Orbital decompression surgery among Medicare beneficiaries in the post-teprotumumab era.

KEY POINTS: Utilization of orbital decompressions (ODS) increased (CAGR: +3.2%) from 2000 to 2019. FDA approved teprotumumab in January 2020; ODS utilization decreased (CAGR: -14.9%) from 2019 to 2022. In 2022, total spending was substantially higher for teprotumumab ($325 million) than surgery ($580,000).

A New Patient-reported Outcomes Measure for Surgically Treated Epiphora: Tearing Assessment and Rating Scale-12 (TEARS-12).

BACKGROUND: No widely accepted, validated instrument currently exists to measure clinical outcomes in patients who undergo dacryocystorhinostomy (DCR) for treatment of epiphora. OBJECTIVE: To develop a patient-reported outcome measure applicable to this population. METHODS: Psychometric evaluations, consultation with experts, and review of the literature informed item generation of a 12-question questionnaire to incorporate the most relevant symptoms experienced by patients with nasolacrimal duct obstruction. This questionnaire, known as the Tearing Assessment and Rating Scale-12 (TEARS-12), was administered to 32 patients before and after intervention, in the form of endoscopic DCR. Statistical analysis was performed to measure internal consistency, responsiveness, and test-retest reliability. RESULTS: Pre-operative and post-operative TEARS-12 scores (28.2 [standard error (SE) 3.19] vs 11.8 [SE 3.25], respectively, P = 0.001) demonstrated improved patient outcome within 6 weeks following endoscopic DCR. Cronbach's alpha for the questionnaire was 0.90, indicating high overall reliability. Additionally, each question demonstrated internal reliability, with a corrected item-total correlation greater than 0.30. The intraclass correlation between the two pre-operative scores was 0.858 (P < 0.001), indicating high test-retest reliability. CONCLUSION: TEARS-12 is a statistically valid, easy-to-administer instrument to measure clinical outcomes in patients who undergo endoscopic DCR.

Five-year EuroQol 5-Dimension Outcomes After Endoscopic Sinus Surgery.

OBJECTIVE: The EuroQol 5-Dimension (EQ-5D) is a general health survey that is quick to administer, widely used, and directly convertible to health utility values (HUV). We aim to describe the five-year EQ-5D outcomes among patients who undergo surgical treatment for chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective observational cohort study. METHODS: Patients with CRS completed the EQ-5D questionnaire preoperatively and annually for five years following endoscopic sinus surgery. Paired t-tests and McNemar's tests were used to compare preoperative and postoperative scores. Mixed-effects modeling was used for multivariate analysis. RESULTS: Among 1296 patients enrolled in our study, 812 (74.7%) completed the postoperative survey at one year and 336 (38.9%) completed it at five years. There was a significant and sustained reduction of patients reporting pain/discomfort (74.9% vs. 58.0%, p < 0.001) and anxiety/depression (49.6% vs. 38.1%, p = 0.01) out to five years. Frequency of problems reported in the usual activity domain decreased at one year and was sustained through year four (30.6% vs 19.7%, p = 0.003). After multivariable modeling, female gender (p = 0.02), prior sinus surgery (p = 0.01), tobacco use (p = 0.038), headaches (p = 0.013), allergies (p = 0.001), diabetes (p = 0.022), hypertension (p = 0.036), higher preoperative SNOT-22 score (p < 0.001), and a lower preoperative Lund-Mackay score (p < 0.001) were associated with significantly worse EQ-5D HUV over time. Similarly, a worse EQ-5D Visual Analog Scale (VAS) over time was associated with allergies (p = 0.03), diabetes (p < 0.001), hypertension (p = 0.04), higher preoperative SNOT-22 score (p < 0.001), and prior sinus surgery (p < 0.001). CONCLUSION: Patients with chronic rhinosinusitis experience significant sustained improvements in health-related quality of life up to five years after ESS as measured by the EQ-5D instrument. LEVEL OF EVIDENCE: Level 2 Laryngoscope, 134:2592-2601, 2024.

The Impact of Gender on Long-Term Quality of Life After Sinus Surgery for Chronic Rhinosinusitis.

