Purpose: Assess if a rigid, image-guided balloon could be used effectively and safely in revision sinus surgery. Materials and methods: A prospective, non-randomized, single-arm, multicenter study to assess the safety and device performance of the NuVentTM EM Balloon Sinus Dilation System. Adults with CRS in need of revision sinus surgery were enrolled for balloon sinus dilation of a frontal, sphenoid, or maxillary sinus. The primary device performance endpoint was the ability of the device to (1) navigate to; and (2) dilate tissue in subjects with scarred, granulated, or previously surgically-altered tissue (revision). Safety outcomes included the assessment of any operative adverse events (AEs) directly attributable to the device or for which direct cause could not be determined. A follow-up endoscopy was conducted at 14 days post-treatment for assessment of any AEs. Performance outcomes included the surgeon's ability to reach the target sinus (es) and dilate the ostia. Endoscopic photos were captured for each treated sinus pre- and post-dilation. Results: At 6 US clinical sites, 51 subjects were enrolled; 1 subject withdrew before treatment due to a cardiac complication from anesthesia. 121 sinuses were treated in 50 subjects. The device performed as expected in 100 % of the 121 treated sinuses, with investigators able to navigate to the treatment area and dilate the sinus ostium without difficulty. Ten AEs were seen in 9 subjects, with 0 related to the device. Conclusion: The targeted frontal, maxillary or sphenoid sinus ostium were safely dilated in every revision subject treated, with no AEs directly attributed to the device.

Background A current challenge in osteoporosis is identifying patients at risk of bone fracture. Purpose To identify the machine learning classifiers that predict best osteoporotic bone fractures and, from the data, to highlight the imaging features and the anatomical regions that contribute most to prediction performance. Study Type Prospective (cross‐sectional) case–control study. Population Thirty‐two women with prior fragility bone fractures, of mean age = 61.6 and body mass index (BMI) = 22.7 kg/m 2 , and 60 women without fractures, of mean age = 62.3 and BMI = 21.4 kg/m 2 . Field Strength/ Sequence: 3D FLASH at 3T. Assessment Quantitative MRI outcomes by software algorithms. Mechanical and topological microstructural parameters of the trabecular bone were calculated for five femoral regions, and added to the vector of features together with bone mineral density measurement, fracture risk assessment tool (FRAX) score, and personal characteristics such as age, weight, and height. We fitted 15 classifiers using 200 randomized cross‐validation datasets. Statistical Tests: Data: Kolmogorov–Smirnov test for normality. Model Performance: sensitivity, specificity, precision, accuracy, F1‐test, receiver operating characteristic curve (ROC). Two‐sided t ‐test, with P < 0.05 for statistical significance. Results The top three performing classifiers are RUS‐boosted trees (in particular, performing best with head data, F1 = 0.64 ± 0.03), the logistic regression and the linear discriminant (both best with trochanteric datasets, F1 = 0.65 ± 0.03 and F1 = 0.67 ± 0.03, respectively). A permutation of these classifiers comprised the best three performers for four out of five anatomical datasets. After averaging across all the anatomical datasets, the score for the best performer, the boosted trees, was F1 = 0.63 ± 0.03 for All‐features dataset, F1 = 0.52 ± 0.05 for the no‐MRI dataset, and F1 = 0.48 ± 0.06 for the no‐FRAX dataset. Data Conclusion: Of many classifiers, the RUS‐boosted trees, the logistic regression, and the linear discriminant are best for predicting osteoporotic fracture. Both MRI and FRAX independently add value in identifying osteoporotic fractures. The femoral head, greater trochanter, and inter‐trochanter anatomical regions within the proximal femur yielded better F1‐scores for the best three classifiers. Level of Evidence: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;49:1029–1038.

Rhinoscopy became a formal field of study in the mid-nineteenth century as improvements in nasal specula were made and the potent vasoconstrictive effects of cocaine on the intranasal tissues were discovered. Since then, a multitude of advances in visualization and illumination have been made. The advent of the Storz-Hopkins endoscope in the mid-twentieth century represents a culmination of efforts spanning nearly 2 centuries, and illumination has evolved concomitantly. The future of endoscopic sinus surgery may integrate developing technologies, such as 3-dimensional endoscopy, augmented reality navigation systems, and robotic endoscope holders.

