A Prospective Study on the Safety and Effectiveness of a Composite Sinus Stent for Use After Endoscopic Sinus Surgery.

BACKGROUND: The composite sinus stent was developed to support the nasal walls, stabilize the middle turbinate, and prevent adhesions following endoscopic sinus surgery (ESS). OBJECTIVE: This study sought to assess its safety and effectiveness. METHODS: A prospective clinical trial was conducted in a single medical center in 2016-2018. The study included 30 patients (64% males) with a mean age of 41.9 years, who were scheduled for bilateral ESS, were randomized to undergo composite sinus stent implantation for 14 to 28 days or middle meatus placement of a Telfa tampon for 2 to 3 days. Telfa is a nonadherent absorbent dressing that has been compared favorably with other packs for use following ESS. Both groups received the same postoperative treatment. Outcomes were evaluated endoscopically by the principal investigator and also by an independent investigator blinded to the intervention the patient had and by self-report questionnaires at 3 and 12 weeks postoperatively. RESULTS: The stent was successfully implanted and removed in all 29 treated sinuses, without complications. None of the stents showed granulation tissue or crusting. Compared to the tampon group, the stent group had significantly less inflammation (mean visual analog scale scores 0.2 vs 4.2 at 12 weeks, P = .01). The probability of having adhesion was 9.3 times greater in the control group compared to the study group ( P = .026), and middle turbinate lateralization rate at 12 weeks was 3.8% versus 44% in the study group and the control group, respectively, at 12 weeks ( P = .006). Patients who underwent stent implantation experienced higher symptomatic improvement (Sino-Nasal Outcome Test 22 of -37.13 vs -28.07, P = .01, in study and control groups, respectively). During stent implantation (2-4 weeks), patients did not suffer from any discomfort. CONCLUSIONS: The composite sinus stent is safer and more effective than the Telfa tampon in maintaining sinus cavity patency and promoting healing following ESS.

Removable sinus stent for endoscopic sinus surgery: An animal trial.

BACKGROUND: The goal of endoscopic sinus surgery in chronic sinusitis is to create good drainage of the paranasal sinuses. Metal stents used to prevent lateralization of the middle concha are associated with adverse effects. OBJECTIVE: The aim of this experimental study was to evaluate the feasibility and safety of a newly developed composite removable stent. METHODS: The composite removable stent was implanted in nine sheep (18 stents) in the ethmoid cavity after performing an ethmoidectomy and was examined for stability, ease of removal, and adverse effects. Histologic findings were compared between implantation and nonimplantation sites at several time points after stent deployment and removal. RESULTS: None of the stents migrated or fell out of the nose. After 4 weeks, there was no infection in the nose or around the stents, and there was no damage to the mucosa. An histologic study showed only mild-to-moderate inflammatory cell infiltration relative to control sites, with no damage to the mucosal epithelium and no necrosis at distant sites. At 2 weeks after stent removal, slight-to-moderate fibroplasia was noted in the deep nasal tissue, with slight-to-moderate osteocartilaginous metaplasia and bone remodeling but no necrotic or inflammatory changes in surrounding tissues. At 4 weeks after stent removal, the middle meatus remained open. CONCLUSION: The promising results of the composite removable stent in a sheep model justify further studies in patients undergoing endoscopic sinus surgery for chromic sinusitis.

Acute Rhinosinusitis in Immunosuppressed Children: Diagnostic and Therapeutic Management.

BACKGROUND: Immunosuppressive therapy places pediatric patients at risk of developing life-threatening sinonasal infections. Diagnosis and treatment are challenging owing to nonspecific signs and symptoms. The aim of this study was to present our department's experience with the surgical management of acute rhinosinusitis in immunosuppressed children. METHODS: The records of all children with a hematologic or oncologic disease who underwent endoscopic sinus surgery (ESS) for acute rhinosinusitis from January 2005 to May 2014 were reviewed. Data were retrospectively collected on demographics, clinical and imaging characteristics, microbiology, pathology, treatment and outcome. RESULTS: Thirty-four-immunosuppressed children underwent ESS for acute rhinosinusitis. Most patients had a fungal infection. Nineteen patients died at the end of follow-up; 10 deaths were infection-related. Facial swelling was the only symptom that correlated with death of infection. Relapse of the underlying disease, bone marrow transplantation, and long duration of neutropenia correlated with infection-related mortality. Fungal infection, and specifically Aspergillus, correlated with death from infection. CONCLUSIONS: ESS is a safe and efficient procedure for diagnosing and treating immunosuppressed pediatric patients with acute rhinosinusitis. Early detection and aggressive medical and surgical treatment, with control of underlying risk factors, are crucial to improve outcome.

