Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2).

BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays. OBJECTIVE: Assess EDS-FLU efficacy for CRS (irrespective of nasal polyps). METHODS: Two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2) were conducted at 120 sites in 13 countries. Patients received EDS-FLU 1 or 2 sprays/nostril, or EDS-placebo, twice daily for 24 weeks. Coprimary measures were composite symptom score through week 4 and ethmoid/maxillary sinus percent opacification by computed tomography at week 24. RESULTS: ReOpen1 (N = 332) composite symptom score least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001); ReOpen2 (N = 223), -1.54 and -1.74 versus -0.81 (P = .011, P = .001). In ReOpen1, sinus opacification least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), and in ReOpen2, -7.00 and -5.14 versus +1.19 (P < .001, P = .009). Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude, symptom reductions in patients using standard-delivery nasal steroid products just before entering the study (P < .001). Adverse events were similar to standard-delivery intranasal steroids. CONCLUSIONS: EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status.

Clinical and economic burden of chronic rhinosinusitis with nasal polyposis: A U.S. administrative claims analysis.

Background: Limited data exist on the clinical and economic burden of chronic rhinosinusitis with nasal polyposis (CRSwNP). Objective: To describe patient characteristics, health-care resource utilization (HCRU), and health-care costs among patients with CRSwNP with and without comorbid asthma (primary analysis) and with surgical management of nasal polyps (secondary analysis). Methods: This was a retrospective study of patients diagnosed with CRSwNP conducted using administrative claims data from January 1, 2013, through March 31, 2019. Study outcomes were assessed over a 2-year follow-up. Results were stratified by baseline asthma status (primary analysis) and presented separately for patients with surgically managed CRSwNP (secondary analysis). Results: The primary analysis included 10,999 patients with CRSwNP (2649 with asthma, 8350 without asthma). Patients with versus without asthma had higher medication use, HCRU, and all-cause medical costs (mean ± standard deviation $34,667 ± $42,234 versus $27,122 ± $45,573; p < 0.001) across the full follow-up period. CRSwNP-related medical costs were significantly higher for patients with versus without asthma in year 2 of follow-up. In the surgical management analysis (n = 4943), most categories of medication use and CRSwNP-related HCRU declined from baseline levels during follow-up, and CRSwNP-related pharmacy costs in year 2 were less than half of baseline levels. Conclusion: Patients diagnosed with CRSwNP and asthma had a greater burden of illness than those without asthma. Higher CRSwNP-related medical costs in year 2 of follow-up for patients with asthma may indicate worsening symptoms over time. Among patients with surgically managed CRSwNP, HCRU and costs increased in year 1 of follow-up but decreased below baseline levels in year 2, potentially reflecting improved symptom severity.

Systemic Corticosteroid-related Adverse Outcomes and Health Care Resource Utilization and Costs Among Patients with Chronic Rhinosinusitis with Nasal Polyposis.

PURPOSE: Nasal polyps (NPs) develop in 20% to 30% of patients with chronic rhinosinusitis. Severe forms of chronic rhinosinusitis with nasal polyposis (CRSwNP) may be treated with systemic corticosteroids (SCSs), which increase the risk for adverse clinical outcomes. This study compared the incidence of SCS-related adverse outcomes and health care resource utilization and costs between patients with CRSwNP who had SCS exposure and those who did not have SCS exposure. METHODS: This retrospective cohort study used health care claims data from adult patients with CRSwNP identified in the IBMⓇ MarketScanⓇ Databases between January 2003 and June 2019. The first SCS prescription date in SCS users or a matched date in SCS nonusers (controls) represented the index date. Enrollment for ≥1 year before and after the index date was required. SCS-related adverse outcomes and costs were compared between all SCS users and controls, and among subgroups of patients who had claims for 1-3 and ≥4 SCS prescriptions in the 12-month postindex period. Comparisons were also made among SCS users and controls who previously had and did not have NP surgery, and those with and without comorbid asthma. Inverse probability of treatment weights was applied to all comparisons, which were evaluated for a variable-length follow-up period. FINDINGS: SCS users (n = 37,740) had a greater risk for any adverse outcome than controls (n = 7032) (incidence rate ratio [IRR] = 1.10; 95% CI, 1.05-1.16). The risk for adverse outcomes was highest in the subgroups that did not have NP surgery and that had ≥4 SCS claims (n = 2993) versus controls who did not have NP surgery (n = 5078) (IRR = 1.30; 95% CI, 1.18-1.44). Similarly, patients with asthma and ≥4 SCS claims (n = 4195) had a greater risk for SCS-related outcomes versus controls with asthma (n = 1226) (IRR = 1.36; 95% CI, 1.19-1.55). SCS users incurred 60% higher all-cause costs versus non-SCS users (P < 0.001). IMPLICATIONS: In patients with CRSwNP, SCS use was associated with a higher risk for adverse outcomes and with increased health care costs compared with controls without SCS exposure. Alternative treatment strategies that avoid and/or reduce SCS use may decrease health care costs and the risk for adverse outcomes among patients with CRSwNP.

