Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab: Real-World Use and Outcomes.

BACKGROUND: Biologic medications are increasingly incorporated into chronic rhinosinusitis with nasal polyps (CRSwNP) management. However, little is known about prescribing patterns in real-world settings and how this relates to proposed international guidelines and outcomes. OBJECTIVES: To characterize use patterns of dupilumab for CRSwNP better in relation to proposed guidelines and explore real-world outcomes. METHODS: We used the TriNetX Web-based tool to identify patients who were prescribed dupilumab for CRSwNP. Patients prescribed dupilumab for a CRSwNP indication were included for analysis. Dupilumab initiation criteria were determined via the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS2020). RESULTS: In total, 121 patients were identified who were prescribed dupilumab for a CRSwNP indication. Of these, 86 (71%) met EPOS2020 indications for biologic initiation and 35 (29%) did not. Overall, patients had significant improvements in the 22-item SinoNasal Outcome Test scores (mean improvement of 24.3 points) and nasal polyp scores (mean improvement of 1.0 point). However, 20 patients (30%) did not show meaningful improvement in the 22-item SinoNasal Outcome Test scores. Twenty-one patients (17%) failed a previous biologic attempt. Therapy was discontinued by six patients (5%) due to side effects, and by six (5%) owing to a lack of efficacy. CONCLUSIONS: In our experience, patients prescribed dupilumab for CRSwNP frequently may not meet EPOS2020 Guidelines. Over 25% of those who do not meet criteria may not have CRSwNP. Overall, dupilumab use among well-selected patients appears to be safe and effective. Further real-world study of biologic use for CRSwNP will help improve its judicious use and identify populations who benefit most from biologic therapies.

Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation.

Objective: Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management. Study Design: Case series. Setting: FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management. Results: A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported. Conclusion: Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.

Ayurvedic medicine for the treatment of chronic rhinosinusitis: a systematic review of randomized and non-randomized trials.

OBJECTIVES: This article provides a comprehensive systematic review and qualitative analysis of the current research investigating Ayurveda chronic rhinosinusitis (CRS) treatment. CONTENT: PRISMA guidelines for systematic reviews was followed and our search utilized MEDLINE, Embase, Ayush Portal, and Cochrane Library databases. Articles published prior to March 2022, 10 or more patients that investigated Ayurveda as a treatment for CRS in humans were included. This resulted in thirteen articles meeting inclusion criteria. Ayurvedic treatments included herbal medications for oral consumption, nasal instillation, and steam inhalation used alone or in combination. All studies concluded that Ayurvedic therapy led to improvements in subjective CRS symptoms and objective radiographic and hematologic criteria. However, all 13 studies had a significant risk of bias due to study design and statistical methods utilized. SUMMARY: Ayurvedic therapy may be a useful CRS treatment for some patients and overall appears to be well tolerated. However, definitive recommendation for when Ayurvedic treatments would be beneficial in the treatment of CRS remains not possible. OUTLOOK: Given the overall positive effects shown in the current published evidence and growing interest in complementary and integrative therapies, Ayurvedic treatments for CRS deserve further investigation in the form of well-designed controlled trials.

Actinomyces Acute Rhinosinusitis Complicated by Subperiosteal Abscess in an Immunocompromised 12-Year-Old: Case Report and Literature Review.

Objective: To describe a rare case of pediatric actinomycotic rhinosinusitis with orbital subperiosteal abscess and review the current literature to assess methods of diagnosis, treatment modalities, and outcomes with appropriate treatment. Methods: A case report and a review of the literature. Results: A 12-year-old patient with Crohn's disease on infliximab presented with rhinosinusitis with orbital subperiosteal abscess formation. Endoscopic sinus surgery was performed and cultures grew actinomyces. A prolonged course of antibiotics was started, resulting in the complete resolution of the infection. In a literature review, all cases of uncomplicated and complicated actinomyces rhinosinusitis managed with appropriate surgery and prolonged antibiotics resulted in a cure. Our case is the first reported in a pediatric patient and the first taking immunosuppressive medication. Overall, only 3 cases of actinomyces rhinosinusitis in immunosuppressed individuals have been reported, each with uncontrolled diabetes and each also responded well to surgery and appropriate antibiotics. Conclusion: Actinomycosis of the paranasal sinuses poses a diagnostic challenge, with infections varying widely in presentation and extent of disease. A high index of suspicion, appropriate testing, and early aggressive treatment are critical in managing patients with this infection. Our case and prior published studies show that actinomyces rhinosinusitis can be successfully managed with endoscopic sinus surgery, abscess drainage as necessary, and a prolonged course of antibiotics, even in immunocompromised and pediatric populations.

