Biologic Therapy in Pediatric Chronic Rhinosinusitis: A Systematic Review.

OBJECTIVE: Provide clinicians with current evidence for biologic therapy in children with chronic rhinosinusitis with nasal polyposis (CRSwNP). DATA SOURCES: PubMed, MEDLINE, Cochrane, and clinical trial registries. REVIEW METHODS: Key search terms related to biologic therapy in pediatric CRSwNP were identified via a structured query of current medical literature and clinical trial databases. CONCLUSIONS: There is a dearth of active clinical trials and research studies for biologics targeting pediatric CRSwNP. There is an ongoing compassionate-use clinical trial involving Dupilumab for children with nasal polyps as well as only 1 published work specifically focused on Dupilumab for pediatric CRSwNP in the setting of aspirin-exacerbated respiratory disease. IMPLICATIONS FOR PRACTICE: For children with atopic dermatitis, asthma, and chronic idiopathic urticaria, biologic therapies such as Omalizumab, Dupilumab, and Mepolizumab have gained Food and Drug Administration approval. The role of biologic therapy in pediatric CRSwNP demonstrates significant promise in the comprehensive management of the unified airway. Additional Phase III trials are necessary to broaden clinical indications for children with comorbid conditions and complex sinonasal disease.

Management of Velopharyngeal Dysfunction (VPD) Following Cleft Palate Repair: A Comprehensive Decision-Making Process Based on Severity and Structural Deficiencies.

OBJECTIVE: To describe a comprehensive decision-making process for surgical correction of structural Velopharyngeal Dysfunction (VPD) following cleft palate repair and evaluate its efficacy. DESIGN: Retrospective study. SETTING: Tertiary care hospital. PATIENTS: 300 consecutive patients with unilateral or bilateral cleft lip and palate (CLP) or isolated cleft palate (CP) diagnosed with clinical VPD following cleft palate repair between 2009 and 2014. Of these 206 patients had structural VPD and underwent surgical correction. INTERVENTIONS: Surgical corrections were carried out according to the comprehensive two stage decision making process developed by the investigators. Step 1 of decision-making involved visualisation of the VP sphincter function by nasoendoscopy. This was followed by step 2 which involved per-operative identification of scarring, tissue loss, hypoplasia and other structural deficiencies in the soft palate and septal mucoperiosteum. The choice of operation was then made from a repertoire of interrelated and escalating surgical procedures consisting of palate revision and pharyngoplasties ranging from most anatomical to the least. MAIN OUTCOME MEASURES: Evidence of postoperative restoration of VP function on nasoendoscopy, evaluation of speech for hypernasality, understandability, acceptability and symptoms of obstructive sleep apnea. RESULTS: Complete VP closure was demonstrated in 94% of patients treated using this algorithm. There was significant improvement in all speech parameters (p < 0.00001). CONCLUSION: Our comprehensive decision-making process is designed to effectively correct structural VPD according to the severity of structural and functional deficiencies in the soft palate and avoid over treatment.

Minimally invasive, single-stage, multilevel surgery for obstructive sleep apnoea: A systematic review and meta-analysis.

OBJECTIVES: Minimally invasive, single-staged multilevel surgery (MISS MLS) could be an optimal treatment for selected patients with obstructive sleep apnea (OSA). We aim to systematically review the efficacy of MISS MLS for patients with OSA, as well as the clinical outcomes and possible complications in OSA patients before and after MISS MLS. DESIGN AND SETTING: Systematic review and meta-analysis. Six databases were searched, and the PRISMA guideline was followed. PARTICIPANTS: Patients with OSA receiving MISS MLS. MAIN OUTCOME MEASURES: The random-effects model was adopted for the statistical synthesis. The percentage and 95% confidence interval (CI) were adopted as the effect measurements of MISS MLS for OSA. Subgroup analyses and sensitivity analyses were also performed to identify the heterogeneity among the studies. RESULTS: There were initially 154 articles for identification. Eventually, six studies with a total of 848 OSA patients completely met the inclusion criteria and were further enrolled for analysis. The pooled analysis showed statistically significant lower AHI (apnea/hypopnea index, /hr.; mean difference: -8.931, 95% CI: -11.591 to -6.271, I2 = 87.4%), ESS (mean difference: -2.947, 95% CI: -4.465 to -1.429, I2 = 94.9%), and snoring severity with 0-10 visual analog scale after surgery (mean difference: -4.966, 95% CI: -5.804 to -4.128, I2 = 96.4%). The success rate was 46% in mild/moderate OSA; however, 18% in severe OSA. There were no major complications occurred. CONCLUSIONS: The acceptable surgical outcomes, esp. in mild/moderate OSA, and rare complications are the major advantages of MISS MLS. The evidence of this study could aid the decision making in selecting suitable treatment programs for OSA patients.

