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Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) is a chronic disease with a high prevalence and high disease burden, and the lack of a cure. The socioeconomic burden of the disease is substantial and has been disproportionally increasing over past decades. Treatment is aimed at attaining disease control. Traditionally, topical corticosteroids, endoscopic sinus surgery, and oral corticosteroids are used to treat CRSwNP. The advent of biologics has revolutionized CRSwNP treatment, but these drugs are expensive. From an economic standpoint, it is worth debating whether biologics should be employed in patients with severe uncontrolled CRSwNP who fail to attain disease control with current therapies. This clinical commentary review provides an overview of the socioeconomic burden of chronic rhinosinusitis and treatment modalities, compares endoscopic sinus surgery versus biologics for severe CRSwNP, discusses management recommendations, and highlights future needs in this field. New ways to reduce costs of biologic treatments need to be explored to attain cost-effectiveness and provide patients who have severe CRSwNP with adequate treatment.

The anteromedial temporal region and lateral wall of the sphenoid sinus, in which the second and third divisions of the trigeminal nerve (V2, V3), internal carotid artery, cavernous sinus, and temporal lobe exist can be the site of an array of pathology including trigeminal schwannoma, encephalocele, cholesterol granuloma of the petrous apex, malignancy with or without perineural spread, infection, and sellar pathology extending to the lateral cavernous sinus. Approaches to this region are technically challenging and the existing approach requires sacrifice of the all of the turbinate include nasolacrimal duct, which can cause postoperative complications. We describe a novel anatomical landmark between the periorbita and periosteum of the pterygopalatine fossa (which is located at the inferior lateral periorbital periosteal line: ILPPL). The posterior one third of the incision line lies between the foramen rotundum and superior orbital fissure, which is proximity of the maxillary strut Using a 1.5-cm incision can divide the orbital and pterygoid contents and lead us to the posterior infra-lateral orbital region, antero-medial temporal region, lateral wall of the sphenoid sinus, and lateral wall of cavernous sinus. Combined with multi- angled approach with ILPPL enable us to preserve all of the turbinates and septum, nasolacrimal duct allowing for the preservation of physiological function and pedicled flaps, such as the middle turbinate, inferior turbinate, and septum membrane flap. The ILPPL is a simple, effective, and novel landmark for the minimally invasive approach to the anteromedial temporal fossa.

Empty nose syndrome (ENS) is characterized by the paradoxical perception of nasal obstruction despite patent sinonasal anatomy after surgery. We investigated the relationship between ENS, and anxiety, depression, obsessive-compulsive disorder, and somatic symptom disorder (SSD) compared to individuals with chronic rhinitis (CR) and chronic rhinosinusitis (CRS).This cross-sectional survey study compared ENS and CR and CRS patients. A total of 116 patients participated: 58 ENS patients from digital support groups, and 58 CRS and CR patients from tertiary rhinology clinics. Study participants completed four validated surveys: (1) Empty Nose Syndrome 6-Item Questionnaire, (2) Rhinosinusitis Disability Index (RSDI), (3) Obsessive Compulsive Inventory - Revised (OCI-R), and (4) PRIME MD Patient Health Questionnaire (PHQ).ENS patients exhibited a mean RSDI of 78.6, 95% confidence interval [CI] 72.8-84.5, compared to 25.2, 95% CI 18.6-31.8 for CRS/CR patients (p 0.0001). This difference was seen across all subdomains. Using the PHQ, 53% of ENS patients met diagnostic thresholds for SSD compared to 14% of CRS patients (p 0.0001). In relation to obsessive compulsive disorder (OCD), 18.37% of ENS patients compared to 8.62% of CRS/CR patients scored above the diagnostic threshold (21) on the OCI-R questionnaire (p = 0.159).ENS patients had diminished sinonasal quality of life and a higher prevalence of comorbid anxiety and depression, compared to CR and CRS. ENS patients were more likely to exceed thresholds for OCD and SSD compared to controls. Future studies are needed to assess the role of SSD in ENS to help optimize treatment for these complex patients.