Indications for absorbable steroid-eluting sinus implants: Viewpoint via the Delphi method.

Absorbable steroid-eluting sinus implants provide targeted corticosteroid release over a sustained period and are designed to prevent both undesirable adhesion formation and sinus ostia restenosis. Here, we highlight the key evidence of these implants to date and query a group of experts via a Delphi process on the indications and optimal timing for intraoperative or in-office placement of these implants. Six of a total of 12 statements reached consensus and were accepted. Overall, experts largely agree that intraoperative or in-office use of steroid-eluting stents could be considered for patients: (1) who are diabetic or intolerant of oral steroids, (2) undergoing extended frontal sinus surgery, and (3) with recurrent stenosis. Given the lack of expert consensus on other key statements, clinicians should carefully consider these treatment options on a case-by-case basis after shared decision-making.

Medical Malpractice Allegations in Nasal Turbinate Surgery.

BACKGROUND: Despite studies showing most patients significantly improve their nasal congestion with surgical management of nasal turbinates, not all achieve acceptable results. Rarely, patients report substantial worsening of symptoms leading to litigation risk. OBJECTIVE: Document the United States medicolegal environment for nasal turbinate surgery. METHODS: We searched the Westlaw database for turbinate related terms for 1987- July 2019, recording demographics, claims, legal arguments, and outcomes in legal cases related to nasal turbinate surgery. We assessed prevalence and correlations with case outcomes. RESULTS: Of the 39 cases identified, the most common complaint was nose/facial pain (53.8% of cases). Surgeons prevailed in 87.2% of cases, with total liabilities of $3,224,606 [mean $97,715.3, ±$283,900.8]. Surgeons had statistically significant favorable outcomes when patients claimed dryness, headache, congestion, crusting, breathing problems, and disfigurement (all p < 0.05). Revision surgery was indicated in 23.1% of cases and was claimed in 40.0% of patient awards. Surgical negligence was claimed in 40.0% of patient awards versus 67.9% of surgeon awards (p = 0.333). Lack of informed consent was claimed in 20.0% of patient awards versus 32.1% of surgeon awards (p = 0.601). CONCLUSIONS: There are inherent litigation risks for surgeons when performing nasal turbinate surgery. Most claims against surgeons, are resolved in favor of the surgeon. Understanding the types of claims and legal arguments that are made by patients could help assessing the risks of a proposed litigation. Documenting clear indications for surgery and written informed consent may reduce litigations against surgeons.

Manuka honey versus saline sinus irrigation in the treatment of cystic fibrosis-associated chronic rhinosinusitis: A randomised pilot trial.

