Previous Endoscopic Sinus Surgery Research Articles

Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature.

The recent approval of Dupilumab has profoundly revolutionized the management of patients affected by severe and recalcitrant Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). However, a review that summarizes the results of real-life studies and compares them to phase 3 studies SINUS-24 and 52 is still lacking. A search of all real-life studies published from 2019 to 2023 was performed. Patients characteristics at baseline and 6 and 12 months after starting Dupilumab were extracted and compared to those from phase 3 trials: age, sex, smoking habits, comorbid asthma and aspirin-exacerbated respiratory disease (AERD), previous endoscopic sinus surgery (ESS), hematic eosinophils and total IgE, NasalAQ2 Polyps Score (NPS), smell, SNOT-22, adverse events (AEs), and response to treatment. 15 papers were included with an overall number of 1658 patients. A higher rate of comorbidities and previous ESS was found in patients from real-life studies. In addition, they had worse smell and SNOT-22 at baseline compared to patients from SINUS-24 and 52. Comorbid and post-ESS patients tended to have a faster NPS and SNOT-22 improvement, although the absolute values were not clinically relevant. A more extensive surgery and a number of ESS ≥ 2 were related to worse olfactory outcomes, probably due to iatrogenic damage. No correlation was found between hematic eosinophils and outcomes. AEs were reported by 12.4% of patients and 2.2% had to discontinue dupilumab. Weight gain was an emergent AE (0.8%), probably related to the restored sense of smell and taste. Non-responders were 3.5% and they were switched to systemic steroid, ESS, or another biologic. Despite some differences in prescription criteria between countries, dupilumab was demonstrated to be effective even in the real-life scenario. However, emerging AEs and possible unknown long-term AEs of a likely lifelong therapy should be considered.

Clinical outcomes of functional endoscopic sinus surgery in cystic fibrosis patients - a single centre experience.

Endoscopic sinus surgery (ESS) is an established surgical option for cystic fibrosis (CF) patients with chronic rhinosinusitis that is refractory to conventional medical management. Objective and subjective evidence of benefit of ESS in this cohort of patients is currently conflicting in the literature. A single center retrospective study was undertaken of all CF patients (transplanted and non-transplanted) over the age of 16 who underwent an ESS over a six-year period from 2015 to 2021. Patients on triple-therapy CFTR modulators were excluded. Data was collected on demographics, clinical management, and outcome measures. The objective outcome measures were lung function (%predicted FEV1), pulmonary exacerbations (total number of days of IV antibiotics- both ambulatory and in hospital). The subjective outcome measure was SNOT-22 scores preand 6 months post-operatively. A minimally clinical important difference (MCID) in SNOT-22 scores of 9 points was used. 55 patients were included in our study, with a median age of 31 and 53% females. Median Lund-Mackay scores for the cohort was 13 (3- 24). There was a significant improvement in lung function at 1-year post-surgery, and a significant MCID reduction in SNOT-22 scores at 6 months post-surgery across the cohort. Sub-group analysis revealed a sustained MCID reduction in SNOT-22 scores in both lung-transplanted and native lung groups, and in patients with primary ESS or previous ESS. However, there was no post-operative pulmonary function improvement in lung transplanted patients and patients with previous ESS. There was no impact on the rate of pulmonary exacerbations across the cohort. 2 patients in the cohort died secondary to pulmonary disease. There was a demonstrated clinical and symptomatic benefit of ESS in CF patients in this study. Stricter guidelines for indications for ESS need to be established with regards to CF patients who will undergo ESS in the future.

Eosinophilia, asthma, NERD and the use of oral corticosteroids predict uncontrolled chronic rhinosinusitis with nasal polyps after surgery.

Severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) is a challenging condition to treat. The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS2020) has the following criteria when considering biological therapy for severe uncontrolled CRSwNP: eosinophilia, need for oral corticosteroids (OCS), symptom score, loss of sense of smell and co-morbid asthma. This study aimed at finding associations of baseline factors with uncontrolled CRSwNP after endoscopic sinus surgery (ESS). Electronic health record data of CRSwNP patients (N = 137) undergoing ESS in 2002-17 were used. Endpoints of uncontrolled CRSwNP were revision ESS, purchased OCS and antibiotic courses during follow up. Baseline factors were chosen based on EPOS2020 and the data available: nasal polyp (NP) eosinophilia, peripheral blood eosinophilia, co-existing asthma and/or non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD), need for OCS during the previous year, previous ESS, endoscopic NP score, and Lund-Mackay score of sinus computed tomography scans. During the follow-up of 10.1 ± 3.1 (mean ± standard deviation) years, 35 (25.5%) individuals underwent revision ESS. The best predictive model was obtained by a sum of baseline (1) blood eosinophilia ≥ 250 cells/≥l and/or NP eosinophilia ≥ 30% (Eos), (2) asthma/NERD, and (3) ≥ 1 OCS/year. It was significantly associated with revision ESS, purchased doctor-prescribed OCS and antibiotic courses during follow-up. We identified similar predictive variables for uncontrolled CRSwNP that are used in the EPOS2020 indications of biological therapy, thus suggesting that these estimates are usable in clinical practice.

Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience

ObjectiveThis study aimed to evaluate the effectiveness and safety of dupilumab during the first year of treatment in a real-life setting, focusing on improvement in nasal polyp score (NPS) as well as specific symptoms, quality of life and olfactory function. Methodology/principalA multicentric observational cohort study was carried out. A total of 170 patients were enrolled in the Otorhinolaryngology Unit of the three University Hospitals and considered for dupilumab therapy. All recorder characteristics were age (at the first dupilumab application visit), sex, smoke habits, previous local and systemic corticosteroid therapy, history of endoscopic sinus surgery, number of previous endoscopic sinus surgery, concomitant asthma, history of an allergic condition, immunoglobulin E (IgE), allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), Aspirin Exacerbated Respiratory Disease (AERD), other comorbidities associated, blood eosinophils, nasal polyp score, sinonasal outcome test 22 (SNOT 22), sniffin' stick test, the start date of dupilumab therapy and number of doses of dupilumab and eventually, Dupilumab's adverse events related to administration. The Wilcoxon test for dependent samples was performed to compare variables. Statistical significance was assumed for p values < 0.05. ResultsA statistically significant reduction in SNOT-22 and NPS was shown at the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). A statistically significant increase value at the Sniffin' sticks test was shown in the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons).At the 12-month follow-up, according to EUFOREA indications, all patients were considered to remain in treatment with dupilumab and continued the treatment because of a reduced NPS, improved quality of life and a reduced need for system corticosteroids.Dupilumab seemed to be well tolerated by all patients. Any adverse effect of the drug led to the quit of biological treatment. ConclusionsThis multi-centric real-life study supported the effectiveness of dupilumab as an add-on therapy to intranasal corticosteroids in patients with severe uncontrolled CRSwNP in improvement of quality of life, severity of symptoms, polyp size reduction and smell function. Furthermore, our data support the safety profile of monoclonal therapy with dupilumab.

Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study.

Despite molecular underlying advances, limited and divergent data on monoclonal antibodies (mAb)therapy in chronic rhinosinusitis with nasal polyps (CRSwNP) make further analysis necessary. The objective of this study is to evaluate the effect of omalizumab as an adjunct to endoscopic sinus surgery (ESS) on the treatment of CRSwNP under real-life conditions. Since the introduction of omalizumab, as the first biologic agent for the treatment of diseases such as severe allergic asthma, different studies have demonstrated an effect of omalizumab on CRSwNP, with significant improvements in sinonasal symptoms and endoscopic scores. The high efficacy derived from mAb therapy and the need for ESS prior to mAb recommended by guidelines, has led to compare both therapeutic alternatives, finding discrepancies in their effect on quality of life (QoL) and complementary tests outcomes. Patients with moderate-to-severe asthma with clinical criteria for omalizumab indication, and coexistent CRSwNP disease, were selected for a non-randomized interventional retrospective study into four treatment subgroups.Measures were analyzed and compared between groups and over time at the baseline, 16weeks and 1 and 2years after treatment. Omalizumab treatment in patients with previous ESS exhibited an earlier and more pronounced improvement in QoL, symptoms scale and endoscopic findings (nasal polyp score and the bilateral modified Lund-Kennedy) as early from week 16, which improvement persisted for 2years. A greater mean improvement of 33.4 ± 6.5 (95% CI: 20.3-46.4; p < 0.001) points in sinonasal outcome test 22 (SNOT-22) was associated with ESS at week 16, against omalizumab effect (17.8 ± 7.6 [95% CI: 2.6-33.0]; p = 0.023). At year 2, an improvement in SNOT-22 of 62.6 ± 8.9 (95% CI: 48.4-84.1; p < 0.001) points was exclusively associated with omalizumab. Clinical evidence of the effect of omalizumab added to ESS treatment is provided in this study in the short- and long-term.

Influence of Prior Endoscopic Sinus Surgery Extent on Dupilumab Effectiveness in CRSwNP Patients.