OBJECTIVE To investigate whether training otorhinolaryngology residents to criterion performance levels (proficiency) on the Endoscopic Sinus Surgery Simulator produces individuals whose performance in the operating room is at least equal to those who are trained by performing a fixed number of surgical procedures. DESIGN Prospective cohort. SETTING Two academic medical centers in New York City. PARTICIPANTS Otorhinolaryngology junior residents composed of 8 experimental subjects and 6 control subjects and 6 attending surgeons. INTERVENTION Experimental subjects achieved benchmark proficiency criteria on the Endoscopic Sinus Surgery Simulator; control subjects repeated the surgical procedure twice. MAIN OUTCOME MEASURES Residents completed validated objective tests to assess baseline abilities. All subjects were videotaped performing an initial standardized surgical procedure. Residents were videotaped performing a final surgery. Videotapes were assessed for metrics by an expert panel. RESULTS Attendings outperformed the residents in most parameters on the initial procedure. Experimental and attending groups outperformed controls in some parameters on the final procedure. There was no difference between resident groups in initial performance, but the experimental subjects outperformed the control subjects in navigation in the final procedure. Most important, there was no difference in final performance between subgroups of the experimental group on the basis of the number of trials needed to attain proficiency. CONCLUSIONS Simulator training can improve resident technical skills so that each individual attains a proficiency level, despite the existence of an intrinsic range of abilities. This proficiency level translates to at least equal, if not superior, operative performance compared with that of current conventional training with finite repetition of live surgical procedures.

Mycotoxins are toxic secondary metabolites produced by a variety of fungi including Aspergillus, Alternaria, and Penicillium species. The presence of mycotoxins in sinonasal tissue and secretions and any possible link to chronic rhinosinusitis (CRS) or other diseases of the head and neck have not been reported. The authors performed an exploratory study to determine the presence and levels of mycotoxins in the sinonasal tissue and secretions of 18 subjects undergoing endoscopic sinus surgery for CRS. Using commercial enzyme-linked immunosorbent assay kits, samples were analyzed for the following mycotoxins: aflatoxin, deoxynivalenol, zearalenone, ochratoxin, and fumonisin. All specimens were negative for aflatoxin, deoxynivalenol, zearalenone, and fumonisin. Four (22%) of 18 specimens were positive for ochratoxin. The clinical significance of this finding remains to be determined.

ObjectiveEstablish the feasibility of a predictive validity study in sinus surgery simulation training and demonstrate the effectiveness of the Endoscopic Sinus Surgery Simulator (ES3) as a training device.Study DesignProspective, multi‐institutional controlled trial.SettingFour tertiary academic centers with accredited otolaryngology‐head and neck surgery residency programs.SubjectsTwelve ES3‐trained novice residents were compared with 13 control novice residents.MethodsSubjects were assessed on the performance of basic sinus surgery tasks. Their first in vivo procedure was video recorded and submitted to a blinded panel of independent experts after the panel established a minimum inter‐rater reliability of 80 percent. The recordings were reviewed by using a standardized computer‐assisted method and customized metrics. Results were analyzed with the Mann‐Whitney U test. Internal rater consistency was verified with Pearson moment correlation.ResultsCompletion time was significantly shorter in the experimental group (injection P = 0.003, dissection P < 0.001), which, according to the rater panel, also demonstrated higher confidence (P = 0.009), demonstrated skill during instrument manipulation (P = 0.011), and made fewer technical mistakes during the injection task (P = 0.048) compared with the control group. The raters' post hoc internal consistency was deemed adequate (r > 0.5 between serial measurements).ConclusionThe validity of the ES3 as an effective surgical trainer was verified in multiple instances, including those not depending on subjective rater evaluations. The ES3 is one of the few virtual reality simulators with a comprehensive validation record. Advanced simulation technologies need more rapid implementation in otolaryngology training, as they present noteworthy potential for high‐quality surgical education while meeting the necessity of patient safety.

