Impact on patient outcomes of spondyloarthritis-inflammatory bowel disease multi-disciplinary meetings.

OBJECTIVES: To assess the impact on patient outcomes of the spondyloarthritis (SpA) and inflammatory bowel disease (IBD) multidisciplinary team (MDT) meetings in a large university hospital. METHODS: A single-centre retrospective observational case-note review was conducted assessing the outcome of all 226 cases discussed at the SpA-IBD MDT meetings in a large UK university hospital between 2017-2022. RESULTS: A total of 226 patients were discussed. It was deemed that 97% of MDT meetings helped to improve communication between teams, and 100% were educational. A total of 57% of discussions led to an instant change of disease management, while 40% of discussions resulted in a treatment plan that avoided the use of dual advanced therapy. This improved patient safety by reducing immunosuppression. The MDT meetings were highly cost and time efficient; 125 referrals between specialists were avoided, and in 51 cases there was a significant chance of reducing future drug costs. A timely investigation or appointment was arranged following 50% of MDT discussions, helping to clarify the diagnosis and optimise patient care. 9% of meetings enabled drugs to be prescribed to patients that are not yet licenced for the other speciality, thereby improving treatment options available in the management of complex cases. CONCLUSION: The MDT meetings have been beneficial for patients, the clinical team and the institution. This approach might be considered by other rheumatology and gastroenterology departments.

Effectiveness of Intranasal Mometasone Furoate vs Saline for Sleep-Disordered Breathing in Children: A Randomized Clinical Trial.

Importance: Obstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy children and is associated with significant morbidity. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by polysomnography; however, the effect on symptoms and quality of life is unclear. Objective: To determine whether intranasal mometasone furoate is more effective than intranasal saline for improving symptoms and quality of life in children with SDB. Design, Setting, and Participants: The MIST trial was a multicenter, randomized, double-blind, placebo-controlled trial, recruiting participants from June 8, 2018, to February 13, 2020. Children aged 3 to 12 years who were referred to a specialist for significant SDB symptoms were included; exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB. Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022. Interventions: Participants were randomly assigned to receive mometasone furoate, 50 µg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles. Main Outcomes and Measures: The primary outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer requiring referral to a specialist as per the American Academy of Pediatrics guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score. Results: A total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited, 138 in each treatment arm. Resolution of significant SDB symptoms occurred in 56 of 127 participants (44%) in the mometasone group and 50 of 123 participants (41%) in the saline group (risk difference, 4%; 95% CI, -8% to 16%; P = .51) with 26 participants lost to follow-up and missing values managed by multiple imputation. The main adverse effects were epistaxis, affecting 12 of 124 participants (9.7%) in the mometasone group and 18 of 120 participants (15%) in the saline group, and nasal itch/irritation, affecting 12 of 124 participants (9.7%) in the mometasone group and 22 of 120 participants (18%) in the saline group. Conclusions and Relevance: Results of this randomized clinical trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for the management of SDB symptoms. The results suggest that almost one-half of children with SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended. Trial Registration: Australian New Zealand Clinical Trials Registry: ANZCTRN12618000448246.

Non-Eosinophilic Granulomatous Disease and the Unified Airway.

Granulomatous and vasculitic diseases of the airway may be part of more widespread systemic disease but can occur in isolation. They may present to the ear, nose, and throat (ENT) surgeon initially with vague symptoms that mimic more common chronic inflammatory unified airway conditions, such as rhinitis, chronic rhinosinusitis, and asthma. Early diagnosis is associated with better long-term outcomes, so a high index of suspicion is required. Bloody nasal discharge and crusting are highly suspicious for granulomatous disease, which should also be considered in atypical or recalcitrant disease. A combination of clinical findings, serologic tests, imaging, and histology may be required to confirm the diagnosis..

The Use of Beta-Blockers in Hereditary Hemorrhagic Telangiectasia-Related Epistaxis: A Systematic Review.