Angular Photogrammetric Analysis of Facial Soft Tissue by Image Processing Algorithms.

BACKGROUND: The main aim of this study was to present an automatic method based on image processing algorithms for facial anatomical landmark localization and angular photogrammetric analysis applicable for rhinoplasty surgery. We studied and measured color profile photographs of 100 patients before and after rhinoplasty surgery. METHODS: In facial anthropometry analysis, anatomical landmarks are often defined by specialists, manually. This process is time-consuming and requires training and skill. The Cascade Regression Method (CRM) was utilized for facial landmark detection to overcome the mentioned problem. In this study, 11 anatomical landmarks were used to measure 9 facial angular metrics. Finally, a t-test (with the significance level set at a p-value of 0.05) was applied to analyze before surgery versus after surgery comparisons. RESULTS: Experimental results dedicated that there is a significance difference (p < 0.001) in nasofrontal, nasolabial, mentolabial, nasomental, facial convexity including nose, facial convexity excluding nose, projection of the upper lip to chin, and H angles before and after surgery. Also, results showed that there is not a significance difference in nose tip angle. CONCLUSION: We believe that the presented system can aim to reduce the personal errors made by manual measurement and to facilitate facial anthropometry analysis before and after surgery with high accuracy. Also, the normative data for Iranian women can be used as a guide for the diagnosis and planning of oral and maxillofacial, ENT, and plastic surgeries. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Inflammatory biomarkers of neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios in 563 severe OSA patients before and after surgery.

BACKGROUND: Evidence has proved that high neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were risk factors for cardiovascular comorbidities. The alterations of NLR and PLR following obstructive sleep apnea (OSA) treatment were under studied and thus should be investigated. This study aimed to evaluate the changes of inflammatory biomarkers including NLR and PLR in severe OSA patients after surgical interventions of the upper airway, and their relationships with improvements in polysomnographic (PSG) parameters. METHODS: This retrospective cohort study included 563 consecutive severe OSA patients at a tertiary academic medical center who received OSA surgery, as well as underwent pre- and post-operative polysomnographic (PSG) examinations and blood tests. The changes of major PSG estimates, NLR, and PLR before and at least 3 months after OSA surgery were analyzed using paired t-tests with subgroup analyses. Pearson's correlations were performed to discover which PSG parameter contributed to the improvement of the values. RESULTS: After OSA surgery, the major PSG estimates, NLR and PLR dropped significantly in the overall population. In those with a higher preoperative NLR (pre-operative NLR≧3) and PLR (pre-operative PLR≧150), the mean (SD) difference of NLR (- 0.8 [1.6], 95% CI - 1.5 to - 0.2) and PLR (- 41.6 [40], 95% CI - 52.8 to - 30.5) were even more substantial. The changes of the "apnea, longest (r = 0.298, P = .037)" and "hypopnea, longest (r = 0.321, P = .026)" were found significantly related to the improvement of PLR. CONCLUSION: NLR and PLR did significantly drop in severe OSA patients following OSA surgery, and this could be related to the alterations of sleep indices. The findings could possess clinical importance for severe OSA patients after OSA surgeries in reducing possible OSA-associated cardiovascular comorbidities.

Middle Ear Status in Cleft Lip and Palate Patients: A Five-Year Follow-Up.