Cystic fibrosis (CF) is a multisystem disease that often requires otolaryngology care. Individuals with CF commonly have chronic rhinosinusitis but also present with hearing loss and dysphonia. Given these manifestations of CF, otolaryngologists are frequently involved in the care of patients with CF; however, there is limited consensus on optimal management of sinonasal, otologic, and laryngologic symptoms.The Cystic Fibrosis Foundation convened a multidisciplinary team of otolaryngologists, pulmonologists, audiologists, pharmacists, a social worker, a nurse coordinator, a respiratory therapist, two adults with CF, and a caregiver of a child with CF to develop consensus recommendations. Workgroups developed draft recommendation statements based on a systematic literature review, and a ≥80% consensus was required for acceptance of each recommendation statement.The committee voted on 25 statements. Eleven statements were adopted recommending a treatment or intervention, while five statements were formulated recommending against a specific treatment or intervention. The committee recommended eight statements as an option for select patients in certain circumstances, and one statement did not reach consensus.These multidisciplinary consensus recommendations will help providers navigate decisions related to otolaryngology consultation, medical and surgical management of CF-CRS, hearing, and voice in individuals with CF. A collaborative and multidisciplinary approach is advocated to best care for our patients with CF. Future clinical research is needed utilizing standardized, validated outcomes with comprehensive reporting of patient outcome, effects of modulator therapies, and genetic characteristics to help continue to advance care, decrease morbidity, and improve the quality of life for individuals with CF.

Background: Patient-reported outcome measures (PROMs) are useful instruments that give providers insight into patients’ experiences with disease by quantifying the symptoms that matter most to patients. Results of these questionnaires can help guide management in chronic rhinosinusitis. However, these tools are often developed for native English speakers, which disadvantages others, who already have a language barrier to care. The aim of this study is to evaluate accessibility and readability of Spanish PROMs used to evaluate rhinosinusitis. Methods: Three Spanish readability measures, Gilliam, Peña & Mountain; SOL; and Fernandez-Huerta were used to evaluate PROMs utilized for rhinosinusitis. PROMs with sixth-grade readability level or easier were considered to meet health literacy recommendations. Results: Four Spanish PROMs utilized in assessment of rhinosinusitis were identified and evaluated. Cuestionario Español de Calidad de Vida en Rinitis (ESPRINT-15) was the most readable PROM and met readability recommendations in two of three measures. Nasal Obstruction Symptom Evaluation met suggested levels in one measure. The remainder of readability scores were more difficult than recommended. Conclusion: PROMs are powerful clinical tools that help patients communicate their symptoms and self-advocate. For providers to gain accurate and useful information, these measures should be written at appropriate readability levels. Most Spanish PROMs used for assessment of rhinosinusitis were above recommended readability. Development of future PROMs should ensure appropriate readability levels to provide good patient-centered care for our primarily Spanish speaking patients.

Purpose of review Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a phenotypic designation of the broader condition of chronic rhinosinusitis. The advent of targeted biologics has shown promise in targeting different aspects of the inflammatory pathway, yet there remains a lack of consensus on the correct timing and use of these medications. This review seeks to provide a concise update of the available literature on the pathophysiology of CRSwNP, the evolution and cost utility of biologics as it pertains to management of patients with CRSwNP, and evidence for each available biologic and its use in CRSwNP. Recent findings There are two biologics with FDA approval for use in CRSwNP: dupilumab and omalizumab. Recent clinical trials of other biologic therapies targeting type 2 inflammatory pathways have also demonstrated efficacy both in symptom scores and nasal polyp reduction. However, studies have questioned the cost utility of these medications compared to other interventions. Furthermore, timing of use with respect to other interventions including surgery remains challenging.

OBJECTIVES: To date, there is still a significant debate on the role of human papilloma virus (HPV) infection in transformation of inverted papillomas (IPs) to squamous cell carcinoma (SCC). This study was designed to determine if the presence of HPV in a sinonasal IP increases the risk of malignant transformation to IPSCC. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 19 high-quality case-control and cohort studies with tissue-diagnosed IP or IPSCC and HPV diagnosis were analyzed. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using the Mantel–Haenszel method with correction for random effects. Subgroup, publication bias and a sensitivity analyses were also performed. RESULTS: Nineteen studies with minimal bias met the inclusion criteria for quality and identified HPV infection in an IP. The pooled data revealed a strong association with progression to malignancy with an unweighted, pooled OR of 2.38 (CI(95) 1.47 to 3.83) and a weighted OR of 2.80 (CI(95) 1.42 to 5.51). Sensitivity analysis revealed that no single study contributed significantly to our pooled OR calculations (ORs 2.52 to 3.57). Subgroup analyses stratified by publication date, nucleic acid target, HPV detection method and type, sample size, and region all demonstrated a positive association of HPV with IPSCC. CONCLUSIONS: There appears to be a significant association between HPV infection and malignant transformation of IPs. While HPV testing is not currently the standard of care for IPs, these data suggest a link between the two and suggest further studies should be performed to identify a link between the virus and malignant transformation.