Guidelines recommend that the vast majority of patients with severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) should have at least one endoscopic sinus surgery (ESS) prior to starting biologics. Because ESS can be performed with a variable extension, the aim of this study would be to evaluate the association between surgical extensiveness, as measured by ACCESS score, and outcomes collected in patients treated with Dupilumab. This is a multicentric retrospective study; patients affected by CRSwNP who were subjected to Dupilumab therapy and who underwent at least one ESS prior to Dupilumab initiation were included. ACCESS score was assigned to each patient's pre-Dupilumab CT scan. Subjective and objective parameters (SNOT-22, NPS, VAS scores, Sniffin' Sticks) were collected before and during the administration of therapy. Statistical correlations between ACCESS scores and clinical outcomes were investigated. A total of 145 patients were included; mean time from last previous ESS was 68.6 months, and on average, patients were subjected to 2.2 surgeries. Many correlations with ACCESS scores were demonstrated: better NPS at all timepoints and subjective scores (30-days SNOT-22, VAS nasal obstruction, and rhinorrhea) were achieved in patients with low ACCESS score (more extensive ESS). On the other hand, significantly worse VAS loss of smell values were demonstrated in patients with lower ACCESS scores. Dupilumab patients subjected to a prior extensive ESS may have reduced size of polyps and improved subjective indicators, together with a decreased chance to recover smell, when compared with patients who underwent a minimal excision. 3 Laryngoscope, 134:1556-1563, 2024.

The Effect of Corticosteroids on Sinus Microbiota in Chronic Rhinosinusitis Patients with Nasal Polyposis.

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a multifactorial disease with no known single cause, but it is thought that bacteria play a role in the disease process. This pilot study aims to assess the longitudinal effect of corticosteroid therapy on sinus microbiota in chronic rhinosinusitis patients with nasal polyposis (CRSwNP). A longitudinal prospective case-control study was done on patients with CRSwNP and healthy controls. Patients with CRSwNP were randomly allocated to a corticosteroids and antibiotics treatment group (CRSwNP-SA) or a corticosteroid-only treatment group (CRSwNP-S). Data were collected at three-time points (before treatment, 1, and 3 months after treatment). Specimens were cultured and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry (MS) was used as a bacterial detection method. Data from 29 patients with CRSwNP (16 CRSwNP-SA and 13 CRSwNP-S) was compared to 15 healthy subjects. Patients reported significant symptom improvement initially (1 month), but not in the long-term (3 months). This result was found in both treatment groups, whether or not antibiotics were used. After 3 months from treatment, the prevalence of Corynebacterium genera tended to increase in the CRSwNP-SA, while Staphylococcus and Gram-negative genera (Pseudomonas) tended to increase in the CRSwNP-S. Smoking, aspirin sensitivity, and previous endoscopic sinus surgery were found to be co-factors significantly associated with the response to systemic corticosteroid therapy. In this pilot study, both treatment options were effective to improve symptoms in the short-term but not in the long-term, and were not linked to any clear sinus microbiota response. As a result, this study supports the avoidance of systemic antibiotics without evidence of active infection.

Quality of life in CRSwNP: evaluation of ACCESS and Lund-Mackay computed tomography scores versus the QoL questionnaire.

Recently, a new CT scan classification of the extent of previous endoscopic sinus surgery called The Amsterdam Classification of Completness of Endoscopic Sinus Surgery (ACCESS) was published. The aim of this study was to investigate possible associations between traditionally used Lund-Mackay CT score and ACCESS score and their possible relationship to pre- and postoperative quality of life in a narrowly defined group of patients with recurrent CRSwNP. Forty-nine patients who underwent a revision ESS for CRSwNP were enrolled in a retrospective study. CT imaging scans were evaluated, LM and ACCESS scores determined. All patients completed the validated Czech version of the SNOT-22 questionnaire before and 6months after surgery. The correlation between the two CT scores and the QoL questionnaire was tested using Pearson's correlation tests. No correlation was demonstrated between LM scores and patient-based SNOT-22 scores neither preopratively nor postoperatively (r = - 0.0580; p = 0.918 and r = 0.0252; p = 0.8634, respectively. Similarly, no correlation was found between the ACCESS score and SNOT-22 before and after surgery (r = - 0.1988; p = 0.1708 and r = - 0.943; p = 0.5193, respectively). No linear relationship was demonstrated between the LM score and the ACCESS score (r = 0.075; p = 0.6053). The results show that even the CT score evaluating the completeness of previous procedures has no linear relationship to the quality of life preoperatively and cannot serve as a predictor for the outcomes of surgical treatment. This study also confirms that ACCESS evaluates a different aspect of the radiological finding than the traditionally used LM score.

Rectal Staphylococcus aureus Carriage and Recurrence After Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyps: A Prospective Cohort Study.