Introduction: The best strategy to treat otitis media with effusion in cleft lip/palate patients is still under debate. This research aimed to evaluate the otologic outcomes in children at least five years post-repair. Materials and Methods: A retrospective study was conducted on 40 children who underwent palatoplasty between January 1, 2012, and January 1, 2014, at Children's Medical Center (Tehran, Iran). Patients had intervelar veloplasty under magnification (Sommerlad's Technique). Based on patients' charts, their age, gender, cleft type, date of palatoplasty, as well as the date and the frequency of ventilation tube (VT) insertion, were recorded. Furthermore, otomicroscopy, middle ear status, and tympanometry were assessed five years postoperatively. Results: There was no significant difference in middle ear status between children with complete and incomplete cleft palates. The mean age at the time of study and the mean follow-up duration were significantly higher in the normal middle ear group, compared to the abnormal middle ear group (7.7±1.6 vs. 6.8±0.9, P=0.03 and 6±1.15 vs. 5.42±0.9, P=0.04, respectively). Middle ear status was not significantly different between early or late palatoplasty patients. In addition, the frequency and timing of VT insertion were not significantly different between the two groups. Conclusions: Middle ear status improved as patients grew older; however, the age of palatoplasty and the frequency of VT insertion were not significant prognostic factors in patients who underwent intervelar veloplasty under magnification.

Cartilage Chips in Rhinoplasty.

OBJECTIVE: This study reveals that the cartilage chips can be a good solution for camouflage and augmentation in rhinoplasty. METHODS: In this study, 64 patients who had undergone rhinoplasty from 2014 to 2019 were retrospectively studied. The average age was 31. Forty-nine patients had primary and 15 revision rhinoplasties. Cartilage chips were cut into less than 0.5-mm thickness dimensions changing from 2 to 10 mm. They were used to fill deep radix, depressions at the key area, supratip area, around the grafts to prevent their visibility at the tip. In addition, they were used in the fascia for augmentation. The cartilage chips were sculpted from the septal cartilage in 47, rib in 16, and ear cartilage in one case. RESULTS: They were applied on the radix in 25, middle vault in 37, supratip area in 32, and on the tip in 12 cases. In 30 cases, cartilage chips were mixed with cartilage dust for better fixation and camouflage. They were placed in the fascia in three cases for dorsal augmentation. Complications were seen in three cases in the form of irregularities. CONCLUSION: Cartilage chips are found to be a powerful solution in terms of camouflage and augmentation.

Primary rhinoplasty in unilateral incomplete cleft lip nose: A 4-year follow up.

OBJECTIVE: The aim of this study was to assess aesthetic result and parents' satisfaction of primary rhinoplasty in unilateral incomplete cleft lip patients. METHODS: Thirty-two consecutive unilateral incomplete cleft lip nose patients were operated in the tertiary hospital from 2012 to 2014. Primary rhinoplasty was done following the principle of the modified McComb repair. Nostril height, dome height, alar base width, nostril height to width ratio, dome height to nostril width ratio, nasolabial angle and columella deviation were measured on preoperative and 4-year postoperative photographs. Visual analogue scale (VAS) was assessed for each parent before the surgery and 4-year postoperatively. RESULTS: The preoperative and postoperative photographic analysis revealed significant improvement in nostril height ratio and dome height ratio. Nostril height to width ratio and dome height to nostril width ratio significantly increased. Alar base width significantly decreased. The nasolabial and columella deviation angles improved significantly. The mean parent-related satisfactory assessment based on the VAS showed statistically improved scores postoperatively. CONCLUSION: We believe this technique with minimal dissection could improve symmetry and satisfaction, although every individual surgeon could choose his preferable technique based on the components of correction that he is capable of executing reliably while considering the long-term outcomes.

Postoperative Debridement versus No Debridement in Chronic Rhinosinusitis.

INTRODUCTION: This study aimed to assess the long-term effects of postoperative debridement on the 4th and 8th postoperative weeks versus no debridement in terms of subjective and objective outcomes. MATERIALS AND METHODS: The statistical population of this study (n=80) consisted of 40 patients having chronic rhinosinusitis with nasal polyposis (CRSwNP) and 40 patients having chronic rhinosinusitis without nasal polyposis (CRSsNP). These samples were randomly divided into two groups of debridement and control. RESULTS: According to the results, 8 weeks after endoscopic sinus surgery (ESS), the 22-item Sino-Nasal Outcome Test questionnaire score (P =0.03), Lund-Kennedy score (P<0.001), nasal blockage (P=0.02), and loss/decrease in sense of smell (P=0.02) in CRSwNP were significantly lower in the debridement group than in the control group. Moreover, 6 months after ESS, in both CRSwNP and CRSsNP, no significant difference was observed between the two groups considering the outcomes (P>0.05). CONCLUSION: This study showed that debridement could lead to short-term improvements in CRSwNP patients; however, no long-term benefit was observed.

