Intravenous vs oral acetaminophen in sinus surgery: A randomized clinical trial.

BACKGROUND: Multimodal perioperative analgesia including acetaminophen is recommended by current guidelines. The comparative efficacy of intravenous vs oral acetaminophen in sinus surgery is unknown. We aimed to determine whether intravenous or oral acetaminophen results in superior postoperative analgesia following sinus surgery. METHODS: This was a prospective randomized trial with blinded endpoint assessments conducted at a single large academic medical center. Subjects undergoing functional endoscopic sinus surgery were randomized to intravenous vs oral acetaminophen in addition to standard anesthetic and surgical care. The primary outcome was visual analogue scale pain score at 1 hour postoperatively. RESULTS: One hundred and ten adult patients were randomized; 9 were excluded from the data analysis. Fifty patients were assigned to intravenous acetaminophen and 51 to oral acetaminophen. Postoperative pain scores at 1 hour (primary endpoint) were not significantly different between the intravenous and oral acetaminophen groups. Similarly, there was no significant difference in pain scores at 24 hours postoperatively. Finally, there was no significant difference in postoperative opioid usage in the postanesthesia care unit or over the first 24 hours postoperatively. CONCLUSIONS: This is the first comparative efficacy trial of oral vs intravenous acetaminophen in sinus surgery. There was no significant difference in pain scores at 1 or 24 hours postoperatively, and no difference in postoperative opioid use. Intravenous acetaminophen offers no apparent advantage over oral acetaminophen in patients undergoing sinus surgery. LEVEL OF EVIDENCE: 1b.

Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia: An Evidence-based Review.

Objective Epistaxis is a primary complaint in 90% to 96% of patients with hereditary hemorrhagic telangiectasia (HHT). Numerous surgical and medical treatments aim to decrease the frequency and severity of epistaxis in this patient population. Bevacizumab is a recombinant, humanized monoclonal antibody to vascular endothelial growth factor, an angiogenic factor elevated in HHT. It has been used in several forms to treat epistaxis in HHT but thus far, evidence-based recommendations are limited. Study Design Systematic review with evidence-based recommendations. Methods A systematic review of the literature following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed using Embase, MEDLINE, MEDLINE In-Process/Epub, and Cochrane databases. English language abstracts were reviewed for relevance. Results Eleven manuscripts met inclusion criteria and were analyzed. Submucosal injection, submucosal injection plus laser coagulation, intravenous (IV), and topical formulations of bevacizumab were evaluated for their therapeutic impact on epistaxis in patients with HHT. Three randomized controlled trials failed to show topical bevacizumab to be more effective in controlling epistaxis than saline or other moisturizers. Conclusions The use of submucosal and IV bevacizumab shows promise, but further study is necessary to determine the true efficacy in the treatment of epistaxis as only grade C level exists currently. Based on the available literature, the use of topical bevacizumab is not recommended (grade B).

International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.

BACKGROUND: Critical examination of the quality and validity of available allergic rhinitis (AR) literature is necessary to improve understanding and to appropriately translate this knowledge to clinical care of the AR patient. To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR). METHODS: Using previously described methodology, specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus. RESULTS: The ICAR:AR document addresses over 100 individual topics related to AR, including diagnosis, pathophysiology, epidemiology, disease burden, risk factors for the development of AR, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR. CONCLUSION: This critical review of the AR literature has identified several strengths; providers can be confident that treatment decisions are supported by rigorous studies. However, there are also substantial gaps in the AR literature. These knowledge gaps should be viewed as opportunities for improvement, as often the things that we teach and the medicine that we practice are not based on the best quality evidence. This document aims to highlight the strengths and weaknesses of the AR literature to identify areas for future AR research and improved understanding.

Medical treatment of epistaxis in hereditary hemorrhagic telangiectasia: an evidence-based review.

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant hereditary disorder resulting in vascular dysplasia and formation of arteriovenous malformations. Recurrent epistaxis is a hallmark of the disease. An array of medical therapies are used in this patient population, but robust evidence-based recommendations regarding the medical treatment of epistaxis are lacking. This systematic review was performed to look at the current literature and make meaningful evidence-based recommendations. METHODS: A search of the Ovid MEDLINE, Embase, and Cochrane databases was conducted by a research librarian. Abstracts in the English language and published in a peer-review journal were reviewed for relevance and inclusion. PRISMA guidelines were followed. RESULTS: Eighteen studies met the inclusion criteria. In a few small studies, thalidomide was shown to consistently improve severity and frequency of epistaxis and improve hemoglobin concentrations while decreasing the need for transfusion. Tranexamic acid appeared to only impact the epistaxis severity score and not other clinical outcomes. Selective estrogen modulators (SERMs), propranolol, rose geranium oil, and N-acetylcysteine, have demonstrated promising efficacy in small trials. CONCLUSION: Appropriate medical therapies for epistaxis outcomes in HHT remain undefined, and there is no "gold standard." Many of the studies are small and the data reported are heterogeneous, and therefore the ability to make strong evidence-based recommendations is limited. However, many different medications appear to be promising options.