Chronic rhinosinusitis with nasal polyps (CRSwNPs) remains a major challenge due to its high recurrence rate after endoscopic sinus surgery (ESS). We aimed to investigate the risk factors of recurrence among patients who underwent ESS for Chronic rhinosinusitis (CRS). Prospective cohort study including 391 cases in a single institution receiving ESS were included for analysis from 2014 and 2017. Baseline characteristics including rectal Staphylococcus aureus (S aureus) carriage in patients receiving ESS for CRSwNPs. The primary outcome was the recurrence of CRSwNPs. Multivariate regression model was established to identify independently predictive factors for recurrence. Overall, 142 (36.3%) cases with recurrence within 2 years after ESS were observed in this study. After variable selection, multivariate regression model consisted of 4 variables including asthma (odds ratio [OR] = 3.41; P < .001), nonsteroidal anti-inflammatory drug allergy (OR = 2.27; P = .005), previous ESS (OR = 3.64; P < .001), and preoperative carriage of S aureus in rectum (OR = 2.34; P = .001). Based on our results, surgeons could predict certain groups of patients who are at high risk for recurrence after ESS. Rectal carriage of S aureus is more statistically related to the recurrence of CRSwNP after ESS compared with skin and nasal carriage.

The influence of contoured sinus endoscopy on the recurrence of nasal polyps

Objective:The aim of this stusy is to study the effect of endoscopic surgery quality on the recurrence of nasal polyps. Methods:A total of 32 patients（64 sides） with recurrent nasal polyps were collected from December 2016 to June 2018, all of which were bilateral type Ⅱ diffuse nasal polyps in stage 3. According to the post-operative pathological results, patients were divided into eosinophilic nasal polyps group（EOS） and non-eosinophilic nasal polyps group（NEOS）. All patients underwent sinus CT scan and three-dimensional reconstruction, combined with the sinus CT image performance and intraoperative findings, the quality of the patients' previous endoscopic sinus surgery was analyzed, and the CT L-M scores of sinuses before and after reoperation were compared between the two groups. Endoscopic L-K score, nasal symptoms VAS score, quality of life Snot-20 score. Results:Among 32 patients with recurrent nasal polyps, 17 cases （53.1%） of EOS nasal polyps were confirmed pathologically after surgery, and 15 cases （46.9%） of NEOS nasal polyps were confirmed. After the previous operation, the patient still has 60 sides（93.8%） of ethmoidal cells or ethmoidal septum, 56 sides（87.5%） of bone hyperplasia, 50 sides（78.1%） of bones in frontal recess air-cell or bone air-cell, and nasal cavity adhesion there were 10 sides（15.6%）, residual uncinate process 8（12.5%）, improper treatment of maxillary sinus ostia or atresia were 6（9.4%）, sphenoid sinus not open or atresia were 8（12.5%）, nasal septal deviation untreated were 4 cases（12.5%）, 1 case（3.1%） had recurrence without ethmoidal cells and residual bone interval. Patients both in the EOS group or the NEOS group were followed up with L-M score, L-K score, VAS score, and Snot-20 score after surgery, the result were significantly improved compared with the preoperative results. After follow-up of 1.5-3 years, 25 cases of polyps were completely controlled and 7 cases were partially controlled. Among them, 2 cases of EOS nasal polyps and asthma patients still had some polypoid changes in local mucosa one year after operation and was currently under medication control. Conclusion:Although the recurrence of nasal polyps is closely related to its intrinsic type, the technique of endoscopic surgery is also an important factor affecting the recurrence of nasal polyps. For patients with bilateral symmetric diffuse nasal polyps, high-quality sinus surgery of first time combined with standardized follow-up can reduce the recurrence rate of nasal polyps and prolong the relapse time.

Factors affecting upper airway control of NSAID-exacerbated respiratory disease: A real-world study of 167 patients.