Objective: We report a case of allergic fungal sinusitis causing bone erosion and diplopia. Case report: A 43-year-old man presented with a four-month history of increased nasal congestion and progressive diplopia. Clinical examination revealed bilateral nasal polyposis and a right lateral gaze deficit, consistent with a VIth cranial nerve palsy. Computed tomography of the paranasal sinuses demonstrated a large sellar mass with extensive bony erosion and both supra- and infra-sellar extension. An endoscopic approach to the sphenoid sinus, clivus and posterior cranial fossa with image guidance was performed, enabling surgical treatment involving nasal polypectomy, wide marsupialisation of the sphenoid sinus and removal of the extensive allergic fungal mucin. The patient awoke from anaesthesia with complete resolution of his diplopia. Conclusion: Otolaryngologists should be aware that approximately 20 per cent of patients with allergic fungal sinusitis demonstrate paranasal sinus expansion and bone erosion involving surrounding anatomical structures. Such patients may have clinical findings involving the orbit and cranial vault.

Objective: This study aimed to investigate the utility of three-dimensional reconstructions of paranasal sinus computed tomography data in depicting the anatomy of the frontal sinus drainage pathway.Methods: Twenty-nine patients underwent imaging of the sinuses for various clinical indications. Variations in frontal sinus recess anatomy were determined from 0.75-mm thick coronal, axial and sagittal computed tomography images. Three-dimensional, reformatted images were generated from manually segmented volumes of interest. Observations were made on the variation and usefulness of these reconstructions.Results: Three-dimensional, reformatted images of segmented volumes aided delineation of the spatial relationships of the frontal sinus, frontal sinus drainage pathway, infundibular and meatal direction of drainage, agger nasi cells, ethmoid bulla cells, supraorbital cells, and suprabullar cells.Conclusion: Three-dimensional, reformatted images of frontonasal anatomy enable improved understanding of the frontal sinus drainage pathway anatomy and of the spatial relationships between ethmoid air cells in this region. Such images may provide a useful adjunct to surgical planning and education.

ObjectiveFlat panel cone beam CT is a relatively new technology that improves upon traditional multidetector CT scanners by generating images with greater spatial resolution at lower radiation doses. 1) Learn whether flat panel cone beam CT evaluation is an effective imaging modality for the sinuses. 2) Learn which doses of radiation provide quality evaluation of the sinuses while exposing the patient to the least amount of radiation.MethodsIn 2007, a panel consisting of neuroradiologists and otolaryngologists blindly reviewed images from flat panel sinus CTs (Xoran MiniCAT) of 11 live human subjects, each irradiated at all 3 different techniques (denoted as: low dose mAs=9.27, medium dose mAs = 18.41, high dose mAs=36.7) and rated the image quality of a pre‐designated list of sinus anatomic structures. Techniques were compared in a pairwise manner using a Wilcoxon matched‐pairs signed ranks test.ResultsCompared to the low dose technique CT scan, the high dose CT scan technique had significantly better image quality (P=.0029) and image noise (P=.0049). Similarly, the medium dose CT scan technique had significantly better image quality (P=.0020) and image noise (P =. 0010) compared to the low dose technique. No difference in image quality and image noise existed between the medium and high dose techniques. No difference in visualization of 13 specific anatomic structures existed between any of the dose techniques.ConclusionsLower dose CT techniques achieved by flat panel cone beam CT may be an effective and safe alternative to traditional multidetector CT scanners. This imaging modality may help patients avoid unnecessary radiation to sensitive organs.

With the availability of high-resolution computed tomography (CT), a great deal of attention has been paid to the anatomy of the paranasal sinuses. But while investigators have focused on the osteomeatal complex and its relation to chronic rhinosinusitis, there has been little discussion of the superior turbinate. Although a few anatomic studies have tried to quantify pneumatization of the superior turbinate, the prevalence of this finding on radiography is not well addressed in the literature. We prospectively studied 100 consecutively presenting patients who underwent coronal CT of the paranasal sinuses (200 sides) for the evaluation of symptoms of chronic rhinosinusitis at an academic tertiary referral center to determine the prevalence of pneumatization of the superior turbinate. We found evidence of pneumatization in 44 of the 200 sides, for a prevalence of 22%. In all, pneumatized superior turbinates were found in 27 patients (27%)-bilaterally in 17 (17%) and unilaterally in 10 (10%).