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disease affecting 1 in 5000 individuals. Epistaxis is seen in more than 90% of patients with HHT. Severe recurrent epistaxis can significantly decrease quality of life and may be resistant to standard treatment measures. Dysregulation of angiogenesis has been shown to cause the proliferation of abnormal blood vessels. As such, antiangiogenic treatments have been investigated including beta-blockers. OBJECTIVE: A systematic review of the efficacy of beta-blockers in topical treatment of epistaxis in patients with HHT based on epistaxis duration, frequency, and severity. METHODS: A systematic search was performed using the PubMed, Embase via Ovid, and Cochrane databases. The Preferred Items for Systematic Reviews and Meta-Analyses guidelines were followed. Studies that measured the efficacy of beta-blocker treatment of epistaxis in patients with HHT were included for qualitative analysis. RESULTS: Five studies (3 randomized controlled trials and 2 case series) with a total of 132 patients were included. Administration (systemically or topically via a spray or gel) of timolol and propranolol showed mixed evidence of improvement in epistaxis frequency, severity, and duration when compared with control groups. The evidence for propranolol appears more promising than timolol. CONCLUSION: There are significant limitations in the included studies, and further investigation with larger longitudinal or randomized prospective trials is recommended. The available evidence suggests that beta-blocker treatment may have a positive effect on HHT-related epistaxis.

Cost and economic determinants of paediatric tonsillectomy.

Objective Hospital utilisation research is important in pursuing cost-saving healthcare models. Tonsillectomy is one of the most common paediatric surgeries and the most frequent reason for paediatric hospital readmission. This study aimed to report the government-funded costs of paediatric tonsillectomy in the state of Victoria, Australia, extrapolate costs across Australia, and identify the cost determinants. Methods A population-based longitudinal study was conducted with a bottom-up costing approach using linked datasets containing all paediatric tonsillectomy and tonsillectomy with adenoidectomy surgeries performed in the state of Victoria between 2010 and 2015. Results The total average annual cost of tonsillectomy hospitalisation in Victoria was A$21 937 155 with a median admission cost of A$2224 (interquartile range (IQR) 1826-2560). Inflation-adjusted annual tonsillectomy costs increased during 2010-2015 (P < 0.001), not explained by the rising number of surgeries. Hospital readmissions resulted in a total average annual cost of A$1 427 716, with each readmission costing approximately A$2411 (IQR 1936-2732). The most common reason for readmission was haemorrhage, which was associated with the highest total cost. The estimated total annual expenditure of both tonsillectomy and resulting readmissions across Australia was A$126 705 989. Surgical cost in the upper quartile was associated with younger age, male sex, lower socioeconomic status, surgery for reasons other than infection alone, overnight vs day case surgery, public hospitals and metropolitan hospitals. Surgery for obstructed breathing during sleep had the strongest association to high surgical cost. Conclusions This study highlights the cost of paediatric tonsillectomy and associated hospital readmissions. The study findings will inform healthcare reform and serve as a basis for strategies to optimise patient outcomes while reducing both postoperative complications and costs.

Hospital revisits after paediatric tonsillectomy: a cohort study.

BACKGROUND: Tonsillectomy, with or without adenoidectomy, is the leading reason for paediatric unplanned hospital readmission, some of which are potentially avoidable. Reducing unplanned hospital revisits would improve patient safety and decrease use of healthcare resources. This study aimed to describe the incidence, timing and risk factors for any surgery-related hospital revisits (both emergency presentation and readmission) following paediatric tonsillectomy and adenotonsillectomy in a large state-wide cohort. METHODS: We conducted a population-based cohort study using linked administrative datasets capturing all paediatric tonsillectomy and adenotonsillectomy surgeries performed between 2010 and 2015 in the state of Victoria, Australia. The primary outcome was presentation to the emergency department or hospital readmission within 30-day post-surgery. RESULTS: Between 2010 and 2015, 46,583 patients underwent 47,054 surgeries. There was a total of 4758 emergency department presentations (10.11% total surgeries) and 2750 readmissions (5.84% total surgeries). Haemorrhage was the most common reason for both revisit types, associated with 33.02% of ED presentations (3.34% total surgeries) and 67.93% of readmissions (3.97% total surgeries). Day 5 post-surgery was the median revisit time for both ED presentations (IQR 3-7) and readmission (IQR 3-8). Predictors of revisit included older age, public and metropolitan hospitals and peri-operative complications during surgery. CONCLUSIONS: Haemorrhage was the most common reason for both emergency department presentation and hospital readmission. The higher risk of revisits associated with older children, surgeries performed in public and metropolitan hospitals, and in patients experiencing peri-operative complications, suggest the need for improved education of postoperative care for caregivers, and avoidance of inappropriate early discharge.