I. Executive summary BACKGROUND: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR-RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR-RS-2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence-based findings of the document. Methods ICAR-RS presents over 180 topics in the forms of evidence-based reviews with recommendations (EBRRs), evidence-based reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary. Results ICAR-RS-2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidence-based management algorithm is provided. Conclusion This ICAR-RS-2021 executive summary provides a compilation of the evidence-based recommendations for medical and surgical treatment of the most common forms of RS.

INTRODUCTION: Intranasal corticosteroids sprays (INCS) are first line treatment for allergic rhinitis and are frequently used for chronic rhinosinusitis. Improperly aiming INCS increases the risk of epistaxis and may decrease the efficacy of the medication. The goal of this study was to determine how patients position INCS for drug delivery and if verbal or written instructions improve their positioning. METHODS: Patients in rhinology clinics were photographed while administering a generic spray bottle. The angle of the spray bot- tle relative to the patients’ head and a fixed background was determined. RESULTS: A total of 46 participants were included. The average spray angle for the right naris was 10.1o towards the septum and 67.2o below the Frankfurt Horizontal plane. The average spray angle for the left naris was 4.5o towards the septum and 62.2o below the Frankfurt horizontal plane. The angle of the spray bottle ranged from 50o toward the septum to 43o away from the sep- tum. Only 8 patients aimed away from the septum for both nares. Patients who recalled receiving verbal and written instructions aimed the INCS bottle at the lateral wall and inferior turbinate in contrast to patients who only received one form of instruction or no instructions. CONCLUSIONS: Most patients (83%) incorrectly aim INCS when compared to current guidelines. There was statistically significant improvement in the positioning of patients who reported receiving both verbal and written instruction; however, this study high- lights a greater need for patient education.

Background Recent indirect evidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission during endoscopic endonasal procedures has highlighted the dearth of knowledge surrounding aerosol generation with these procedures. As we adapt to function in the era of Coronavirus Disease 2019 (COVID-19) a better understanding of how surgical techniques generate potentially infectious aerosolized particles will enhance the safety of operating room (OR) staff and learners. Objective To provide greater understanding of possible SARS-CoV-2 exposure risk during endonasal surgeries by quantifying increases in airborne particle concentrations during endoscopic sinonasal surgery. Methods Aerosol concentrations were measured during live-patient endoscopic endonasal surgeries in ORs with an optical particle sizer. Measurements were taken throughout the procedure at six time points: 1) before patient entered the OR, 2) before pre-incision timeout during OR setup, 3) during cold instrumentation with suction, 4) during microdebrider use, 5) during drill use and, 6) at the end of the case prior to extubation. Measurements were taken at three different OR position: surgeon, circulating nurse, and anesthesia provider. Results Significant increases in airborne particle concentration were measured at the surgeon position with both the microdebrider (p = 0.001) and drill (p = 0.001), but not for cold instrumentation with suction (p = 0.340). Particle concentration did not significantly increase at the anesthesia position or the circulator position with any form of instrumentation. Overall, the surgeon position had a mean increase in particle concentration of 2445 particles/ft3 (95% CI 881 to 3955; p = 0.001) during drill use and 1825 particles/ft3 (95% CI 641 to 3009; p = 0.001) during microdebrider use. Conclusion Drilling and microdebrider use during endonasal surgery in a standard operating room is associated with a significant increase in airborne particle concentrations. Fortunately, this increase in aerosol concentration is localized to the area of the operating surgeon, with no detectable increase in aerosol particles at other OR positions.

