATERIALS AND METHODS: Systematic review of the literature and a case series of UARS patients at a large integrated healthcare system. Meta-analysis was performed. RESULTS: For the systematic review, 971 abstracts were reviewed and 3 articles were included, yielding 49 subjects. All of the included studies were of level 3 or 4 evidence. Significant improvement in Epworth Sleepiness Scale (ESS) score was noted after surgery in two level 4 studies. No significant change in ESS was noted in one level 3 study. Our retrospective chart review of eleven UARS patients compared preoperative and postoperative ESS scores, as well as sleep study data. Patients underwent a variety of surgical procedures. Our findings show a significant improvement in mean ESS scores after surgery, from 11.0 (±3.5) to 7.0 (±4.8) with p = 0.01, though no difference in apnea hypopnea index (AHI) and respiratory disturbance index (RDI) were identified. Meta-analysis was performed on 2 studies from the systematic review and our cases series data. UARS surgery showed a mean change in ESS of -5.89 (95% CI, -8.29 to -3.50). CONCLUSIONS: This systematic review, meta-analysis and retrospective case series indicate that surgery may improve ESS scores in patients with UARS. AHI and RDI are unlikely to be impacted by surgery.

Reducing opioid use in post-operative otolaryngology patients: A quality improvement project.

PURPOSE: In opioid-naive patients, many low-risk surgical procedures are associated with an increased risk of chronic opioid use. The goal of this quality improvement project was to reduce the amount of opioid prescriptions after commonly performed surgeries in otolaryngology. MATERIALS AND METHODS: Pre-intervention opioid prescribing state was measured using anonymous provider and patient surveys, as well as pharmacy provider prescription data. Next, this information was used to develop an opioid prescription protocol that both standardized opioid prescribing practices and encouraged multimodal analgesia following routine surgery. Finally, post-intervention data were gathered and compared to pre-intervention data to assess changes in prescribing patterns. RESULTS: By patient survey, the worst pain and average pain after surgery (scale of 1-10) were unchanged after the intervention (5.1 to 4.8, p = 0.52; 4.1 to 3.6, p = 0.35, respectively). Post-intervention, 41% of patients reported receiving no opiates, whereas pre-intervention 100% of patients surveyed received opiates. The amount of ibuprofen and acetaminophen prescribed post-intervention increased 113% and 71%, respectively. By survey, the average number of opioid doses decreased from 24.0 ± 7.0 to 18.4 ± 6.6 (p = 0.018). CONCLUSIONS: The implementation of a standardized physician opioid prescription protocol did not affect patient pain perceptions, resulted in an increase in multimodal analgesia prescription, and increased provider awareness of opioid over prescription.

Opioid Use After Orbital, Eyelid, or Lacrimal Surgery.

PURPOSE: Opioids may be indicated to mitigate pain after oculofacial surgery. The opioid crisis prompted attention to how these medications are dispensed and disposed. This study aims to characterize opioid usage and handling of patients undergoing oculofacial plastic surgery. METHODS: Eighty-nine adult patients were surveyed on their opioid usage after undergoing orbital, lacrimal, or eyelid (including esthetic) surgery at a tertiary oculofacial plastic surgery practice. Each patient was prescribed 10 tablets of hydrocodone/acetaminophen 5 mg/325 mg; one tablet taken orally as needed every 6 hours for pain not relieved by acetaminophen. Subset analysis was performed for type of surgery, age, and gender. RESULTS: Patients consumed an average of 3 ± 0.4 tablets. In the subsets, the averages were 2.1 ± 0.5 (n = 38) tablets after eyelid surgery, 1.6 ± 0.6 (n = 24) after lacrimal surgery, and 5.6 ± 0.9 (n = 27) after orbital surgery. Greater opioid usage was observed after orbital versus eyelid surgery (p = 0.0007) and orbital versus lacrimal surgery (p = 0.0005) but not eyelid versus lacrimal surgery (p = 0.8604). Forty-six patients (51.7%) used no opioids. Over half (57.3%; n = 51) filled their prescription. Thirty-three patients (37.1%) had unused medications, of which 21 patients did not properly dispose of their medications. The mean age of patients who used opioids was less than the mean age of those who needed no opioids (p = 0.024). There were no gender differences in opioid usage use versus not (p = 0.62). CONCLUSIONS: Opioid needs after oculofacial plastic surgeries, especially eyelid and lacrimal, were minimal in this cohort. For most patients, the prescription exceeded needs. Younger age but not gender was associated with opioid use versus not. Most did not properly discard these medications. Quality improvement in both the dispensing and disposal of opioids in oculofacial surgical practice may be warranted.

