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Background: Budesonide high-volume saline irrigations (HVSIs) are routinely used to treat chronic rhinosinusitis (CRS) due to improved sinonasal delivery and efficacy compared to intranasal corticosteroid sprays. The off-label use of budesonide is assumed to be safe, with several studies suggesting the systemically absorbed dose of budesonide HVSI is low. However, the actual budesonide dose retained in the sinonasal cavity following HVSI is unknown. The objective of this study was to quantify the retained dose of budesonide after HVSI. Methods: Adult patients diagnosed with CRS who had undergone endoscopic sinus surgery (ESS) and were prescribed budesonide HVSI were enrolled into a prospective, observational cohort study. Patients performed budesonide HVSI (0.5 mg dose) under supervision in an outpatient clinic, and irrigation effluent was collected. High-performance liquid chromatography was employed to determine the dose of budesonide retained after HVSI. Results: Twenty-four patients met inclusion criteria. The average corrected retained dose of budesonide across the cohort was 0.171 ± 0.087 mg (37.9% of administered budesonide). Increased time from ESS significantly impacted the measured retained dose, with those 3 months post-ESS retaining 27.4% of administered budesonide (P =.0004). Conclusion: The retained dose of budesonide in patients with CRS after HVSI was found to be significantly higher than previously estimated and decreased with time post-ESS. Given that budesonide HVSI is a cornerstone of care in CRS, defining the retained dose and the potential systemic implications is critical to understanding the safety of budesonide HVSI. [ABSTRACT FROM AUTHOR]

Background: Despite significant morbidity, there remains a critical need for prospective analyses to investigate the impact of comorbid chronic rhinosinusitis (CRS) with asthma (CRSwA) on patient centered outcomes. The objective of this study was to ascertain critical stakeholder feedback from patients that could inform future study design based on patient preferences, in an effort to optimize patient enrollment. Methods: A prospective, descriptive study was performed in order to determine the importance of various factors on CRSwA treatment among critical stakeholders. A Likert-scale survey highlighting various aspects of treatment of CRSwA and elucidating patient enthusiasm for clinical enrollment was constructed and prospectively administered to patients with CRSwA. A univariate analysis was instituted to understand the significance of the different trial design preferences. Results: Survey responses were collected from a total of 17 patients with CRSwA. With Likert scores >4/5, responses indicated significant stakeholder interest in research focused on understanding symptom triggers, including the impact of air quality and allergens. Importantly, the highest mean scores noted were for studies focused on improving (1) overall quality of life (4.8/5) and (2) lung function (4.8/5). Patients appeared least interested in participation in a randomized trial, whereas the greatest support was communicated for a purely observational trial (P =.08). Conclusion: Patients with CRSwA demonstrate enthusiasm for participation in research that focuses on improving patient centered outcomes—specifically quality of life and lung function. Stakeholder feedback also indicates a preference for observational study design over randomized control trials. [ABSTRACT FROM AUTHOR]

Objective: Steroid eluting stents have proven to be a highly useful adjunctive therapy for chronic rhinosinusitis (CRS) and play an important role in the treatment of many inflammatory diseases of the sinuses. Few reports of adverse events were reported in clinical trials and are described in the literature. However, we describe the first known case of an immunocompetent patient developing non-invasive fungal tissue infection as a sequelae of stent-related tissue necrosis requiring surgical debridement. Methods: A 69-year-old immunocompetent male with CRS had Propel™ stents placed in the bilateral frontal sinus outflow tracts during revision endoscopic sinus surgery. He presented 2 weeks post-operatively with severe facial pain without vision changes, fevers, mental status changes, or evidence of cranial neuropathies. On rigid nasal endoscopy, necrotic tissue and gross fungal elements were visualized in the left frontal sinus outflow tract at the area of previous steroid stent position. Results: The patient was taken for urgent endoscopic sinus surgery and debridement given significant symptoms and concern for invasive fungal infection. A revision left maxillectomy, ethmoidectomy, and draf 2b frontal sinus drillout were performed, with healthy bleeding tissue encountered beneath necrotic tissue. Pathology revealed tissue necrosis, exudative lumenal debris, and extensive fungal elements with no evidence of tissue invasion, and cultures yielded growth of aspergillus niger. The patient's symptoms improved significantly on post-operative day 1, he had normal post-operative changes at 2 weeks following debridement, and had no recurrence of fungal infection with complete healing at 4 months. Conclusion: While likely rare, steroid-eluting stents may pose a risk of saprophytic tissue infection as a result of tissue necrosis and local immunosuppression. Caution should be taken in using these devices in immunocompromised patients. [ABSTRACT FROM AUTHOR]