Background Balloon sinuplasty is increasingly used in the outpatient clinic for treatment of chronic rhinosinusitis, but radiologic analysis of its effects on sinonasal anatomy is largely uncharacterized in the known literature. Objective The purpose of this study is to examine the anatomic effects of balloon sinuplasty in a cadaveric model. Methods Five fresh cadaver heads underwent sequential endoscopic balloon dilation of maxillary ostia, frontal recess outflow tracts, and sphenoid ostia bilaterally by fellowship-trained rhinologists. Pre- and post-procedural CT imaging was obtained. CT scans were imported into Mimics™ software and sinonasal anatomy was analyzed systematically. Results Visual confirmation of balloon dilation was achieved in all 3 sites bilaterally in each cadaver. Radiologic analysis demonstrated that the frontal sinus outflow tract was appropriately dilated 60% (6/10 sites) of the time while the agger was inadvertently dilated 30% of the time (3/10). The sphenoid os was successfully dilated 70% (7/10 sites) of the time. In two cases, a posterior sphenoethmoid (Onodi) cell was dilated instead of the sphenoid. Successful dilation of maxillary os was noted 60% of the time (6/10 sites). No significant change in maxillary os was noted after balloon dilation. Normal middle turbinates were significantly medialized following balloon dilation 75% (6/8 sites) of the time. Conclusions While the goal of balloon sinuplasty is to improve natural sinonasal drainage by dilating existing outflow tracts, as evidenced by radiologic evaluation the procedure appears not to achieve this in all cases, while occasionally creating unintended changes in sinonasal anatomy as well. These unrecognized changes in anatomy may be responsible for the post-procedure change in symptomatology that some patients experience.

Background Primary ciliary dyskinesia (PCD) is a genetically diverse disease which causes impaired mucociliary clearance, and results in pulmonary, otologic, and rhinologic disease in affected patients. Genetic mutations in multiple genes impair the ability of patients to clear mucous from the lungs, middle ear, and sinonasal cavity and lead to chronic pulmonary and sinonasal symptoms. Methods We identified 17 PCD patients who had available CT scans. Volumes for bilateral maxillary, sphenoid, and frontal sinuses were calculated. A control population of patients who had preoperative CT scans for endoscopic endonasal resection of skull base pathology without sinonasal cavity involvement was also identified. Results The mean age of PCD was 33 and ranged from 13 to 54 years. Patients were age- and gender-matched to a control group that underwent resection of anterior skull-base tumors and had a mean age of 35 that ranged between 17–53 years old. The volumes for all thee sinus cavities were significantly smaller (p Conclusions Overall sinus volumes were smaller in patients with PCD compared to our control population. Future studies will be aimed at understanding defects in sinus development as a function of specific genetic mutations in PCD patients. Ultimately, a better understanding of the underlying pathophysiology of PCD will allow us to identify the optimal treatment practices for this unique patient group.

Topical intra-nasal sprays are amongst the most commonly prescribed therapeutic options for sinonasal diseases in humans. However, inconsistency and ambiguity in instructions show a lack of definitive knowledge on best spray use techniques. In this study, we have identified a new usage strategy for nasal sprays available over-the-counter, that registers an average 8-fold improvement in topical delivery of drugs at diseased sites, when compared to prevalent spray techniques. The protocol involves re-orienting the spray axis to harness inertial motion of particulates and has been developed using computational fluid dynamics simulations of respiratory airflow and droplet transport in medical imaging-based digital models. Simulated dose in representative models is validated through in vitro spray measurements in 3D-printed anatomic replicas using the gamma scintigraphy technique. This work breaks new ground in proposing an alternative user-friendly strategy that can significantly enhance topical delivery inside human nose. While these findings can eventually translate into personalized spray usage instructions and hence merit a change in nasal standard-of-care, this study also demonstrates how relatively simple engineering analysis tools can revolutionize everyday healthcare., Comment: 24 pages, 8 figures, 5 tables

Background Allergic rhinitis is a widespread disease that has significant quality-of-life ramifications. Symptoms include rhinorrhea, nasal obstruction, cough, and postnasal drip. Intranasal corticosteroids are a hallmark of treatment of allergic rhinitis. However, the benefits of treatment are dependent on correct nasal spray technique, of which many patients are not aware. Patient instructions are included with the purchase of these medications. The readability and understandability for these educational materials has been minimally assessed in the medical literature. The aim of this study was to evaluate the readability and understandability of commonly used intranasal steroids. Methods Three readability measures (Gunning Fog, Simple Measure of Gobbledygook [SMOG], and FORCAST) and an understandability assessment (Patient Education Materials Assessment Tool for Printable Materials [PEMAT-P]) were used to evaluate the instructions for use of commonly prescribed intranasal steroids. Instructions with 6th grade readability level or lower were considered to meet health literacy experts' recommendations. Higher understandability values correlate to easier understandability. Results Instructions for 10 intranasal corticosteroid brands were reviewed. Gunning Fog consistently estimated easiest readability, whereas FORCAST estimated most difficult readability. Twenty percent (20%) of analyzed instructions met National Institutes of Health and health literacy experts' recommended reading levels. Understandability of instructions ranged from 33% to 90%, with an average of 66%. Conclusion The benefit of intranasal corticosteroids is contingent on correct use by patients. However, the prepackaged instructions provided are most often above recommended reading levels and are difficult to understand. Future development of intranasal steroid instructions should meet recommended readability levels and be understandable to maximize their utility.