BackgroundNonsteroidal anti‐inflammatory drug (NSAID) exacerbated respiratory disease (N‐ERD) is a triad with asthma, chronic rhinosinusitis with nasal polyps, and NSAID intolerance. Uncontrolled N‐ERD forms a major public health problem due to frequent and difficult‐to‐treat exacerbations and/or requiring putatively frequent endoscopic sinus surgeries (ESS). Our aim was to study factors affecting control of N‐ERD.MethodsRetrospective patient record data (patient characteristics, prior sinus surgeries, follow‐up data in 2020) from 167 N‐ERD patients undergoing consultation at three tertiary hospitals from 2001 to 2017 was used. Outcome measurements reflecting uncontrolled N‐ERD were revision ESS, corticosteroids/biological therapy, and antibiotic courses during 2016–2020. Associations were analyzed by using nonparametric tests, Cox's proportional hazard, and binary logistic regression models.ResultsNasal polyp eosinophilia increased the risk of revision surgery during the follow‐up (adjusted hazard ratio [aHR] 3.21, confidence interval 1.23–8.38). Also baseline oral corticosteroids (OCS; HR, 1.73, 1.04–2.89) and baseline surgery without total ethmoidectomy increased the risk of revision ESS (HR, 2.17, 1.07–4.42) in unadjusted models. In addition, both baseline OCS (adjusted odds ratio [aOR] 2.78, 1.23–6.26) and a history of ≥4 previous ESS (aOR, 2.15, 0.98–4.70) were associated with the use of OCS/biological therapy during the follow‐up, but not with high number of antibiotics.ConclusionsNasal polyp eosinophilia, baseline OCS, and a history of recurrent ESS predict uncontrolled N‐ERD. These factors might be clinically useful in risk‐estimation of uncontrolled disease and for organizing follow‐ups. Prospective cohort studies with larger sample size are needed to further study the factors affecting the upper airway control of N‐ERD.

Factors Affecting the Control of Chronic Rhinosinusitis With Nasal Polyps: A Comparison in Patients With or Without NERD

ObjectivesThe aim was to compare the control of chronic rhinosinusitis with nasal polyps (CRSwNP) after endoscopic sinus surgery (ESS), in patients with/without nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NERD).Study Desing: A retrospective hospital-based sample of CRSwNP patients with/without NERD with follow-up.SettingTertiary rhinology centers.MethodsElectronic patient record data from 116 CRSwNP patients (46 with NERD and 70 without NERD) undergoing ESS during 2001–17 were studied. Mean follow-up time was 9.9 years (range 1.1–15.3). Endpoints reflecting uncontrolled CRSwNP were revision ESS, and need for rescue/advanced therapy (e.g. antibiotics, oral corticosteroids and/or biological therapy) during follow-up. NERD was variable of interest and gender, age, asthma, allergic rhinitis (AR), smoking, Lund-Mackay (LM) score of sinus computed tomography scans previous ESS and baseline total ethmoidectomy were used as covariates.ResultsTwenty-one (49.7%) NERD patients and 18 (25.7%) non-NERD patients underwent revision ESS within a mean ± SD of 4.3 ± 2.8 and 3.7 ± 2.6 years, respectively (p = .013, by Logrank test). In Cox´s regression models, NERD, female gender, young age, asthma, AR, previous ESS, and lack of total ethmoidectomy were associated with revision-ESS. In adjusted model, only the total ethmoidectomy predicted revision-free survival. In adjusted logistic regression model, there was an insignificant trend that NERD and LM score were associated with the need for rescue/advanced therapy in the follow-up.ConclusionsPatients with NERD had higher risk of uncontrolled CRSwNP than patient group without NERD, as measured by revision ESS and/or need for rescue/advanced therapy in the follow-up. In addition, baseline total ethmoidectomy was associated with revision-free survival.

A Nomogram Combing Peripheral Parameters for Estimation of CRSwNP Recurrence

The preoperative prediction of the recurrence of chronic rhinosinusitis with nasal polyps (CRSwNP) remains difficult in clinical practice. We aimed to develop a nomogram that combined peripheral risk factors to clinically predict the recurrence of CRSwNP. Data from 158 CRSwNP patients who underwent endoscopic sinus surgery (ESS) from January 2012 to December 2016 were collected, and the patients were followed up for 3 years. Of these, 96 patients who underwent ESS in an earlier period formed the training cohort for nomogram development, and 62 patients who underwent ESS thereafter formed the validation cohort to confirm the model's performance. Risk factors for recurrence identified by univariate and multivariate logistic regression were used to create a nomogram. The recurrence rate was 29.2% (28/96) for the training cohort and 35.5% (22/62) for the validation cohort. Univariate analysis identified blood eosinophils (Eos), serum IgE level, asthma comorbidity, and the number of previous ESSs as risk factors for recurrence. Among those four parameters, serum IgE level and a previous ESS surgery were identified as two independent risk factors. A nomogram consisting of blood Eos, total serum IgE level, asthma comorbidity, and the number of previous ESSs was constructed, demonstrating a C index of 0.81 (95% CI, 0.79-0.83) and 0.80 (95% CI, 0.77-0.83) for predicting recurrence in the training and validation cohorts, respectively. The nomogram had well-fitted calibration curves. The nomogram might be able to preoperatively predict the recurrence of CRSwNP by using currently available and objective parameters. Further studies are required to validate its reliability and effectiveness.

