Corticosteroid-eluting implants for the management of chronic rhinosinusitis with or without nasal polyps.

INTRODUCTION: Topical corticosteroid therapies are the most popular prescribed medications for patients with chronic rhinosinusitis (CRS). While topical corticosteroids effectively reduce the inflammatory burden associated with CRS, their distribution inside the nasal cavity is limited and primarily dependent on their delivery device. Corticosteroid-eluting implants serve as relatively novel technology, allowing targeted, sustained release of a high concentration of corticosteroids directly onto the sinus mucosa. Three types of corticosteroid-eluting implants can be characterized: 1. intraoperatively inserted corticosteroid-eluting sinus implants, 2. postoperatively inserted, office-based corticosteroid-eluting sinus implants, and 3. office-based corticosteroid-eluting implants for naïve paranasal sinuses. AREAS COVERED: The review summarizes the different steroid-eluting sinus implants, their indications for use in CRS patients, and the existing evidence regarding their clinical efficacy. We also highlight potential areas for improvement and development. EXPERT OPINION: Corticosteroid-eluting sinus implants highlight an evolving field that is constantly investigating and adding new treatment options to the market. Presently, corticosteroid-eluting implants for CRS are most commonly applied intraoperatively and postoperatively with endoscopic sinus surgery, providing significant improvements in mucosal healing and reducing the amount of surgical failures. Future development around corticosteroid-eluting implants should focus on strategies to reduce the amount of crusting around the implants.

Postoperative Polyp Scale (POPS): Development of a New Sinonasal Polyp Grading Scale.

OBJECTIVE: Commonly used endoscopic grading scales, such as the nasal polyp scale, inadequately describe the degree of polyposis found postoperatively in the paranasal sinus cavities. The purpose of this study was to create a novel grading system that more accurately characterizes polyp recurrence in postoperative sinus cavities, the Postoperative Polyp Scale (POPS). METHODS: A modified Delphi method was utilized to establish the POPS using consensus opinion among 13 general otolaryngologists, rhinologists, and allergists. Postoperative endoscopy videos from 50 patients with chronic rhinosinusitis with nasal polyps were reviewed by 7 fellowship-trained rhinologists and scored according to the POPS. Videos were rated again 1 month later by the same reviewers, and scores were assessed for test-retest and inter-rater reliability. RESULTS: Overall inter-rater reliability for the first and second reviews of the 52 videos was Kf = 0.49 (95% CI 0.42-0.57) and Kf = 0.50 (95% CI 0.42-0.57) for the POPS. Intra-rater reliability showed near-perfect test-retest reliability for the POPS with Kf = 0.80 (95% CI 0.76-0.84). CONCLUSION: The POPS is an easy-to-use, reliable, and novel objective endoscopic grading scale that more accurately describes polyp recurrence in the postoperative state which will be useful in the future for measuring the efficacy of various medical and surgical interventions. LEVEL OF EVIDENCE: 5 Laryngoscope, 133:2885-2890, 2023.

Predictive value of pituitary tumor morphology on outcomes and complications in endoscopic transsphenoidal surgery.

Purpose: Endoscopic transsphenoidal surgery (ETSS) is an increasingly utilized approach for resection of pituitary tumors. Prior studies have evaluated preoperative tumor size, location, and extent as prognostic factors for surgical resection. There is little data on the relationship between preoperative pituitary tumor radiographic morphology and surgical outcomes. Study Design: Retrospective longitudinal study. Setting: Single tertiary care institution. Subjects and Methods: Preoperative magnetic resonance imaging and computed tomography scans from patients undergoing ETSS for pituitary tumor resections from 2007 to 2017 were retrospectively evaluated. A neuroradiologist classified these pituitary tumors into six morphologic groups, each defined by volume, dimensions, extension, and shape. Surgical difficulty, rates of incomplete resection, and postoperative complications were then stratified in relation to the morphologic groups. Results: Pituitary tumors from 131 patients were classified from preoperative imaging into six characteristic morphologies: (1) microtumor, (2) round, (3) transverse oblong, (4) superior-inferior oblong, (5) bilobed, and (6) large lobulated. Tumors that were characterized with the large lobulated, bilobed, and transverse oblong morphologies correlated with higher rates of postoperative evidence of residual tumor (70%, 36%, and 47%, respectively, all P < 0.002). Likewise, large lobulated, bilobed, and transverse oblong morphologies were also associated with intraoperative cerebrospinal fluid leaks (70%, 31%, and 35%, respectively, all P < 0.05). Conclusions: We describe a novel descriptive system for the morphology of pituitary tumors that can be determined from preoperative imaging. Different tumor morphologic groups are associated with varying degrees of gross tumor resection, complications, and surgical difficulty. Utilizing pituitary tumor morphology may aid surgeons in planning the extent of resection, need for complex closure, and patient counseling.

A review of phase III clinical trials of US FDA-approved biologic therapies for chronic rhinosinusitis with nasal polyposis.

Chronic rhinosinusitis with nasal polyposis is a heterogenous disease with complex underlying pathophysiologic mechanisms. Biologics have been proven to be an effective add-on therapeutic option in severe and/or refractory cases. Currently, dupilumab, omalizumab and mepolizumab have phase III data to support their use in these patients and have received approval from the United States Food and Drug Administration specifically for the treatment of nasal polyposis. Each of these biologics has shown its ability to reduce nasal polyp size and improve nasal congestion/obstruction and sense of smell, but additional research is needed to directly compare the efficacy and safety of the different biologic agents for different nasal polyposis endotypes.