BACKGROUND Care coordination for cystic fibrosis (CF) is essential. The objectives of this study were to: (1) compare otolaryngologists' and pulmonlogists' understanding of long-term chronic rhinosinusitis (CRS) management; and (2) query patient perceptions of otolaryngologic care and CRS. METHODS A cross-sectional survey was administered by the Cystic Fibrosis Foundation in 2018 to patients with CF or their caregivers, otolaryngologists, and pulmonologists. Statistical analysis was performed comparing specialists. Descriptive statistics were computed for patient/caregiver-reported data. RESULTS Respondents included 126 otolaryngologists, 115 pulmonologists, and 186 patients with CF or their caregivers. Pulmonologists had greater experience caring for CF patients compared with otolaryngologists (66.7% vs 43.2% with 13+ years of experience, respectively), but more otolaryngologists cared for both adult and pediatric CF patients (39.2% vs 10.4%, respectively). Significantly more otolaryngologists advocated for establishing otolaryngologic care at time of CF diagnosis (64.8%) compared with pulmonologists (14.4%, p < 0.001), of whom 60.4% recommended otolaryngologist referral when sinonasal symptoms affect quality of life. More otolaryngologists perceived sinus surgery as beneficial for pulmonary function (74.5% vs 57.7%, p = 0.009); 60.8% of patients first sought otolaryngologic care in infancy or childhood (

Objectives Pain management remains a point of emphasis given the ongoing opioid crisis. There are no studies in the literature interrogating opioid prescribing and use following endoscopic pituitary surgery. This study investigates provider prescribing tendency, patient utilization of analgesics, and patient outcomes regarding pain management after endoscopic pituitary surgery. Methods We identified 100 patients undergoing endoscopic pituitary surgery at one institution from 2016 to 2018 in the electronic medical record (EMR) and state narcotic database to determine postoperative analgesic regimens. A telephone survey was used to characterize postoperative analgesic use and satisfaction with prescribed regimen. Results Fifty-two different pain control regimens were prescribed to the study patients. Also, 93% of study patients were prescribed an opioid postoperatively. The average quantity of opioids prescribed per patient in morphine milligram equivalents (MMEs) was 625 (equivalent 83 oxycodone 5-mg tablets) with an average MME/day of 59 (equivalent 8 oxycodone 5-mg tablets). A total of 71% survey respondents who used opioids reported using 50% of their postoperative opioid intake in the first 24 to 48 hours after discharge. There were no significant differences in pain outcome between opioid users and nonopioid users. Conclusion Vast heterogeneity exists in narcotic prescribing by providers at our institution following endoscopic pituitary surgery. Narcotic prescribing patterns exceeded most patients' analgesic needs. Opioid analgesics were not superior to nonopioids regimens in patient-reported pain outcomes in this study population.

BACKGROUND: Cystic fibrosis (CF) chronic rhinosinusitis (CRS) has emerged as a distinct diagnostic entity, unique from other endotypes of CRS in its presentation, pathophysiology, diagnosis, treatment, and outcomes. As the sinonasal health of this patient population may have broad effects on pulmonary health and quality of life, a comprehensive understanding of the diagnostic and therapeutic approach to CF CRS is essential. Recognizing recent scientific advances and unique treatment modalities specific to this challenging patient population, this review systematically evaluates the scientific literature and provides an evidenced-based review with recommendations (EBRR) for fundamental management principles of CF CRS. METHODS: A systematic review of the literature was performed. Studies evaluating interventions for the management of CF CRS were included. An iterative review process was implemented in accordance with EBRR guidelines. A treatment recommendation was generated based on an assessment of the benefits, harms and the overall grade of evidence. RESULTS: This review evaluated the published literature on five unique topics. Each of the following therapeutic categories was investigated explicitly with regard to treatment outcomes in patients with CF CRS: 1) nasal saline; 2) intranasal corticosteroids (INCS); 3) topical antibiotics; 4) cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy; and 5) endoscopic sinus surgery (ESS). CONCLUSION: Based on the currently available evidence, nasal saline, ESS, and CFTR modulators are recommended in the management of CF CRS when appropriate. INCS and topical antibiotics are options. Clinical judgment and experience are essential in caring for patients with this uniquely challenging disorder.