Olfactory Function After Surgical Treatment of CRS: A Comparison of CRS Patients to Healthy Controls.

Many patients with chronic rhinosinusitis (CRS) have persistent olfactory dysfunction (OD) following endoscopic sinus surgery (ESS). Few studies compare outcomes to control subjects so it is unknown if residual OD is due to persistent CRS. Compare postoperative measures of OD in case patients with CRS to healthy controls without sinonasal disease. Prospective, observational, multicenter cohort study between October, 2016 and May, 2019. Case participants were selected from referred adult patients diagnosed with CRS, with or without nasal polyposis (NP), electing ESS as subsequent treatment modality. Controls voluntarily enrolled from a community-based sample without a history of CRS. Primary outcomes included measures of preoperative and postoperative OD using "Sniffin' Stick" pens which summarize odorant threshold (T), discrimination (D), and identification (I) scores. Secondary outcomes included the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) survey and olfactory cleft endoscopy scores (OCES). Outcomes were compared between 113 cases and 164 controls of similar average age and gender. Cases reported significantly worse baseline Sniffin' Sticks TDI total scores (-6.8[SE ± 1.0]; 95% CI: -4.9 to -8.7), QOD-NS (8.9[SE ± 1.1]; 95% CI: 6.8-10.9), and OCES (3.5[SE ± 0.4]; 95% CI: 2.9-4.2) on average. Cases reported significant postoperative improvement in TDI total score (3.7[SD ± 8.2]; 95% CI: 2.2-5.2), QOD-NS (-5.9[SD ± 8.7]; 95% CI: -7.6 to -4.3), and OCES (-1.7[SD ± 3.8]; 95% CI: -2.7 to -0.8) on average, while 63% of anosmics reported improved postoperative olfaction. Multivariate regression identified that NP (OR = 0.4; 95% CI: 0.2-1.0) and previous ESS (OR = 0.3; 95% CI: 0.1-0.8) decreased the odds of postoperative improvement equal to mean TDI scores of controls, while septoplasty increased those odds (OR = 4.5; 95% CI: 1.5-13.7). ESS improved olfactory metrics and restored olfactory function in approximately 50% of patients with CRS to that of healthy controls. Concurrent septoplasty increased the likelihood of achieving normal olfaction, while NP and previous ESS decreased those odds.

Free mucosal grafts and anterior pedicled flaps to prevent ostium restenosis after endoscopic modified Lothrop (frontal drillout) procedure: a randomized, controlled study.

The endoscopic modified Lothrop procedure (EMLP) is used to manage ongoing refractory frontal sinusitis after failed previous endoscopic sinus surgery (ESS), but this approach has a significant restenosis rate. We evaluated the potential benefits of mucosal grafts and pedicled flaps on the opening of the newly formed frontal ostium. Fifty patients with refractory frontal sinusitis or mucoceles after ESS were randomized to undergo EMLP, either with (n = 27) or without (n = 23) mucosal grafts and pedicled flap reconstruction of the neo-ostium. The frontal neo-ostium was measured with Lindholm distending forceps, and anteroposterior (A-P) and lateral dimensions were measured intraoperatively, and then again at 6 weeks, 6 months, and 12 months postoperatively. Olfaction outcomes were assessed using the Taiwan Smell Identification Test (TWSIT) and a smell visual analog scale (VAS) score preoperatively and at 6 months postsurgery. The initial intraoperative mean lateral and A-P dimensions were 23.2 ± 2.7 mm and 14.8 ± 2.3 mm and were significantly decreased at all time-points postoperatively. The mucosal grafts and pedicled flaps had greater lateral and A-P dimensions, and a greater percentage of intraoperative frontal neo-ostium area at all time-points postoperatively (all p < 0.05). At 6 months postoperatively, TWSIT (p = 0.027), but not the smell VAS score (p = 0.063), was significantly improved compared with baseline. TWSIT and smell VAS score changes did not differ between groups (p = 0.92 and p = 0.85, respectively). The use of mucosal grafts and pedicled flaps reduces stenosis of the frontal neo-ostium postsurgery and should be considered after EMLP.

Budget Impact of a Steroid-Eluting Sinus Implant Versus Sinus Surgery for Adult Chronic Sinusitis Patients with Nasal Polyps.