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a complex disease that has many different causes. Biological therapies have been proven to be effective when added on to standard treatment in severe and/or cases that are not responsive to initial treatment. Currently, dupilumab, omalizumab and mepolizumab have data supporting their use in such patients and have received approval by the United States Food and Drug Administration for the treatment of CRSwNP. Each of these biologics has shown its ability to reduce nasal polyp size and improve nasal congestion/obstruction and sense of smell, but additional research is needed to directly compare the efficacy and safety of the different biologic agents for different CRSwNP subtypes.

Biologics for chronic rhinosinusitis with nasal polyps: Economics and ethics.

Biologics have recently been approved for use in chronic rhinosinusitis with nasal polyps patients. While effective in controlling disease on subjective and objective short-term outcome measures, limited data suggest that biologics have the potential to be used long term. The current wholesale acquisition costs for biologics are quite high. Widespread, prolonged use of these medications may create a large burden to our healthcare system. Cost-effectiveness analyses, particularly for specific patient cohorts, are needed to determine appropriate use of these medications. The ethics of patient preference of various treatment options, counseling regarding side effect profiles, and healthcare economics also need to be addressed.

Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study.

OBJECTIVES/HYPOTHESIS: To assess the long-term (12-24 months) safety and effectiveness of cryoablation of the posterior nasal nerve as treatment for chronic rhinitis. STUDY DESIGN: A multicenter, prospective, single-arm clinical study. METHODS: The study was conducted from February 2017 to April 2020. Study endpoints included change from baseline in the reflective Total Nasal Symptom Score (rTNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), physician assessment of improvement using the Clinical Global Impression-Improvement (CGI-I), and the incidence of treatment-related adverse events. RESULTS: Ninety-one participants completed the study through the initial 12-month study period. Sixty-two participants consented to the long-term follow-up with 57 completing the 24-month follow-up. Significant improvements in the total rTNSS were reflected in a median change from baseline of -3.0 or -4.0 at all timepoints (P < .001). Greater than 80.0% of participants achieved the minimum clinically important difference (MCID) of improvement by ≥1 point on the rTNSS at all follow-ups. Total RQLQ scores indicated significant improvement (P < .0001) in quality of life. Over 77% of participants achieved the MCID (≥0.5 points) for the total RQLQ score. According to the CGI-I, ≥83.0% experienced improvement at all but the 12-month visit (61.9%). One participant experienced two treatment-related serious adverse events (epistaxis and retained pledget). A total of 29 nonserious treatment-related AEs were reported in 23 participants; most events were transient and resolved with little to no intervention. CONCLUSIONS: Cryotherapy significantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1952-1957, 2021.

Intraoperative Applications of Topical Corticosteroid Therapy for Chronic Rhinosinusitis.

OBJECTIVES: To provide an overview of recent techniques and technologies for the application of topical corticosteroid therapy immediately following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). METHODS: A comprehensive search in the PubMed and Google Scholar databases was conducted to identify publications between January 2000 and December 2019 detailing clinical trials that have evaluated the efficacy and safety of intraoperative applications of topical corticosteroids for CRS. RESULTS: A total of 21 articles, all of which highlight a variety of corticosteroid-infused products, including Propel corticosteroid-eluting stents, NasoPore, Merocel, SinuBand, calcium alginate, and bioresorbable gel-type products, are included for review. Propel stents are the only devices that have achieved level 1A evidence in terms of efficacy and have data to support their safety. The remaining products have shown mixed results in terms of efficacy and safety. CONCLUSION: A wide range of techniques and technologies have been introduced to enhance the topical delivery of corticosteroids into the neosinuses after ESS for CRS. Regarding efficacy, there is level 1A evidence to support the use of Propel stents. Most of the remaining strategies show some degree of efficacy. Direct comparisons across the different strategies are limited owing to the varied uses of delivery vectors, corticosteroid choices, and doses of corticosteroids. Propel stents and SinuBand have sufficient data to support systemic and ocular safety, whereas the remaining products have limited data to support their safety.

Establishing Urinary Leukotriene E4 as a Diagnostic Biomarker for Chronic Rhinosinusitis with Comorbid Asthma and Atopy.

OBJECTIVE: While urinary leukotriene E4 (uLTE4) is a validated biomarker for the cysteinyl leukotriene pathway, which is central to the pathophysiology of asthma, atopy, and chronic rhinosinusitis (CRS), the contributions of comorbid asthma and atopy to uLTE4 levels in various CRS subtypes have not been previously characterized. We sought to (1) identify reference values for uLTE4 in subjects with and without CRS and (2) determine how the presence of comorbid atopy and asthma affects uLTE4 levels in CRS. SETTING: Tertiary referral medical center. SUBJECTS AND METHODS: A prospective case-control study was conducted to compare uLTE4 levels between patients with CRS and healthy controls. Urinary LTE4 levels were measured by enzyme immunoassay and were adjusted for urinary creatinine concentrations (pg/mg Cr). Patients with CRS were stratified by the clinical comorbidities to determine normative uLTE4 values for patients with CRS with and without comorbid asthma or atopy. RESULTS: A total of 153 patients (mean age, 47.3; 47.1% female) were included in the study. Patients with CRS demonstrated significantly higher concentrations of uLTE4 than healthy controls (1652 vs 1065 pg/mg Cr, P = .032). Within the group of patients with CRS, comorbid asthma also individually correlated with elevated uLTE4 levels (1597 pg/mg Cr, P = .0098). Patients with CRS who did not have comorbid allergy and asthma, in contrast, did not have statistically higher uLTE4 levels than healthy controls (1142 pg/mg Cr, P = .61). CONCLUSION: Urinary LTE4 serves as a noninvasive measure of the inflammatory state in CRS. Comorbid asthma and atopy contribute to elevated uLTE4 levels in CRS.