Closure of skull base defects after endoscopic endonasal transsphenoidal surgery: the role of the local sphenoid mucosal flap for low flow leaks.

A local sphenoid mucosal flap (SMF) is naturally raised during endonasal exposure of the sella. Typically, these flaps are repositioned; however, they could be used in place of a nasoseptal flap (NSF) for closure of low-grade CSF leaks. In this study, we aim to establish the safety and efficacy of SMF closure for low-grade CSF leaks and to assess the impact on sinonasal quality of life (QoL) compared to NSF closure. In a consecutive, prospective cohort of anterior skull base pathology, data regarding sellar and suprasellar extension (Hardy grade), cavernous sinus invasion (Knosp grade), intraoperative (Kelly grade) and postoperative CSF leak, and sino-nasal QoL data (SNOT-22) were analysed. Of 187 patients with no/low flow (Kelly 0-1) intraoperative CSF leak, 127 (67.9%) received a SMF and 60 (32.1%) received a NSF. A total of 141/187 (75.4%) had no intraoperative leak, while 46/187 (24.6%) had grade-1 leaks. SMF were used in 70.9% (100/141) of cases without intraoperative leak, and 58.7% (27/46) of cases with Kelly grade-1 leaks. Hardy grade 4, grade E and Knosp grade 4 lesions were all more commonly closed with a NSF (p < 0.05). Two patients (1.1%) had postoperative CSF leaks, both in the SMF group, and both after no discernible intraoperative leak. Sinonasal QoL was below baseline for up to 3 months postoperatively. SMF cases tended to have better sinonasal QoL for up to 6 weeks after surgery. Thus, in the largest cohort to date, SMF are a safe alternative to NSF for closure low-grade skull base defects. Sinonasal QoL was better in the first 6 weeks after SMF closure than NSF closure.

Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study.

BACKGROUND: Topical steroids are first-line treatment for chronic rhinosinusitis (CRS), but fail to provide adequate symptom control for all patients. Designed for medical treatment failures, LYR-210 is an implantable matrix that locally elutes mometasone furoate to inflamed sinonasal tissue for up to 24 weeks in CRS patients. In an open-label phase 1 study, LYR-210 demonstrated clinically relevant improvement in the 22-item Sino-Nasal Outcome Test (SNOT-22). Safety and efficacy of LYR-210 in CRS were evaluated in the LANTERN Phase 2 study. METHODS: Sixty-seven surgically naive adult CRS patients who were inadequately controlled by previous medical management and seeking an alternative treatment enrolled in a multicenter, blinded, controlled, dose-ranging study. Patients had moderate-to-severe disease based on SNOT-22 and composite 7-day average scores of the 4 cardinal CRS symptoms (4CS), with diagnosis confirmed by nasal endoscopy and magnetic resonance imaging. Patients were randomized (1:1:1) to saline irrigation-only control or bilateral in-office administration of LYR-210 (2500 µg) or LYR-210 (7500 µg). Safety and efficacy were evaluated over 24 weeks. RESULTS: Both LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 demonstrated rapid and durable dose-dependent symptom improvement based on 4CS and SNOT-22, with LYR-210 (7500 µg) achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. LYR-210 (7500 µg) reduced rescue treatment use and radiographic ethmoid opacification at week 24. CONCLUSIONS: LYR-210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps.

