Long-term outcomes following impedance-controlled radiofrequency ablation for the treatment of chronic rhinitis.

Objective: To assess long-term safety and effectiveness of a multipoint, impedance-controlled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up. Methods: A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events. Results: Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study. Conclusions: Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.

Objective: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods: A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results: Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post-procedure. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

Preservation of natural frontal sinus outflow in the management of frontal sinus osteomas.

INTRODUCTION: Management of frontal sinus tumors has traditionally been through open approaches with obliteration of the sinus. Recently, increased comfort with endoscopic techniques has made endoscopic resection an alternative to more morbid approaches. However, many skilled endoscopists still champion obliteration of the frontal sinus after the open treatment of large osteomas. METHODS: A retrospective review of the senior author's experience with frontal sinus osteomas was performed. RESULTS: Twelve frontal sinus osteomas were treated surgically without obliteration. All patients with greater than 2 cm vertical extension of their tumor into the frontal sinus required an open approach (n = 4), whereas the remainder (n = 8) were treated endoscopically. Frontal ostia were stented if greater that 40% of the mucosa of the frontal recess was denuded. Eleven of 12 patients had patent, functional frontal sinuses. CONCLUSION: Successful resection of frontal sinus osteomas can be performed with preservation of the natural drainage of the frontal sinus in almost all cases. EBM RATING: C-4.

Stereotactic computer assisted navigation: state of the art for sinus surgery, not standard of care.

There are circumstances in which image guidance is clearly useful to facilitate a more complete operation. By confirming the identity of known anatomic structures, a knowledgeable surgeon's understanding of the disease process can improve and only the necessary structures removed. CT guidance is a clear aid to understanding altered anatomy when combined with a thorough analysis of the preoperative CT scan and office nasal endoscopy. It is the combination of this preoperative planning with image guidance that allows a skilled surgeon to operate with confidence. This discussion intentionally did not refer to image guidance as the standard of care, because although this technology is clearly useful, valuable, and helpful in confirming anatomy and performing many procedures, it is not always necessary in achieving a complete operation. Therefore, it should not be considered the standard of care.

Precursor B-cell lymphoblastic lymphoma presenting as an isolated external ear swelling in a two-year-old child.

The incidence of lymphoma in children is increasing in the United States and is the third most common childhood cancer. The head and neck is second only to the abdomen as the most common site of extranodal presentations of non-Hodgkin's lymphoma (NHL). We present and discuss the diagnosis and management of the first report of a child with an auricular mass as the sole manifestation of B-cell non-Hodgkin's lymphoma. In summary, the otolaryngologist and pediatrician should be cognizant of potential for NHL in atypical lesions of the head and neck in children.

Computed tomography's ability to predict sacrifice of hypoglossal nerve at resection.

OBJECTIVE: To assess whether preoperative computed tomography (CT) scan can determine if the hypoglossal nerve (cranial nerve XII) will be sacrificed in floor-of-mouth, oral tongue, and tongue base tumor resections. STUDY DESIGN: Retrospective review. METHODS: Patients who underwent resection of floor-of-mouth, oral tongue, and tongue base tumors from 1990 to 1999 were identified. Preoperative CT scans were reviewed by a neuroradiologist. The postoperative status of cranial nerve XII was predicted to be "saved" or "sacrificed." Hypoglossal nerve "sacrifice" was predicted if the fat planes surrounding the takeoff of the proximal lingual artery were obliterated by tumor. The nerve was determined to be sacrificed or spared during resection by review of the operative report. RESULTS: Of the 45 patients, 14 tumors were predicted radiographically to involve the hypoglossal nerve. Twenty-seven of 31 nerves that were predicted to be saved were saved at the time of surgery. Seven of 14 nerves that were predicted to be sacrificed were sacrificed at the time of surgery. The sensitivity was 0.64 (95% confidence interval [CI], 0.35-0.86) with a specificity of 0.79 (95% CI, 0.70-0.87). The positive predictive value was 0.50 (95% CI, 0.27-0.68) with a negative predictive value of 0.87 (95% CI, 0.77-0.95). CONCLUSIONS: The ability to predict preoperatively whether a tumor can be resected without sacrificing the hypoglossal nerve would be an important factor in determining management of these tumors. The results indicate that CT scan accurately predicts the ability of the surgeon to spare the hypoglossal nerve (negative predictive value, 87%) with a specificity of 0.79.

The role of soluble interleukin-4 receptor and interleukin-5 antibody in preventing late-phase allergy-induced eustachian tube dysfunction.