OBJECTIVE: To identify the impact of gender on the clinical outcomes of endoscopic sinus surgery (ESS) through the comparison of quality of life measures in female and male patients who undergo surgical treatment for chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective observational cohort study. METHODS: Patients with CRS completed the 22-item Sino-Nasal Outcome Test (SNOT-22) and EuroQol 5-Dimension Survey (EQ-5D) preoperatively and annually for 5 years following ESS. Health utility values (HUV) were calculated from EQ-5D scores. Comparisons of cohort characteristics were performed with chi-square and t-tests. A multivariable linear mixed effects model evaluated changes in SNOT-22 and HUV over time by gender. RESULTS: Among the 1268 patients (54% female) enrolled, 789 and 343 completed postoperative surveys at one and 5 years, respectively. Preoperatively, females experienced more severe symptoms: mean SNOT-22 score (51.1 ± 20.9 female vs. 44.7 ± 20.0 male, p < 0.001) and HUV (0.80 ± 0.14 female vs. 0.84 ± 0.11 male, p < 0.001). These gender differences were resolved by year one postoperatively (SNOT-22: p = 0.083; HUV: p = 0.465). Two years after surgery, however, females reported more severe symptoms (SNOT-22: 25.6 ± 20.7 female vs. 21.5 ± 17.4 male, p = 0.005; HUV: 0.88 ± 0.12 female vs. 0.90 ± 0.11 male, p = 0.018), a difference that persisted at year five. These gender-related differences remained after adjusting for age, race, ethnicity, nasal polyps, history of prior ESS, and smoking status (p < 0.001). Within-subject improvement was comparable between genders (SNOT-22: p = 0.869; HUV: p = 0.611). CONCLUSION: Females with CRS reported more severe symptoms both before and 5 years after surgery compared to their male counterparts. Understanding the mechanism behind these gender-related differences is important for optimizing CRS treatment. LEVEL OF EVIDENCE: 2 Laryngoscope, 133:3319-3326, 2023.

Defining the Health Utility Value of Medical Management of Chronic Rhinosinusitis: A Prospective Pilot Study.

The extent to which medical management of chronic rhinosinusitis (CRS) may improve health utility value (HUV) remains unknown. We conducted a prospective pilot study to longitudinally assess HUV via the EQ-5D-5L questionnaire in patients with CRS who were receiving medical therapy but did not undergo sinus surgery. The primary study outcome was HUV at 12-month follow-up; secondary end points included HUV at baseline and 3- and 24-month follow-up. Our study enrolled 115 patients who received the following medical treatments: saline irrigations (n = 83, 72.2%), steroid sprays (n = 93, 80.9%), antihistamines (n = 64, 55.7%), steroid irrigations (n = 29, 25.2%), and oral antibiotics (n = 58, 50.4%). There was a statistically significant improvement (mean, +0.073; P = .003) in HUV at 12 months (minimum clinically important difference, 0.055) as compared with baseline. However, there was no statistically significant trend in HUV over time between baseline and 24-month follow-up (P = .3033). These findings can inform cost-effectiveness research as new medical therapies for CRS emerge.

Endoscopic sinus surgery for chronic rhinosinusitis: 22-item Sino-Nasal Outcome Test 5-year results.

BACKGROUND: Currently, limited data exist as to long-term disease-specific outcomes after endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). In this report, we present outcomes data collected over 5 years in a large prospective cohort of patients who underwent surgical treatment for CRS. METHODS: Patients who completed the 22-item Sino-Nasal Outcome Test (SNOT-22) before ESS were asked to complete the same survey at yearly intervals for 5 years thereafter. The impact of patients' demographics and clinical characteristics on clinical outcome was measured using mixed effects modeling for univariate and multivariable analysis. Multivariable logistic regression threshold analyses were also performed. RESULTS: Among the 925 patients enrolled in the study, the SNOT-22 was completed after ESS by 641 patients (69.3%) at 1 year and 338 patients (36.5%) at 5 years. The mean preoperative SNOT-22 score of 48.5 (standard error [SE], 0.69) improved at all subsequent yearly time-points, including 5 years (mean, 25.8; SE, 1.08; p < 0.0001). SNOT-22 scores over time were impacted by nasal polyps (p < 0.001), environmental allergies (p = 0.010), diabetes (p = 0.032), and preoperative Lund-Mackay score (p < 0.001). CONCLUSION: Endoscopic sinus surgery appears to be effective at improving the quality of life of patients with CRS for both the short and long term. The successful outcome of such surgery, however, is influenced by a variety of clinical factors, which should be taken into account by clinicians who are considering surgical treatment of CRS for select patients.