Endoscopic versus external dacryocystorhinostomy: temporal and regional trends in the United States Medicare population.

Purpose: Endoscopic surgeries, such as dacryocystorhinostomy (DCR), are increasingly performed for orbital and lacrimal conditions. This study describes and compares recent trends in endoscopic DCR with open, or external, DCR in the United States (US). Methods: Medicare-Part-B National Summary data files were analyzed from 2000 to 2015 for temporal and geographic trends in endoscopic and external DCR. Medicare Physician and Other Supplier public use files detailing provider information were collected and analyzed from 2012 to 2015. Results: Between 2000 and 2015, the number of external DCRs remained relatively unchanged (8008 to 7086, -0.7% average annual growth), while the number of endoscopic DCRs steadily increased (881 to 1674, 4.6% average annual growth). The greatest number of endoscopic DCRs were performed in the South Atlantic region, whereas the Mountain region had the greatest number per capita. From 2000 to 2015, the average payment per procedure for external DCR was $526.63, compared with $512.45 for endoscopic DCR. Of endoscopic DCRs performed from 2012 to 2015, 831 (79%) were performed by Ophthalmology, 184 (18%) were performed by Otolaryngology, and the remainder by other subspecialties. Conclusions: The number of endoscopic DCR surgeries increased over the last 15 years while the number of external DCR surgeries remained stable and continued to surpass endoscopic procedures. While ophthalmologists perform the overwhelming majority of endoscopic DCR, otolaryngologists are performing a growing number.

Impact of Frailty on Postoperative Outcomes in Extended Endonasal Skull Base Surgery for Suprasellar Pathologies.

OBJECTIVE: Frailty metrics estimate a patient's ability to tolerate physiologic stress and there are limited frailty data in patients undergoing expanded endonasal approaches (EEA) for suprasellar pathologies. Elevated frailty metrics have been associated with increased perioperative complications in patients undergoing craniotomies. We sought to examine this potential relationship in EEA. STUDY DESIGN: Retrospective cohort study. SETTING: Two tertiary academic skull base centers. METHODS: Cases of patients undergoing EEA for suprasellar pathologies were reviewed. Demographic, treatment, survival, and postoperative outcomes data were recorded. Frailty was calculated using validated indexes, including the American Society of Anesthesiologists (ASA) classification, the modified 5-item frailty index (mFI-5), and the Charlson comorbidity index (CCI). Primary outcomes included 30-day medical and surgical complications. RESULTS: A total of 88 patients were included, with 59 (67%) female patients and a mean age of 54 ± 15 years. The most common pathologies included 53 meningiomas (60.2%) and 21 craniopharyngiomas (23.9%). Most patients were ASA class 3 (54.5%) with mean mFI-5 0.82 ± 1.01 and CCI 4.18 ± 2.42. There was no association between increased frailty and 30-day medical or surgical outcomes (including postoperative cerebrospinal fluid leak), prolonged length of hospital stay, or mortality (all P > .05). Higher mFI-5 was associated with an increased risk for 30-day readmission (odds ratio: 2.35, 95% confidence Interval: 1.10-5.64, P = .04). CONCLUSION: Despite the patient population being notably frail, we only identified an increased risk for 30-day readmission and observed no links with deteriorating surgical, medical, or mortality outcomes. This implies that conventional frailty metrics may not effectively align with EEA outcomes.

Multi-institutional Analysis of Endoscopic Sellar Surgical Volumes During the COVID-19 Pandemic.