Objective/Hypothesis: The role of fungal pathogens in the etiology of nasal polyposis remains unclear. The aim of this study was to determine whether there was a correlation between the presence of Alternaria-specific immunoglobulin (Ig)E antibodies, eosinophilic inflammation, and the development of nasal polyps.Study Design: Prospective study.Methods: Serum and nasal tissue homogenates from 21 patients with manifestations of chronic sinusitis with nasal polyps were compared with specimens from 13 chronic sinusitis patients without polyps and 8 healthy controls. The Phadia ImmunoCAP and enzyme-linked immunosorbent assay were used to quantify levels of total IgE and Alternaria-specific (IgE, IgG, and IgA) antibodies. Eosinophil cationic protein (ECP) and tryptase levels were measured in tissue homogenates, whereas the inflammatory response was evaluated using tissue eosinophil counts in tissue samples.Results: Serum analysis revealed no difference in the levels of total IgE and Alternaria-specific IgE, IgG, and IgA antibodies between the study groups. In contrast, the levels of Alternaria-specific IgE in tissue with polyps were significantly higher than in nonpolyp tissue. Increases in total tissue IgE paralleled increased levels of Alternaria-specific IgG and IgA antibodies in chronic sinusitis with nasal polyps as compared with control groups. A positive correlation was found between Alternaria-specific IgE and ECP in tissue. Increased mean levels of ECP corresponded to increased eosinophil counts in the group of patients with polyps.Conclusions: Alternaria-specific IgE and eosinophilic inflammation in nasal tissue correlates with the incidence of nasal polyps irrespective of specific IgE antibodies in serum. Together, the correlation between the local immune responses and the eosinophilic inflammation in nasal polyps suggests a possible role of Alternaria in the pathogenesis of nasal polyposis.