Educational utility of an online video-based teaching tool for sinus and skull base surgery.

OBJECTIVE: Surgical education has undergone major changes in recent years, as hands-on learning opportunities have been replaced or supplemented with online tools. The goal of this project is to examine the educational impact of a surgical training website, SinusVideos.com, on otolaryngologists at various levels of training. METHODS: Visitors to the website were asked to complete a survey after viewing a narrated video of a surgical procedure. Surveys were analyzed for demographics, needs assessment, and educational impact. RESULTS: A total of 105 completed surveys were completed by 68 (64.8%) attendings/practicing physicians, 32 residents/fellows (30.5%), and 5 medical students (4.8%). Whereas 14.3% of viewers reported online videos as their primary source for surgical preparation, 70.5% considered them important secondary supplements. After viewing a video, 92.4% of respondents reported a gained confidence in performing the surgery, and 62.9% said the video altered how they would perform the surgery in the future. Viewers' ratings of their knowledge (on a 1-7 Likert scale) of a particular surgical procedure before vs after watching the observed procedure increased significantly for participants at all levels of training-medical students (2.8 before vs 5.4 after, P < .01), residents/fellows (4.8 before vs 5.8 after, P < .0001), and attendings/practicing physicians (5.6 before vs 6.4 after, P < .0001). CONCLUSION: High quality online surgical videos appear to be an effective learning tool for surgical trainees and practicing physicians alike. The educational benefit of such tools, as well as their widespread accessibility, makes them a powerful instrument for the training of surgeons worldwide. LEVEL OF EVIDENCE: Level 5.

Cost Utility Analysis of Dupilumab Versus Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyps.

OBJECTIVE: Both endoscopic sinus surgery (ESS) and biologic therapies have shown effectiveness for medically-refractory chronic rhinosinusitis with nasal polyps (CRSwNP) without severe asthma. The objective was to evaluate cost-effectiveness of dupilumab versus ESS for patients with CRSwNP. STUDY DESIGN: Cohort-style Markov decision-tree economic model with a 36-year time horizon. METHODS: A cohort of 197 CRSwNP patients who underwent ESS were compared with a matched cohort of 293 CRSwNP patients from the SINUS-24 and SINUS-52 Phase 3 studies who underwent treatment with dupilumab 300 mg every 2 weeks. Utility scores were calculated from the SNOT-22 instrument in both cohorts. Decision-tree analysis and a 10-state Markov model utilized published event probabilities and primary data to calculate long-term costs and utility. The primary outcome measure was incremental cost per quality-adjusted life year (QALY), which is expressed as an Incremental Cost Effectiveness Ratio. One-way and probabilistic sensitivity analyses were performed. RESULTS: The ESS strategy cost $50,436.99 and produced 9.80 QALYs. The dupilumab treatment strategy cost $536,420.22 and produced 8.95 QALYs. Because dupilumab treatment was more costly and less effective than the ESS strategy, it is dominated by ESS in the base case. One-way sensitivity analyses showed ESS to be cost-effective versus dupilumab regardless of the frequency of revision surgery and at any yearly cost of dupilumab above $855. CONCLUSIONS: The ESS treatment strategy is more cost effective than dupilumab for upfront treatment of CRSwNP. More studies are needed to isolate potential phenotypes or endotypes that will benefit most from dupilumab in a cost-effective manner. LEVEL OF EVIDENCE: 2C Laryngoscope, 131:E26-E33, 2021.

Infection After Endoscopic Dacryocystorhinostomy: Incidence and Implications.

