Delivering Therapy to the Olfactory Cleft: A Comparison of the Various Methods of Administering Topical Nasal Medications.

Background and objective Chronic rhinosinusitis (CRS) is an inflammatory condition affecting the nasal mucosa, and it causes olfactory dysfunction (OD) in up to 78.2% of patients. Corticosteroids are the mainstay of treatment to shrink nasal polyposis, reduce inflammation, and improve olfactory function. While many delivery methods for topical nasal corticosteroids exist, there is scarce data on the efficacy of the various medication delivery methods to the olfactory cleft (OC). In light of this, this study aimed to compare the following delivery methods to the OC: conventional nasal spray (NS), nasal drops in the Kaiteki position (KP), and exhalation delivery system (EDS). Methods We evaluated 16 sinonasal cavities from eight cadaver specimens in this study. Each sinonasal cavity was administered fluorescein dye solution via NS, KP, and EDS. Following administration, nasal endoscopy was employed to capture staining patterns in the OC. OC staining was rated with scores ranging from 0 (no staining) to 3 (heavy staining) after each administration of dye solution. Mean OC staining ratings were calculated and compared using the Kruskal-Wallis rank sum test and the Wilcoxon signed-rank test. Results The mean OC staining score for the different delivery methods was as follows - NS: 1.095 ± 1.008, EDS: 0.670 ± 0.674, and KP: 2.038 ± 1.097. Nasal drops in the KP had a significantly higher staining score compared to NS (p=0.041) and EDS (p=0.003). However, there was no significant difference in staining scores between NS and EDS. Conclusions Nasal drops in the KP are more effective at reaching the OC than NS or EDS and should be considered as a first-line modality for administering topical medications when treating OD.

Nasoseptal Flap to Repair Large Maxillary Sinus Floor Defects.

This case highlights the successful use of a large nasoseptal flap to repair a large maxillary sinus floor defect. Surgeons can therefore rely on this flap for repairing maxillary sinus floor defects of most sizes and locations. Laryngoscope, 134:87-91, 2024.

Accessing the Eustachian tube: Conventional nasal spray vs. exhalation delivery system and the impact of targeted endoscopic sinus surgery on topical distribution patterns.

BACKGROUND: Eustachian tube dysfunction (ETD) may occur distinct from, or in conjunction with, chronic rhinosinusitis (CRS+ETD). Intranasal corticosteroid sprays are often prescribed for ETD, although ET distribution may be limited. To date, no anatomic studies compare nasopharynx (NP) distribution between conventional nasal sprays (NS) and exhalation delivery systems (EDS) after surgery. This study utilizes a cadaver model to examine topical NP delivery using EDS vs. NS before and after targeted endoscopic sinus surgery (ESS). METHODS: Sixteen sinonasal cavities were administered fluorescein solution via NS and EDS before and after maxillary antrostomy and anterior ethmoidectomy, followed by nasal endoscopy of the NP and ET orifice. Seven blinded experts submitted staining ratings of endoscopy images on a 0- to 3-point scale, with ratings averaged for analysis. RESULTS: Interrater reliability was excellent (intraclass correlation, 0.956). EDS was associated with significantly greater NP staining vs. NS in a pooled cohort of nonsurgical and ESS specimens (1.19 ± 0.81 vs. 0.78 ± 1.06; p = 0.043). Using a logistic regression model, EDS significantly outperformed NS in nonsurgical (odds ratio [OR], 3.49; 95% confidence interval [CI], 1.21-10.09; p = 0.021) and post-ESS (OR, 9.00; 95% CI, 1.95-41.5; p = 0.005) specimens, with the greatest relative staining observed for EDS after targeted ESS (OR, 18.99; 95% CI, 3.44-104.85; p = 0.001). CONCLUSIONS: EDS is more effective than NS in topical delivery to the NP and ET orifices in cadavers. Targeted ESS may facilitate greater NP penetration by EDS compared with NS, with possible synergism after ESS for augmented delivery. These findings suggest a role for EDS delivery methods for ETD management and in CRS+ETD patients undergoing sinus surgery.

Contralateral Transmaxillary Approach to Petrous Apex Granuloma with Lateral Maxillotomy: 2-Dimensional Operative Video.