The Effectiveness of Skeletal Reconstruction in Severe Post-Rhinoplasty Nasal Deformity.

BACKGROUND: Revision rhinoplasty in patients with multiple prior surgeries is among the most challenging procedures in facial plastic surgery. Evaluating patient satisfaction in this unique patient population is important in determining which technique is effective. OBJECTIVES: The aim of this study was to determine the outcomes of total nasal skeletal reconstruction in patients with severe post-rhinoplasty deformity due to multiple previous revision surgeries. METHODS: A retrospective medical record analysis of ambulatory surgery and hospital databases was performed relating to rhinoplasty patients between April 2014 and December 2018. Patient demographics, surgical technique, and functional and aesthetic outcome assessment data were retrieved. Patients' functional satisfaction was measured with the Nasal Obstruction Symptom Evaluation (NOSE) instrument, and the Rhinoplasty Outcome Evaluation (ROE) instrument was used to evaluate cosmetic results. RESULTS: A total of 253 revision rhinoplasties were extracted. Of these, 25 patients were revision cases with total skeletal reconstruction. The patients had undergone a mean of 3.2 previous rhinoplasties. Mean [standard deviation] preoperative ROE and NOSE scores were 6.36 [3.69] and 80.33 [12.02], respectively. Septum, tip, dorsum, and side walls were reconstructed in all cases. The mean postoperative ROE and NOSE scores after 1 year were 17.27 [4.67] and 53.33 [19.80], respectively, which represented a statistically significant improvement (P < 0.001). CONCLUSIONS: Having the knowledge and experience to perform total nasal skeletal reconstruction by rebuilding an unsalvageable nose leads to long-standing satisfactory functional and aesthetic results.

Preoperative Computer Simulation in Rhinoplasty Using Previous Postoperative Images.

Importance: Providing realistic and useful preoperative counseling based on a surgeon's knowledge and experience. Objective: Using previous preoperative and postoperative patients' images to predict the postoperative result of a new query patient. Design, Setting, and Participants: After preprocessing for image standardization, facial landmarking was done using 68 points on the frontal view and 19 points on the profile view. Facial features were calculated and image retrieval was done based on similarity measurement between the query image's feature vector and database images' feature vectors. The nasal areas on the postoperative retrieved images were swapped to the corresponding region on the query patient's face at a unicenter tertiary hospital. We randomly selected the color profile photographs of 400 patients (360 women and 40 men) from the database of all rhinoplasty patients who had been successfully operated at Valiasr hospital from 2010 to 2018. Results: The accuracy of this preoperative simulation was >80% in our pilot study in 20 patients. Conclusions and Relevance: This system is fast, easy to handle, reliable, and accurate to simulate postoperative outcomes both in frontal and profile views. We believe that this system could not only improve more informative communication between surgeons and patients but also could facilitate the training of surgeons and residents.

Evaluating the Effect of Endoscopic Sinus Surgery on Laryngeal Mucosa Stroboscopic Features.

INTRODUCTION: The major presenting symptom of nasal polyps is nasal obstruction. The role of nasal obstruction in the genesis of laryngeal disorders is still unknown. MATERIALS AND METHODS: The aim of this study was to evaluate laryngeal videostroboscopic changes after functional endoscopic sinus surgery (FESS) in patients with nasal polyposis. A longitudinal study was carried out from March 2012 to June 2013. Thirty patients with bilateral nasal polyposis who did not respond to maximum medical treatment and were candidates for FESS were recruited. Laryngeal videostroboscopy was performed before and 3 months after FESS. Glottic gap, true vocal cord (TVC) borders and pliability, false vocal cord (FVC) movement, laryngeal erythema and mucosal edema were documented. RESULTS: Laryngeal erythema and TVC edema were significantly decreased after FESS. Laryngeal erythema was documented in 18 patients after a 3-month follow-up. Four patients (13.3%) showed mild-to-moderate TVC edema and 26 patients (86.7%) had normal TVC mucosa. CONCLUSION: The results of this study show that FESS has a significant impact on laryngeal videostroboscopic features including laryngeal erythema and TVC edema.