Sociodemographic associations of geographic variation in paediatric tonsillectomy and adenoidectomy.

Geographic variation of paediatric tonsillectomy, with or without adenoidectomy, (A/T) has been described since the 1930s until today but no studies have investigated the factors associated with this variation. This study described the geographical distribution of paediatric A/T across the state of Victoria, Australia, and investigated area-level factors associated with this variation. We used linked administrative datasets capturing all paediatric A/T performed between 2010 and 2015 in Victoria. Surgery data were collapsed by patient residence to the level of Local Government Area. Regression models were used to investigate the association between likelihood of surgery and area-level factors. We found a 10.2-fold difference in A/T rates across the state, with areas of higher rates more in regional than metropolitan areas. Area-level factors associated with geographic variation of A/T were percentage of children aged 5-9 years (IRR 1.07, 95%CI 1.01-1.14, P = 0.03) and low English language proficiency (IRR 0.95, 95% CI 0.90-0.99, P = 0.03). In a sub-population analysis of surgeries in the public sector, these factors were low maternal educational attainment (IRR 1.09, 95% CI 1.02-1.16, P < 0.001) and surgical waiting time (IRR 0.99635 95% CI 0.99273-0.99997, P = 0.048). Identifying areas of focus for improvement and factors associated with geographic variation will assist in improving equitable provision of paediatric A/T and decrease variability within regions.

Adenotonsillectomy for paediatric sleep disordered breathing in Australia and New Zealand.

AIMS: To review the contributions of Australian and New Zealand research on adenotonsillectomy for the treatment of symptoms of obstructed breathing during sleep (sleep disordered breathing, SDB) in children. METHODS: A search of the scientific literature was conducted using the MEDLINE (Ovid), PubMed and Scopus databases in August 2020. The following search string was used: (tonsillectomy OR adenoidectomy OR adenotonsillectomy) AND (paediatric OR child) AND (Australia OR New Zealand). A focused internet search was additionally conducted on Google to identify grey literature. RESULTS: Researchers from Australia and New Zealand have made important contributions to the understanding and improvement of adenotonsillectomy (AT), including its epidemiology, cost, surgical techniques and peri-operative safety. Rates of AT have fluctuated over the years, becoming the most common paediatric surgery today, with SDB becoming the most common indication. Research in Australia and New Zealand has also focussed on the impact of AT on quality of life, and behaviour, neurocognition and cardiovascular sequelae. CONCLUSIONS: Australian and New Zealand researchers have played a significant role in understanding the epidemiology and improving the safety of AT. There are promising directions in research still to come, including better understanding of the reasons for geographical variation in surgery rates, developing more efficient pre-operative risk assessment tools and alternative treatment options for mild OSA.

Olfactory and Gustatory Function in Patients With Different Types of Maxillofacial Trauma.

OBJECTIVES/HYPOTHESIS: To investigate olfactory and gustatory function in patients with maxillofacial trauma and associated fractures. STUDY DESIGN: Retrospective cohort study. METHODS: Olfactory and gustatory function was assessed psychophysically in 124 patients who had sustained maxillofacial trauma with an associated fracture. Five groups were defined based on the fracture type: Le Fort, mandibular, nasal, orbital, and zygomatic. Olfaction was measured with Sniffin' Sticks (threshold, discrimination, identification [TDI] score) and gustation with the taste spray method. Patients self-rated olfactory and gustatory function on a visual analog scale prior to formal testing. RESULTS: Ten out of 124 patients were found to be anosmic (8%), with half of them found in the Le Fort (skull base) group. The Le Fort fracture group had significantly lower olfactory function than other fracture types (TDI score = 22.4 ± 10.7; P = .01; possible range = 1-48). The mean gustatory spray test score was 3.82 ± 0.4 (possible range = 0-4) without any intergroup differences. Self-rated olfactory function showed a correlation with the measured scores (r = 0.61, P < .001) across all groups. CONCLUSIONS: The present data show a significant effect of maxillofacial fracture type on the development of anosmia. Maxillofacial fractures involving the skull base, such as Le Fort fractures, are more likely to cause permanent smell loss, whereas the other fracture types are rarely associated with anosmia. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E331-E337, 2021.