The endoscopic endonasal approach (EEA) has proven to be a valuable tool to access the petrous apex (PA).1 Although lesions located medial to the PA can be easily accessed through an EEA with minimal risk to the internal carotid artery (ICA), more laterally seated lesions represent a surgical challenge. The contralateral transmaxillary approach is an effective extension of the normal EEA to the PA, allowing a more lateral trajectory and thereby reducing the risks connected to paraclival ICA manipulation.2-4 This is a 47-year-old female presenting with tinnitus, hearing loss, and right facial twitching. The preoperative audiogram showed a 60 dB sensorineural hearing loss, and magnetic resonance imaging demonstrated an expansive lesion of the PA with high signal intensity in T1- and T2-weighted sequences. A high-riding jugular bulb ruled out the use of an infracochlear infralabyrinthine approach, and a middle cranial fossa approach was felt to render a high risk of recurrence due to the potential for incomplete resection. Ultimately, a contralateral transmaxillary approach was selected. Due to the extreme lateral position of the lesion, the maxillotomy was created in the lateral wall of the maxillary sinus to allow a coaxial approach to the PA. Postoperatively, the patient did not report new neurologic deficits. Anatomic pathology was consistent with cholesterol granuloma (Video 1). In the surgical management of PA granulomas, recognizing relevant anatomic structures such as the paraclival ICA, cochlea, jugular bulb, and vestibule preoperatively is of paramount importance to tailor the surgical approach and reduce its risks.

Demographic Disparities in the Federal Drug Approval Process for Allergic Rhinitis Medications.

OBJECTIVE: Demographic minorities are underrepresented in clinical trials. For the approval of new drug applications (NDAs), the Food and Drug Administration (FDA) has asserted that clinical trial enrollment should represent the demographics of patients likely to receive the trial drug. The aim of this study is to assess the demographics of clinical trials included in NDAs and biologics license applications (BLAs) approved by the FDA since 1990 for allergic rhinitis (AR), a condition whose demographic prevalence mirrors the US population. METHODS: Federal Freedom of Information Act requests were submitted to the US government to obtain documents related to all relevant NDAs and BLAs. The Drugs@FDA database was queried for all clinical trial documentation. Demographic data were extracted from clinical trials used to inform FDA approval for AR pharmacotherapies. Demographics were analyzed relative to national US Census data. RESULTS: Since 1990, 22 drugs have been approved for AR. The racial, ethnic, and sex composition of all included study populations differed significantly (p < 0.05) from the demographics of AR and from US Census data. Most NDAs and BLAs included overrepresentation of White participants and underrepresentation of Black, Asian, Pacific Island, Native American, and Hispanic participants. CONCLUSION: The patients enrolled in clinical trials used to inform FDA approval for AR pharmacotherapeutics do not represent the demographics of the United States or the demographics of AR. The clinical significance of unrepresentative demography between study and treatment populations has been examined for several medical disorders, but has not been studied for AR. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:755-763, 2023.

Exclusively endoscopic surgical resection of esthesioneuroblastoma: A systematic review.

Background: Historically sinonasal malignancies were always addressed via open craniofacial surgery for an oncologic resection. Increasingly esthesioneuroblastomas are excised using an exclusively endoscopic approach, however, the rarity of this disease limits the availability of long-term and large scale outcomes data. Objective: The primary objective is to evaluate the treatment modalities used and the overall survival of patients with esthesioneuroblastoma managed with exclusively endoscopic surgery. Methods: In accordance with PRISMA guidelines, PubMed was queried to identify studies describing outcomes associated with endoscopic management of esthesioneuroblastomas. Results: Forty-four out of 2462 articles met inclusion criteria, totaling 399 patients with esthesioneuroblastoma treated with an exclusively endoscopic approach. Seventy-two patients (18.0%) received adjuvant chemotherapy and 331 patients (83.0%) received postoperative radiation therapy. The average age was 50.6 years old (range 6-83). Of the 399 patients, 57 (16.6%) were Kadish stage A, 121 (35.2%) were Kadish stage B, 145 (42.2%) were Kadish stage C, and 21 (6.1%) were Kadish stage D. Pooled analysis demonstrated that 66.0% of patients had Hyams histologic Grade Ⅰ or Ⅱ, while 34.0% of patients had Grade Ⅲ or Ⅳ disease. Negative surgical margins were achieved in 86.9% of patients, and recurrence was identified in 10.3% of patients. Of those with 5-year follow-up, reported overall survival was 91.1%. Conclusion: Exclusively endoscopic surgery for esthesioneuroblastoma is performed for a wide range of disease stages and grades, and the majority of these patients are also treated with adjuvant chemotherapy or radiation therapy. Reported overall recurrence rate is 10.3% and 5-year survival is 91.1%.