RationaleTo elucidate role of fungal pathogens in the etiology of nasal polyposis, we have examined the relationship between the presence and level of Alternaria-specific IgE antibodies, eosinophilic inflammation and the development of nasal polyps (NP).MethodsSerum and nasal tissue homogenates from patients with chronic sinusitis and NP were compared to specimens from chronic sinusitis patients without polyps and healthy controls. Total IgE and Alternaria-specific (IgE, IgG, and IgA) antibodies were quantified in tissue homogenates and serum. Eosinophil cationic protein (ECP), tryptase levels and eosinophil numbers were also analyzed in tissues.ResultsThe level of Alternaria-specific IgE in nasal tissue containing polyps was significantly higher (p < 0.05) than in non-polyp tissues (0.71 kU/L vs. < 0.35 kU/L respectively). Increases in total tissue IgE antibody paralleled the increased levels of Alternaria-specific IgG and IgA antibodies in chronic sinusitis with NP as compared to both control groups. In contrast, no significant differences were detected in the levels of those antibodies in serum between the study groups. A positive correlation (r = 0.83, p < 0.005) was found between Alternaria-specific IgE and ECP in polyp tissue. Increased mean serum ECP levels correlated with increased eosinophil counts in patients with polyps.ConclusionsAlternaria-specific IgE and eosinophilic inflammation in nasal tissue correlates with the incidence of NP, irrespective of specific IgE antibodies levels in serum. The correlation between the localized humoral immune response and eosinophilic inflammation in NP suggests a possible role of Alternaria in the pathogenesis of nasal polyposis. RationaleTo elucidate role of fungal pathogens in the etiology of nasal polyposis, we have examined the relationship between the presence and level of Alternaria-specific IgE antibodies, eosinophilic inflammation and the development of nasal polyps (NP). To elucidate role of fungal pathogens in the etiology of nasal polyposis, we have examined the relationship between the presence and level of Alternaria-specific IgE antibodies, eosinophilic inflammation and the development of nasal polyps (NP). MethodsSerum and nasal tissue homogenates from patients with chronic sinusitis and NP were compared to specimens from chronic sinusitis patients without polyps and healthy controls. Total IgE and Alternaria-specific (IgE, IgG, and IgA) antibodies were quantified in tissue homogenates and serum. Eosinophil cationic protein (ECP), tryptase levels and eosinophil numbers were also analyzed in tissues. Serum and nasal tissue homogenates from patients with chronic sinusitis and NP were compared to specimens from chronic sinusitis patients without polyps and healthy controls. Total IgE and Alternaria-specific (IgE, IgG, and IgA) antibodies were quantified in tissue homogenates and serum. Eosinophil cationic protein (ECP), tryptase levels and eosinophil numbers were also analyzed in tissues. ResultsThe level of Alternaria-specific IgE in nasal tissue containing polyps was significantly higher (p < 0.05) than in non-polyp tissues (0.71 kU/L vs. < 0.35 kU/L respectively). Increases in total tissue IgE antibody paralleled the increased levels of Alternaria-specific IgG and IgA antibodies in chronic sinusitis with NP as compared to both control groups. In contrast, no significant differences were detected in the levels of those antibodies in serum between the study groups. A positive correlation (r = 0.83, p < 0.005) was found between Alternaria-specific IgE and ECP in polyp tissue. Increased mean serum ECP levels correlated with increased eosinophil counts in patients with polyps. The level of Alternaria-specific IgE in nasal tissue containing polyps was significantly higher (p < 0.05) than in non-polyp tissues (0.71 kU/L vs. < 0.35 kU/L respectively). Increases in total tissue IgE antibody paralleled the increased levels of Alternaria-specific IgG and IgA antibodies in chronic sinusitis with NP as compared to both control groups. In contrast, no significant differences were detected in the levels of those antibodies in serum between the study groups. A positive correlation (r = 0.83, p < 0.005) was found between Alternaria-specific IgE and ECP in polyp tissue. Increased mean serum ECP levels correlated with increased eosinophil counts in patients with polyps. ConclusionsAlternaria-specific IgE and eosinophilic inflammation in nasal tissue correlates with the incidence of NP, irrespective of specific IgE antibodies levels in serum. The correlation between the localized humoral immune response and eosinophilic inflammation in NP suggests a possible role of Alternaria in the pathogenesis of nasal polyposis. Alternaria-specific IgE and eosinophilic inflammation in nasal tissue correlates with the incidence of NP, irrespective of specific IgE antibodies levels in serum. The correlation between the localized humoral immune response and eosinophilic inflammation in NP suggests a possible role of Alternaria in the pathogenesis of nasal polyposis.

ObjectiveObstructive sleep apnea events are more common in REM sleep, although there is no relationship between sleep phase and pharyngeal airway status. We studied the patency of the nasal airway during REM and non‐REM sleep with the use of acoustic rhinometry.MethodsSerial acoustic rhinometric assessment of nasal cross‐sectional area was performed in 10 subjects, before sleep and during REM and non‐REM sleep. All measurements were standardized to a decongested baseline with mean congestion factor (MCF).ResultsMCF in the seated position was 10.6% (±3.7) and increased with supine positioning to 16.2% (±2.3). In REM sleep, MCF was highest, at 22.3% (±1.7). In non‐REM sleep, MCF was lowest, at 2.3% (±3.1). All interstage comparisons were statistically significant on repeated measures ANOVA (P < 0.05).ConclusionREM sleep is characterized by significant nasal congestion; non‐REM sleep, by profound decongestion. This phenomenon may be attributable to REM‐dependent variation in cerebral blood flow that affects nasal congestion via the internal carotid system. REM‐induced nasal congestion, an indirect effect of augmented cerebral perfusion, may contribute to the higher frequency of obstructive events in REM sleep.