OBJECTIVES: We investigated the role of soluble interleukin (IL)-4 receptors (sIL-4R) and IL-5 antibodies (IL-5Ab) in preventing allergic eustachian tube dysfunction (ETD) and middle ear effusion (MEE). STUDY DESIGN: Brown-Norway rats were sensitized to ovalbumin (OVA) and challenged transtympanically. Two groups of rats received either IL-4R or IL-5Ab transtympanically 1 hour before challenge. Three additional groups were used as controls. Following the second transtympanic challenge, the ventilatory and clearance functions of the eustachian tube (ET) were assessed at 0, 2, and 8 hours. Histology was prepared using cut paraffin sections stained with hematoxylin and eosin. RESULTS: sIL-4R-pretreated rats showed no significant changes in ventilatory or clearance functions of the ET or inflammatory changes in ET mucosa, whereas IL-5Ab pretreatment showed significant late ventilatory and clearance dysfunction as well as inflammatory mucosal changes. CONCLUSION: These data demonstrate that the late-phase allergic inflammatory response that leads to subsequent formation of ETD and MEE is prevented by pretreatment with sIL-4R and, more modestly, with IL-5Ab.

Eustachian tube dysfunction after tobacco smoke exposure.

OBJECTIVE: To examine the effects of tobacco smoke exposure on eustachian tube (ET) function. STUDY DESIGN: ET pressures of Sprague Dawley Rats (n = 16) were measured after 1, 7, and 15 exposures and in control animals. Passive opening pressure, passive closing pressure, active clearance of positive pressure, and active clearance of negative pressure were measured. Mucociliary clearance times were also quantified (n = 32). RESULTS: Passive opening and passive closing pressures of smoke-exposed animals were greater than controls (P < 0.05). Passive opening pressure in smoke-exposed animals increased with increasing exposure (P < 0.001). Animals with 1 exposure had an active clearance of positive pressure higher than controls (P = 0.005) and those with 7 and 15 exposures had more negative active clearance of negative pressure than controls (P = 0.002, 0.03) Mucociliary clearance time was significantly elevated in experimental animals with 7 exposures (P = 0.006). CONCLUSIONS: Alterations in ET function exist in animals exposed to tobacco smoke. SIGNIFICANCE: ET dysfunction after tobacco smoke exposure may predispose children to the development of otitis media.

The limitations of isolated palatal surgery for patients with obstructive sleep apnea.

Obstructive sleep apnea is a condition for which palatal surgery in isolation has been shown to have limited success. In comparison, palatal procedures combined with other surgical approaches that address the multiple sites of obstruction in the upper aerodigestive tract seem to have improved success in the carefully selected patient.

Effect of intranasal histamine challenge on Eustachian tube function.

OBJECTIVE: To show a relationship between intranasal histamine challenge, the development of middle ear effusion and Eustachian tube (ET) dysfunction in a rat model. METHODS: Non-allergic Sprague-Dawley rats weighing between 450-600 g were randomly assigned to receive an intranasal infusion of 16 microl of 10% histamine or normal saline. ET function was assessed by using the forced-response test to measure passive and active opening and closing pressures at time intervals of 6, 10, 14, 18, 22, and 26 min and 24 h post-infusion. Mucociliary clearance times (MCCTs) of the tubotympanum at 18 min post-infusion were measured by timing the transit of dye from the middle ear to the nasopharynx. Outcome measures were ET dysfunction and evidence of clinical effusion. RESULTS: Intranasal histamine caused acute ET dysfunction when introduced into the nasopharynx demonstrated by significant elevations in passive and active opening and closing pressures (P < or = 0.001) compared to controls. The largest difference was seen at 26 min post-infusion. Furthermore, MCCTs were 2.4 times longer after infusing intranasal histamine than after saline infusion. No clinically significant effusions were evident in either group at any time interval. CONCLUSION: These data demonstrate a successful development of an intranasal histamine rat model, in addition to a relationship between intranasal histamine challenge and development of acute ET dysfunction.

Treatment of chronic maxillary atelectasis using balloon dilation.

Balloon dilation may offer a more expedient and cost-effective treatment method compared with traditional endoscopic sinus surgery for chronic maxillary atelectasis. We sought to demonstrate the feasibility of balloon dilation of the maxillary os as a treatment modality for patients with chronic maxillary atelectasis by investigating the short-term outcomes in a retrospective case series of 4 patients representing 5 sinuses treated between 2011 and 2013. All sinuses were successfully balloon dilated without complications. Follow-up ranged from 1 week to 4 months. Aeration of the treated sinuses without restenosis was confirmed by postoperative endoscopy, sinus computed tomography, or both. All patients reported subjective symptomatic improvement. Balloon dilation of the maxillary os may be a feasible treatment option for maxillary sinus atelectasis. Longer follow-up and a larger study sample will be needed to validate the safety of this technique and determine the rate of restenosis.