Polypoid change of middle turbinate is associated to an increased risk of polyp recurrence after surgery in patients with chronic rhinosinusitis with nasal polyps.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) affects approximately 4% of general population. Patients with CRSwNP have greater burden of CRS symptoms and higher rate of relapse after either medical or surgical treatments. The aim of this study was to evaluate the association between polypoid change of anterior free border of middle turbinate and rate of relapse in patients with CRSwNP. METHODS: A controlled prospective cohort study was performed. Seventy-seven adult patients with CRSwNP in whom their MT polypoid change was proved and 77 patients without MT polypoid change were recruited. Allergy, asthma, aspirin hypersensitivity, Lund Kennedy and Lund Mackay scores and eosinophilic scores of polyp and middle turbinate were recorded. Patient's health-related quality of life was assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire. All patients were evaluated 12 months after ESS. Polyp relapse, Lund Kennedy scores and SNOT-22 scores were documented. RESULTS: The relapse rate in patients with MT polypoid change was significantly higher than the control group (37.14 vs. 20.58, p value = 0.03). Eosinophil score of nasal polyps and MT specimens were significantly higher in patients with MT polypoid change than patients without polypoid change. The postoperative Lund Kennedy and SNOT-22 scores in patients with MT polypoid change were significantly higher than the control group. CONCLUSION: This study showed a significant association between polypoid change of anterior free border of middle turbinate and nasal polyp relapse. This new and simple criterion of severity of CRSwNP could have clinical implications.

A Comparison of Uvulopalatopharyngoplasty and Modified Radiofrequency Tissue Ablation in Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial.

STUDY OBJECTIVES: To compare the efficacy of modified radiofrequency tissue ablation (MRFTA) with uvulopalatopharyngoplasty (UPPP) based on both subjective and objective outcome measures in patients with mild to moderate obstructive sleep apnea (OSA). METHODS: Forty patients with mild to moderate OSA were randomly divided into UPPP and MRFTA groups. Evaluation was made based on the apneahypopnea index (AHI), Sleep Apnea Quality of Life Index (SAQLI) and Epworth Sleepiness Scale (ESS), immediately before the surgery and 6 months postoperatively. RESULTS: The postoperative AHI scores were improved significantly in both groups, although the postoperative AHI in the UPPP group was significantly lower than in the MRFTA group (P = .02). The difference between success rates for moderate OSA in UPPP and MRFTA was significant (77% versus 30%, P = .03) but there was no significant difference between success rates for mild OSA in UPPP and MRFTA groups (70% versus 50%, P = .36). Comparing postoperative ESS scores in the 2 groups showed no significant difference (P = .24). The postoperative scores in social interaction, treatment-related symptoms domain, and SAQLI total score were significantly higher in the MRFTA group. CONCLUSIONS: MRFTA as well as UPPP can greatly improve daytime sleepiness and AHI, especially in patients with mild OSA. MRFTA proved to be more effective than UPPP to enhance quality of life of patients with OSA. Further studies with longer follow-up are required to evaluate long-term safety and efficacy of these procedures. COMMENTARY: A commentary on this article appears in this issue on page 1023. CLINICAL TRIAL REGISTRATION: Trial name: Comparison of RFTA (Radio-Frequency-Tissue-Ablation) and UPPP (Uvulopalatopharyngoplasty) in patients with mild to moderate obstructive sleep apnea. URL: http://en.search.irct.ir/view/18617. Registration number: IRCT2014060910160N3.

Adaptation of the 10-Item Functional Outcomes of Sleep Questionnaire to Iranian Patients with Obstructive Sleep Apnea.