A novel use of the discrete templated notes within an electronic health record software to monitor resident supervision.

OBJECTIVE: Monitoring the supervision of residents can be a challenging task. We describe our experience with the implementation of a templated note system for documenting procedures with the aim of enabling automated, discrete, and standardized capture of documentation of supervision of residents performing floor-based procedures, with minimal extra effort from the residents. MATERIALS AND METHODS: Procedural note templates were designed using the standard existing template within a commercial electronic health record software. Templates for common procedures were created such that residents could document every procedure performed outside of the formal procedural areas. Automated reports were generated and letters were sent to noncompliers. RESULTS: A total of 27 045 inpatient non-formal procedural area procedures were recorded from August 2012 to June 2014. Compliance with NoteWriter template usage averaged 86% in the first year and increased to 94.6% in the second year ( P = .0055).Initially, only 12.5% of residents documented supervision of any form. By the end of the first year, this was above 80%, with the gains maintained into the second year and beyond. Direct supervision was documented to have occurred where required in 62.8% in the first year and increased to 99.8% in the second year ( P = .0001) after the addition of hard stops. Notification of attendings prior to procedures was documented 100% of the time by September 2013. Letters sent to errant residents decreased from 3.6 to 0.83 per 100 residents per week. CONCLUSION: The templated procedure note system with hard stops and integrated reporting can successfully be used to improve monitoring of resident supervision. This has potential impact on resident education and patient safety.

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.

BACKGROUND: The body of knowledge regarding rhinosinusitis(RS) continues to expand, with rapid growth in number of publications, yet substantial variability in the quality of those presentations. In an effort to both consolidate and critically appraise this information, rhinologic experts from around the world have produced the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR:RS). METHODS: Evidence-based reviews with recommendations(EBRRs) were developed for scores of topics, using previously reported methodology. Where existing evidence was insufficient for an EBRR, an evidence-based review (EBR)was produced. The sections were then synthesized and the entire manuscript was then reviewed by all authors for consensus. RESULTS: The resulting ICAR:RS document addresses multiple topics in RS, including acute RS (ARS), chronic RS (CRS)with and without nasal polyps (CRSwNP and CRSsNP), recurrent acute RS (RARS), acute exacerbation of CRS (AECRS), and pediatric RS. CONCLUSION: As a critical review of the RS literature, ICAR:RS provides a thorough review of pathophysiology and evidence-based recommendations for medical and surgical treatment. It also demonstrates the significant gaps in our understanding of the pathophysiology and optimal management of RS. Too often the foundation upon which these recommendations are based is comprised of lower level evidence. It is our hope that this summary of the evidence in RS will point out where additional research efforts may be directed.

Current practice trends in allergy: results of a united states survey of otolaryngologists, allergist-immunologists, and primary care physicians.

BACKGROUND: Clinical practices for the diagnosis and treatment of allergic disease evolve over time in response to a variety of forces. The techniques used by various physician specialties are not clearly defined and may vary from published descriptions or recommendations in the literature. METHODS: This work is a Web-based survey enrolling 250 U.S. physicians in the following specialties: otolaryngology (ENT), allergy-immunology (A/I), and primary care (PCP). RESULTS: Respondents reported that skin-prick testing is the most common diagnostic testing method, followed by in vitro specific immunoglobulin E (IgE) testing. ENTs were more likely to use intradermal testing compared to other specialties (p = 0.0003 vs A/I; p < 0.0001 vs PCP). Respondents reported a wide distribution in number of allergens tested, regardless of testing method (range, 11 to >60). Significant use of home immunotherapy injections (defined as >10% of immunotherapy patients) ranged from 27% to 36% of physicians, with no statistically significant difference noted based upon specialty. PCPs reported greater use of sublingual immunotherapy (PCP, 68%; A/I, 45%; otolaryngology, 35%; A/I vs PCP, p = 0.005; ENT vs PCP p < 0.001)). CONCLUSION: A variety of allergy testing and treatment methods are employed by U.S. physicians, with some differences noted based upon specialty. Home immunotherapy continues to be employed in allergy practices, and sublingual immunotherapy is a common form of delivery, especially in primary care practices.

Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis.

Chronic rhinosinusitis (CRS) has a significant impact not only on individuals who are afflicted but also on society as a whole. An increasing emphasis is being placed on incorporating the best available evidence into the care of patients, in association with an individual clinician's expertise and the patient's values. Recent evidence-based reviews with recommendations (EBRRs) have distilled our knowledge of CRS treatment options and have also pointed out continued gaps in this knowledge. This review synthesizes the findings of 8 EBRRs regarding CRS published in the International Forum of Allergy and Rhinology between 2011 and 2014. The recommendations in this review are based on the best available evidence and are meant to be incorporated into each patient's individual care, along with the practitioner's expertise and the individual patient's values and expectations. It is hoped that the EBRRs, and the process that spawned them, can provide the foundation for future guidelines in the diagnosis and management of CRS.

Sinonasal manifestations of sarcoidosis: a single institution experience with 38 cases.

BACKGROUND: Sarcoidosis is a chronic disease process characterized by non-caseating granulomatous inflammation, usually involving the lower respiratory tract. Given the rarity of rhinologic involvement, the objectives of the present study were (1) to describe clinical features, and (2) to review outcomes of rhinologic surgery for sinonasal sarcoidosis. METHODS: Retrospective analysis was performed of patients evaluated at a tertiary care referral center between January 2006 and July 2011. RESULTS: The mean age of the 38 patients with sinonasal sarcoidosis was 52 years, with a female:male ratio of 2.8:1. The most common presenting symptoms included nasal obstruction (65.8%), crusting (29.9%), and epistaxis (18.4%). Most frequent endoscopic findings included crusting (55.3%), mucosal thickening (44.7%), and subcutaneous nodules (21%). Computed tomography (CT) imaging demonstrated turbinate or septal nodularity (21%), osteoneogenesis (15.8%), and bone erosion (10.5%). Medical management was typically comprised of saline irrigations (73.3%), topical nasal steroids (68.4%), and oral steroids (63.2%). Refractory sinus symptoms required sinonasal surgery in 4 cases. Overall subjective symptom improvement was noted in 39.5% at mean follow-up of 16.2 months. CONCLUSION: Sinonasal involvement was noted in approximately 30% of patients with known sarcoidosis evaluated in the otolaryngology clinic. Patients typically present with nasal obstruction and endoscopic evidence of crusting and mucosal thickening. Medical therapy with irrigations and topical/oral steroids suffices in majority of patients, with surgery for refractory symptoms being required in a small subset of cases.

Antimicrobials and chronic rhinosinusitis with or without polyposis in adults: an evidenced-based review with recommendations.

BACKGROUND: Chronic rhinosinusitis (CRS) is characterized by inflammation of the mucosa of the nose and paranasal sinuses. The role of bacterial or fungal infection in CRS is unclear, yet antimicrobials are commonly prescribed for this condition. Published guidelines offer little direction regarding antibiotic strategies for CRS. The purpose of this article is to provide an evidence-based approach to the use of antibacterial and antifungal antibiotics in the management of CRS. METHODS: A systematic review of the literature was performed following recommendations of the Clinical Practice Guideline Manual, Conference on Guideline Standardization (COGS), and the Appraisal of Guidelines and Research Evaluation (AGREE). Inclusion criteria were: age ≥18 years old, chronic rhinosinusitis with or without polyps, antibiotic treatment as the experimental group, and clearly defined primary clinical endpoint. Studies involving patients with cystic fibrosis or acute invasive fungal sinusitis were excluded. RESULTS: The review identified and evaluated the literature on 8 classes of antimicrobials for CRS: oral antibacterial antibiotics ≤3 weeks, oral antibacterial antibiotics >3 weeks, macrolide antibiotics, intravenous antibacterial antibiotics, topical antibacterial antibiotics, oral antifungals, intravenous antifungals, and topical antifungals. CONCLUSION: Based on the available evidence, oral antibacterial antibiotics and prolonged macrolide antibiotics are considered therapeutic options in the treatment of CRS while the use of topical antibacterial antibiotics, intravenous antibacterial antibiotics and oral, topical, or intravenous antifungals would be recommended against. These evidence-based recommendations should not necessarily be applied to all patients with CRS and are not intended to supersede clinical judgment based on individual patient circumstances.

Ossifying fibroma of the nose and paranasal sinuses.