Radiographic resolution of chronic rhinosinusitis without polyposis after 6 weeks vs 3 weeks of oral antibiotics.

BACKGROUND: Maximal medical therapy is poorly defined in chronic sinusitis treatment. OBJECTIVE: To objectively evaluate the radiographic response of chronic rhinosinusitis without polyposis after 3 and 6 weeks of oral antibiotics. METHODS: Thirty-five patients with confirmed chronic sinusitis without polyposis (disease apparent on initial computed tomography [CT] with appropriate symptom duration) were prescribed 6 weeks of antibiotics. When possible, culture-directed antibiotics were used; otherwise clindamycin was used empirically. A CT was performed after 3 and 6 weeks of therapy. CTs were then graded by the Lund-Mackay system. Demographic data were reviewed. RESULTS: Of the 35 patients, 16 underwent all 3 CT scans and completed all 6 weeks of antibiotics. Three patients completed only 3 weeks of antibiotics, and 16 did not undergo the interval 3-week CT. Six patients (38%) had statistically significant improvement in their CT scans between weeks 3 and 6. In this subset of patients who improved, 37% of their overall radiographic improvement occurred in the 3- to 6-week treatment interval. No prognostic variables predicted which patients would radiographically improve after 3 weeks of antibiotics. CONCLUSION: Some patients achieve radiographic improvement and disease resolution after the completion of a 3-week course of antibiotics. Therefore, maximal medical therapy for chronic sinusitis may consist of longer than 3 weeks of therapy to ensure maximal benefit.

American Rhinologic Society member survey on "maximal medical therapy" for chronic rhinosinusitis.

BACKGROUND: "Maximal medical therapy" is the standard of care for chronic rhinosinusitis (CRS) treatment before the recommendation for surgery. However, this therapy is not consistent. Therefore, as a first step in determining the role of the disparate "maximal medical" treatments for CRS, American Rhinologic Society (ARS) members were surveyed. METHODS: A survey was mailed to all nonresident members of the ARS (n=723). Focusing on the time period before surgical intervention is first considered for CRS patients, the survey assessed types of therapies, frequency of use, details on antibiotic and steroid usage, use of computed tomography (CT), and demographic data of respondents. All responses were anonymous. RESULTS: Three hundred eight surveys were returned (43%). A majority of respondents used oral antibiotics and nasal steroids "almost always (>90%)". Oral antibiotics, oral steroids, nasal steroids, saline irrigation, and allergy testing were most commonly used at least "usually (50-90%)". The median antibiotic length was 3.1-4 weeks. The mean peak prednisone dose was 51.7 mg when oral steroids were used. Therapies that were rarely or never used by the majority included oral antifungals, antifungal spray, antibiotic spray, antibiotic nebulizer, steroid nebulizer, and i.v. antibiotics. CONCLUSION: Oral antibiotics (median, 3.1-4 weeks) and nasal steroids are used >90% of the time by a majority of ARS members for maximal medical treatment of CRS.

Sinonasal epithelial cell expression of toll-like receptor 9 is decreased in chronic rhinosinusitis with polyps.

BACKGROUND: Innate immune recognition of pathogens by sinonasal epithelial cells may play an important role in the pathogenesis of chronic rhinosinusitis (CRS). Previous studies have indicated that toll-like receptor (TLR) mRNA is present in sinonasal mucosa, and levels of TLR9 expression are decreased in recalcitrant CRS with nasal polyps (CRSwNP). However, the cellular source and function of TLR9 in the sinonasal epithelium is not known. In this study, primary epithelial cell cultures were analyzed from control subjects and CRSwNP patients to determine the presence and function of TLR9 protein. METHODS: Primary epithelial cell cultures were established from 5 controls and 10 CRSwNP patients undergoing sinus surgery. Flow cytometry was used to confirm purity of epithelial cells and to assess expression of TLR9 protein. Epithelial cells were stimulated with TLR9 agonist, and mRNA was analyzed by real-time PCR for expression of human beta-defensin (HBD) 2 and interleukin (IL)-8. RESULTS: Flow cytometry showed TLR9 protein in 100% of epithelial cells from controls and CRSwNP patients. The level of expression was 50% lower in CRS patients than in controls. Stimulation of epithelial cells with TLR9 agonist produced a 1.5- to 9-fold increase in HBD-2 and IL-8 mRNA expression. CONCLUSION: Functional TLR9 protein is expressed by normal and diseased sinonasal epithelial cells. The level of TLR9 expression is decreased in CRSwNP patients, consistent with the previous finding of decreased TLR9 mRNA in whole sinonasal tissue. These findings suggest that impaired innate immune responses to pathogens via TLR9 on sinonasal epithelial cells may represent a critical mechanism in chronic inflammatory sinus disease.