Repair of caudal septal deviation: the fishing line technique.

BACKGROUND: Repair of caudal septal deviation using currently described methods is challenging technically. The aim of this work is to describe a novel and simple technique for the treatment of caudal septal deviations that protects the nasal tip, by fixating of cartilage to the columella. METHODS: All patients with caudal septal deviation operated on between June 2008 to November 2013 in 2 major medical centers were operated using the "fishing line technique." Patient satisfaction was recorded by a standard questionnaire (16-item Sino-Nasal Outcome Test [SNOT-16]), before and after surgery. The fishing line technique was performed in 63 patients with a severe caudal septal deviation of which 14 also had rhinoplasty. A mucoperichondrial flap was elevated on either side of the damaged septal cartilage. The cartilage was excised and remodeled into a straight sheet, and then repositioned between the mucoperichondrial flaps, and fixed to the septal columella. RESULTS: Mean age of the study group was 36 years. Follow-up ranged from 24 to 70 months. At the last follow-up, the septum was straight in all cases, with no deviation from the nostrils to the choana. Good airway was found in 53 patients. Eight patients had partial turbinate hypertrophy with an impaired airway, and 2 had severe turbinate hypertrophy. SNOT-16 mean score improved from 27 to 10 (p < 0.001). All patients were satisfied with the aesthetic outcome. CONCLUSION: The fishing-line technique for severe caudal septum deviations is easy to perform and yields satisfactory anatomic and aesthetic results.

Bacteriology of the Middle Meatus in Chronic Rhinosinusitis with and without Polyposis.

There are only limited data in the literature, and none specifically from the Middle East, on the pathogenic bacteria in chronic rhinosinusitis (CRS) as opposed to healthy nasal cavities and their association with disease severity. The present study was conducted in the department of head and neck surgery of a tertiary medical center. Middle meatal swabs were taken preoperatively from patients with CRS with nasal polyposis (CRSwNP) (n = 60), CRS without nasal polyposis (CRSsNP) (n = 50), and control patients with septal deviation (n = 26) or no nasal abnormalities (n = 27). Culture findings were compared among the groups and correlated with CRS severity. Positive pathogenic culture rates were 78% in the CRSwNP group and 64% in the CRSsNP group. Twenty pathogenic bacterial species were identified; the most common was Staphylococcus aureus (27%). The most common Gram-negative isolate was Citrobacter spp. (17%). Gram-negative species were significantly more prevalent in the CRSwNP group than the others. Mean Lund-Mackay scores were 12.8 in the CRSwNP group and 6.9 in the CRSsNP group, and were unrelated to the culture findings. Positive culture rates were significantly higher in the septal deviation (54%) than the nasal healthy group (26%), although both values were significantly lower than in the CRS groups. In conclusion, patients with CRS have higher rates of bacterial isolates than patients without CRS. CRSwNP is associated with more Gram-negative bacteria than CRSsNP, regardless of disease severity. The relatively high positive culture rate in patients with septal deviation merits investigation.

Effect of intranasal steroids on glucose and hemoglobin A1c levels in diabetic patients.