Do Federal Regulations Affect Gender, Racial, and Ethnic Disparities in Chronic Rhinosinusitis Research?

OBJECTIVE: The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population. STUDY DESIGN: Cross-sectional study. SETTING: Not applicable. METHODS: ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data. RESULTS: Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females (P < .05). CONCLUSION: The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

The management of cystic fibrosis chronic rhinosinusitis: An evidenced-based review with recommendations.

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. In recognizing recent scientific advances and unique treatment modalities specific to this challenging patient population, in this review we systematically evaluate the scientific literature and provide 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: We evaluated the published literature on 5 unique topics. Each of the following therapeutic categories was investigated explicitly for 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.

Patterns of Facial Fractures in a Major Metropolitan Level 1 Trauma Center: A 10-year Experience.

OBJECTIVE/HYPOTHESIS: To report characteristics and management of facial fractures in a major metropolitan center within the United States. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective review at a level 1 trauma academic medical center of 3,946 facial fractures in 1,914 patients who presented from 2008 to 2017. Demographics, injury mechanism, associated injuries, and treatment information were collected. Logistic regression analyses were performed to determine factors associated with management. RESULTS: There were 1,280 males and 630 females with a median age of 42 years. Orbital fractures were the most common (41.4%) followed by maxilla fractures (21.9%). The most common mechanism was fall (43.6%). Surgical management was recommended for 38% of patients. The odds of surgical management were less for females (OR 0.59, 95% CI 0.48-0.73). Patients over 70 years were significantly less likely to undergo surgery compared to other age groups (OR 0.15-0.36, P < .001). The odds of surgical management were 1.69 times greater for patients with more than three fractures than for a single fracture (95% CI 1.18-2.42) and 2.23 times greater for traffic injuries compared to injuries from activities of daily living (95% CI 1.42-3.5). CONCLUSIONS: This represents one of the largest comprehensive databases of facial fractures. Our patients were most frequently injured during activities of daily living, most commonly from falls. The majority of patients were managed conservatively. Gender, age, fracture number, and mechanism of injury were independently associated with the decision to treat surgically. Our data are in stark contrast to that from other populations in which assault or motor vehicle accidents predominate. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2176-E2180, 2021.

Race in Rhinology Clinical Trials: A Decade of Disparity.

OBJECTIVE/HYPOTHESIS: The aim of this study is to assess the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data. STUDY DESIGN: Systematic Review and Population analysis. METHODS: A systematic review was performed to identify CRS clinical trials, conducted in the U.S. and published between 2010 and 2020 in which patients were prospectively enrolled. Pooled racial and ethnicity data were compared to national and corresponding regional census data. RESULTS: Eighty-three studies were included, comprising 12,027 patients. 50.4% were male and the average age was 49.2 years. 8,810 patients underwent a surgical procedure. Of the 12,027 patients, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% were classified as Other. The racial and ethnic composition of the pooled study population differs significantly from the national U.S. census data with the underrepresentation of each minority population (P ≤ .0002). Regional sub-analyses yield variable results. In the Northeast and West, there was an underrepresentation of all minority populations. In the South and Midwest, Black enrollment was similar to the U.S. census data, while all other minorities were underrepresented. CONCLUSIONS: The racial and ethnic composition of patients enrolled in prospective CRS clinical trials differs significantly from the demographics of the U.S. POPULATION: The generalizability and external validity of findings derived from studies comprised of demographically mismatched populations has not been established. Future efforts to enroll more representative populations should be emphasized by the research community, funding bodies, and editorial boards. LEVEL OF EVIDENCE: NA Laryngoscope, 131:1722-1728, 2021.

Effect of highly effective modulator therapy on quality of life in adults with cystic fibrosis.

