Efficacy of the exhalation delivery system with fluticasone in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery.

BACKGROUND: Sinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE® ) uses a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that significantly alter the deposition of the topically acting anti-inflammatory medication. We ask whether EDS-FLU efficacy differs for patients with recurrent symptoms after sinus surgery versus patients without surgery. OBJECTIVE: We aimed to compare EDS-FLU treatment responses in patients with recurrent symptoms after endoscopic sinus surgery (ESS) and patients who have never had sinus surgery. METHODS: Data were pooled from two large, controlled trials (NAVIGATE I and II) for exploratory analyses. Chronic rhinosinusitis symptoms, polyp grade, and quality-of-life measures were compared between patients with prior ESS and those without prior ESS. RESULTS: Patients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU 186 µg [n = 52], and EDS-FLU 372 µg [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 µg [n = 108], and EDS-FLU 372 µg [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose. CONCLUSIONS: Patients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality-of-life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (two sprays per nostril twice a day).

International consensus statement on allergy and rhinology: Olfaction.

BACKGROUND: The literature regarding clinical olfaction, olfactory loss, and olfactory dysfunction has expanded rapidly over the past two decades, with an exponential rise in the past year. There is substantial variability in the quality of this literature and a need to consolidate and critically review the evidence. It is with that aim that we have gathered experts from around the world to produce this International Consensus on Allergy and Rhinology: Olfaction (ICAR:O). METHODS: Using previously described methodology, specific topics were developed relating to olfaction. Each topic was assigned a literature review, evidence-based review, or evidence-based review with recommendations format as dictated by available evidence and scope within the ICAR:O document. Following iterative reviews of each topic, the ICAR:O document was integrated and reviewed by all authors for final consensus. RESULTS: The ICAR:O document reviews nearly 100 separate topics within the realm of olfaction, including diagnosis, epidemiology, disease burden, diagnosis, testing, etiology, treatment, and associated pathologies. CONCLUSION: This critical review of the existing clinical olfaction literature provides much needed insight and clarity into the evaluation, diagnosis, and treatment of patients with olfactory dysfunction, while also clearly delineating gaps in our knowledge and evidence base that we should investigate further.

Identifying Treatments for Taste and Smell Disorders: Gaps and Opportunities.

The chemical senses of taste and smell play a vital role in conveying information about ourselves and our environment. Tastes and smells can warn against danger and also contribute to the daily enjoyment of food, friends and family, and our surroundings. Over 12% of the US population is estimated to experience taste and smell (chemosensory) dysfunction. Yet, despite this high prevalence, long-term, effective treatments for these disorders have been largely elusive. Clinical successes in other sensory systems, including hearing and vision, have led to new hope for developments in the treatment of chemosensory disorders. To accelerate cures, we convened the "Identifying Treatments for Taste and Smell Disorders" conference, bringing together basic and translational sensory scientists, health care professionals, and patients to identify gaps in our current understanding of chemosensory dysfunction and next steps in a broad-based research strategy. Their suggestions for high-yield next steps were focused in 3 areas: increasing awareness and research capacity (e.g., patient advocacy), developing and enhancing clinical measures of taste and smell, and supporting new avenues of research into cellular and therapeutic approaches (e.g., developing human chemosensory cell lines, stem cells, and gene therapy approaches). These long-term strategies led to specific suggestions for immediate research priorities that focus on expanding our understanding of specific responses of chemosensory cells and developing valuable assays to identify and document cell development, regeneration, and function. Addressing these high-priority areas should accelerate the development of novel and effective treatments for taste and smell disorders.

Advances in Understanding Parosmia: An fMRI Study.

INTRODUCTION: A number of patients with a diminished sense of smell also can suffer from parosmia. These patients with such a qualitative smell disorder are often more severely affected than patients exhibiting only a quantitative smell disorder. Qualitative smell disorders have heretofore been poorly investigated. The focus of the present study was, using functional MRI, to compare the central processing of olfactory stimulation in patients with qualitative smell disorders. MATERIAL AND METHODS: A total of 23 patients were investigated, 12 hyposmic patients without parosmia (HYP group) and 11 hyposmic patients with parosmia (PAR group). Both groups were matched with regard to sex and age. The olfactory smells used were peach and coffee odors. RESULTS: The two groups exhibited different patterns of activation. In HYP patients a stronger activation was observed in the medial orbitofrontal cortex, anterior cingulate cortex, and parahippocampal gyrus, whereas in the PAR group stronger activation in the thalamus and putamen was seen. DISCUSSION: These results are consistent with the hypothesis that there are specific patterns in the central processing of olfactory stimuli which differ in hyposmic patients with and without parosmia.

NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis.