OBJECTIVES: Manuka honey attacks biofilms, which contribute to bacterial persistence in cystic fibrosis sinusitis. The primary objective was to determine feasibility of investigating manuka honey as an irrigation treatment for cystic fibrosis sinusitis and secondarily to assess the treatment's preliminary effectiveness. DESIGN: Prospective, single-blinded (clinician only), randomised, parallel two-arm pilot trial. SETTING: Tertiary rhinology clinic. PARTICIPANTS: Subjects had recalcitrant cystic fibrosis sinusitis and previous sinus surgery. They received manuka honey or saline sinus irrigations twice daily for 30 days. MAIN OUTCOME MEASURES: Main outcomes were recruitment/retention rates and tolerability. Preliminary effectiveness was assessed based on quality-of-life Sinonasal Outcome Test-22 and Lund-Kennedy endoscopic change scores and post-treatment culture negativity. RESULTS: Over 10 months, 13 subjects were enrolled, and 77% (10/13) were included in the analysis. Manuka honey irrigations were well-tolerated. The quality-of-life change score was clinically significant for manuka honey (-9 [-14,-6]) but not saline (-5 [-9,-1]), although the difference was not statistically significant (P = .29). Lund-Kennedy endoscopic change score was significantly better for manuka honey (-3 [-5,-3]) versus saline (0 [0,0]) (P = .006). There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (P = 1.00). CONCLUSIONS: Manuka honey irrigations were well tolerated, and retention rates were high. Preliminary data showed that manuka honey achieved a clinically important difference in quality-of-life score and a significantly better endoscopic outcome. Microbiological control was difficult to achieve. A future definitive trial would require multi-institutional recruitment.

Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.

OBJECTIVES: The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations. MATERIALS AND METHODS: This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary). RESULTS: Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported. CONCLUSIONS: In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture "control" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.

A multi-institutional review of outcomes in biopsy-proven chronic invasive fungal sinusitis.

BACKGROUND: Chronic invasive fungal sinusitis (CIFS) is a rare, life-threatening infection of the nose and sinuses. This study aims to identify factors that impact survival in 1 of the largest cohorts to date. METHODS: Pathology records were reviewed for biopsy-proven CIFS from 3 tertiary academic institutions from 1995 to 2016. Variables were analyzed using log-rank survival analysis. Univariate Cox regression was performed at 1 and 12 months. RESULTS: Thirty-eight patients were included. Hematologic malignancy and diabetes were the most common underlying diseases (32% each). Aspergillus was the most common fungus (63%). Greater than 75% of the patients had an absolute neutrophil count (ANC) >1000 at the time of diagnosis. Overall survival at 1, 6, and 12 months was 89%, 68%, and 48%, respectively. In univariate analysis, factors associated with worse survival included: ANC <500 at 12 months (hazard ratio [HR] 4.8; p = 0.01), ANC <1000 at 12 months (HR 5.8; p = 0.001), and recent chemotherapy (HR 4; p = 0.01). The following factor was associated with improved survival in univariate analysis: ANC as a linear variable in the entire cohort (HR 0.7; p = 0.005). CONCLUSION: We present a multi-institutional case-series of CIFS and long-term follow-up. ANC <1000 at time of diagnosis and recent chemotherapy (within 1 month of diagnosis) are associated with poorer survival, whereas a rising ANC >1000 is associated with improved survival at 12 months. Further prospective studies are needed to further define factors that affect outcomes.

Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study.

INTRODUCTION: Management of pain following endoscopic sinus surgery (ESS) often involves intermittent use of opioid medications. Given the current opioid crisis, many surgeons aim to minimize opioid prescriptions. However, surgeons often avoid the use of NSAIDs following ESS out of concern for increased bleeding risk. We sought to evaluate the effectiveness and safety of over the counter dosing of ibuprofen on pain and bleeding rates following ESS. METHODS: Prospective cohort pilot study of patients undergoing ESS. Patients self-selected either control arm (acetaminophen and PRN oxycodone) or intervention arm (alternating ibuprofen with acetaminophen, and PRN oxycodone). Outcome measures included pain (10-point visual analog scale [VAS]), bleeding rate (10-point VAS), and number of opiate pills consumed. RESULTS: Thirty-nine patients completed the study (15 control and 24 intervention). Overall, patients in the intervention arm reported decreased pain levels at days 1 (-0.9 [95%CI: -2.2, 0.5], 3 (-0.9 [95%CI: -2.3, 0.5]), and 7 (-0.6 [95%CI: -1.8, 0.6]), as well as decreased postoperative bleeding at those same days -0.9 [95%CI: -2.1, 0.4], -0.9 [95%CI: -2.1, 0.4], and -0.7 [95% CI: -1.2, -0.7], compared to controls. Opiate consumption was similar between groups with patients consuming on average four opiate pills (oxycodone 5 mg). CONCLUSIONS: Over the counter dosing of ibuprofen along with acetaminophen may yield better pain control after sinus surgery compared to acetaminophen alone. Additionally, there was no significant difference in epistaxis in the ibuprofen cohort compared to the cohort who did not take ibuprofen. Furthermore, this study showed very few opioid pills were consumed after routine ESS regardless of pain regimen prescribed. A larger trial is needed to make definitive statements on safety and efficacy. LEVEL OF EVIDENCE: 2b.