A corticosteroid-eluting sinus implant was recently approved by the FDA as a drug to treat adult patients with nasal polyps who have undergone previous endoscopic sinus surgery (ESS) of the ethmoid sinuses. ESS is performed in an operating room under general anesthesia, whereby diseased tissue and bone are removed to provide improved drainage. ESS typically involves dissection of 1 or more of the 4 paired sinus cavities (maxillary, ethmoid, sphenoid, or frontal). The implant, containing 1,350 mcg of mometasone furoate, is inserted by a physician in an office setting and offers controlled localized release of corticosteroid to the polypoid sinus tissue. The implant has demonstrated significant improvements in clinical testing; however, little research has been conducted on its economic impact. To evaluate and quantify the budget impact to a commercial payer of using this implant instead of ESS in patients with nasal polyps after a previous ESS. Since essentially all patients with recurrent nasal polyps after ESS are patients with chronic sinusitis (CS) diagnosis, this study also identified patients with CS with nasal polyposis (CSwNP) for consistency with the patient population studied in clinical trials evaluating the implant. A budget impact analysis was conducted from a U.S. commercial payer perspective over a 1-year time horizon with patients who received the implant or revision ESS. Primary outcomes of interest were annual total and per-member per-month (PMPM) direct health care costs. Costs were estimated using a decision analysis model, assuming 50% implant utilization as an alternative to revision ESS in eligible patients, with other levels (25%, 75%) also considered. The model utilized the results of a recently published analysis of 86,052 patients in the Blue Health Intelligence database, results from published clinical trials evaluating the implant, a literature review, and published Medicare national payment amounts. A commercial health plan with 1 million members could anticipate 1,000 CSwNP patients as candidates for receiving the implant or revision ESS. Estimated direct treatment costs for refractory CSwNP using only revision ESS are $11.03 million ($0.92 PMPM). If the implant replaced surgery in 50% of cases and if 63% those patients received a second treatment with the implant during the year, the estimated total cost savings would be $2.56 million ($0.21 PMPM). Cost savings associated with using the implant changed to $0.11 PMPM and $0.32 PMPM with implant adoption of 25% and 75%, respectively. In a large commercially insured U.S. population, annual revision ESS costs are substantial. Using the implant instead of revision ESS could result in considerable cost savings for payers at various levels of adoption. This study was sponsored by Intersect ENT, which was involved in study design and manuscript review. Ernst and Imhoff are employed by CTI Clinical Trial and Consulting Services, which contracted with Intersect ENT to conduct this study. Ernst and Imhoff also report other financial support from Intersect ENT during the conduct of the study. DeConde reports personal fees from Intersect ENT during the conduct of the study, as well as personal fees from Optinose, Stryker Endoscopy, and Olympus, outside the submitted work. Manes reports grants from Intersect ENT during the conduct of the study, as well as grants from Optinose and Sanofi outside the submitted work.

Turbinate-septal suture for middle turbinate medialization during endoscopic sinus surgery

Background Lateralization of middle turbinate (MT) and synechia formation are common complications after endoscopic sinus surgery (ESS). These complications can be prevented with one of MT medialization techniques. Aim The aim of this study was to evaluate the effectiveness of MT-septal suturing technique in prevention of lateralization of MT and synechia formation after ESS. Patients and methods A total of 25 patients were selected for this prospective cohort study in the period between January 2017 and January 2018 at the Otorhinolaryngology Department, Tanta University Hospital, complaining of chronic rhinosinusitis refractory to medical treatment. The age of the patients ranged from 16 to 60 years. We selected patients who did not have a history of previous ESS, nasal tumors, or bleeding disorders. A total of 25 patients of the study had undergone MT medialization (suturing technique) after ESS. All the patients were assessed by endoscopic nasal examination (preoperative, 2 weeks, and 3 months postoperatively) and sinonasal outcome test (SNOT-22) questionnaire (preoperatively and 3 months postoperative). Results Two-week postoperative endoscopic nasal examination of 25 patients showed that there was mild adhesion and synechia to lateral nasal wall in two patients in one side (8%) owing to separated sutures. Synechia was divided in outpatient clinic. No synechia was detected on 3-month postoperative endoscopic examination. Conclusion Lateralization MT and synechia formation after ESS complications can be prevented with one of MT medialization techniques. The MT suturing technique is simple, reliable, and effective in prevention of lateralization of MT and synechia formation after ESS.

Bioabsorbable steroid-releasing implants in the frontal sinus ostia: a pooled analysis.