Smell and taste loss in COVID-19 patients: assessment outcomes in a Victorian population.

Background: It has been noted that olfactory and gustatory disturbances may precede or accompany the typical features of COVID-19, such as fever and cough. Hence, a high index of suspicion is required when patients report sudden loss of smell or taste, in order to facilitate timely diagnosis and isolation.Aims/objectives: The aim of this study was to assess the frequency of olfactory and gustatory disturbances in COVID-19 positive patients from a cohort representative of Melbourne, Australia.Methods: A retrospective descriptive study was conducted on patients who tested positive for COVID-19. Standardised phone consultations and online follow-up questionnaires were performed to assess clinical features of COVID-19, with a focus on smell and taste disorders.Results: The most frequent symptoms experienced were taste and smell disturbances with 74% experiencing either smell or taste disturbance or both. Post-recovery, 34% of patients continued to experience ongoing hyposmia and 2% anosmia, whereas 28% continued to suffer from hypogeusia or ageusia.Conclusion and significance: This study presents the high rates of improvement of both olfactory and gustatory disturbance in a short-lived period. It also highlights the importance of these symptoms in prompting appropriate testing, quarantine precautions, initiate early olfactory retraining and the potential for continued sensory disturbance.

A pituitary metastasis, an adenoma and potential hypophysitis: A case report of tumour to tumour metastasis in the pituitary.

Tumour to tumour metastasis is a rare event, especially in the pituitary. Metastases to pituitary adenomas most commonly occurs in late stage disease, commonly presenting with visual field defects and adenohypophyseal dysfunction. The most frequent primary cancers are lung, breast and renal carcinoma which deposit most commonly in prolactinomas, somatotropinomas, gonadotropinomas. In nearly 40% of cases, sellar symptoms are the harbinger to the diagnosis of primary malignancy. The abnormal vascularity and growth promoting microenvironment of pituitary adenomas may encourage metastatic seeding and proliferation of these "collision tumours". Here, we present a case of a breast carcinoma metastasis to a pituitary null-cell adenoma in the setting of immunotherapy. Infundibular thickening in the setting of immunotherapy is often ascribed to hypophysitis, but our case highlights that metastatic spread should be part of the differential diagnosis.

Continuous oximetry recordings on the first post-operative night after pediatric adenotonsillectomy-a case-control study.

BACKGROUND: Children with obstructive sleep apnea (OSA) with recurrent dips in oxygen saturation (SpO2) during sleep are known to be at increased risk of post-operative airway compromise after adenotonsillectomy (AT). We aimed to determine the extent of desaturation on the first post-operative night in children known to have recurrent desaturation pre-operatively and to compare the extent of desaturation in that group with results in children known to have normal oximetry recordings pre-operatively. METHODS: Prospective sequential recruitment of 57 children who had overnight oximetry performed on the first night after adenotonsillectomy was undertaken, including 28 with a McGill Oximetry Score (MOS) of 2-4 pre-operatively (high risk group) and 29 with a normal/inconclusive pre-operative MOS (low risk group). Oximetry parameters (mean SpO2, SpO2 nadir, and rates of SpO2 dips below 90% and dips of ≥4%) were compared to the pre-operative oximetry result. Demographic and clinical factors, and the occurrence of post-operative complications, were derived from the medical record. RESULTS: In the high risk group, the MOS improved in 23/28 children, but remained abnormal in 82%. Conversely, in the low risk group 26/29 (90%) had a normal post-operative oximetry. The remaining 3, all of whom had severe OSA on pre-operative polysomnography, had a lowered baseline SpO2 post-operatively. Mean SpO2 was slightly lower post-operatively in both groups. In the high risk group, all other SpO2 measures improved post-operatively. Respiratory adverse events were more common in the high risk group as expected (39% compared to 3% in the low risk group, p = 0.001). An adverse event requiring clinical intervention was significantly more likely if the post-operative oximetry was abnormal (result unknown to the treating team), occurring in 73% of children with an abnormal compared with 32% of children with a normal post-operative oximetry (p = 0.002). CONCLUSION: Most children with an abnormal oximetry pre-operatively continued to have an abnormal oximetry on the first night after AT, albeit somewhat improved. While adverse events were more frequent in children with an abnormal post-operative oximetry, half (54%) did not suffer a clinical respiratory adverse event despite having repetitive desaturations on downloadable oximetry. These findings support close clinical observation of children at high risk of complications post-operatively, especially those with abnormal oximetry pre-operatively, rather than focusing on recurrent dips in SpO2 on post-operative oximetry downloads in the absence of clinically evident complications.