BACKGROUND: Elexacaftor/tezacaftor/ivacaftor is a highly effective modulator that improves function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, resulting in improved pulmonary function in patients with cystic fibrosis (CF). We hypothesize that improvements in lung function are associated with improvements in health-related quality of life and sinonasal health. The aim of this study is to measure the effect of elexacaftor/tezacaftor/ivacaftor on patient-reported sinonasal and overall quality of life, and to determine the relationship between changes in these 2 outcome measures. METHODS: A prospective cohort study was conducted at an accredited adult CF care center. Participants completed the 22-item Sino-Nasal Outcome Test (SNOT-22) and the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a validated patient-reported outcome metric for CF patients, at baseline and at 3 months after initiation of elexacaftor/tezacaftor/ivacaftor. RESULTS: Forty-three individuals completed the study. There was significant improvement in nearly all domains of the SNOT-22 and CFQ-R after 3 months of therapy. SNOT-22 improved from 34.8 to 24.4 (p = 0.000003). Mean baseline FEV-1 improved from 65% to 76% predicted (p = 0.0000005). The greatest effect was seen in those participants previously taking modulator therapy. Linear regression between the change in SNOT-22 individual domains and the CFQ-R respiratory domain revealed the strongest correlation between the extranasal domain score and the respiratory domain of the CFQ-R (R2 = 0.24). CONCLUSION: CF patients taking elexacaftor/tezacaftor/ivacaftor experience a significant improvement in both sinonasal and health-related quality of life.

Zero-Degree Endoscopic Visualization of the Frontal Sinus Predicts Improved Topical Irrigation Delivery.

OBJECTIVE: Management of chronic frontal rhinosinusitis is challenging with high rates of treatment failure, exacerbated by limitations of topical irrigation delivery. We hypothesize that intraoperative zero-degree visualization of the frontal sinus predicts improved postoperative irrigation penetration. Extending a Draf IIa frontal sinusotomy with a limited resection of the middle turbinate axilla-agger nasi complex can allow zero-degree endoscopic visualization of the frontal sinus. This study investigates the change in frontal sinus irrigation delivery after standard Draf IIa frontal sinusotomy versus further resection to achieve zero-degree visualization. STUDY DESIGN: This is a prospective cohort study conducted in a surgical skills laboratory. METHODS: The extent of irrigant penetration into the frontal sinuses was evaluated in 10 cadaveric frontal sinuses following Draf IIa sinusotomy using a standardized trephine visualization model. Irrigant penetration was assessed by three blinded reviewers using the following scale: 0 = irrigation restricted to nasal cavity; 1 = irrigation reaches frontal recess; 2 = irrigation reaches frontal sinus proper; 3 = irrigation fills entire frontal sinus. These results were compared to irrigation after achieving zero-degree endoscopic visualization by performing limited resection of the middle turbinate axilla-agger nasi complex. RESULTS: Irrigant penetration following standard Draf IIa frontal sinusotomy improved after the axilla-agger nasi complex was resected to achieve zero-degree endoscopic visualization (median score 2 [interquartile range: 1-2] vs. 3 [interquartile range: 2-3], P < .01). CONCLUSION: This study demonstrates improved penetration of frontal sinus irrigation following limited resection of the middle turbinate axilla-agger nasi complex to achieve zero-degree endoscopic visualization of the frontal sinus as compared to standard Draf IIa frontal sinusotomy. LEVEL OF EVIDENCE: N/A Laryngoscope, 131:250-254, 2021.

Office-Based Sinus Surgery for Cystic Fibrosis Chronic Rhinosinusitis.

OBJECTIVE: Chronic rhinosinusitis (CRS) is nearly ubiquitous in the cystic fibrosis (CF) population, and many patients require multiple endoscopic sinus surgeries throughout their lifetime. Recent studies have demonstrated the profound pulmonary and systemic health benefits of comprehensive CRS treatment. Both endotracheal intubation with mechanical ventilation and inpatient hospital care represent significant risks for CF patients. The goal of this study is to evaluate the safety and feasibility of performing revision endoscopic sinus surgery for CF patients in the outpatient office setting using only local anesthesia to decrease the need for mechanical ventilation and inpatient hospitalization. METHODS: This is a prospective cohort study conducted at a tertiary care academic medical center with a CF Foundation-accredited care center. Patients with CF and refractory CRS despite prior surgery and medical therapy were eligible for inclusion. Comprehensive revision ESS was performed in the office using only local anesthesia. RESULTS: Five patients were enrolled and underwent revision endoscopic sinus surgery without complication. The average preoperative Sinonasal-Outcome Test-22 score was 52.0 ± 12.1 and the average preoperative Lund-Mackay score was 15.2 ± 3.8. No patients requested aborting the procedure early due to pain, discomfort, or any other reason. No subjects required prolonged observation or postoperative hospital admission. CONCLUSION: This prospective pilot study is the first to demonstrate the safety and feasibility of performing comprehensive revision endoscopic sinus surgery for CF patients in the outpatient office setting using only local anesthesia.

Olfactory outcomes in the management of aspirin exacerbated respiratory disease related chronic rhinosinusitis.