BACKGROUND: Chronic rhinosinusitis is common and sometimes complicated by nasal polyps (NPs). Corticosteroid nasal sprays are often unsatisfactory because they are ineffective at delivering medication to high/deep sites of inflammation. OBJECTIVE: We sought to assess whether an exhalation delivery system with fluticasone (EDS-FLU) capable of high/deep drug deposition improves outcomes. METHODS: Patients (n = 323) 18 years and older with moderate-to-severe congestion and NPs were randomized to twice-daily EDS-FLU (93, 186, or 372 µg) or exhalation delivery system (EDS)-placebo for 24 weeks (16 double-blind plus 8 open-label when all received 372 µg). Coprimary end points were change in nasal congestion/obstruction at 4 weeks and summed bilateral polyp grade at 16 weeks. Secondary end points included symptoms, polyp elimination, and functioning. RESULTS: EDS-FLU was superior on both coprimary end points (P < .001 vs EDS-placebo, all doses). Mean polyp grade improved continuously through week 24 (P < .009, all comparisons), with polyps eliminated on at least 1 side in approximately 25% of patients at week 24 versus 8.7% with EDS-placebo (P ≤ .014, all comparisons). Sino-Nasal Outcomes Test scores also improved significantly versus those in patients receiving EDS-placebo (-21.1 to -21.4 vs -11.7 at week 16, P < .05 all doses). At the end of the double-blind period, EDS-FLU (all doses) significantly improved all 4 defining disease symptoms. In most patients (68%), those receiving EDS-FLU reported "much" or "very much" improvement. The number of patients eligible for surgery decreased by 62%-67%. The safety profile was similar to that reported in prior trials evaluating conventional corticosteroid nasal sprays in comparable populations. CONCLUSION: EDS-FLU produces clinically and statistically significant improvement in all 4 diagnostically defining disease symptoms, polyp grade, and quality of life in patients with chronic rhinosinusitis with NPs.

Olfactory cocainization is not an effective long-term treatment for phantosmia.

Phantosmia, the perception of an odor when there are no odorants in the environment, can be a very debilitating symptom. In the 1960s, Zilstorff reported olfactory distortions could be treated by the topical application of a cocaine solution to the olfactory epithelium. In evaluating this treatment, we observed no long-term benefit using cocaine on 6 patients with phantosmia. Based on our observations, the patient's olfactory ability was not a determining factor in the initiation or quality of their phantosmia. Following topical cocainization, we observed a remarkable delay of hours to days in the return of olfactory ability, and when cocaine was applied to only 1 nostril, there was a decreased olfactory ability on the noncocainized side. These results may suggest the possibility that phantosmia is related to a central processing problem.

Distorted olfactory perception: a systematic review.

The sense of smell provides people with valuable input from the chemical environment around them. The human sense of smell generally fails in three ways; one is an intensity reduction and the other two are the quality of changes. Smell disorders can be classified into central or peripheral depending on their origin. Central causes can be related to an area of hyper-functioning brain cells generating this odor perception, thus olfactory distortions have also been observed with epilepsy and migraine. In this paper, we present a review of the current clinical understanding of olfactory distortions and discuss how they can be evaluated and therapies to treat this debilitating condition.

Smell and taste disorders.

Olfaction and taste promote satisfaction and protection in daily life. The astute facial plastic surgeon recognizes the importance of a baseline smell test to document the patients' olfactory status before surgery. After surgery, the surgeon must be alert to the possible mechanisms of hyposmia and anosmia and the pertinent treatment strategies. The surgeon must also understand the importance of counseling the patient and family regarding the cause of the dysfunction and the proper treatments. This article updates the facial plastic surgeon on the importance of smell and taste and associated disorders with a current review of the literature.

Gastric bypass does not influence olfactory function in obese patients.

Morbidly obese individuals have altered sense of taste and smell. Gastric bypass (GBP) alters taste but olfactory function has not been evaluated. Changes in these senses may influence dietary preferences following GBP. Our aim was to evaluate the effect of abdominal operation, specifically GBP, and weight loss on olfactory function. Fifty-five persons undergoing GBP and cholecystectomy and 40 persons undergoing cholecystectomy (CC) alone were administered the Cross Cultural Smell Identification Test (CC-SIT) preoperatively and 2 and 6 weeks postoperatively. Patients undergoing GBP underwent further tests at 3, 6, 9, and 12 months. Body mass index (BMI) was also assessed. Mean BMI was significantly greater preoperatively in the GBP group (50.6 ± 8.0 vs. 30.6 ± 7.3 kg/m(2), p < 0.05). Significantly more GBP patients had abnormal CC-SIT results preoperatively (12.7% vs. 5.0%). There were no significant differences in percentage of abnormal tests at 2 and 6 weeks within groups but remained lower in CC patients (2 weeks, GBP 6.2% vs. CC 5.7%; 6 weeks, GBP 9.8% vs. CC 3.2%, p < .05). BMI decreased in the GBP group at 12 months (50.6 ± 8.0 preoperatively to 31.9 ± 6.9 p < 0.05). Absolute olfactory dysfunction (AOD) was present at each interval up to 12 months after GBP. Only 22% of patients with AOD remained obese. GBP does not appear to influence olfactory function. AOD present in morbidly obese persons is not affected by weight loss. These findings support that olfactory dysfunction may be a contributing factor to the development of obesity.