PURPOSE: The purpose of this study was to evaluate the psychometric properties of the Farsi version of 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10) in Iranian patients with obstructive sleep apnea (OSA). METHODS: The FOSQ-10 was translated into Farsi using the standard forward-backward method. One hundred patients who fulfilled the inclusion criteria completed a series of questionnaires including IR-FOSQ-10, Medical Outcome Survey Short Form 12 (SF-12) and Epworth Sleepiness Scale (ESS). Internal consistency, test-retest reliability, concurrent validity, discriminant validity and responsiveness of IR-FOSQ-10 were investigated. RESULTS: The Cronbach's alpha coefficient was 0.85 in IR-FOSQ-10 total score and ranged from 0.78 to 0.83 in each subscale. The test-retest reliability demonstrated by intraclass coefficient was 0.92. There were significant moderate-to-good negative correlations between IR-FOSQ-10 subscales and ESS except for sexual relationship subscale. FOSQ-10 subscales generally correlated higher with related subscales of SF-12. The IR-FOSQ-10 was able to distinguish patients with abnormal sleepiness score from those with normal sleepiness score. The results of sensitivity to change proved that the IR-FOSQ-10 was able to detect changes after continuous positive airway pressure therapy. CONCLUSION: The psychometric properties of the IR-FOSQ-10 suggest that it is a reliable and valid measure among Iranian patients with OSA.

Translation, cultural adaptation, and validation of the Sleep Apnea Quality of Life Index (SAQLI) in Persian-speaking patients with obstructive sleep apnea.

PURPOSE: The aim of this study was the translation, cross-cultural adaptation, and validation of the Sleep Apnea Quality of Life Index (SAQLI) in Persian-speaking patients with obstructive sleep apnea (OSA). METHODS: Ninety-six patients with OSA completed a series of questionnaires including SAQLI, Epworth Sleepiness Scale (ESS),10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10), and Medical Outcome Survey Short form 12 (SF-12) for assessment of reliability, validity, and responsiveness of Persian version of SAQLI. RESULTS: The Persian version of SAQLI had a very good internal consistency and also demonstrated good test-retest reliability. Concurrent validity was confirmed by significant correlations with ESS, FOSQ-10 and SF-12 subscale scores. Comparison of SAQLI scores in groups of patients categorized by ESS showed the high discriminative power of this instrument. However, there was no significant difference in the SAQLI scores of patients with mild, moderate, and severe sleep apnea. The results of sensitivity to change verified that the SAQLI was able to detect changes after continuous positive airway pressure (CPAP) treatment. CONCLUSION: The findings of this study indicate that the Persian version of SAQLI is a reliable, valid, and responsive measure for evaluation of quality of life in patients with OSA.

Long-term postoperative azithromycin in patients with chronic rhinosinusitis: A randomized clinical trial.

BACKGROUND: Chronic rhinosinusitis (CRS) is recognized as a common disease that imposes a big burden on the health system worldwide. There is ongoing evidence of the anti-inflammatory effect of long-term macrolide in the management of patients with CRS. OBJECTIVE: The aim of this randomized clinical trial was to evaluate the efficacy of long-term consumption of low-dose azithromycin after functional endoscopic sinus surgery. METHODS: Sixty-six patients who fulfilled the inclusion criteria were randomly divided into intervention and control groups. The subjects received the standard conventional treatment (fluticasone nasal spray plus normal saline solution irrigation) or the conventional treatment plus 250 mg of azithromycin on a daily basis for 3 months. Evaluation was made based on the 22-item Sino-Nasal Outcome Test (SNOT-22) immediately before surgery and 3 months after surgery. RESULTS: The intervention group showed a statistically significant improvement in SNOT-22 scores after the treatment and a higher percentage change after 3 months of therapy compared with the control group. A significant correlation was found between the percentage change of SNOT-22 scores and smoking in the placebo group. Lund-Mackay scores, patient age, and the duration of symptoms had no significant correlation with the percentage change. CONCLUSION: Treatment with long-term low-dose azithromycin in combination with the conventional therapy could statistically reduce the recurrence rate of CRS symptoms after functional endoscopic sinus surgery, but there was not sufficient evidence to support clinical significance of azithromycin at the investigated dose. Further larger scale trials, along with a longer follow-up period, is needed to evaluate the effectiveness of the therapy.