Differential effect of omalizumab on pulmonary function in patients with allergic asthma with and without chronic rhinosinusitis.

BACKGROUND: Omalizumab, an anti-immunoglobulin E monoclonal antibody, is approved by the U.S. Food and Drug Administration for the management of patients with allergic asthma and with refractory disease, and has also proven beneficial in the management of selected patients with chronic rhinosinusitis (CRS). The common airway model indicates that patients with both allergic asthma and CRS may be more challenging to manage clinically. This is the first study to evaluate the response of omalizumab in patients with asthma and CRS versus those with asthma alone. OBJECTIVE: To compare pulmonary function test (PFT) responses in omalizumab-treated patients with asthma with CRS with omalizumab-treated patients with asthma without CRS. METHODS: This was a retrospective case-control study at a tertiary university clinic. Between 2007 and 2014, a total of 259 patients with allergic asthma had been prescribed omalizumab for asthma. Outcome measures were absolute, and the percentage changes in PFT results were compared with the baseline. RESULTS: Overall, 81 patients had serial PFT results available for evaluation, among whom 59 (73%) had CRS. Average treatment duration was 27.2, 27.7, and 25.8 months for the entire sample, for patients with asthma and CRS, and for patients with asthma and without CRS, respectively. Overall, PFT metrics improved across all parameters (forced expiratory volume in 1 second, forced vital capacity, forced expiratory volume in 1 second to forced vital capacity ratio, and forced expiratory flow 25-75%). Significant improvement (p < 0.05, paired t-test) was observed for three of four metrics in patients with comorbid CRS but in none of these parameters in patients without CRS. CONCLUSION: Patients with allergic asthma who were treated with omalizumab manifested some improvement in PFT scores. CRS may add to the overall symptom burden experienced by patients with asthma, especially in those with increasing severity, but comorbid CRS did not adversely impact the therapeutic potential of omalizumab. In fact, the benefit of omalizumab was more likely to be observed in patients with asthma and with CRS than in patients with asthma and without CRS.

Outcomes of endoscopic repair of cerebrospinal fluid rhinorrhea without lumbar drains.

OBJECTIVE: Lumbar drains (LD) are commonly used during endoscopic repair of cerebrospinal fluid (CSF) rhinorrhea, either to facilitate graft healing or to monitor CSF fluid dynamics. However, the indications and necessity of LD placement remains controversial. The current study sought to evaluate endoscopic CSF leak repair outcomes in the setting of limited LD use. METHODS: Patients who underwent endoscopic repair of CSF rhinorrhea between 2004 and 2014 were identified by a review of medical records. Demographic and clinical data were extracted and compared between patients who had surgery with and patients who had surgery without a perioperative LD. A univariate analysis was performed to identify factors predictive of recurrence. RESULTS: A total of 107 patients (116 surgical procedures) were identified, with a mean follow-up of 15.8 months. Eighty-eight of 107 patients (82.2%) had surgery without an LD. The mean hospital stay was 4.48 days in the LD group versus 1.03 days in the non-LD group (p < 0.00001). There was no difference in recurrence rate between the LD and non-LD groups. Predictors of recurrence included repair technique (p = 0.04) and size of defect (p = 0.005). Body mass index, leak site (ethmoid, sphenoid, frontal), and etiology (spontaneous, iatrogenic, traumatic) were not predictive of leak recurrence. CONCLUSION: Use of LDs in endoscopic CSF leak repair was not associated with reduced recurrence rates, regardless of leak etiology, and resulted in a significant increase in hospital length of stay. Although the use of perioperative LDs to monitor CSF dynamics may have some therapeutic and diagnostic advantages, it may not be associated with clinically significant improvements in patient outcomes or recurrence rates.

Early Practice: External Sinus Surgery and Procedures and Complications.

External approaches to the paranasal sinuses are rarely used in the endoscopic era. However, their indications for use have not changed, and in every surgeon's career those indications may present themselves. For residents training in the endoscopic era, these procedures are also very rarely seen. In this article, the external approaches to the maxillary, ethmoid, and frontal sinuses are described: their original descriptions, modern use, and potential complications. It is hoped that this article will serve to instruct residents and practitioners alike in these techniques.

Practical aspects of integrating allergy and pulmonology management into a rhinology practice: the Vanderbilt ASAP experience.