Diagnosis and Treatment of Acute Invasive Fungal Sinusitis in Cancer and Transplant Patients.

PURPOSE OF REVIEW: Modern advances in oncologic and end-organ therapies have led to an increase in immunocompromised patients and a corresponding rise in acute invasive fungal sinusitis (AIFS). Here, we present a comprehensive medical and surgical approach to the diagnosis and management of immunocompromised cancer and transplant patients with AIFS. RECENT FINDINGS: Aspergillus and Mucorales are the most common fungi to cause AIFS, though atypical fungal pathogens have been implicated particularly among patients on azole prophylaxis. Symptoms present in the majority of AIFS cases include fever, nasal congestion, and facial swelling. Nasal endoscopy and radiology are adjuncts to clinical exam with the gold standard diagnostic test still being histopathology, though molecular testing such as panfungal PCR is playing a larger role. The treatment of AIFS requires surgery, antifungal therapy, and reversal of immunosuppression. We recommend initiation of liposomal amphotericin B as an empiric therapy for AIFS, transitioned to targeted therapy when/if a fungal pathogen is identified. Goals of surgery include diagnostic sampling and debridement of necrotic tissue. Equally, if not more important, is reversal of underlying immune suppression. Immune-stimulating therapies hold promise for reducing mortality, but require additional study. Despite improvements in medical and surgical management of AIFS, mortality continues to approach 50%. Early diagnosis of this disease entity followed by aggressive surgical and medical management are important, including reversal of the underlying immunosuppression.

International assessment of inter- and intrarater reliability of the International Frontal Sinus Anatomy Classification system.

BACKGROUND: Inconsistencies in the nomenclature of structures of the frontal sinus have impeded the development of a validated "reference standard" classification system that surgeons can reliably agree upon. The International Frontal Sinus Anatomy Classification (IFAC) system was developed as a consensus document, based on expert opinion, attempting to address this issue. The purposes of this study are to: establish the reliability of the IFAC as a tool for classifying cells in the frontal recess among an international group of rhinologists; and improve communication and teaching of frontal endoscopic sinus surgery (ESS). METHODS: Forty-two computed tomography (CT) scans, each with a marked frontal cell, were reviewed by 15 international fellowship-trained rhinologists. Each marked cell was classified into 1 of 7 categories described in the IFAC, on 2 occasions separated by 2 weeks. Inter- and intrarater reliability were evaluated using Light's kappa (κ), the interclass correlation coefficient (ICC), and simple proportion of agreement. RESULTS: Interrater reliability showed pairwise κ values ranging from 0.7248 to 1.0, with a mean of 0.9162 (SD, 0.0537). The ICC was 0.98. Intrarater reliability showed κ values ranging from 0.8613 to 1.0, with a mean of 0.9407 (SD, 0.0376). The within-rater ICC was 0.98. CONCLUSION: Among a diverse sample of rhinologists (raters), there was substantial to almost perfect agreement between raters, and among individual raters at different timepoints. The IFAC is a reliable tool for classification of cells in the frontal sinus. Further outcome studies are still needed to determine the validity of the IFAC.

A multi-institutional review of outcomes in biopsy-proven acute invasive fungal sinusitis.