Radiographic distribution of drops and sprays within the sinonasal cavities.

BACKGROUND: Topical nasal sprays are commonly prescribed for sinonasal disease. Nasal drops applied in a head-down position are described alternatively to sprays. Multiple research methods have investigated the deposition pattern of intranasal medications, each with limitations. This pilot study analyzed the use of a conebeam computed tomography (CBCT) scanner to study deposition patterns of intranasal sprays and drops using radiopaque contrast solution. METHODS: Nine volunteers participated in this two-trial study. In trial 1, participants instilled 3 sprays of contrast into each nostril. After 3 minutes a CBCT scan was performed. In trial 2, 3 drops of contrast were instilled into the participants' nostrils in the "vertex-to-floor" position. Again, after 3 minutes a CBCT scan was performed. Two otolaryngologists and a neuroradiologist reviewed the images and scored 21 sites within the sinonasal cavity for the presence of contrast. RESULTS: Contrast was detected in the nasal vestibule and inferior nasal vault in nearly every trial with the spray and drops. Nasal spray was more diffusely distributed within the nasal cavity and was detected at a greater proportion on the floor of the nose, inferior meatus, anterior inferior nasal cavity, and nasopharynx. Neither spray nor drops were consistently detected in spaces superior to the middle turbinate. CONCLUSION: Radiopaque contrast delivered by nasal spray and drops were detected by the CBCT scanner, with a significant difference at one subsite. Neither spray nor drops were detected in superior nasal spaces. The CBCT scan provides an alternative to conventional CT scans in future studies using this technique.

Sphenoid "drill-out" for chronic sphenoid rhinosinusitis.

BACKGROUND: Chronic sphenoid rhinosinusitis (CSR) refractory to both medical management and 1 or more sphenoidotomies is a difficult entity to treat. In contrast to the surgical hierarchy that exists for the frontal sinus, there is no systematic approach for addressing persistent disease in the sphenoid. Sphenoid marsupialization has been advocated as a method of addressing recurrent sphenoid sinusitis. OBJECTIVE: We present a new technique called the sphenoid drill-out, which we place between traditional sphenoidotomy and sphenoid marsupialization in the surgical hierarchy for management of CSR. METHODS: We performed a retrospective review on all patients undergoing sphenoidotomy between 2005 and 2009. We studied demographics, procedure type, diagnoses, comorbidities, efficacy, revision rate, and endoscopic outcomes using Lund-Kennedy scores. RESULTS: A total of 10 patients underwent sphenoid drill-out for CSR. Average follow up was 17 months. Patients had an average of 5 prior sinus surgeries with 2.6 prior sphenoidotomies. One patient required a revision drill-out procedure. The mean preoperative and postoperative Lund-Kennedy scores were 6.67 and 1.78, which was a statistically significant difference. CONCLUSION: The sphenoid drill-out procedure is safe and effective for the management of recalcitrant CSR. It should be considered as an intermediate procedure between sphenoidotomy and sphenoid marsupialization.

Assessing current technical limitations in the small-hole endoscopic approach to the maxillary sinus.

BACKGROUND: Endoscopic sinus surgery has evolved to become the standard surgical approach to address paranasal sinus disease. To access inflammatory mucosal disease and other benign processes, it is desirable to reach all parts of the maxillary sinus. This project explores the combination of three medial wall small-hole antrostomies with multiple angled microdebrider blades to determine if an ideal combination exists. A prospective cadaveric study was performed. METHODS: Each 3.5-mm blade was passed through the natural ostium and two separate inferior meatal antrostomies. The space reached by the tip of four different microdebrider blades (12, 60, 90 and 120°) within each maxillary sinus was mapped using an image guidance system. Percent volume of the sinus reached and access to subsites were determined. RESULTS: Regardless of instrument or antrostomy combination, mean percent volume of maxillary sinus reached was 28% (range, 24-34%). The anterior wall was rarely reached by any combination, with the best blade/antrostomy combination (90° blade/anterior inferior antrostomy) only reaching 28% of the anterior wall. Likewise, the floor of the maxillary sinus was also poorly reached in general. The lateral and posterior maxillary sinus walls were most reliably reached with the roof and medial walls being intermediate. CONCLUSION: Using the endoscopic small-hole approach to the maxillary sinus results in <⅓ of the sinus being routinely reached regardless of antrostomy or angled microdebrider instrument selected. Further study and development of new technologies to more thoroughly reach benign processes within the maxillary sinus via a small-hole approach is warranted.