Patients with aspirin exacerbated respiratory disease (AERD) experience a severe and recalcitrant form of chronic rhinosinusitis with nasal polyposis (CRSwNP) and asthma, which are exacerbated by aspirin/NSAID ingestion. As compared with aspirin-tolerant CRSwNP, patients with AERD experience more severe olfactory dysfunction, which is one of the key contributors to the observed decrease in quality of life (QOL) in this disease. The objective of this paper is to review the published olfactory outcomes observed with various treatment modalities.

Gross Total Versus Subtotal Surgical Resection in the Management of Craniopharyngiomas.

Craniopharyngiomas (CP) are suprasellar tumors that can grow into vital nearby structures and thus cause significant visual, endocrine, and hypothalamic dysfunction. Debate persists as to the optimal treatment strategy for these benign lesions, particularly with regards to the extent of surgical resection. The goals of tumor resection are to eliminate the compressive effect of the tumor on surrounding structures and minimize recurrence. It remains unclear whether a gross total resection (GTR) or subtotal resection (STR) with adjuvant therapy confers a better prognosis. Chemotherapy and radiation therapy (RT) have been explored as both neoadjuvant and adjuvant treatments to decrease tumor burden and prevent recurrence. The objective of this paper is to review the risks and benefits of GTR versus STR, specifically with regard to risk of recurrence and postoperative morbidity. Aggregated data suggest that STR monotherapy is associated with higher rates of recurrence relative to GTR (50.6% ± 22.1% vs 20.2% ± 13.5%), while STR combined with RT leads to recurrence rates similar to GTR. However, both GTR and RT are independently associated with higher rates of comorbidities including panhypopituitarism, diabetes insipidus, and visual deficits. The treatment strategy for CPs should ultimately be tailored to each patient's individual tumor characteristics, risk, symptoms, and therapeutic goals.

The Nasoseptal Chondromucosal Flap: A Rigid Reconstructive Technique for Skull Base and Orbital Defects.

INTRODUCTION: The pedicled mucoperichondrial nasoseptal flap serves as the predominant reconstructive option for anterior skull base defects. Its use has also been described for repair of the lamina papyracea following orbital tumor removal. Large skull base or orbital defects may benefit from a more rigid reconstruction to reduce the risk of herniation of orbital or intracranial contents into the sinonasal cavity, which could result in enophthalmos, diplopia, or an encephalocele. OBJECTIVE: This study aims to test the feasibility of using a vascularized rigid composite nasoseptal chondromucosal flap for increased structural support in repairing skull base or orbital defects. METHODS: The study was conducted in a cadaver model in a surgical skills laboratory. RESULTS: We demonstrate a novel technique for harvesting and insetting a pedicled vascularized autologous rigid composite nasoseptal chondromucosal flap to repair both orbital and anterior skull base defects. The graft is harvested with intact mucosa, cartilage, and bilateral perichondrium to preserve a contiguous vascular supply. Confirmation of successful reconstruction is achieved via transcranial and transorbital access to visualize the graft from above. CONCLUSION: The cartilaginous support with associated perichondrium adds to the structural integrity of the reconstruction and may serve as an alternative to devascularized autologous grafts or synthetic materials, which may be particularly advantageous in patients with large defects or those requiring adjuvant radiation.

From Morbidity and Mortality to Quality Improvement: Effects of a Structured and Interactive Otolaryngology Conference.

OBJECTIVE: Measure the effects of a structured morbidity and mortality conference format on the attitudes of resident and faculty participants. STUDY DESIGN: Prospective cohort study. SETTING: Otorhinolaryngology-head and neck surgery residency training program. SUBJECTS AND METHODS: Two changes were implemented to the structure of our morbidity and mortality conference: (1) we adopted a recently described presentation framework called situation-background-assessment-recommendation and (2) appointed a faculty moderator to lead the conference. Surveys were distributed to residents and faculty before and after these modifications were implemented to measure changes in attitude of conference attendees. RESULTS: After implementing the above changes to the morbidity and mortality conference, participant engagement increased from "moderately engaged" to "extremely engaged" (P < .01). Among both faculty and residents, the perceived educational value of conference also improved from "moderately educational" to "extremely educational" (P < .01). Finally in the attending cohort, the impact on future patient care increased from "no change" to "greatly enhanced" (P < .01). CONCLUSION: By implementing the situation-background-assessment-recommendation framework and appointing a faculty moderator to morbidity and mortality conference, participants reported significantly enhanced engagement during the conference, increased educational value of the session, and a positive impact on future patient care.