PURPOSE OF REVIEW: In the aftermath of reforms in healthcare laws, there is a focused conversation concerning healthcare delivery with an increasing emphasis on quality, cost containment, improved outcomes and access. Concurrently, providers are experiencing pressure as patient volume escalates yet while funding levels fail to keep pace. Addressing these issues is imperative to the medical practices. In this review, the integration of an allergy and rhinology practice into a center focused on managing chronic airway disease is detailed in the examination of an existing practice. RECENT FINDINGS: In 2010, healthcare spending in the Unites States was nearly US$ 2.6 trillion, 17.9% of the nation's gross domestic product and 10 times 1980 levels. Insurance premiums have increased 113% since 2001 and continue to outpace income gains. Seventy-five percent of spending is attributed to chronic diseases such as stroke, cancer, heart disease, diabetes, Parkinson's disease and Alzheimer's. Airway disease (rhinitis, sinusitis, asthma, chronic obstructive pulmonary disease) is one of the largest chronic disease states. In fact, more patients suffer from airway disease than the aforementioned diseases in total. Any effort to affect costs must include a chronic disease strategy. This review will focus on the nature of the integrated program and its relation to the nature of airway diseases; a detailed description of how it works and why it is different from traditional models. SUMMARY: This integrated model of healthcare will improve the quality of care provided to airway disease patients as well as help contain overall healthcare cost.

Five 'nontraditional' techniques for use in patients with recalcitrant sinusitis.

PURPOSE OF REVIEW: Although endoscopic sinus surgery remains the mainstay of surgical approaches to treating paranasal sinus disease, some disease may require alternative approaches. We review here five techniques: endoscopic middle turbinectomy, maxillary sinoscopy, the Caldwell-Luc procedure, intranasal inflammatory polyp steroid injection, and frontal sinus trephine. RECENT FINDINGS: Recent findings suggest that endoscopic sinus surgery is limited in certain cases to access particular anatomic sites that may contain disease. The anterior, inferior maxillary wall and the frontal sinus may be accessed externally with minimal morbidity, and this access may be critical to treating the disease. The middle turbinate can contribute to preoperative and postoperative obstruction of sinus drainage, and resection of it can benefit the patient in many ways. Finally, the management of intranasal inflammatory polyps remains a challenge. In both preoperative and postoperative patients, the polyps may not respond to standard and even aggressive topical therapies. Intrapolyp steroid injection can provide a substantial anti-inflammatory effect and may avoid surgery for some patients. SUMMARY: This article will review five ancillary procedures that add to the rhinologist's skill set to treat difficult or recalcitrant paranasal sinus disease.

Malpractice in head and neck surgery: a review of cases.

OBJECTIVE: To examine the sources of litigation related to the practice of head and neck surgery. STUDY DESIGN: Analysis of malpractice claims directly related to the diagnosis and treatment of head and neck disease provided by 16 medical liability insurance companies. SETTING: Not applicable. SUBJECTS AND METHODS: Data were obtained from 16 members of the Physician Insurers Association of America. All claims were either filed or closed between 1978 and 2007. Claims were evaluated for patient age, the cause for the claim, any surgical complications, and indemnity paid. RESULTS: Three hundred fifteen claims were identified between 1978 and 2007. The mean patient age was 48 years (median, 47 years). The greatest number of claims came from the 36- to 45-years age group (n = 68, 24.6%). Perioperative complications represented the largest cause of claims (n = 169, 53.7%), followed by delay of or missed diagnosis (n = 109, 34.6%) and persistence or recurrence of disease (n = 21, 6.7%). Among perioperative complications, nerve injuries were the largest group (n = 64, 20.3%), followed by airway-related claims (n = 27, 8.6%), esophageal injuries (n = 14, 4.4%), poor cosmetic results (n = 14, 4.4%), vessel injuries (n = 11, 3.5%), and postoperative infections (n = 2, 0.6%). Overall, mortalities resulted in 62 (19.7%) claims. CONCLUSIONS: Four important risks for malpractice litigation in head and neck surgery were identified: young patient age, perioperative complications, delay of or missed diagnosis, and persistence or recurrence of disease.

First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis.