BACKGROUND: Endoscopic dacryocystorhinostomy (EN-DCR) is an increasingly common procedure performed by otolaryngologists. While EN-DCR has a high rate of success at relieving blockage of the lacrimal system, little is known regarding associated postoperative infection (POI) rates and risk factors. OBJECTIVE: The purpose of this study was to identify factors associated with the occurrence of postoperative orbital and rhinologic infection in a large cohort of patients undergoing EN-DCR. METHODS: A retrospective review of 582 patients who underwent EN-DCR was performed. All patients received antibiotic prophylaxis as a single intraoperative intravenous administration and a ten-day postoperative oral course. Clinical and demographic information was reviewed, including the occurrence of acute orbital or rhinologic infection within 30 days of surgery. Multivariable analysis was performed to identify risk factors associated with POI. RESULTS: Fifteen of 582 patients (2.6%) developed POI following EN-DCR. The most common POI was acute rhinosinusitis (10/15, 66.7%), followed by acute dacryocystitis (2/15, 13.3%), preseptal cellulitis (2/15,13.3%), and acute bacterial conjunctivitis (1/15, 6.7%). The majority of patients (464/582, 79.7%) underwent concurrent endoscopic sinus surgery (ESS). In most cases (302/464, 65.1%), ESS was performed to address comorbid rhinosinusitis, whereas 7.8% (36/464) of patients underwent surgery to enhance surgical access to the lacrimal sac. Patients who underwent concurrent ESS were less likely to develop POI (OR: 0.17, CI: 0.04-0.80, p < 0.05). Evidence of mucopurulence at surgery increased the likelihood of POI (OR: 6.24, CI: 1.51-25.84, p < 0.05). CONCLUSION: Mucopurulence at the time of surgery significantly increased the risk of POI, whereas concurrent ESS, performed most commonly to address comorbid rhinosinusitis, significantly decreased the risk of POI. Awareness of risk factors for POI and appropriate surgical management of concurrent rhinosinusitis can lead to reduced infectious complications after EN-DCR.

Endoscopic Transoral Image-Guided Retrieval of Infratemporal Fossa Foreign Bodies.

Removal of foreign bodies from the infratemporal fossa is surgically challenging and fraught with risks. This report describes our experience with a minimally invasive transoral technique, utilizing endoscopic and image guidance technology, for retrieval of infratemporal fossa foreign bodies in 6 patients. The technique was successfully applied in all cases with identification and retrieval of the foreign bodies, which included 4 hypodermic needles broken off during dental injections, a cottonoid surgical sponge lost during a facial fracture repair, and a maxillary molar displaced during attempted extraction. Complications were limited to transient postoperative lingual and inferior alveolar nerve sensory deficits in 1 patient.

Endoscopic management of lateral sphenoid cerebrospinal fluid leaks: Identifying a radiographic parameter for surgical planning.

OBJECTIVE: Repair of cerebrospinal fluid (CSF) leaks of the lateral recess of the sphenoid (LRS) sinus can be challenging to accomplish via an endoscopic transphenoidal approach. The endoscopic transpterygoid approach can improve surgical access to the lateral recess but requires more extensive surgical dissection. We review our experience with LRS CSF leak repair via both techniques to determine whether preoperative radiologic data can help predict the most appropriate surgical approach. METHODS: Electronic medical records of patients with LRS CSF leaks were retrospectively reviewed at a single tertiary referral center. Radiographic measurements from preoperative computed tomography images were reviewed. RESULTS: Twenty-two LRS CSF leaks were identified. The transphenoidal and transpterygoid approach were used in 6 (27.3%) and 16 (72.7%) cases, respectively.The mean vidian canal to foramen rotundum angle of the repairs accessed transphenoidally as compared to the transptyergoid approach were not significantly different (41.93° ±10.91, 40.72° ±19.49, respectively; P = .63). However, the mean volume of the LRS accessed by the transpterygoid approach was significantly greater compared to those accessed through the transphenoidal approach (0.97 cm3 ± 0.48, 0.39 cm3 ± 0.40, respectively; P = .04). A LRS volume of 0.400 cm3 or greater predicted the use of the transpterygoid approach with 93.3% sensitivity and 60.0% specificity. CONCLUSION: This study demonstrated that LRS CSF leaks that necessitated repair by the transpterygoid approach, rather than transphenoidal approach, were in the context of significantly larger lateral recess. Assessment of the LRS volume is a quantifiable parameter to aid in preoperative surgical planning. LEVEL OF EVIDENCE: Level 4.