BACKGROUND: Intranasal steroids are widely used for the treatment of inflammatory diseases of the nose and sinuses such as rhinosinusitis, allergic rhinitis, and nonallergic rhinitis. Along with the general otherwise healthy population, many diabetic patients use intranasal steroids as well. This study was designed to evaluate the adverse effects of long-term treatment with intranasal corticosteroid preparations in diabetic patients. METHODS: The study group included all diabetic patients treated with intranasal steroids for at least 3 months at primary care clinics in Clalit Health Services Central District in Israel in 2002-2007. The central database had been reviewed for demographic data, medical history, medications, and laboratory test results. RESULTS: A total of 1768 diabetic patients were treated with topical nasal steroid sprays during the study period. Data on hemoglobin A1c (HbA1c) levels both before and during steroid treatment was available for 245 patients, and data on fasting serum glucose levels at both time points was available for 163 patients. On statistical analysis, there was no change in either measure from baseline to 3 months after starting treatment (p = 0.104 and p = 0.101, respectively). Treatment with triamcinolone acetonide was associated with a significantly greater increase in fasting serum glucose levels than other preparations (p = 0.006). CONCLUSION: Intranasal corticosteroids seem to have no adverse effects on HbA1c and serum glucose levels in diabetic patients. Their long-term use appears to be safe, provided that the patients are carefully monitored, especially those receiving triamcinolone acetonide.

Novel grading system for quantifying upper-airway obstruction on sleep endoscopy.

BACKGROUND: The aim of this study was to present a novel anatomically comprehensive and clinically applicable system for the quantification of sleep endoscopy findings in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS). METHODS: Fifty-five adult patients with a polysomnographic diagnosis of OSAHS were referred for midazolam-induced sleep endoscopy following failure of continuous positive airway pressure. Five anatomical sites of possible obstruction along the upper airway were documented: nose/nasopharynx (N), uvulopalatine plane (P), tongue base (T), larynx (L), and hypopharynx (H). Each involved site was assigned a severity grade of 1 (partial obstruction) or 2 (complete obstruction). The digits representing the obstruction pattern at each level were then added to yield a severity index (SI). The SI for each patient was determined by two independent observers. Findings were correlated with the respiratory disturbance index (RDI) and body mass index (BMI). RESULTS: The SI was significantly correlated with the RDI (R=0.746, Pearson; P<0.0001) and predicted disease severity with 65% accuracy. There was no association with BMI. By site, the tongue base and hypopharynx were significantly correlated with obstruction severity; obstruction in the tongue base predicted disease severity with a sensitivity of 68.8 and sensitivity of 81.1. CONCLUSION: Our easy-to-use endoscopic grading system provides physicians with an accurate picture of the pattern of the upper-airway system obstruction in patients with obstructive sleep apnea/hypopnea syndrome. It is a promising tool for estimating the location and severity of upper airway disease and may have implications for treatment planning.

Endoscopic transnasal cerebrospinal fluid leak repair: a 10 year experience.

BACKGROUND: Endoscopic techniques have gained popularity for the repair of anterior skull base defects. OBJECTIVE: To describe the 10 year experience with endoscopic surgical repair of cerebrospinal fluid (CSF) rhinorrhea in a tertiary medical center. METHODS: The files of all patients who underwent endoscopic transnasal CSF leak repair in our institution between 1996 and 2006 were reviewed. RESULTS: Twenty-four patients were identified: 16 women and 7 men with a mean age of 48 years and one child aged 9.5 years. The leak was trauma-induced in 17 patients and occurred spontaneously in the other 7. The defect was localized by preoperative computed tomography or CT/cysternography in 86% of cases. A fascia lata graft was the dominant choice for defect closure, and it was combined with a conchal or septal flap, fat, periosteum, or fibrin glue in 15 patients. The success rate was 83% after the first closure attempt and 91% after the second. Two patients required a craniotomy at the third attempt. Mean hospitalization time was 6.7 days. There were two minor complications. Two patients were lost to follow-up; none of the others had a recurrence during 2 years of follow-up. CONCLUSIONS: The endoscopic transnasal technique for the repair of CSF rhinorrhea is associated with a high success rate and low morbidity, and it should be considered for the majority of cases. Repeated attempts may improve success.

Association of attachment anxiety and satisfaction with nasal surgery.

AIM: To investigate the possible contribution of attachment anxiety (AA) to satisfaction with the outcome of surgery. METHODS: Sixty-three patients with chronic sinusitis who were scheduled for FESS with septoplasty were asked to complete a panel of self-report measures assessing attachment style, quality of life, mental health, and degree of facial pain and nasal obstruction. The questionnaires were filled out two weeks before surgery and one month after surgery. One surgeon performed all procedures. RESULTS: Participants were divided into two groups according to AA scores: high anxiety in attachment and low anxiety in attachment. Postoperatively, the group as a whole showed significant improvement in quality of life, positive thoughts and improvement in pain and sinus congestion. The high AA group reported a significantly lower quality of life than the low AA group. There was an inverse correlation between AA and well-being before and after surgery, and between AA and pain amelioration after surgery. A positive correlation was noted between AA and mental distress. CONCLUSIONS: Even a basic personality factor such as AA can significantly impact patient satisfaction with surgery outcome. Surgeons performing surgery should bear in mind that success is partly related to the patient`s mental state and personality.