BackgroundBioabsorbable steroid‐releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs).MethodsA total of 160 subjects were enrolled in 2 RCTs. After surgery, subjects were randomized to receive an implant in 1 FSO with the contralateral side as control. Data through day 90 from the 2 studies were pooled and subgroup analyses were performed.ResultsAt day 30, relative to controls, steroid‐releasing implants significantly reduced the need for postoperative interventions by 46.8% (95% confidence interval [CI], −60.7 to −27.9), for surgical interventions by 51.2% (95% CI, −68.2 to −25.2), and for oral steroid interventions by 37.2% (95% CI, −54.6 to −13.1) in the pooled data set. At day 90, statistically significant reductions (p < 0.05) in the need for postoperative interventions (relative reduction [RR], 30.2%), restenosis/occlusion rate (RR, 31.7%), and inflammation score (absolute difference, −6.0), and increase in estimated FSO diameter (absolute difference, 1 mm), favoring the treated side, were observed. Subgroup analyses of the pooled data showed statistically significant improvements (p < 0.05) at day 90 in restenosis/occlusion rate, and estimated FSO diameter, favoring the treated side across subgroups, with no statistically significant subgroup‐by‐treatment interactions.ConclusionBioabsorbable steroid‐releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund‐Mackay computed tomography stage in the FSO.

SNOT-22-based clusters in chronic rhinosinusitis without nasal polyposis exhibit distinct endotypic and prognostic differences.

Endotypic and prognosticating features of chronic rhinosinusitis without nasal polyposis (CRSsNP) are poorly understood. Our objectives were to use an unbiased symptom-based approach to: (1) study symptoms, clinical and endotypic features; and (2) identify features predicating outcomes from endoscopic sinus surgery (ESS). Clinical, computed tomography (CT), histopathology, and 22-item Sino-Nasal Outcome Test (SNOT-22) data was collected on 146 adult CRSsNP patients who underwent ESS. Unsupervised network modeling of presurgical SNOT-22 scores was performed to classify symptom-based clusters. Subject characteristics and post-ESS SNOT-22 scores were compared between clusters. Baseline characteristics of the subject population were as follows: females, 56.2%; revision ESS status in 35%; asthma prevalence, 32.6%; median Lund-Mackay CT score, 8; and median SNOT-22 total score, 43. Network mapping and unsupervised clustering of preoperative SNOT-22 scores revealed 4 clusters: (A) severely burdened with high scores in all 4 subdomains; (B) moderately burdened with high scores in the rhinologic subdomain; (C) moderately burdened with high scores in psychological-sleep subdomains; and (D) mildly burdened. The number of previous ESS and asthma prevalence differed significantly between clusters; CT scores were similar. Asthma burden and tissue eosinophilia were greatest in cluster A (p = 0.03). All groups showed significant improvement at 3 months post-ESS (p < 0.0001). At 6 months, patients in cluster C tended to worsen. SNOT-22-based network modeling of CRSsNP patients yielded 4 clusters with distinct features. Asthma prevalence and tissue eosinophilia were highest in the cluster with highest SNOT-22 scores. All patients showed significant improvement from ESS at 3 months; those with high sleep-psychosocial symptoms tended to show worsening at 6 months.

Factors Influencing the Need for Endoscopic Sinus Surgery in Adult Patients with Cystic Fibrosis

Risk factors in adult patients with cystic fibrosis (CF) associated with surgical intervention have not been delineated. To identify characteristics of adult patients with CF and with chronic rhinosinusitis that predict surgical intervention with endoscopic sinus surgery (ESS). Patients were identified in a tertiary sinus center by the International Classification of Diseases, Ninth Revision codes 277.00-277.03, which represent CF. Charts were reviewed for the CF transmembrane conductance regulator (CFTR) gene mutation, Lund-Mackay score (LMS), the 22-item Sino-Nasal Outcome Test (SNOT-22) score, previous ESS, and occurrence of ESS after presentation. The Fisher exact test was used to test frequency of events between the groups, and the Mann Whitney U test and the t-test were used to compare means among LMS, SNOT-22, and age. The Cox proportional hazard analysis was used to calculate hazard ratios (HR) for the impact of LMS, SNOT-22 score, previous ESS, and CFTR gene mutation status on the occurrence of ESS after presentation. One hundred and fifteen patients met the inclusion criteria for the study. Patients with a history of surgery more often underwent ESS after presentation (p ≤ 0.01). The LMS and the SNOT-22 score were not significantly different between the groups of previous ESS and no previous ESS (p = 0.23 and p = 0.28, respectively). A severe mutation genotype was predictive of ESS after presentation (p = 0.03). SNOT-22 scores did not differ between the severe and mild groups (36.0 and 32.4, respectively; p = 0.57), but the mean LMS was significantly higher in the severe mutation group (12.5 and 9.7; p ≤ 0.01). Univariate Cox proportional hazard analysis revealed an increased occurrence of ESS for patients with severe mutations (HR, 3.6; p ≤ 0.01) or a history of ESS (HR, 2.3; p ≤ 0.01). The occurrence of ESS in adult patients with CF was predicted by previous ESS intervention as well as the severity of CFTR mutation.