OBJECTIVES To establish discriminant validity of the endoscopic sinus surgery simulator (ES3) (Lockheed Martin, Akron, Ohio) between various health care provider experience levels and to define benchmarking criteria for skills assessment. DESIGN Prospective multi-institutional comparison study. SETTING University-based tertiary care institution. PARTICIPANTS Ten expert otolaryngologists, 14 otolaryngology residents, and 10 medical students. INTERVENTIONS Subjects completed the ES3's virtual reality curriculum (10 novice mode, 10 intermediate mode, and 3 advanced mode trials). Performance scores were recorded on each trial. Performance differences were analyzed using analysis of variance for repeated measures (experience level as between-subjects factor). MAIN OUTCOME MEASURES Simulator performance scores, accuracy, time to completion, and hazard disruption. RESULTS The novice mode accurately distinguished the 3 groups, particularly at the onset of training (mean scores: senior otolaryngologists, 66.0; residents, 42.7; students, 18.3; for the paired comparisons between groups 1 and 2 and groups 1 and 3, P = .04 and .03, respectively). Subjects were not distinguished beyond trial 5. The intermediate mode only discriminated students from other subjects (P = .008). The advanced mode did not show performance differences between groups. Scores on the novice mode predicted those on the intermediate mode, which predicted advanced mode scores (r = 0.687), but no relationship was found between novice and advanced scores. All groups performed equally well and with comparable consistency at the outset of training. Expert scores were used to define benchmark criteria of optimal performance. CONCLUSIONS This study completes the construct validity assessment of the ES3 by demonstrating its discriminant capabilities. It establishes expert surgeon benchmark performance criteria and shows that the ES3 can train novice subjects to attain those. The refined analysis of trial performance scores could serve educational and skills assessment purposes. Current studies are evaluating the transfer of surgical skills acquired on the ES3 to the operating room (predictive validity).

Background Nasal continuous positive airway pressure (nCPAP) is usually the first-line intervention for obstructive sleep apnea, but up to 50% of patients are unable to tolerate therapy because of discomfort–-usually nasal complaints. No factors have been definitively correlated with nCPAP tolerance, although nasal cross-sectional area has been correlated with the level of CPAP pressure, and nasal surgery improves nCPAP compliance. This study examined the relationship between nasal cross-sectional area and nCPAP tolerance. Methods We performed acoustic rhinometry on 34 obstructive sleep apnea patients at the time of the initial sleep study. Patients titrated to nCPAP were interviewed 18 months after starting therapy to determine CPAP tolerance. Demographic, polysomnographic, and nasal cross-sectional area data were compared between CPAP-tolerant and -intolerant patients. Results Between 13 tolerant and 12 intolerant patients, there were no significant differences in age, gender, body mass index, CPAP level, respiratory disturbance index, or subjective nasal obstruction. Cross-sectional area at the inferior turbinate differed significantly between the two groups (p = 0.03). This remained significant after multivariate analysis for possibly confounding variables. A cross-sectional area cutoff of 0.6 cm2 at the head of the inferior turbinate carried a sensitivity of 75% and specificity of 77% for CPAP intolerance in this patient group. Conclusion Nasal airway obstruction correlated with CPAP tolerance, supporting an important role for the nose in CPAP, and providing a physiological basis for improved CPAP compliance after nasal surgery. Objective nasal evaluation, but not the subjective report of nasal obstruction, may be helpful in the management of these patients.

BACKGROUND:The relationship between nasal airway function and sleep-disordered breathing (SDB) remains unclear. Although correction of nasal obstruction can significantly improve nighttime breathing in some patients, nasal obstruction may not play a role in all cases of SDB. An effective method of stratifying these patients is needed. Acoustic rhinometry (AR) is a reliable, noninvasive method of measuring the dimensions of the nasal airway.METHODS:In 44 patients, we performed acoustic rhinometric measurements of nasal airway cross-sectional area, followed by hospital-based polysomnography and nasal continuous positive airway pressure (nCPAP) level titration. We compared anatomic nasal obstruction to perceived nasal obstruction, as well as respiratory distress index and nCPAP titration level, using the Pearson correlation and multiple linear regression analysis within body mass index groups.RESULTS:Perceived nasal obstruction correlated significantly with objective anatomic obstruction as measured by AR (r = 0.45, p < 0.01). For certain subgroup analyses in patients with a body mass index below 25, AR measurements correlated significantly with both nCPAP titration pressure (r = 0.85, p < 0.01) and respiratory distress index (r = 0.67, p = 0,03).CONCLUSION:Nasal airway function may be a significant component of SDB in some patients, perhaps playing a larger role in patients who are not overweight. The best responders to nasal surgery for SDB may be nonoverweight patients with nasal obstruction. AR along with nasal examination may be helpful in the evaluation and treatment of the SDB patient.