Expression of MMP-1 in invasive well-differentiated thyroid carcinoma.

The objective of this study is to examine the expression of matrix metalloproteinase 1 (MMP-1) in invasive well-differentiated thyroid carcinoma (WDTC) and its relation to clinicopathological features. This retrospective case study group included 26 patients with invasive WDTC who were treated at our center between January 1985 and May 2007. Clinical data were collected from the medical files. MMP-1 expression was tested in samples from paraffin-embedded tumor by immunohistochemical staining. MMP-1 expression correlated with laryngotracheal invasion (p = 0.032), multifocality of the tumor (p = 0.044), and presence of regional (p = 0.034) and distant metastases (p = 0.048). In conclusion, the expression of MMP-1 in invasive WDTC is consistent with tumor aggressiveness, manifested by laryngotracheal invasion, multifocality, and regional and distant metastases. MMP-1 expression may serve as a prognostic marker and an indicator for the need for more aggressive surgical treatment.

KTP/532 YAG laser treatment for allergic rhinitis.

BACKGROUND: The purpose of this study was to investigate the efficacy of the KTP/532 YAG laser to reduce nasal congestion and discharge in patients with allergic rhinitis. METHODS: Forty-eight patients with symptoms of allergic rhinitis were treated with the KTP/532 laser. All had positive skin tests for common allergens. Treatments were provided on an ambulatory basis in one to three sessions under local anesthesia with lidocaine nose spray. Outcome was determined by daily symptom reports and regular endoscopy examination and interviews for 12 months. RESULTS: Treatment was very well tolerated. There were no major side effects. At examination after 1 year, nasal obstruction was improved in 69% and nasal discharge in 40% of cases. CONCLUSION: The KTP/532 YAG laser is effective for the treatment of nasal obstruction and discharge. Comparison with other techniques showed it to be the most effective in reducing nasal discharge. It can be done as an office procedure and does not damage the nasal mucous membrane. The KTP/532 YAG laser is effective as an additional treatment for patients refractory to medication.

Histopathological changes of the nasal mucosa induced by smoking.

Changes in the histopathology of the respiratory epithelium in response to cigarette smoking have been studied in depth in the lungs, but data on the nasal lining are lacking. The aim of the present retrospective study was to investigate the histological changes that occur in the nasal mucosa of smokers compared with non-smokers. The study group included 47 patients who underwent partial resection of the inferior turbinates. Archival nasal tissue samples were collected and examined by light microscopy: the number of goblet cells was counted, and the degree of inflammation, congestion, and edema was graded as mild, moderate, or severe. Epithelial thickness was measured as well. Findings were compared between smokers (n = 21) and non-smokers (n = 26). On statistical analysis, significant differences were found between the smokers and non-smokers in mean number of goblet cells in the nasal epithelium, 43.43 +/- 16.80 vs. 16.23 +/- 5.65 respectively (p < 0.0001), mean edema grade, 2.43 +/- 0.75 vs. 1.12 +/- 0.33 respectively (p < 0.0001), and mean epithelial thickness, 111.9 +/- 25.8 microm vs. 60.4 +/- 18.4 microm respectively (p < 0.0001). The corresponding mean values of congestion were 2 +/- 0.71 and 1.27 +/- 0.67 (p < 0.001), and of inflammation, 1.81 +/- 0.60 and 1.81 +/- 0.85 (NS). In conclusion, the histopathological findings in the nasal mucosa of smokers resemble reported findings in the bronchial respiratory epithelium. The main differences from non-smokers are greater goblet cell hyperplasia and thicker epithelium.

Antiestrogen therapy for hereditary hemorrhagic telangiectasia: a double-blind placebo-controlled clinical trial.