BACKGROUND: Acute invasive fungal sinusitis (AIFS) is a rare, aggressive infection occurring in immunocompromised patients. In this study we examined factors that affect survival in AIFS, and whether immune-stimulating therapies (IST) improve survival. METHODS: Pathology records of biopsy-proven AIFS were reviewed from 3 academic institutions from 1995 to 2016. Univariate and multivariate Cox regressions were performed at 1 and 3 months from diagnosis. RESULTS: One hundred fourteen patients were included; 45 received IST. In the univariate analysis, the following factors were associated with worse survival: hematologic malignancy (3-month hazard ratio [HR], 3.7; p = 0.01); recent chemotherapy (within 1 month of AIFS diagnosis) (3-month HR, 2.3; p = 0.02); recent bone marrow transplant (BMT) (3-month HR, 2.5; p = 0.02); and infection with atypical fungi (1-month HR, 3.1; p = 0.04). The following were associated with improved survival in univariate analysis: increasing A1c% (1-month HR, 0.7; p = 0.01) and surgical debridement (1-month HR, 0.1; p = 0.001). One third of patients with a hematologic malignancy had an absolute neutrophil count (ANC) >1000 at the time of diagnosis. ANC was not associated with prognosis in these patients. The following were associated with worse survival in multivariate analyses: hematologic malignancy; recent chemotherapy; atypical organisms; and cavernous sinus extension. In multivariate analyses, IST was associated with a 70% reduction in mortality at 1 month (p = 0.02). CONCLUSION: We presented the largest series of AIFS. Further studies are needed to examine the importance of ANC in diagnosis and prognosis. Patients diagnosed with atypical organisms may be at higher risk of death. IST likely improves short-term survival, but prospective studies are needed.

Gorilla endoscopic sinus surgery: a life-saving collaboration between human and veterinary medicine.

BACKGROUND: Chronic rhinosinusitis is a common disease process in humans; however, in the primate population of gorillas, it has rarely been described. This case describes lifesaving sinus surgery on a critically ill gorilla performed by a human otolaryngology team in collaboration with the gorilla's veterinary medicine team. METHODS: The 35-year-old western silverback gorilla was treated for 3 months with aggressive medical therapy for a worsening sinus infection. When his condition became severe, a computed tomography (CT) scan was performed showing advanced chronic rhinosinusitis with nasal polyps vs other masses and some bone erosion. As his condition deteriorated further, a tertiary otolaryngology team performed sinus surgery using the latest technology available, including image guidance, steroid-eluting sinus stents, and balloon sinus dilation. The postoperative course was complicated by subcutaneous infection and eventual fistulization. Fortunately, with culture-directed antibiotic therapy his condition gradually improved. One year later he required revision sinus surgery. At that point allergy testing was performed followed by appropriate allergy medical therapy. Now, 3 years out from his initial surgery, he continues to do well and has fathered a young female gorilla. RESULTS: This case represents a unique collaboration between human physicians and veterinarians. The combined medical approach was critical to heal this ailing gorilla. This case discusses many of the challenges and offers recommendations for physicians who may be involved with similar care of animals in the future. CONCLUSION: The success of the surgical and medical treatment of this gorilla's life-threatening sinus infection required many experts, careful planning, and corporate generosity. The interaction between human and animal medicine would not have been successful without the close and trusting collaborations between human and veterinary health providers. We encourage human healthcare providers to seek volunteer opportunities through their local zoos by engaging in discussions with their local veterinarians.

Skills transfer to sinus surgery via a low-cost simulation-based curriculum.