Analysis of methods to assess frontal sinus extent in osteoplastic flap surgery: transillumination versus 6-ft Caldwell versus image guidance.

BACKGROUND: The aim of this study was to compare three common methods (transillumination, plain radiographs, and computerized tomography [CT] image guidance) for estimating the position and extent of pneumatization of the frontal sinus in osteoplastic flap surgery. METHODS: Axial CT scans and 6-ft Caldwell radiographs were performed on 10 cadaver heads. For each head, soft tissue overlying the frontal bone was raised and the anticipated position and extent of the frontal sinus at four points was marked using three common methods. The silhouette of the frontal sinus from the Caldwell plain radiograph was excised and placed in position. Four points at the periphery also were made using information obtained from a passive optically guided image-guided surgery device, and transillumination via a frontal trephination also was used to estimate sinus extent. The true sinus size was measured at each point and compared with experimental values. RESULTS: The use of CT image guidance generated the least difference between measured and actual values (mean = 1.91 mm; SEM = 0.29); this method was found statistically superior to Caldwell (p = 0.040) and transillumination (p = 0.007). Image guidance did not overestimate the size of the sinus (0/36) and was quicker than the Caldwell approach (8.5 versus 11.5 minutes). There was no learning curve appreciated with image guidance. CONCLUSION: Accurate and precise estimation of the position and extent of the frontal sinus is crucial when performing osteoplastic flap surgery. Use of CT image guidance was statistically superior to Caldwell and transillumination methods and proved to be safe, reproducible, economic, and easy to learn.

Endoscopically guided aerobic cultures in postsurgical patients with chronic rhinosinusitis.

BACKGROUND: There is considerable amount of debate in the literature regarding the microbial flora of normal, acutely infected, and chronically infected paranasal sinuses. Few studies have specifically looked at the microbial flora of healthy and infected sinus cavities after functional endoscopic sinus surgery. METHODS: One hundred thirty-four cultures were studied. All cultures were obtained using a standard technique. The nasal cavities were decongested and anesthetized, and nasal endoscopy was performed. When purulent secretions were identified, specimens of purulent secretions were obtained for incubation. Sensitivities were tested according to microorganisms identified. Empiric therapy generally consisted of afluoroquinolone, amoxicillin/clavulanate, or a later-generation cephalosporin, and adjustment in individual instances when appropriate. RESULTS: Twelve cultures showed no growth, 86 grew a single microorganism, and 35 grew two or more microorganisms for a total of 151 microorganisms identified. The most common microorganisms were Staphylococcus aureus, coagulase-negative staphylococci, and Pseudomonas aeruginosa. Other organisms that were cultured <5% of the time included Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, Serratia liquefaciens, Stenotrophomonas (Xanthomonas) maltophilia, alcaligenes, Fusobacterium, Escherichia coli, diphtheroids, Acinetobacter species, Klebsiella species, skin flora, and mixed Gram-negative and Gram-positives. CONCLUSION: Endoscopically guided aerobic cultures in postsurgical patients with acute exacerbations of chronic rhinosinusitis most commonly grew S. aureus, coagulase-negative staphylococci, and pseudomonal species. These cultures altered antibiotic treatment management decisions in a significant number of cases regardless of patients' clinical characteristics or history of previous culture.

Increased role of the otolaryngologist in endoscopic pituitary surgery: endoscopic hydroscopy of the sella.

BACKGROUND: The aim of this study was to discuss the use of nasal irrigation and suction systems in endoscopic pituitary surgery to examine the sella and facilitate tumor removal. We describe a new technique of sellar exploration. METHODS: Following the endoscopic approach to the pituitary by the otolaryngology team, pituitary masses are resected. Then, the ClearESS nasal irrigation and suction system is used by the otolaryngology team to visualize the sella ("hydroscopy"). The combination of this ClearESS technology and angled endoscopes is used to scrutinize previously inaccessible areas of the tumor bed. RESULTS: Over 50 patients have undergone minimally invasive pituitary surgery via the endoscopic approach with postresection hydroscopy of the sella. The use of angled endoscopes in combination with the ClearESS technology greatly increased visualization of the sella, thereby facilitating complete tumor removal. There have been no complications associated with the use of hydroscopy. CONCLUSION: The use of angled endoscopes in conjunction with hydroscopy increases visualization of the sella. The otolaryngologist plays a critical role in this examination with manipulation of the angled endoscopes. Therefore, the role of the otolaryngologist is extended beyond the approach to the pituitary.