Crenotherapy as a Complementary and Integrative Treatment for Chronic Rhinosinusitis: A Systematic Review and Discussion of Current Evidence Limitations.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common condition that affects patients' quality of life. Standard treatments for CRS have known side effects and variable efficacy rates. Thus, complementary and integrative (CIM) treatments for CRS such as crenotherapy, which utilizes high mineral content water or vapor as an inhalation therapy, are of continued interest. OBJECTIVES: To summarize and evaluate the current research investigating crenotherapy's therapeutic potential and clinical outcomes for the treatment of CRS. STUDY DESIGN: Systematic review and qualitative analysis. METHODS: A systematic review was performed, with a comprehensive search strategy applied to 6 databases from inception to March 2021: CINAHL, Cochrane, Embase, PubMed, Scopus, and Web of Science. Studies with at least 10 patients, which investigated crenotherapy as the sole or adjunctive treatment for CRS in humans were included. RESULTS: In total, 10 articles out of 756 were included. Of these, 6 were randomized controlled trials. The remaining four articles were non-randomized prospective cohort studies. Six studies assessed clinical symptoms in response to crenotherapy, and there were unanimous improvements in Visual Analog Scale (VAS), Sino-Nasal Outcome Test-20 (SNOT-20), and other quality of life metrics. The studies that assessed inflammatory markers, cytology, or other measures showed significant improvement in neutrophil count, spores, ciliary motility, IgE, and manometry. Minimal to no adverse events were reported across all 10 studies. CONCLUSION: There is limited data to support crenotherapy's effectiveness in treating patients with CRS. However, published studies suggest that for certain patients crenotherapy can both improve CRS symptoms and objective measures of nasociliary function with minimal side effects. Findings must be interpreted with caution due to study heterogeneity, inconsistent use of standard CRS definitions and outcomes measures, as well as other study design flaws. Given these results, as well as a growing interest in CIM, crenotherapy treatments for CRS deserve further investigation.

Hydraulic dissection technique during endoscopic sinus surgery using a novel balloon sinus dilation device.

BACKGROUND: More than a decade after its introduction, some rhinologic surgeons have incorporated the technique of balloon sinus dilation (BSD) technology into "hybrid" endoscopic sinus surgery (ESS) procedures. A novel BSD device which can be placed over standard surgical instruments, including surgical navigation instruments, has recently been introduced. We present a case series in which this device was used as a hydraulic dissection tool to aid safe efficient surgery in difficult-to-access locations of the paranasal sinuses during hybrid ESS procedures. OBJECTIVE: Highlight the potential role of hydraulic dissection techniques during ESS utilizing BSD. METHODS: Retrospective case series of patients who underwent ESS performed in part with a novel BSD device. RESULTS: A total of 10 patients who underwent hybrid ESS with BSD were reviewed. In all 10 cases, the novel BSD device was used without complication. The device was used over straight and curved suctions while being tracked with surgical navigation in all cases. Thirteen posterior ethmoid dissections, 12 sphenoidotomies, and 8 frontal sinusotomies were assisted with the device. For the selected dissections in which the balloon was utilized, the operating surgeon found it to be helpful in creating more space in difficult to access areas which allowed for continued safe surgical dissection. CONCLUSIONS: Sinus balloon devices can be used as a hydraulic dissection tool and may be a useful adjunct during ESS. The novel dilation system used in this study, which deploys a sinus balloon device over standard surgical instruments with surgical navigation, provides even more opportunity to accurately dissect difficult areas of the paranasal sinuses safely and efficiently. Further studies evaluating the exact role of sinus balloon devices used as a hydraulic dissection tool during ESS are warranted. LEVEL OF EVIDENCE: 4.

The role of CT and endoscopy in the evaluation of patients referred for intranasal Cryoablation.