BACKGROUND: Surgical skill development outside the operating room aims to improve technique and subsequent patient safety. The purpose of this study was to evaluate the correlation between technical and cognitive skills with cadaveric endoscopic sinus surgery (ESS) performance and change in ESS performance before and after implementation of a dedicated ESS simulation-based and knowledge-based curriculum. METHODS: A before-after study design was implemented among 10 medical students and 10 junior otolaryngology residents. Participants completed a knowledge-based, multiple-choice ESS pretest and watched an ESS prosection video. Participants performed 9 tasks on a previously validated low-cost, low-technology, nonbiologic sinus surgery task trainer followed by cadaveric maxillary antrostomy and anterior ethmoidectomy. Participants then completed a simulation-based and knowledge-based ESS curriculum followed by a repeat cadaveric maxillary antrostomy and anterior ethmoidectomy. Performance was graded with a 5-point global rating scale (GRS) and a 5-point ESS-specific checklist. RESULTS: We observed a stronger correlation between the multiple-choice, knowledge-based, ESS pretest scores and cadaveric ESS GRS score (r = 0.73) than between task trainer performance and cadaveric ESS GRS score (r = 0.43). We also noted a significant increase in precurriculum vs postcurriculum mean ± standard deviation (SD) cadaveric ESS checklist scores for both medical students (1.18 ± 0.25 vs 2.58 ± 0.57; p = 0.0002) and residents (2.09 ± 0.78 vs 2.88 ± 0.54; p = 0.023). The greatest improvements for residents were in performance of uncinectomy, enlargement of maxillary os, and identification of the bulla. CONCLUSION: These findings provide evidence supporting the use of ESS training curricula outside the operating room.

Are multiple sinus cultures necessary during sinus surgery for chronic rhinosinusitis?

BACKGROUND: Multiple cultures are commonly obtained from different sinuses where purulence is encountered during endoscopic sinus surgery (ESS). This brings into question the utility and necessity of obtaining multiple cultures. The purpose of this study was to evaluate if multiple cultures obtained during a single case is informative in finding additional pathogens or if it is a redundant, cost-increasing practice. We hypothesized that multiple sinus cultures are necessary to identify the pathogens responsible for an individual's sinus disease. We seek to add information on the utility of performing multiple sinus cultures from a patient care and a health economics standpoint. METHODS: This study was a retrospective review of a single rhinologist's surgical database from 2008 to 2016. Patients that underwent ESS for chronic rhinosinusitis (CRS) and had multiple cultures obtained during surgery were included. Culture difference was recorded as a discrepancy of an infectious pathogen between cultures. RESULTS: We identified 231 patients with multiple sinus cultures. Of those, 39.4% had a difference of pathogens noted on culture between different sinuses. Only 5% of the cohort received clinically relevant benefit from the second culture obtained in regard to a change in antibiotics. CONCLUSION: In this retrospective review we showed that, for the practitioner who obtains sinus cultures intraoperatively, limiting this practice to a single culture rather than multiple is cost-effective and sufficient for identifying the pathogen to be treated. This study, and the resultant change in practice, has the potential to reduce healthcare costs associated with the surgical care of the patient with CRS.

Outcomes of Endoscopic Dacryocystorhinostomy in Secondary Acquired Nasolacrimal Duct Obstruction: A Case-Control Study.

INTRODUCTION: Secondary acquired nasolacrimal duct obstruction (SANDO), where the obstruction is caused by a known process, is becoming more commonly treated by endoscopic dacryocystorhinostomy (endoDCR). This study evaluates outcomes of endoDCR for cases of SANDO in comparison to endoDCR outcomes treating primary acquired nasolacrimal duct obstruction (PANDO). METHODS: All patients undergoing endoDCR from 2006 to 2015 at a tertiary referral center were reviewed for etiology of nasolacrimal duct obstruction (NLDO) and success of procedure. Inclusion criteria were preoperative determination of NLDO via probing and irrigation, greater than 60-day follow up with assessment of duct patency via probing and irrigation after silicone tube removal, and postoperative survey for recurrent epiphora. Exclusion criteria were cases treating partial NLDO, patients undergoing concurrent conjunctivodacryocystorhinostomy, and patients lost to follow up or with incomplete records. Preanalysis stratification was performed for the following preexisting conditions: PANDO, granulomatosis with polyangiitis, sarcoidosis, midfacial radiotherapy, radioactive iodine therapy, severe prolonged sinusitis, prior failed DCR, and midface trauma. The primary outcome was postoperative anatomical patency of the nasolacrimal system with resolution of epiphora. Fisher-Freeman-Halton exact tests were performed comparing each SANDO group to the PANDO group with statistical significance set at p < 0.05. RESULTS: Fifty-nine cases of NLDO underwent endoDCR in this series, 21 of which had a diagnosis consistent with SANDO. All patients treated with the aggressive perioperative management protocol the authors describe achieved anatomical patency. Patients with history of radioactive iodine therapy and radiotherapy had statistically worse outcomes compared with patients with PANDO, p = 0.011, p = 0.045, respectively. Stratified groups with increased intranasal sinus inflammation trended toward worse outcomes, but were not statistically different. CONCLUSIONS: EndoDCR is a viable approach for the treatment of SANDO. In patients with history of radiotherapy or radioactive iodine therapy, however, endoDCR demonstrated decreased success rates as compared with patients with PANDO. Modifications of operative and postoperative management based on underlying etiology of NLDO may improve outcomes of endoDCR in SANDO cases. The authors describe an aggressive protocol for perioperative management of patients with pathologic nasal inflammation undergoing endoDCR.