OBJECTIVE: We sought to quantify trends in operative volumes and complications of endoscopic sellar surgery before and after the COVID-19 pandemic onset. STUDY DESIGN: We performed a retrospective analysis. SETTING: TriNetX database analysis. METHODS: All adults undergoing neuroendoscopy for resection of pituitary tumor (Current Procedural Terminology code 62165) with diagnosis of benign/malignant neoplasm of pituitary gland (D35.2/C75.1) or benign/malignant neoplasm of craniopharyngeal duct (D35.3/C75.2) were included using the TriNetX database for 2 years before (pre-COVID group) and 2 years after (post-COVID group) February 17, 2020. RESULTS: A total of 1238 patients in the pre-COVID group and 1186 patients in the post-COVID group were compared. Age, gender, and race were statistically similar between the groups (P > .05). Surgical volume decreased by 6% in the post-COVID group. In 2020 Q2, operative volume decreased by 19%, and in 2021 Q4 (peak COVID-19 caseload in the United States), operative volumes decreased by 29% compared to 2 years prior. Postoperative complications including meningitis (P = .49), cerebrospinal fluid leak (P = .36), visual field deficits (P = .07), postoperative pneumonia or respiratory failure (P = .42), and 30-day readmission rates (P = .89) were similar between the 2 groups. CONCLUSION: Overall, endoscopic sellar surgery may continue to fluctuate with increased COVID-19 outbreaks. Patient outcomes do not appear to be worsened by decreased operative volumes or delays in nonurgent surgeries.

The Utility of a "Second-Look" Debridement Following Endonasal Skull Base Surgery in the Pediatric Population.

Background Sinonasal debridement is typically performed in the weeks following endonasal skull base surgery (ESBS). In the pediatric population, this second-look procedure may require general anesthesia; however, there is currently little evidence assessing the benefit of this practice. Methods This was a multicenter retrospective study of pediatric patients (age <18 years) undergoing a planned second-look debridement under general anesthesia following ESBS. Intraoperative findings, interventions performed, and perioperative complications were reviewed. Multivariate regression analysis was performed to identify associations between intraoperative findings and clinical factors. Results We reviewed 69 cases of second-look debridements (age mean 8.6 ± 4.2 years, range: 2-18 years), occurring a mean of 18.3 ± 10.3 days following ESBS. All abnormal findings were noted in patients age ≤12 years. Synechiae were noted in 8.7% of cases, bacterial rhinosinusitis in 2.9%, and failed reconstruction with cerebrospinal fluid leak in 4.5% (two cases of flap malposition and one case of flap necrosis). All failed reconstructions were noted following expanded endonasal cases for craniopharyngioma, and in each case, a revision reconstruction was performed during the second-look surgery. Synechiae were not significantly associated with younger age, revision cases, or cases with reconstructive flaps. There were no perioperative complications. Conclusion Second-look debridement under general anesthesia may be useful in the identification and intervention of sinonasal pathology following endoscopic skull base surgery, particularly in children ≤12 years old or those with pedicled flap reconstructions. Larger controlled studies are warranted to validate this practice and refine indications and timing of this second procedure.

Endoscopic Repair of Anterior Skull Base Cerebrospinal Fluid Leaks is Successful in Frail Patients.