BACKGROUND: Cryoablation (CA) of the posterior nasal nerves has garnered increasing interest as an office-based procedure for chronic rhinitis (CR). Standardized preoperative evaluation, specifically the role of computed tomography (CT) and nasal endoscopy, has yet to be defined. We report a series of patients who underwent CT and endoscopy as part of CR work-up in patients referred for CA. OBJECTIVE: Highlight the importance of both nasal endoscopy and CT scan in the evaluation of CR given significant overlap of symptoms and common occurrence of related sinonasal conditions. METHODS: Retrospective analysis of all patients referred to a single tertiary rhinology practice for CA was performed. RESULTS: Fifteen patients were sent for CA by medical allergists. Five patients were deemed CA candidates, and 1 patient received only medical CR treatment. Four patients had evidence of incomplete prior sinus surgery and/or continued chronic rhinosinusitis on endoscopic exam. These 4 patients received a combination of medical and surgical management with either complete resolution or improvement in CR symptoms. In 3 patients, CT confirmed chronic rhinosinusitis that was not apparent on endoscopy, and received a combination of medical and surgical management with symptom improvement. In the last two patients, final diagnoses were nasal valve collapse and recurrent acute rhinosinusitis. CONCLUSIONS: Referrals for CA are becoming more common and the optimal preoperative work up remains unclear. In this limited retrospective review, 67% of patients had diagnoses other than CR and thus were not deemed candidates for CA. Both CT and endoscopy are complementary to a detailed history and physical examination and can aid in CA candidate selection.

Image-Guided Surgery and Intraoperative Imaging in Rhinology: Clinical Update and Current State of the Art.

INTRODUCTION: Image-guided surgery (IGS) has gained widespread acceptance in otorhinolaryngology for its applications in sinus and skull base surgery. Although the core concepts of IGS have not changed, advances in image guidance technology, including the incorporation of intraoperative imaging, have the potential to enhance surgical education, allow for more rigorous preoperative planning, and aid in more complete surgery with improved outcomes. OBJECTIVES: Provide a clinical update regarding the use of image guidance and intraoperative imaging in the field of rhinology and endoscopic skull base surgery with a focus on current state of the art technologies. METHODS: English-language studies published in PubMed, Cochrane, and Embase were searched for articles relating to image-guided sinus surgery, skull base surgery, and intraoperative imaging. Relevant studies were reviewed and critical appraisals were included in this clinical update, highlighting current state of the art advances. CONCLUSIONS: As image guidance and intraoperative imaging systems have advanced, their applications in sinus and skull base surgery have expanded. Both technologies offer invaluable real-time feedback on the status and progress of surgery, and thus may help to improve the completeness of surgery and overall outcomes. Recent advances such as augmented and virtual reality offer a window into the future of IGS. Future advancements should aim to enhance the surgeon's operative experience by improving user satisfaction and ultimately lead to better surgical results.

Retroductal Nanoparticle Injection to the Murine Submandibular Gland.

Two common goals of salivary gland therapeutics are prevention and cure of tissue dysfunction following either autoimmune or radiation injury. By locally delivering bioactive compounds to the salivary glands, greater tissue concentrations can be safely achieved versus systemic administration. Furthermore, off target tissue effects from extra-glandular accumulation of material can be dramatically reduced. In this regard, retroductal injection is a widely used method for investigating both salivary gland biology and pathophysiology. Retroductal administration of growth factors, primary cells, adenoviral vectors, and small molecule drugs has been shown to support gland function in the setting of injury. We have previously shown the efficacy of a retroductally injected nanoparticle-siRNA strategy to maintain gland function following irradiation. Here, a highly effective and reproducible method to administer nanomaterials to the murine submandibular gland through Wharton's duct is detailed (Figure 1). We describe accessing the oral cavity and outline the steps necessary to cannulate Wharton's duct, with further observations serving as quality checks throughout the procedure.

Murine Salivary Functional Assessment via Pilocarpine Stimulation Following Fractionated Radiation.

Hyposalivation is commonly observed in the autoimmune reaction of Sjögren's syndrome or following radiation injury to the major salivary glands. In these cases, questions remain regarding disease pathogenesis and effective interventions. An optimized technique that allows functional assessment of the salivary glands is invaluable for investigating exocrine gland biology, dysfunction, and therapeutics. Here, we present a step by step approach to performing pilocarpine stimulated saliva secretion, including tracheostomy and the dissection of the three major murine salivary glands. We also detail the appropriate murine head and neck anatomy accessed during these techniques. This approach is scalable, allowing for multiple mice to be processed simultaneously, thus improving the efficiency of the work flow. We aim to improve the reproducibility of these methods, each of which has further applications within the field. In addition to saliva collection, we discuss metrics for quantifying and normalizing functional capacity of these tissues. Representative data are included from submandibular glands with depressed salivary gland function 2 weeks following fractionated radiation (4 doses of 6.85 Gy).