Introduction: The coronavirus 2019 pandemic has altered how modern healthcare is delivered to patients. Concerns have been raised that masks may hinder effective communication, particularly in patients with hearing loss. The purpose of this study is to determine the effect of masks on speech recognition in adult patients with and without self-reported hearing loss in a clinical setting. Methods: Adult patients presenting to an otolaryngology clinic were recruited. A digital recording of 36 spondaic words was presented to each participant in a standard clinical exam room. Each word was recorded in 1 of 3 conditions: no mask, surgical mask, or N95 mask. Participants were instructed to repeat back the word. The word recognition score was determined by the percent correctly repeated. Results: A total of 45 participants were included in this study. Overall, the mean word recognition score was 87% without a mask, 78% with a surgical mask, and 61% with an N95 mask. Among the 23 subjects (51.1%) with self-reported hearing loss, the average word recognition score was 46% with an N95 mask compared to 79% in patients who reported normal hearing (p < 0.001). Conclusion: Our results suggest that masks significantly decrease word recognition, and this effect is exacerbated with N95 masks, particularly in patients with hearing loss. As masks are essential to allow for safe patient-physician interactions, it is imperative that clinicians are aware they may create a barrier to effective communication.

Extraocular muscle injury is a rare but potentially devastating complication of endoscopic sinus surgery. Preoperative analysis of the patient’s CT will help the surgeon to form a mental roadmap of the planned surgery, while also identifying anatomic features and “danger zones” that may lead to increased risk of injury. Intraoperative strategies to mitigate injury including careful, meticulous dissection of the lamina papyracea using proper techniques with both hand instruments as well as microdebriders further reduce risk. Control of intraoperative bleeding in the surgical field is also critical to injury prevention. Employing these strategies will help to reduce the risks to the patient, even in the setting of distorted anatomy and advanced disease.

BACKGROUND Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae. CONCLUSION Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.

Background Topical intranasal drugs are widely prescribed for chronic rhinosinusitis (CRS), although delivery can vary with device type and droplet size. The study objective was to compare nebulized and sprayed droplet deposition in the paranasal sinuses and ostiomeatal complex (OMC) across multiple droplet sizes in CRS patients using computational fluid dynamics (CFD). Methods Three-dimensional models of sinonasal cavities were constructed from computed tomography (CT) scans of 3 subjects with CRS refractory to medical therapy using imaging software. Assuming steady-state inspiratory airflow at resting rate, CFD was used to simulate 1-µm to 120-µm sprayed droplet deposition in the left and right sinuses and OMC with spray nozzle positioning as in current nasal spray use instructions. Zero-velocity nebulization simulations were performed for 1-µm to 30-µm droplet sizes, maximal sinus and OMC deposition fractions (MSDF) were obtained, and sizes that achieved at least 50% of MSDF were identified. Nebulized MSDF was compared to sprayed droplet deposition. We also validated CFD framework through in vitro experiments. Results Among nebulized droplet sizes, 11-µm to 14-µm droplets achieved at least 50% of MSDF in all 6 sinonasal cavities. Four of 6 sinonasal cavities had greater sinus and OMC deposition with nebulized droplets than with sprayed droplets at optimal sizes. Conclusion Nebulized droplets may target the sinuses and OMC more effectively than sprayed particles at sizes achieving best deposition. Further studies are needed to confirm our preliminary findings. Several commercial nasal nebulizers have average particle sizes outside the optimal nebulized droplet size range found here, suggesting potential for product enhancement.