OBJECTIVES/HYPOTHESIS: Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of cases. Good response to hormone treatment has been documented, although its use remains controversial. The aim of this study was to examine the efficacy of an antiestrogenic agent, Tamoxifen, in the treatment of HHT-associated epistaxis. METHODS: Twenty-five patients (11 men, 14 women; mean age 51 years) with a diagnosis of epistaxis due to HHT were randomly assigned to receive treatment with oral tamoxifen 20 mg/d or placebo for 6 months. Follow-up consisted of physical examination and once-monthly blood tests. RESULTS: The groups were similar in age and sex distribution. Of the 21 participants who completed the trial, alleviation of the epistaxis was noted in 9 of 10 tamoxifen-treated patients and 3 of 11 placebo-treated patients (including 2 with only temporary improvement). The difference between the groups at the trial end point was significant for both frequency (P = .01) and severity (P = .049) of the disease. Hemoglobin concentration rose in 4 tamoxifen-treated patients and decreased in 5 controls. CONCLUSIONS: Tamoxifen appears to be an effective agent for the treatment of epistaxis due to HHT.

Expression of human DNA Topoisomerase II-alpha in squamous cell carcinoma of the larynx and its correlation with clinicopathologic variables.

The aggressiveness of laryngeal squamous cell carcinoma (SCC) is unpredictable. Topoisomerase (Topo) II-alpha is an essential nuclear enzyme; its expression rises at the end of the S-G2/M phase and drops at completion of mitosis. This study sought to determine if Topo II-alpha expression can serve as a prognostic factor in laryngeal SCC. Specimens from 56 consecutive patients were immunohistochemically stained for Topo II-alpha, and the number of positive cells in the areas of highest staining was counted in 3 highpower fields (X400) (Topo II-alpha index). Differences in the Topo II-alpha index by the presence or absence of recurrence, tumor stage and grade, and disease course were analyzed statistically. On multivariate Cox regression analysis, the Topo II-alpha index (>70 or < or =70) (P = .008) and tumor grade (P = .034) independently predicted disease-free survival. These findings suggest that high Topo II-alpha expression may be a useful indicator of tumor aggressiveness and poor outcome in laryngeal SCC.

Human topoisomerase II-alpha is highly expressed in sinonasal-inverted papilloma, but not in inflammatory polyp.

Sinonasal-inverted papilloma is a benign tumour with a high rate of recurrence, but possible malignant transformation. Therefore, investigation of predisposition to malignant transformation of sinonasal-inverted papilloma gives clinicians the opportunity for adequate treatment. Topoisomerase II-alpha (topoII-alpha) and Ki67 are markers of cell proliferation in both normal and neoplastic tissues and its level o expression could be used as a predictive parameter. Our goal was to investigate by immunochemistry the expression level of topoII-in inverted papilloma, inflammatory nasal polyp and normal sinonasal epithelium and to compare it with expression level of Ki67. TopoI alpha nuclear immunostaining showed a differential positivity in the investigated cases. The topoII-alpha index was 30.6 +/- 12.8 in inverte papilloma, 10.7 +/- 6.6 in the adjacent epithelium of inverted papilloma, but only 2.3 +/- 2.0 in the normal sinonasal epithelium. The differences in topoII-alpha expression between inverted papilloma and normal sinonasal epithelia were statistically significant. In inflammatory nasal polyp group, topoII-alpha index was 2.4 +/- 2.1, and the difference in the topoII-alpha index between inverted papilloma and inflammatory polyp group was also statistically significant. Nuclear immunostaining for Ki67 followed a similar variation. The Ki67 index was 50.0 +/- 20. in inverted papilloma, 9.0 +/- 6.6 in the adjacent epithelium of inverted papilloma and 2.4 +/- 0.9 in normal sinonasal epithelium. The differences in Ki67 expression between inverted papilloma and either adjacent or normal sinonasal epithelia were statistically significant. Significant correlation coefficients were found between topoII-alpha and epithelial thickness (r = 0.70, P > 0.0001), and between Ki67 index and epithelial thickness (r = 0.71, P> 0.0001). In the inflammatory nasal polyp group Ki67 index was 5.9 +/- 3.4. The difference in th Ki67 index between inverted papilloma and inflammatory nasal polyp groups was statistically significant. Significant correlation coefficient was found between topoII-alpha index and Ki67 index in inverted papilloma (r = 0.42, P > 0.05). These results suggest that the inverte papilloma contains a significantly higher cell population with proliferative activity by comparison with normal sinonasal and inflammatory polyp epithelia, showing a significant correlation between topoII-alpha and Ki67 expression, and indicating that topoII-alpha could be a independent prognostic factor for a putative malignant transformation.