BACKGROUND: The purpose of this work was to perform a systematic review regarding ossifying fibroma and its multiple variants of the paranasal sinuses, and to identify any clinical differences between the multiple variants. METHODS: A search of the U.S. National Library of Medicine (PubMed) database was performed for the non­Medical Subject Heading (MeSH) search term "ossifying fibroma." The bibliographies of the retrieved manuscripts were searched to identify additional potentially relevant articles. Finally, textbooks of head and neck pathology were searched to identify peer-reviewed literature that addresses the histopathology of ossifying fibroma and its variants. Abstracts were screened by 2 of the authors to identify reports of ossifying fibroma lesions (and its variants) that involved the paranasal sinuses. Extracted data from case reports or case series included the clinical presentation, age, gender, site of involvement, surgical approach, treatment outcome, follow-up period, and recurrence rate. Information derived from cases is summarized in tables, and simple descriptive statistics were applied to the data. RESULTS: A total of 137 distinct patients were identified in 103 reports. Extracted data did not show any appreciable difference in clinical presentation or outcomes. Data on recurrence of these lesions was often limited by a lack of follow-up. CONCLUSION: Although differentiation between the subtypes of ossifying fibroma can be made histologically, and a diverse nomenclature exists, there does not appear to be any overriding clinical significance to the histopathologic differentiation of OF variants.

A novel finding on computed tomography in the diagnosis and localization of cerebrospinal fluid leaks without a clear bony defect.

BACKGROUND: The purpose of this work was to describe a clinical and radiographic pattern of findings that helps localize the site of spontaneous cerebrospinal fluid (CSF) leaks. METHODS: This study was a retrospective review of CSF leaks treated at the University of Texas Southwestern Medical Center from 2000 to 2009. Data collected included demographics, nature of presentation, imaging findings, intraoperative location of skull-base defect, and clinical follow-up. RESULTS: Forty-six patients' charts were reviewed. Among these patients, 15 did not show a bony skull-base defect on high-resolution computed tomography (CT) scan. They did, however, each show a small area of opacification in the olfactory cleft. In each case, this area of opacification correlated with the site of the CSF leak. Intrathecal fluorescein was not used, except in 2 instances. Successful repair was noted in all patients on follow-up, without evidence of recurrence at the repair site. CONCLUSION: In the absence of a clearly identifiable bony skull-base defect, opacification of the olfactory cleft is a localizing sign in some cases of spontaneous CSF rhinorrhea. Such a finding should direct endoscopic repair, and may serve as the only marker for the specific leak site.

Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis.

BACKGROUND: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent interventions. A bioabsorbable, steroid-releasing sinus implant has been studied in 2 prospective, randomized clinical trials for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS. The objective of this study was to perform a meta-analysis of the efficacy results from the 2 trials. METHODS: The 2 prospective, randomized, double-blinded, multicenter trials enrolled a total of 143 patients utilizing an intrapatient control design. Postoperative day 30 videos were obtained for each patient, randomly ordered, and presented to an independent panel of 3 otolaryngologists for grading of efficacy endpoints. The need for postoperative interventions, formation of polyposis, and adhesions were assessed. Results from the 2 studies were then pooled. RESULTS: Implants were successfully placed in all 286 ethmoid sinuses. According to the grading done by the panel, drug-releasing implants reduced postoperative interventions by 35% (p = 0.0008), lysis of adhesions by 51% (p = 0.0016), and oral steroid need by 40% (p = 0.0023), compared to controls. The relative reduction in frank polyposis was 46% (p < 0.0001). CONCLUSION: Early postoperative healing is a predictor of longer-term success after sinus surgery. Evaluation of postoperative outcomes by a blinded independent panel demonstrates that steroid-releasing implants that provide a sustained release of corticosteroid improve surgical outcomes by reducing frank polyp formation, sinus adhesions, and middle turbinate lateralization. Steroid-releasing implants reduce the need for surgical intervention, and the need for oral steroid treatment.

Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants.