Endoscopic dacryocystorhinostomy following head and neck radiation therapy.

This article determines the efficacy of endoscopic dacryocystorhinostomy (endoDCR) in patients who have undergone adjuvant external beam radiation therapy (XRT) following head and neck cancer resection. A retrospective chart review was performed on all patients who underwent endoDCR between 2006 and 2014 at a tertiary referral center. Cases were reviewed and selected for the following inclusion criteria: history of adjuvant sinonasal XRT following head and neck cancer resection, preoperative probing and irrigation demonstrating nasolacrimal duct obstruction (NLDO), postoperative probing and irrigation following silicone tube extubation. Exclusion criteria included active dacryocystitis, postoperative follow-up of less than 4 months, presence of epiphora prior to XRT, lack of probing/irrigation at preoperative or postoperative visit, and lid malposition including ectropion, facial palsy, and/or poor tear pump. Six patients (7 eyes) met the selection criteria. EndoDCR was performed at a mean time of 30 months following last radiation treatment (range, 3-71 months). Mitomycin C was used in 4/7 cases. Silicone tube removal occurred between 3-8 months postoperatively. Five out of 6 patients had postoperative sinonasal debridement and nasal saline/corticosteroid irrigation. Five out of 6 patients (83%) had both resolution of epiphora and anatomic patency confirmed by probing and irrigation. Our experience suggests that endoDCR procedures can be effective in patients with NLDO following prior sinonasal XRT for head and neck neoplasms. Postoperative management with sinonasal debridement and combined saline/corticosteroid nasal irrigation may help to improve surgical success in patients with increased post-radiotherapy mucosal inflammation.

Face, content, and construct validation of a low-cost, non-biologic, sinus surgery task trainer and knowledge-based curriculum.

BACKGROUND: The purpose of this study was to evaluate face and content validity of a low-cost, low-technology, non-biologic endoscopic sinus surgery (ESS) task trainer and knowledge-based curriculum followed by construct validation of the task trainer. METHODS: A sinus surgery task trainer and curriculum were developed. Attending otolaryngologists were surveyed regarding the utility of the task trainer and curriculum. A cross-sectional construct validation study was performed including medical students, residents, and attending otolaryngologists. Nine tasks were performed on the task trainer and graded using a global rating scale (GRS). Predictors of task trainer performance were evaluated, and spatial performance was measured. Regression analyses were performed to assess main associations. RESULTS: All attending physicians (n = 7) agreed that the task trainer accelerates the learning curve and incorporates essential ESS techniques and that the knowledge-based curriculum describes anatomical and technical knowledge germane to ESS. Twelve medical students, 9 otolaryngology residents, and 5 attending otolaryngologists completed task trainer testing. GRS score varied by level of training after adjusting for potential confounders (slope = 2.63; p = 0.001). There was evidence of an association between a history of video gaming (slope = 1.33; p = 0.077), sports experience (slope = 2.08; p = 0.033), and sinus surgery simulation (slope = 2.72; p = 0.023) with GRS score, although not statistically significant. CONCLUSION: This study demonstrated validity of a knowledge-based sinus surgery curriculum and low-cost, sinus task trainer supporting use in early training. Participants with prior video gaming, sports participation, and sinus surgery simulation experience perform better at baseline on the task trainer.

Manuka honey sinus irrigation for the treatment of chronic rhinosinusitis: a randomized controlled trial.