BACKGROUND: To report outcomes for subjects undergoing balloon dilation in either the operating room (OR) or the clinic and define criteria to identify suitable candidates for local anesthesia procedures. METHODS: Subjects with medically refractory chronic rhinosinusitis (CRS) underwent de novo surgery via transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum. Concomitant nasal or endoscopic sinus surgeries were contraindicated. Technical success, surgical parameters, and long-term outcomes were evaluated through 12-month follow-up. RESULTS: Seventy-one subjects underwent balloon dilation and 94% completed follow-up through 12 months. A total of 132 maxillary ostia were targeted for treatment and 129 were successfully dilated (98%). Almost one-half (33) of the procedures were performed in the OR under local anesthesia with intravenous sedation. Average balloon procedure times for unilateral and bilateral treatment were 28.3 ± 21.1 and 40.2 ± 17.7 minutes, respectively. Thirty-three ostial dilations in 19 subjects were attempted in the clinic. Each ostium was successfully accessed and ballooned under local anesthesia. Patient tolerance was very good with an average self-reported pain level of 2.7 (2 = hurts a little bit) out of 10. Each subject was discharged within 2 hours of the procedure and there was no postoperative bleeding. Symptomatic improvement of the clinic subgroup at 3, 6, and 12 months postprocedure was statistically significant (p ≤ 0.0012) and clinically meaningful and similar in magnitude to improvement seen across all subjects regardless of site of service. CONCLUSION: Transantral balloon dilation can be performed safely in the clinic and operative settings with symptom improvement sustained through 1 year.

Comparison of maxillary sinus specimens removed during Caldwell-Luc procedures and traditional maxillary sinus antrostomies.

The cases of 80 patients who underwent Caldwell-Luc surgery for the treatment of chronic rhinosinusitis between 2002 and 2007 at Vanderbilt University Medical Center's Department of Otolaryngology were reviewed. Data on demographics, comorbidities, details of surgery, surgical pathology, and histology were collected. These data were compared with those of 40 patients who underwent standard functional endoscopic sinus surgery in 2007. Statistically significant differences were found in terms of mean patient age, sex, mean number of sinuses surgically addressed, number of prior surgeries, and tissue eosinophil counts. Microscopic examination revealed the presence of "necrotic bone" in 2 Caldwell-Luc specimens, and "necrotic debris" in 2 other Caldwell-Luc specimens. No similar finding was seen in the control group. Caldwell-Luc is a surgery of last resort for patients who fail aggressive interventions for maxillary sinus disease. The mucosal lining of this small group of patients appears to be different from that of patients who respond favorably to functional endoscopic sinus surgery.

Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum.

BACKGROUND: Although multiple clinical trials have demonstrated that balloon dilation of sinus ostia in patients diagnosed with chronic rhinosinusitis (CRS) results in sustained symptomatic improvement, less data are available to measure the effects of sinusitis on worker productivity. The objective of our research was to analyze work and activity impairment before and after transantral, endoscopically-guided balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. METHODS: Subjects diagnosed with CRS and computed tomography (CT) evidence of disease in the maxillary sinuses alone, or maxillary and anterior ethmoid sinuses, completed the Work Productivity and Activity Impairment (WPAI) questionnaire and the Work Limitation Questionnaire (WLQ) before treatment and at 3, 6, and 12 months postprocedure. RESULTS: A total of 56 subjects were enrolled and 53 completed the 1-year follow-up. The lost productivity composite score computed from the WLQ improved by 73% (9.0 to 2.4; p < 0.0001) at 1-year follow-up whereas lost productivity at work as measured by the WPAI improved by approximately 76% (38.3 to 9.2; p < 0.0001) 12 months after treatment. CONCLUSION: These results indicate that sinus-related health problems impose a substantial burden on work productivity and physical/mental activity levels. Treatment of CRS by dilating the maxillary sinus ostium and ethmoid infundibulum can significantly improve quality of life (QOL) and work productivity.

Proton pump inhibitor therapy improves symptoms in postnasal drainage.