Background: The potential risk for transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) duringendoscopic endonasal instrumentation has been described in recent anecdotal reports. Additionally, recent simulations incadaveric models have demonstrated aerosol generation during power endonasal instrumentation. Endonasal proceduresare commonly performed in the outpatient clinic setting, and with a potential for aerosol generation, these procedures maypose a potential exposure risk to clinic staff. Objective: To provide a greater understanding of aerosol generation and exposure risk during endoscopic endonasalinstrumentation in the outpatient clinic setting. Methods: Using an optical particle sizer, airborne particles concentrations in particles per cubic foot (p/ft ) were measuredduring 30 nasal endoscopies in the outpatient clinic setting. Aerosol measurements were collected within an 18-inch radiusfrom the patient's head during 11 different diagnostic nasal endoscopies and 19 different nasal endoscopies with suctionand mechanical debridement. To identify any particle effect from endonasal instrumentation, airborne particles measuring0.3, 0.5, 1.0, 2.5, 5.0, and 10.0 microns (μm) in diameter were recorded at distinct time points throughout diagnostic anddebridement endoscopies. To account for the effects of native patient breathing on aerosol concentrations, all endoscopymeasurements were compared to aerosol concentrations measured prior to procedure initiation. Results: Compared to preprocedure aerosol levels, no significant increase in mean aerosol concentrations was measuredduring diagnostic nasal endoscopies. However, compared to preprocedure aerosol levels, a statistically significant increasein mean particle concentrations was measured during cold instrumentation at 2,462 p/ft (95% CI: 837-4,088;p = 0.005).The use of suction instrumentation was also associated with a statistically significant increase in mean particleconcentrations at 2,973 p/ft (95% CI: 1,419-4,529;p = 0.001). In total, greater than 99% of all measured particles wereless than 2.5 μm in diameter, with comparable particle size distributions observed during all forms of endonasalinstrumentation. Conclusion: When measured with an optical particle sizer, diagnostic nasal endoscopy with a rigid endoscope is notassociated with increased particle aerosolization in patients for which sinonasal debridement is not indicated. In patientsneeding sinonasal debridement, the use of cold and suction instrumentation was associated with increased particle aerosolization. The observed generation of airborne particles, especially sub-micrometer aerosols, during endonasaldebridement may increase exposure risk for clinic staff to SARS-CoV-2 compared to patient native breathing. Appropriatepersonal protective equipment use and patient screening should be utilized for all office-based endonasal procedures.

Background: Evidence regarding prevalence of COVID-19 related Olfactory dysfunction (OD) among ambulatory patients is highly variable due to heterogeneity in study population and measurement methods. Relatively few studies have longitudinally investigated OD in ambulatory patients with objective methods. Methods: We performed a longitudinal study to investigate OD among COVID-19 ambulatory patients compared to symptomatic controls who test negative. Out of 81 patients enrolled, 45 COVID-19 positive patients and an age- and sex-matched symptomatic control group completed the BSIT and a questionnaire about smell, taste and nasal symptoms. These were repeated at 1 month for all COVID-19 positive patients, and again at 3 months for those who exhibited persistent OD. Analysis was performed by mixed-effects linear and logistic regression. Results: 46.7% of COVID-19 patients compared to 3.8% of symptomatic controls exhibited OD at 1-week post diagnosis (p

Objective Recent anecdotal reports and cadaveric simulations have described aerosol generation during endonasal instrumentation, highlighting a possible risk for transmission of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) during endoscopic endonasal instrumentation. This study aims to provide a greater understanding of particle generation and exposure risk during endoscopic endonasal instrumentation. Study design Prospective quantification of aerosol generation during office-based nasal endoscopy procedures. Methods Using an optical particle sizer, airborne particles concentrations 0.3 to 10 microns in diameter, were measured during 30 nasal endoscopies in the clinic setting. Measurements were taken at time points throughout diagnostic and debridement endoscopies and compared to preprocedure and empty room particle concentrations. Results No significant change in airborne particle concentrations was measured during diagnostic nasal endoscopies in patients without the need for debridement. However, significant increases in mean particle concentration compared to preprocedure levels were measured during cold instrumentation at 2,462 particles/foot3 (95% CI 837 to 4,088; P = .005) and during suction use at 2,973 particle/foot3 (95% CI 1,419 to 4,529; P = .001). In total, 99.2% of all measured particles were ≤1 μm in diameter. Conclusion When measured with an optical particle sizer, diagnostic nasal endoscopy with a rigid endoscope is not associated with increased particle aerosolization in patient for whom sinonasal debridement is not needed. In patients needing sinonasal debridement, endonasal cold and suction instrumentation were associated with increased particle aerosolization, with a trend observed during endoscope use prior to tissue manipulation. Endonasal debridement may potentially pose a higher risk for aerosolization and SARS-CoV-2 transmission. Appropriate personal protective equipment use and patient screening are recommended for all office-based endonasal procedures. Level of evidence 3 Laryngoscope, 2020.