Laryngeal and hypopharyngeal obstruction in sleep disordered breathing patients, evaluated by sleep endoscopy.

The objectives of our study were to demonstrate the patterns and sites of the upper airway (UA) collapse in obstructive sleep apnea/hypopnea syndrome (OSAHS) patients, utilizing the sleep endoscopy technique, and to describe the technique and summarize our experience in a large series of patients. UA findings during sleep endoscopy with midazolam were examined prospectively in 55 surgical candidates with OSAHS. The uvulopalantine was the most common site of obstruction (89%), followed by the tongue base, hypopharynx and larynx (33% each), and nose (21%); 72% of the patients had multiple obstructions. There was a significant correlation between the number of obstructions and the respiratory distress index (RDI). Laryngeal obstruction was typically supraglottic. Hypopharyngeal obstruction involved concentric UA narrowing. Our findings emphasize the considerable rate of laryngeal and hypopharyngeal obstructions in patients with OSAHS and suggest that their misdiagnosis may explain at least part of the high surgical failure rate of UPPP for OSAHS patients. The number of obstruction sites correlates with respiratory distress index. Sleep endoscopy is safe and simple to perform.

Endoscopic transnasal repair of choanal atresia.

OBJECTIVES: To present our experience with a new endoscopic technique for transnasal repair of choanal atresia. METHODS: Seventeen patients aged 2 months to 13 years with choanal atresia, bilateral in 6 and unilateral in 11, underwent endoscopic repair using a mucoperichondrial flap developed from the nasal septum. The bony stenosis was opened with a surgical curette or drill, and the raw surface was covered by the flap. All patients in these case series with bilateral atresia had been treated with dilatation at birth and had restenosis. RESULTS: A total of 23 choanae were operated. Follow-up ranged from 10 to 60 months. There was one case of complete restenosis and one of partial restenosis, for a success rate of 91%. CONCLUSIONS: Endoscopic repair of choanal atresia is a safe and rapid procedure even in very young children, with no complications and a high rate of success.

Endoscopic adenoidectomy in children with submucosal cleft palate.

OBJECTIVE: To determine the safety and effectiveness of endoscopic partial adenoidectomy for the treatment of nasal obstruction in children with submucosal cleft palate. METHODS: The medical files of children with symptoms of nasal obstruction and submucosal cleft palate who underwent partial transnasal endoscopic adenoidectomy from January 1993 to December 2003 were reviewed. Operative complications, relief of nasal obstruction, presence of postoperative velopharyngeal insufficiency were recorded. RESULTS: There were no operative complications. All the children had relief of nasal obstruction. Velopharyngeal insufficiency was not observed during the postoperative follow-up. CONCLUSIONS: Endoscopic partial adenoidectomy is a safe and effective procedure for the treatment of nasal obstruction in children with submucosal cleft palate.

Hemostatic effect of tranexamic acid in elective nasal surgery.

BACKGROUND: Bleeding is the most frequent complication of nasal surgery. The aim of this prospective study was to evaluate the effectiveness of tranexamic acid (TA), an antifibrinolytic agent, in reducing bleeding during and after nasal surgery. METHODS: The study sample included 400 patients aged 18-60 years who underwent combination functional endoscopic sinus surgery with septoplasty and conchotomy. Two hundred patients were not given a hemostatic agent (control group) and 200 patients were administered 1 g of oral TA three times daily starting 2 hours before surgery, for 5 days. Bleeding was monitored during surgery and for 2 weeks postoperatively. RESULTS: Patients given oral TA showed significantly less operative and postoperative bleeding compared with controls. No patients required additional packing, compared with five patients in the control group. Adverse reactions to TA were minimal, and they disappeared when the treatment stopped. CONCLUSION: TA is a safe and effective drug for the reduction of bleeding in nasal surgery. It may be recommended for routine use.