OBJECTIVE: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) may be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent intervention. To address this issue, the authors investigated the safety and effectiveness of controlled delivery of mometasone furoate to the sinus mucosa via bioabsorbable implants deployed at the time of ESS. STUDY DESIGN: Prospective, multicenter, randomized, controlled, double-blind trial using an intrapatient control design. SETTING: Otolaryngology-head and neck surgery centers; both academic and private practices. SUBJECTS AND METHODS: The study enrolled 105 patients with CRS undergoing bilateral ethmoidectomy to compare the effect of drug-releasing to non-drug-releasing implants using an intrapatient control design. Postoperative interventions, polyposis, and adhesions were assessed postoperatively. Efficacy was determined through independent analysis of randomized video-endoscopies by 3 blinded sinus surgeons. Safety assessments included ocular examinations. RESULTS: Implants were successfully deployed in all 210 ethmoid sinuses. Compared with control sinuses with non-drug-releasing implants, the drug-releasing implant provided a 29.0% relative reduction in postoperative interventions (P = .028) and a 52% (P = .005) decrease in lysis of adhesions. The relative reduction in frank polyposis was 44.9% (P = .002). Similar reductions were observed in real-time grading performed by the clinical investigators. No clinically significant changes from baseline in intraocular pressure or cataracts were observed. CONCLUSION: This study provides a high level of evidence that use of steroid-releasing implants that apply a sustained release of corticosteroid improves surgical outcomes by reducing synechiae formation, polyposis, and the need for postoperative interventions, with no observable ocular safety risk.

Comorbidities and allergic rhinitis: not just a runny nose.

Allergic rhinitis is rarely found in isolation and should be considered in the context of upper and lower airway disease. People with AR are at greater risk of suffering asthma, rhinosinusitis, and other related upper airway conditions. Most people with both nasal allergies and asthma report that their asthma gets better when their nasal allergies are under control. People with AR are more than twice as likely to suffer problems sleeping due to their nasal allergy symptoms.

Prospective evaluation of intraoperative computed tomography imaging for endoscopic sinonasal and skull-base surgery.

BACKGROUND: The objective of this study was to prospectively evaluate the clinical impact of intraoperative computed tomography (CT) imaging on endoscopic sinonasal and skull base procedures. METHODS: A total of 49 patients were enrolled after informed consent from December 2009 to May 2010. Patients underwent intraoperative volume CT imaging (xCAT, Xoran Technologies, Ann Arbor, MI) at the conclusion of their proposed surgery. RESULTS: The mean age was 48.6 years with male:female ratio of 1.3:1. Surgical procedures included revision or primary endoscopic sinonasal surgery (ESS) (36), endoscopic benign or malignant tumor resection (10), endoscopic mucocele drainage (2), and endoscopic tumor biopsy (1). The mean Lund-Mackay (L-M) score was 10.6 (range 1-21). The indications for intraoperative imaging included extent of paranasal sinus dissection in 38 (77.6%), extent of tumor resection in 11 (22.4%), adequacy of mucocele drainage in 3 (6.1%), and frontal stent position in 2 (4.1%) cases. Average acquisition time was 5.3 minutes. The CT acquisition quality was deemed excellent in 24 (49.0%), good in 15 (30.6%), fair in 5 (10.2%), and unattainable in 5 (10.2%) cases. Additional interventions were performed in 8 of 44 cases (18%) based on the intraoperative CT dataset. Analysis of predictive factors for additional intervention, including presence of polyps, presence of tumor, previous surgery, use of image guidance, and CT quality did not reach statistical significance. CONCLUSION: Intraoperative CT scanning may hold important utility in selected endoscopic sinonasal and skull base procedures with additional interventions being performed in 18% of cases. The present study was unable to identify specific factors that would preoperatively predict the need for intraoperative imaging. Future clinical trials should include a multi-institutional design to better delineate these important variables.

Balloon catheter technology in rhinology: Reviewing the evidence.

Balloon catheter technology (BCT) for management of paranasal sinus inflammatory disease was introduced to otolaryngology in 2005. Since its introduction, BCT has been a subject of considerable controversy with proponents for and against adoption of the technology. Balloon procedures have been promoted as a less invasive alternative to endoscopic sinus surgery that results in reduced pain and quicker recovery. The technology and its promotion have generated significant press coverage and interest by the lay public looking for new solutions for sinonasal problems. Over time, alternate balloon devices have been advocated for operating room and office-based sinus ostia dilatation. This contemporary review will evaluate the existing evidence on the available balloon devices. The frank strengths and weaknesses of the peer-reviewed literature will be highlighted. The potential complications unique to balloon catheters and radiation exposure from fluoroscopy will also be discussed.

Middle turbinate medialization for improved access during endoscopic sinus surgery.

INTRODUCTION: Proper management of the middle turbinate in endoscopic sinus surgery is often a topic of debate. Most authors, however, agree in the need to prevent lateralization. We describe our preferred technique and stress the timing of the medialization procedure. METHODS: The middle turbinates are sutured to the nasal septum at the beginning of the operation. This allows optimal access to the nasal cavity and paranasal sinuses during the entirety of the operation. DISCUSSION: Multiple techniques have been described to prevent lateralization of the middle turbinate. It is our opinion that implementing the proposed technique at the start of the surgery allows for optimal exposure during the operation.