National Geographical Variation in Sinus Balloon Dilation.

OBJECTIVE: The primary aim of this study was to describe national variations in sinus balloon dilation (SBD), examine the relationship between endoscopic sinus surgery (ESS) and SBD prevalence patterns, and evaluate associations between reimbursement rates and regional variations in sinus surgery. STUDY DESIGN: Retrospective observational study. SETTING: Medicare Provider Utilization and Payment (PUP) Part B Data from January 1, 2016, to December 31, 2016. SUBJECTS AND METHODS: Physicians in the PUP Part B Database Performing ESS or SBD in 2016. States were stratified into average- or high-volume utilizers based on the number of ESS procedures and SBD procedures per population and compared. RESULTS: Eight states were classified as high-volume utilizers of SBD-Florida, Kansas, Louisiana, Mississippi, Nevada, New Mexico, South Dakota, and Texas. Only 3 of these states-Kansas, Mississippi, and Nevada-were classified as high-volume utilizers of ESS. Reimbursement rates were significantly higher for SBD as compared to ESS ($1538 [interquartile range (IQR), 1473-1664] vs $335 [IQR, 261-412] per procedure, P < .001). High-volume utilizer SBD states had a higher number of otolaryngologists (13.0 [IQR, 7-16] vs 6.0 [IQR, 2-3]) otolaryngologists per state (P < .001) and a trend toward an increased rate of performing ESS procedures (19 [IQR, 19-41] vs 6.0 [IQR, 2-32], P = .034) procedures per million residents) than average-volume utilizer SBD states. CONCLUSIONS: The southern United States has a significantly higher rate of SBD procedures performed compared to the rest of the country, but these rates do not appear to be directly related to statewide variations in SBD reimbursement.

The role of routine nasolacrimal sac biopsy during endoscopic dacryocystorhinostomy.

OBJECTIVES/HYPOTHESIS: Most patients who undergo endoscopic dacryocystorhinostomy (DCR) have a diagnosis of idiopathic nasolacrimal duct obstruction. The purpose of this study was to examine the impact of routine biopsy of the lacrimal sac performed at time of DCR on subsequent patient diagnosis and treatment. STUDY DESIGN: Retrospective review. METHODS: The histopathology of nasolacrimal specimens (n = 769), obtained from 654 consecutive patients undergoing endoscopic DCR by a single surgeon over a 30-year period, were reviewed. Specific focus included the identification of unanticipated pathologic findings as they related to pertinent patient demographics, clinical presentation, radiologic findings, and intraoperative observations. RESULTS: The study population was 69.6% female, with an average age of 56.1 ± 18.2 years. Pathological findings of tissue from the nasolacrimal sac, which was routinely sampled in all cases, showed inflammation (n = 566 [73.6%]), normal histology (n = 147 [19.1%]), granulomas (n = 8 [1.0%]), and neoplastic process (n = 7 [0.9%]). Patient history, preoperative CT scan, and/or intraoperative findings alerted the surgeon to the possibility of an unusual diagnosis in 12 of the 15 patients. An unsuspected neoplastic or granulomatous cause of lacrimal obstruction was identified on intraoperative biopsy in three patients (0.46%). CONCLUSIONS: Although neoplastic and granulomatous diseases are relatively rare causes of lacrimal obstruction necessitating DCR surgery, they may be identified by through patient evaluation in most cases and by routine intraoperative biopsy of the lacrimal sac in all cases. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:584-589, 2020.

Predictors of long-term success and failure in primary and revision endoscopic dacryocystorhinostomy.

