Image guided dilation of sinus ostium in revision sinus surgery.

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 NuVent™ 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.

Flat panel cone beam computed tomography of the sinuses.

OBJECTIVE: This study aims to compare the image quality and potential diagnostic accuracy of paranasal sinus CT scans generated by flat panel cone beam CT at three specific data acquisition times. STUDY DESIGN: Prospective, single blinded analysis. SUBJECTS AND METHODS: Eleven patients without previous radiologic evaluation were selected based on history and findings suspicious for chronic sinusitis. Each patient was scanned at three different acquisition times: 10, 20, and 40 seconds. A panel of neuroradiologists and otolaryngologists, blinded to the scan acquisition time, individually reviewed images and rated overall image quality and visualization of specific anatomic sites. Image noise values were also calculated. Techniques were compared with a Wilcoxon matched-pairs signed ranks test. RESULTS: Compared to the 10-second acquisition time, the 40- and 20-second acquisition time techniques had significantly better image quality (P < 0.05) and image noise (P < 0.05). No difference in image quality and image noise existed between the 20- and 40-second techniques. No difference in visualization of specific anatomic structures existed between any of the time techniques. CONCLUSION: The quality of flat panel CT imaging of the sinuses directly relates to scan time and thus radiation dose.

Role of local immunoglobulin E specific for Alternaria alternata in the pathogenesis of nasal polyposis.

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.

REM-associated nasal obstruction: a study with acoustic rhinometry during sleep.

OBJECTIVE: Obstructive 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. METHODS: Serial 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). RESULTS: MCF 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). CONCLUSION: REM 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.

Construct validity of the endoscopic sinus surgery simulator: II. Assessment of discriminant validity and expert benchmarking.

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).

Evolution in Visualization for Sinus and Skull Base Surgery: From Headlight to Endoscope.

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.

Accuracy and cost analysis of image-guided sinus surgery.

The use of image guidance in FESS has become widespread over the past several years. Numerous studies involving large numbers of patients illustrate the accuracy of these systems. In addition, case reports concerning patients who have extensive sinonasal neoplasms or distorted anatomy serve to demonstrate the usefulness of IGS. Studies by Metson et al [22] and Fried et al [23] have also investigated the surgeons' opinions of IGS. The vast majority of sinus surgeons have been pleased with the systems' ease of use and accuracy. Increased confidence in precisely localizing anatomical structures was the primary benefit. The major drawback to using image-guided systems was the increased operative time. Despite this, almost all surgeons who were questioned reported that they expect to increase their use of IGS in the future. By giving the surgeon real-time localization of surgical instruments, IGS could result in safer and more thorough surgery. This effect could have major implications for difficult surgeries in which distorted anatomy or extensive disease might otherwise result in incomplete eradication of the disease process. Studies examining these issues are necessary before a final conclusion can be drawn as to whether the accuracy achieved with current systems is truly beneficial and the cost is worth incurring.

Isolation of fungi by standard laboratory methods in patients with chronic rhinosinusitis.

OBJECTIVES/HYPOTHESIS: Allergic fungal sinusitis and the role of fungi in the pathogenesis of chronic rhinosinusitis are topics of interest and controversy in rhinology. The classification of chronic rhinosinusitis as either a bacterial infection or an allergic (eosinophilic) reaction to fungi has significant implications for treatment of this disease process. We designed a study to determine whether standard isolation techniques, as employed in a university hospital mycology laboratory, could isolate and identify fungi in the intraoperative specimens from patients undergoing functional endoscopic sinus surgery for chronic rhinosinusitis. STUDY DESIGN: Forty-five random patients with a diagnosis of chronic rhinosinusitis by clinical and computed tomography criteria underwent endoscopic sinus surgery during 2001, performed by two senior surgeons (J.B.J., R.A.L.). Specimens of mucin, sinus secretions, and/or tissue were obtained intraoperatively and sent to the New York University Medical Center (New York, NY) mycology laboratory for isolation and identification of fungi. METHODS: Specimens were treated with Sputolysin and chloramphenicol; plated on Sabouraud, ChromAgar/Candida, Mycosel, and Niger seed agar plates; and incubated at 30 degrees C (or 37 degrees C) for up to 1 month. RESULTS: We were able to demonstrate the presence of fungi in 56% of intraoperative specimens obtained from patients undergoing surgery for chronic rhinosinusitis. CONCLUSIONS: Using a standard hospital mycology laboratory protocol, which is relatively inexpensive and readily available, fungus can be isolated from a majority of patients undergoing functional endoscopic sinus surgery for chronic rhinosinusitis. Educational statement: Discuss the possible role of fungus in chronic rhinosinusitis and evaluate the efficacy of documenting the presence of fungus in a routine fashion to encourage clinically relevant directed treatments.)

Criterion-based (proficiency) training to improve surgical performance.

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.

Measurement of mycotoxins in patients with chronic rhinosinusitis.

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.

From virtual reality to the operating room: the endoscopic sinus surgery simulator experiment.

OBJECTIVE: Establish 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 DESIGN: Prospective, multi-institutional controlled trial. SETTING: Four tertiary academic centers with accredited otolaryngology-head and neck surgery residency programs. SUBJECTS: Twelve ES3-trained novice residents were compared with 13 control novice residents. METHODS: Subjects 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. RESULTS: Completion 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). CONCLUSION: The 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.

Superior turbinate pneumatization in patients with chronic rhinosinusitis: prevalence on paranasal sinus CT.

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%).

Acoustic rhinometry predicts tolerance of nasal continuous positive airway pressure: a pilot study.

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.

Nasal obstruction and sleep-disordered breathing: a study using acoustic rhinometry.

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.

Utility of sagittal reformatted computerized tomographic images in the evaluation of the frontal sinus outflow tract.

BACKGROUND: Anatomic and mucosal obstruction of the frontal sinus outflow tract (FSOT) can result in frontal sinusitis often associated with frontal headache. Thorough evaluation of symptomatic patients requires axial and coronal computerized tomographic (CT) scans of the paranasal sinuses (PNS). With the advent of multichannel multidetector CT scanning, the availability of high-quality sagittal images has become increasingly widespread. However, the utility of these images in the assessment of FSOT patency has not yet been established. METHODS: A retrospective review of coronal and sagittal images from 25 PNS CT scans (50 sides) were randomized, blinded, and independently evaluated by two neuroradiologists. FSOT obstruction by agger nasi cells, the ethmoid bulla, and mucosal disease was assessed. A degree of confidence was rendered for each of these findings. The results were then compared against a consensus diagnosis, which was rendered based upon simultaneous reading of the coronal and sagittal images. Generalized estimating equations were used to assess the difference between sagittal and coronal images in terms of reader confidence and diagnostic concordance with the consensus. RESULTS: Review of sagittal images had a higher degree of concordance with the consensus than did coronal images, and was highest for mucosal disease. Both readers were more confident in rendering a diagnosis based upon the sagittal images. CONCLUSION: Sagittal reformatted CT images of the PNS are helpful in the radiologic evaluation of the FSOT. Experienced neuroradiologists had a higher degree of confidence in the diagnosis of the obstruction of the FSOT using sagittal reformatted images.