The changing face of paranasal sinus fungus balls.

OBJECTIVES: We describe the clinical, radiographic, and histopathologic characteristics of fungus balls. METHODS: We performed a retrospective review of 24 consecutive patients with the diagnosis of a paranasal sinus fungus ball (mycetoma) from 2001 to 2008. RESULTS: We found that 18 of the 24 primarily involved sinuses had bony thickening, and 13 of the 24 had notable dilatation of the ostium. Eleven of the 24 patients were found to have some degree of immunocompromise (from organ transplantation, diabetes, etc). The patient's immune status correlated with the type of fungus involved. (Mucor-like fungi were more common in immunocompetent patients, and aspergillus-like fungi were more common in immunocompromised patients.) Also, there was a predilection for immunocompetent patients to have dilatated ostia, whereas immunocompromised patients were more likely to have a nondilatated ostium (p = 0.019). CONCLUSIONS: Our series of paranasal sinus fungus balls defines a group of patients heretofore poorly described in the literature. Our data reveal an increased incidence in immunocompromised patients. We also found consistent radiographic patterns, correlations between immune status and the fungal pathogen, correlations between ostial enlargement and immune status, and the presence of cranial nerve pareses. These represent new findings that merit further study.

Surgeon radiation exposure in ESS with balloon catheters.

OBJECTIVE: Less invasive instruments such as balloon catheters are available for sino-ostial dilation during endoscopic sinus surgery (ESS). Currently, balloon catheter position is confirmed under fluoroscopic visualization. Radiation exposure has been an area of concern. This study was initiated to determine surgeon radiation exposure when fluoroscopy is used during ESS with balloon catheters. STUDY DESIGN: A multi-center, prospective evaluation of surgeon radiation exposure was conducted. SUBJECTS AND METHODS: For three months, 14 sinus surgeons wore dosimeters to record radiation exposure while using C-arm fluoroscopy during balloon catheter-aided sinus surgery. One dosimeter was placed at collar level (chest), outside the lead apron and another dosimeter was placed on a finger (extremity). These dosimeters were sent for readings. Deep, eye, and shallow radiation dose for each surgeon was calculated. RESULTS: Thirteen chest badges recorded annualized averages of 191.08, 193.54, and 187.69 mrems for deep, eye, and shallow exposure respectively. Eleven ring badges recorded 584.00 mrems. CONCLUSIONS: A recent publication reported low levels of surgeon radiation exposure during ESS with balloon catheters. This study validates radiation exposure among experienced surgeons is well below the annual occupational radiation exposure limit of 50,000 mrem. With vigilant technique and education, fluoroscopy reliance can be minimized.

Congenital familial bilateral branchial tracts: a rare case.

The embryologic development of the head and neck is directed by an ensemble ofnumero us genes. Embryologic malformations of the head and neck are rare. When they do occur, the most common are thyroglossal duct cysts and branchial anomalies. Most malformations are apparent at birth. Complete excision at an early stage is recommended to prevent complications such as infection. We describe an extremely rare case of bilateral branchial tracts in which there was evidence of a genetic etiology. To the best of our knowledge, this is the first case of familial bilateral branchial tracts to be described in the literature.

Treatment of acute and chronic rhinosinusitis in the United States, 1999-2002.

OBJECTIVE: To generalize the prescribing trends of a statistically defined sample of patient visits because of acute or chronic rhinosinusitis in the United States, using reported diagnostic codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. DESIGN: Four-year prospective study. SETTING: Public use data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey collected by the National Center for Health Statistics. RESULTS: The most frequently recommended medications for treatment of both acute and chronic rhinosinusitis are antibiotic agents, followed by antihistamines; nasal decongestants; corticosteroids; and antitussive, expectorant, and mucolytic agents, respectively. In addition, corticosteroids are used for the treatment of chronic rhinosinusitis. CONCLUSIONS: The use of prescription antibiotics far outweighs the predicted incidence of bacterial causes of acute and chronic rhinosinusitis. Frequency of antibiotic class used was not congruent with reported antimicrobial efficacy of the respective classes. Despite contradictory efficacies reported in the literature, inhaled corticosteroids were frequently used to treat acute rhinosinusitis. Antibiotics and inhaled nasal corticosteroids are being used more often than their published efficacies would encourage.