BACKGROUND: Although endoscopic dacryocystorhinostomy (endo-DCR) is a common treatment of nasolacrimal duct obstruction, little is known about the determinants of surgical success and failure. The purpose of this study was to identify patient- and technique-specific factors that may influence surgical outcomes of primary and revision endo-DCR. METHODS: A retrospective review was conducted of 596 patients who underwent endo-DCR over a 30-year period (1989-2018). Patients' demographics and surgical techniques were assessed. RESULTS: Among the cohort of patients (n = 478) who underwent primary endo-DCR, 10% (n = 48) required revision surgery. Patients who failed primary DCR tended to be younger (p = 0.015) and were less likely to have chronic sinonasal inflammation on histopathology (p = 0.047) than the successful surgery group. After adjusting for patient demographics and comorbidities, the occurrence of a postoperative complication was significantly associated with primary DCR failure (odds ratio [OR], 2.2; p = 0.032). Among the cohort of patients (n = 118) who underwent revision endo-DCR, 8.5% (n = 10) required additional revision surgery. Patients who failed revision DCR tended to be younger (p = 0.022), more likely to have had intraoperative laser usage (p = 0.031), and more likely to have had an intraoperative complication (p = 0.013) than the successful revision surgery group. Endo-DCR failure was not associated with smoking status, middle turbinate resection, or intraoperative visualization of the internal common punctum (p > 0.05). CONCLUSION: An understanding of factors associated with primary and revision endo-DCR failure can help to inform preoperative counseling, intraoperative surgical technique, and postoperative care in the treatment of patients with nasolacrimal duct obstruction.

Periostin and Inflammatory Disease: Implications for Chronic Rhinosinusitis.

OBJECTIVE: To provide a comprehensive overview of the emerging role of periostin, an extracellular matrix protein, as a key component in the development, diagnosis, and treatment of patients with chronic rhinosinusitis. DATA SOURCES: Medline database. REVIEW METHODS: A state of the art review was performed targeting English-language studies investigating the role of periostin in cardiopulmonary, neoplastic, and inflammatory diseases, with emphasis on recent advances in the study of periostin in chronic rhinosinusitis. CONCLUSIONS: Periostin has emerged as a novel biomarker and therapeutic target for numerous human pathologies, including cardiac, pulmonary, and neoplastic disease. The upregulation of periostin in chronic rhinosinusitis suggests the potential for similar roles among patients with sinonasal disease. IMPLICATIONS FOR PRACTICE: Chronic rhinosinusitis is a widespread disease with major clinical and societal impact. A critical limitation in the current treatment of patients with chronic rhinosinusitis is the absence of clinically relevant biomarkers to guide diagnosis and treatment selection. A review of the literature supports a likely role of periostin as a biomarker of chronic rhinosinusitis, as well as a novel therapeutic target in the future treatment of patients with sinonasal disease.

Does bilateral inferior turbinate reduction affect long-term quality-of-life outcomes in patients undergoing endoscopic sinus surgery?

BACKGROUND: The objective of this study was to evaluate the impact of bilateral inferior turbinate reduction (BITR) on patient-reported quality of life (QOL) following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). METHODS: This was a prospective cohort study. Patients with CRS, who were recruited from 10 different otolaryngologic practices between 2011 and 2014, completed the 22-item Sino-Nasal Outcome Test (SNOT-22), Chronic Sinusitis Survey (CSS), and EuroQol 5 Dimension (EQ-5D) survey at baseline, and at 12, 24, 36, and 48 months after ESS. A total of 113 patients who underwent ESS with BITR were compared to 788 patients who underwent ESS without BITR. RESULTS: Significant demographic and comorbid differences between BITR and non-BITR cohorts included age (41 vs 49 years, p < 0.0001), presence of asthma (19% vs 36%, p < 0.0001), prior sinus surgery (22% vs 53%, p < 0.0001), and concurrent septoplasty (80% vs 53%, p < 0.0001), respectively. On univariate analysis, patients who underwent ESS with or without BITR were found to have statistically significant improvement in disease-specific (SNOT-22 and CSS) and general (EQ-5D) QOL scores at years 1 through 4 (p < 0.05). On multivariate regression, however, the performance of BITR was not associated with any improvements in these outcome measures. CONCLUSION: Patients undergoing ESS achieve similar long-term improvement in both disease-specific and general QOL regardless of the performance of concurrent BITR.