BACKGROUND: Manuka honey (MH) has been shown in vitro to be effective against biofilm-producing bacteria. This study assessed the effectiveness of MH for patients with active chronic rhinosinusitis (CRS) and prior sinus surgery. METHODS: This prospective single-blinded (clinician only) randomized controlled trial recruited patients with active CRS and prior sinus surgery. Patients received either MH or saline (SAL) sinus irrigations twice daily for 30 days and were offered oral antibiotics and/or oral/topical steroids as indicated. Outcomes were 22-item Sino-Nasal Outcome Test (SNOT-22) change score (primary), culture negativity, and Lund-Kennedy endoscopic change score. RESULTS: Forty-two patients were analyzed (MH, n = 20; SAL, n = 22). The SNOT-22 change score achieved a clinically significant improvement in both groups but was similar between MH (median [interquartile range]: -12 [-20, -1]) and SAL (-12.5 [-22, -6]) (p = 0.57). Culture negativity was better on MH (8/19, 42%) compared to SAL (4/21, 19%), nearing statistical significance (p = 0.11). Lund-Kennedy endoscopic change score improved in both groups but was not statistically better on MH (-3 [-5, 0]) compared to SAL (-1 [-2, 0]) (p = 0.20). For patients not receiving oral antibiotics/steroids, culture negativity was statistically better on MH (5/10, 50%) compared to SAL (0/6, 0%) (p = 0.04). MH was well-tolerated. No adverse events were reported. CONCLUSION: In patients with active CRS and prior sinus surgery, both MH and SAL improved outcomes, but there was no statistically significant difference between these groups. However, in the subset that did not receive oral antibiotics/steroids, culture negativity was statistically better on MH, suggesting that MH alone may be effective for acute exacerbations of CRS.

Culture-directed topical antibiotic treatment for chronic rhinosinusitis.

BACKGROUND: Topical antibiotics, delivered optimally as high-volume culture-directed sinus irrigations, are being increasingly used for recalcitrant chronic rhinosinusitis (CRS). Their impact on subjective and objective outcome measures, however, is still unclear. OBJECTIVE: To assess if the use of topical antibiotics in recalcitrant CRS is associated with improved 20-Item Sino-Nasal Outcome Test and Lund-Kennedy endoscopic scores, and to determine the negative posttreatment culture "control" rate. METHODS: Patients were included in the study if they met diagnostic criteria for CRS, received high-volume topical antibiotic sinus irrigations twice daily for 1 month, between December 2009 and May 2015, and had undergone endoscopic sinus surgery. The primary outcome was the 20-Item Sino-Nasal Outcome Test score. Secondary outcomes were the Lund-Kennedy endoscopic score and a negative posttreatment culture "control" rate. Paired t-tests were used to compare pre- and posttreatment scores. Patients with cystic fibrosis were analyzed separately. RESULTS: Of the 58 patients included, 47% had nasal polyposis, 57% had asthma, 16% had aspirin sensitivity, and 55% had environmental allergies. The median Lund-Mackay computed tomography score was 11 (interquartile range, 6-16), and the median time to follow-up was 8 weeks (interquartile range, 6-10 weeks). The 20-Item Sino-Nasal Outcome Test scores improved from pre- to posttreatment period, although this was not significant mean 1.5 [confidence interval {CI} 1.3, 1.7] to mean 1.3 [CI 1.1, 1.6]; p = 0.16). Lund-Kennedy endoscopic scores, however, significantly improved from pre- to posttreatment (mean 4.9 [CI 4.3, 5.6] to mean 4.1 [CI 3.5, 4.7]; p = 0.05). Of the 47 patients with complete culture data, 72% had negative posttreatment culture results, defined as "controlled." Only one patient discontinued treatment, related to discomfort from irrigations. CONCLUSION: In patients with recalcitrant CRS, the use of topical antibiotics trended toward improvement in symptom severity and significantly improved endoscopic appearance. Furthermore, 72% had negative posttreatment culture results, meaning microbiological "control." The results of this study support the use of high-volume culture-directed topical antibiotics, and, in the future, more rigorous prospective studies are warranted.