OBJECTIVE: Surgical frailty estimates a patient's ability to withstand the physiologic stress of an intervention. There is limited data regarding the impact of frailty on endoscopic cerebrospinal fluid (CSF) leak repair. METHODS: Patients undergoing CSF leak repair at two tertiary academic skull base programs were retrospectively reviewed. Demographic, treatment, and postoperative outcomes data were recorded. Frailty was calculated using validated indices, including the American Society of Anesthesiologists (ASA) classification, Charlson Comorbidity Index (CCI), and the Modified 5-Item Frailty Index (mFI-5). Outcomes included 30-day medical and surgical complications and readmission. RESULTS: A total of 185 patients were included with 128 (69.2%) female patients and average age of 54 ± 14 years. The average body mass index was 34.6 ± 8.5. The most common identified etiology was idiopathic intracranial hypertension (IIH) in 64 patients (34.6%). A total of 125 patients (68%) underwent perioperative lumbar drain placement (primarily to measure intracranial pressures and diagnose IIH). Most patients were ASA class 3 (48.6%) with mean CCI 2.14 ± 2.23 and mFI-5 0.97 ± 0.90. Three patients had postoperative CSF leaks, with an overall repair success rate of 98.4%. There was no association between increased frailty and 30-day medical outcomes, surgical outcomes, or readmission (all p > 0.05). CONCLUSIONS: Endoscopic CSF leak repair in a frail population, including lumbar drain placement and bed rest, was not associated with an increased rate of complications. Previous data suggests increased complications in open craniotomy procedures in patients with significant comorbidities. This study suggests that the endoscopic approach to CSF leak repair is well tolerated in the frail population. LEVEL OF EVIDENCE: IV Laryngoscope, 134:2713-2717, 2024.

Maxillary Antrostomy Versus Complete Sinus Surgery for Odontogenic Sinusitis With Frontal Sinus Extension.

OBJECTIVES: Endoscopic sinus surgery (ESS) is often necessary when managing odontogenic sinusitis (ODS), but ESS extent for ODS with extramaxillary sinus involvement has been incompletely studied. This study compared outcomes after wide maxillary antrostomy (MA) alone versus complete ESS for ODS with frontal sinus involvement. METHODS: A multicenter prospective cohort study was conducted on patients with uncomplicated ODS (no extrasinus spread) who underwent ESS when computed tomography demonstrated maxillary, anterior ethmoid (AE), and frontal sinus opacification. Multiple preoperative and postoperative variables were recorded, including 22-item sinonasal outcome tests (SNOT-22) and endoscopic findings. Ultimate SNOT-22 and endoscopic resolution, and time to SNOT-22 and endoscopic resolution were compared between patients who underwent MA alone versus "complete" ESS (maxillary, ethmoid, frontal; not sphenoid). RESULTS: Of 70 patients, mean age was 59.2 years, and 55.7% were male. Thirty-five underwent MA alone, and 35 had complete ESS. At first postoperative visits (mean 9.3 days), AE sinus purulence was more likely resolved after complete ESS compared with MA (97.1% vs. 71.4%, p = 0.006). However, time to resolution of AE purulence was comparable by 6 weeks postoperatively (p = 0.158). There were no significant differences in times to foul smell resolution and achieving ≥9 point SNOT-22 reduction (p > 0.05). CONCLUSIONS: For ODS with frontal sinus involvement, MA alone and complete ESS both resulted in rapid and long-term symptomatic resolution. While ultimate resolution of sinus purulence was equivalent between surgery groups, complete ESS did lead to faster resolution of frontoethmoidal purulence in a significant number of cases. LEVEL OF EVIDENCE: 2 Laryngoscope, 2024.

Quality-of-Life Outcomes Following Endoscopic Resection of Sinonasal Inverted Papilloma.

OBJECTIVES: There is growing interest in assessing patient quality of life (QOL) following treatment of sinonasal tumors, including inverted papilloma (IP). We aimed to elucidate the natural history of postoperative QOL outcomes in IP patients treated with surgery. METHODS: Cases of sinonasal IP treated surgically at 4 tertiary academic rhinology centers were retrospectively reviewed. SNOT-22 scores were used to evaluate QOL preoperatively and postoperatively (1, 3, 6, 12 months). Repeated-measures ANOVA assessed for differences in mean scores over time. Linear regression identified factors associated with QOL longitudinally. RESULTS: 373 patients were analyzed. Mean preoperative SNOT-22 score was 20.6 ± 20.4, which decreased to 16.3 ± 18.8 (p = 0.041) and 11.8 ± 15.0 (p < 0.001) at 1 and 3 months postoperatively, respectively. No further changes in SNOT-22 scores occurred beyond 3 months postoperatively (p > 0.05). When analyzed by SNOT-22 subdomains, nasal, sleep, and otologic/facial subdomain scores (all p < 0.05) demonstrated improvement at 12-month follow-up compared with preoperative scores; this was not observed for the emotional subdomain score (p = 0.800). Recurrent cases were associated with higher long-term SNOT-22 scores (ß = 7.08; p = 0.017). Age, sex, degree of dysplasia, prior surgery, primary site, and smoking history did not correlate with symptoms (all p > 0.05). CONCLUSIONS: QOL outcomes related to IP resection are largely driven by nasal, sleep, and otologic/facial subdomains, though patients appear to experience enduring improvement as early as 3 months postoperatively. Recurrent disease is a major driver of negative QOL. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Craniopharyngioma surgery for rhinologists.