The History of Myringotomy and Grommets.

The first recorded myringotomy was in 1649. Astley Cooper presented 2 papers to the Royal Society in 1801, based on his observations that myringotomy could improve hearing. Widespread inappropriate use of the procedure followed, with no benefit to patients; this led to it falling from favor for many decades. Hermann Schwartze reintroduced myringotomy later in the 19th century. It had been realized earlier that the tympanic membrane heals spontaneously, and much experimentation took place in attempting to keep the perforation open. The first described grommet was made of gold foil. Other materials were tried, including Politzer's attempts with rubber. Armstrong's vinyl tube effectively reintroduced grommets into current practice last century. There have been many eponymous variants, but the underlying principle of creating a perforation and maintaining it with a ventilation tube has remained unchanged. Recent studies have cast doubt over the long-term benefits of grommet insertion; is this the end of the third era?

An epidemiological study of paediatric adenotonsillectomy in Victoria, Australia, 2010-2015: Changing indications and lack of effect of hospital volume on inter-hospital transfers.

OBJECTIVE: To describe the contemporary epidemiology of paediatric adenotonsillectomy in an Australian setting, examine the incidence rate over 2010-2015 and investigate factors associated with inter-hospital transfer. DESIGN: Retrospective population-based study. SETTING: Multicentre study in the state of Victoria, Australia. PARTICIPANTS: From the Victorian Admitted Episodes Dataset, which included all patients aged 0-19 years who underwent adenoidectomy and/or tonsillectomy in Victoria, Australia between 2010 and 2015. MAIN OUTCOME MEASURES: Annual incidence rate, hospital volume, inter-hospital transfer. RESULTS: Between 2010 and 2015, 59 008 patients underwent 61 281 procedures, with highest number performed in males (52.7%), children aged under 10 years (73.5%) and in the higher socioeconomic groups (24.6% in quintile 4 and 23.2% in quintile 5). Seventy-five cases (0.12%) resulted in inter-hospital transfer, which was significantly associated with young age (under 5 years). More than a third of hospitals (35.7%) performed an average rate of <1 procedure per week. Hospital volume was not associated with risk of inter-hospital transfer. The incidence rate of adenotonsillectomy procedures significantly increased over the study period (P < .001), driven by a significant increase in the rate of surgery performed for obstructive symptoms (P < .001). CONCLUSIONS: The rate of adenoidectomy/tonsillectomy procedures is rising, with a higher proportion being performed in socioeconomically advantaged patients. This raises concerns regarding healthcare access, given the literature supporting higher rates of obstructive sleep-disordered breathing and sore throat in lower socioeconomic groups. A third of hospitals performed small numbers of procedures, but we found no association between hospital volume and inter-hospital transfers.

Nasal Chondrosarcoma of the Lower Lateral Cartilage.

Head and neck chondrosarcomas are incredibly rare with documented cases arising from skull base, maxilla, larynx, and nasal septum. We present the first reported case of chondrosarcoma arising from the lower lateral cartilage of the nose treated with surgical resection and primary reconstruction.

Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous topical steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. METHODS: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. RESULTS: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). CONCLUSION: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.