PURPOSE OF REVIEW: Craniopharyngiomas are rare tumors that that present with loss of pituitary function in most cases. They present in a bimodal age distribution and the most common treatment paradigms include gross total resection or subtotal resection followed by radiation. Endoscopic transnasal access to intradural tumors has become increasingly common due to improvements in equipment, increased familiarity with the surgical corridor and anatomy, and reconstruction techniques. As such, rhinologists play an increasingly important role in the management of craniopharyngiomas. RECENT FINDINGS: Recent years have highlighted our growing experience with pediatric endonasal skull base surgery. Prior concerns including sphenoid pneumatization, midfacial growth restrictions, and intercarotid space limitations have been studied more extensively. It has been found that there are no increased complications with lack of sphenoid pneumatization, no changes to midfacial growth with endonasal techniques, and the inter-carotid distance is stable after around age 5. Advances in surgical and skull base reconstruction techniques and intraoperative monitoring have reduced the risks of complications from surgery. SUMMARY: Rhinologists play an important role in craniopharyngioma surgery. The approach to and reconstruction after tumor removal are vital portions of the procedure that allow for resection and prevent postsurgical complications.

Ocular Surface Adverse Events are not Associated with Dupilumab use in Nasal Polyp Treatment.

OBJECTIVES: Ocular surface reactions (OSR) have been associated with dupilumab for atopic dermatitis (AD) treatment. However, the association of dupilumab-associated OSR (DA-OSR) for nasal polyps (CRSwNP) treatment has not been studied. We evaluated DA-OSR for CRSwNP treatment using the FDA Adverse Event Reporting System (FAERS). METHODS: FAERS was queried for any general ocular reactions (DA-GOR) from 2019Q1 to 2022Q4. DA-OSR were subcategorized from DA-GOR and compared between treatment groups (CRSwNP, asthma, AD). Logistic regression was used to predict DA-OSR. Disproportionality analysis (DPA) of DA-OSR was performed using OpenVigil. RESULTS: There were 60,198 total observations, of which 5344 were treated for CRSwNP. The prevalence of DA-GOR and DA-OSR was greatest for AD (15.3%, 7.8%), followed by CRSwNP (12.2%, 6.7%) and asthma (9.2%, 3.5%). The most commonly reported OSRs were dry eyes (35.9%), conjunctivitis (15.7%), and increased lacrimation (11.0%). The reported odds ratio (ROR) of CRSwNP-treated DA-OSR was 0.84 (0.73-0.97; p = 0.015), compared to 1.29 (1.20-1.40; p < 0.001) for AD and 0.66 (0.59-0.73; p < 0.001) for asthma. For CRSwNP treatment, the DA-OSR ROR was 0.97 (0.90-1.03; p = 0.3) for men and 0.78 (0.73-0.83, p < 0.001) for older adults (age > 50). ROR in the DPA for DA-OSR was 12.5 (12.2-12.8; p < 0.001) for any indication and 0.58 (0.53-0.64; p < 0.001) for CRSwNP treatment only. CONCLUSIONS: While there are limitations to FAERS, this study confirms the association between dupilumab and OSR for AD treatment, and does not support an association between dupilumab and OSR for CRSwNP treatment. Younger adults experience more DA-OSR in CRSwNP treatment without a specific predilection for sex. LEVEL OF EVIDENCE: IV Laryngoscope, 2023.

A National Cancer Database Analysis of Sinonasal Malignant Myoepithelial Carcinoma Outcomes.

OBJECTIVES: Myoepithelial carcinoma (MECA) is a rare salivary gland tumor that can occur in the sinonasal cavity with poor outcomes. There are limited data on sinonasal outcomes to guide management. We sought to use the National Cancer Database (NCDB) to better define treatment outcomes in MECA. METHODS: We conducted a retrospective analysis of the NCDB from 2004 to 2016 for patients with MECA of the sinonasal cavity. Patient demographic, treatment, and survival information were extracted from the database. Unadjusted Kaplan-Meier estimates, log-rank tests, and a multivariable Cox proportional hazard model were used to assess overall survival (OS). RESULTS: A total of 38 patients were included. The average age was 60.7 ± 18.2 years and male patients represented 47.4% of the cohort. Most patients were White (n = 26, 68.4%) and the majority of patients had either private insurance (n = 20, 52.6%) or Medicare (n = 15, 39.5%). The primary site of most tumors was nasal cavity (n = 19, 50%), followed by maxillary sinus (n = 16, 42.1%). Most tumors were >4 cm (n = 17, 44.7%). The 1-, 5-, and 10-year OS was 89.7% (95% confidence interval [CI]: 80.7%-99.8%), 63.6% (95% CI: 49.4%-82%), and 46.4% (95% CI: 31%-69.5%), respectively. The median survival for the overall cohort was 85.8 months. Medicare insurance was associated with a decreased OS (hazard ratio [HR]: 8.2; 95% CI: 2.88-23.4, P < .001). Patients who underwent surgery had a significant survival benefit (HR: 0.04, 95% CI: 0.01-0.21, P < .001). DISCUSSION: MECA of the sinonasal cavity is a rare tumor with poorly understood behavior. Data from the NCDB suggests that it is a relatively aggressive tumor with surgical management associated with better outcomes. This analysis is limited by the small sample size and further research into optimal treatment regimens is needed.

The Impact of Delay in Treatment on Survival in Surgically Managed Sinonasal Undifferentiated Carcinoma.

Background Sinonasal undifferentiated carcinoma (SNUC) is a rare, aggressive malignancy with a poor prognosis, and multimodal therapy is the standard of care. We sought to characterize treatment delays in SNUC managed with surgery and adjuvant radiation and to determine the impact on survival using the National Cancer Database (NCDB). Methods This was a retrospective, population-based cohort study of patients with SNUC between 2004 and 2016 in the NCDB. The intervals of diagnosis to surgery (DTS), surgery to radiation (SRT), and radiation duration (RTD) were examined. Recursive partitioning analysis (RPA) was performed to identify the variables with the greatest impact on survival. The association between treatment delay and overall survival (OS) was then assessed using multivariate Cox proportional hazards regression. Results Of 173 patients who met inclusion criteria, 65.9% were male, average age at diagnosis was 56.6 years, and 5-year OS was 48.1%. Median durations of DTS, SRT, and RTD were 18, 43, and 46 days, respectively. Predictors of treatment delay included Black race, government insurance excluding Medicare/Medicaid, and positive margins. RPA-derived optimal thresholds were 29, 28, and 38 days for DTS, SRT and RTD, respectively. On multivariate analysis, positive margins (hazard ratio [HR]: 4.82; 95% confidence interval [CI]: 2.28-10.2) and DTS less than 29 days (HR: 2.41; 95% CI: 1.23-4.73) were associated with worse OS. Conclusion Our results likely reflect the aggressive nature of the disease with surgeons taking more invasive disease to the operating room more quickly. Median treatment intervals described may serve as relevant national benchmarks.

Image-Guided Surgical Device Failures in Functional Endoscopic Sinus Surgery: A MAUDE Analysis.

OBJECTIVE: Image-guided surgery (IGS) devices have become widely used for anatomic localization during functional endoscopic sinus surgery (FESS). However, there are no studies that analyze the post-market complications associated with IGS device use during FESS. The objective of this study was to better characterize post-market complications associated with the use of IGS devices during sinus surgery. METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for event reports associated with neurological stereotaxic devices utilized in IGS between the dates of January 1, 2016 and December 31, 2020. Medical device reports that were analyzed for this study pertained strictly to FESS. RESULTS: There were 1873 reports involving IGS devices for FESS included in this study. Fifty-five reports involved adverse events to patients (2.9%) and 1818 (97.1%) involved device malfunctions. Of the adverse events to patients, the most common included cerebrospinal fluid leakage (45.6%), tissue damage (12.7%), and nervous system injury (3.6%). The most commonly reported device malfunction was imprecision (21.1%). CONCLUSION: IGS devices are widely utilized in FESS. Of the medical device reports between 2016 and 2020, less than 3% resulted in adverse events. Further studies of the infrequent post-market complications of IGS devices used in FESS can help guide surgeons on the risks of their clinical use. LEVEL OF EVIDENCE: 4-Retrospective database survey without controls Laryngoscope, 133:1310-1314, 2023.

Microdebrider complications in sinus surgery: Analysis of the openFDA database.

Objective: Functional endoscopic sinus surgery is a commonly performed otolaryngologic procedure that often uses the microdebrider device for tissue removal. Given the ubiquitous nature of the instrument, we sought to better define the patterns of device failure using the postmarket surveillance openFDA database. Methods: The openFDA database was queried for all microdebrider-related adverse events from January 1, 2000 to November 1, 2020. Descriptive information on the nature of device failure and any associated patient injury was compiled. Reports not directly related to device failure were excluded from the analysis. Results: A total of 641 events were included in the analysis. The most common device failure was overheating (n = 348, 54.3%), followed by material separation (n = 173, 27%), and inconsistent device activation (n = 52, 8.1%). Of the reported events, the vast majority did not result in patient harm (n = 579, 90.3%). On review of the remaining cases, only 24 events (3.7%) resulted in true harm to the patient, defined as a temporary or permanent injury or >30 min of additional anesthesia time. Of these cases, the need to reschedule surgical cases (n = 5, 0.8%), retained foreign body (n = 5, 0.8%), and thermal tissue injury (n = 3,0.5%) were the most common. Five patients suffered an injury due to surgeon error unrelated to device malfunction (n = 5, 0.8%). Conclusions: Microdebrider device failures are extremely rare. When they do occur, less than 10% result in patient harm. In cases of patient harm related to microdebrider failure, preoperative testing of the device before use could prevent many of the reported malfunctions.

Carcinosarcoma of the nasal cavity and paranasal sinuses: Review of the national cancer database.

Background: Carcinosarcomas are rare, aggressive malignancies that can arise in the nasal cavity and paranasal sinuses. There are limited outcome data available. Accordingly, we sought to use the National Cancer Database (NCDB) to characterize patient demographics and outcomes. Method: A retrospective analysis of the NCDB from 2004 to 2016 for patients with sinonasal carcinosarcoma was conducted. Results: Thirty patients were included. The patients were predominantly male (n = 20), white (n = 23), and privately insured (n = 15), with an average age of 62.4 years. The nasal cavity was the most common subsite (n = 14), followed by the maxillary sinus (n = 8). Most patient were treated with surgery followed by radiation (n = 23), with the remaining undergoing surgery alone (n = 4), radiation alone (n = 2), or no treatment (n = 1). One-third (n = 10) received adjuvant chemotherapy. The 1- and 5-year overall survival (OS) in the cohort were 79.2% and 43.3%, respectively. Univariate log-rank testing showed OS varied based on intervention (P < 0.029), sex (P < 0.042), and age (P < 0.025), while on multivariate analysis none of these factors independently predicted OS. Conclusions: We describe the demographics and presenting features of a national cohort of sinonasal carcinosarcoma patients. Future research is needed to identify predictors of overall survival, and to assess the optimal roles for radiation and systemic chemotherapy.