BACKGROUND & AIMS: Gastroesophageal reflux is common among patients with postnasal drainage. We investigated whether proton pump inhibitor therapy improved symptoms in patients with postnasal drainage without sinusitis or allergies. METHODS: In a parallel-group, double-blind, multi-specialty trial, we randomly assigned 75 participants with continued symptoms of chronic postnasal drainage to groups that were given 30 mg of lansoprazole twice daily or placebo. Participants were followed up for 16 weeks. Symptoms were assessed at baseline and after 8 and 16 weeks. Ambulatory pH and impedance monitoring assessed presence of baseline reflux. The primary objective of the study was to determine if acid suppressive therapy improved postnasal drainage symptoms. The secondary objective was to assess if pH and impedance monitoring at baseline predicted response to treatment. RESULTS: Postnasal drainage symptoms improved significantly among patients given lansoprazole compared with placebo. After 8 and 16 weeks, participants given lansoprazole were 3.12-fold (1.28-7.59) and 3.50-fold (1.41-8.67) more likely to respond, respectively, than participants given placebo. After 16 weeks, median (interquartile) percent symptom improvements were 50.0% (10.0%-72.0%) for participants given lansoprazole and 5.0% (0.0%-40.0%) for participants given placebo (P = .006). Neither baseline presence of typical reflux symptoms nor esophageal physiologic parameters predicted response to therapy. CONCLUSIONS: Among participants with chronic postnasal drainage without evidence of sinusitis and allergies, twice-daily therapy with proton pump inhibitors significantly improved symptoms after 8 and 16 weeks. The presence of heartburn, regurgitation, abnormal levels of esophageal acid, or nonacid reflux did not predict response to therapy.

A review of malpractice cases after tonsillectomy and adenoidectomy.

OBJECTIVE: To examine sources of litigation following tonsillectomy and/or adenoidectomy. STUDY DESIGN: Analysis of malpractice claims filed after tonsillectomy or adenoidectomy provided by 16 medical liability insurance companies. SETTING: Not applicable. SUBJECTS AND METHODS: Data was obtained from 16 members of the Physician Insurers Association of America. All claims were either filed or closed between 1985 and 2006. Claims were evaluated and categorized according to the type of complication. RESULTS: One hundred and fifty-four claims were identified between 1985 and 2006. Six categories were created based on frequency of claims (bleeding complication n=27 [17.5%], airway fire n=2 [1.5%], burns n=28 [18.2%], consent related n=9 [5.8%], medication related n=9 [5.8%] and residual tissue/recurrence n=9 [5.8%]). Other less frequent claims were grouped as miscellaneous n=70 [45.5%]. CONCLUSIONS: A significant portion of malpractice claims following tonsillectomy or adenoidectomy are related to complications not commonly discussed in the literature.

Prevention and management of complications in maxillary sinus surgery.

This article is divided into six sections that are related to six commonly used operations for surgery on the maxillary sinus. The authors discuss maxillary sinoscopy, the Caldwell-Luc procedure, extended middle meatus antrostomy, endoscopic maxillary sinus antrostomy, minimally invasive sinus technique, and balloon sinus procedures. In each of these procedures, the authors discuss potential complications and address prevention and management strategies. Maxillary sinus surgery can greatly improve patients' symptoms and disease process. The authors encourage the surgeon to take great care in ensuring sound surgical principles. Understanding the potential areas in which surgery can fail will help tremendously in preventing complications.

Malpractice claims in nasal and sinus surgery: a review of 15 cases.

Otolaryngologists may encounter claims of medical malpractice during the course of their careers. A sample of 15 cases involving patient claims of medical malpractice relating to care delivered for problems of the nose and paranasal sinus is presented. A short summary of each case is provided, which may be useful to practicing otolaryngologists.

The ethmo-frontal angle: a new anatomic and radiologic landmark for use in sinus surgery.

OBJECTIVE: To identify anatomic and radiologic landmarks to assist with frontal sinus surgery. STUDY DESIGN: Retrospective review. SUBJECTS AND METHODS: Sinus CT scans of 50 patients were evaluated with respect to a new radiologic and anatomic landmark, the ethmo-frontal angle (EFA). RESULTS: Right-sided EFA ranged from 135 to 171 degrees. Left-sided EFA ranged from 136 to 167 degrees. Measurements of both sides displayed a normal distribution. When right and left sides within individuals were compared, there was no correlation to indicate a high degree of variation between any particular patient's right and left side EFA. CONCLUSION: The EFA is a new landmark to assist otolaryngologists during surgery on and around the frontal sinus. Normal values for this angle have been presented. Surgeons should be aware that asymmetry in a patient's EFA is common, and each side should be examined individually.

Endoscopic endonasal repair of difficult-to-access cerebrospinal fluid leaks of the frontal sinus.

BACKGROUND: Cerebrospinal fluid (CSF) leaks located within the frontal sinus can be difficult to repair effectively. Additional challenges arise from the need to simultaneously repair the leak or defect and to ensure the future patency of the sinus itself. METHODS: The cases of two patients who underwent surgical repair of CSF leaks and skull base defects located in difficult to access locations within their frontal sinuses were reviewed. RESULTS: Two patients with CSF leaks in the frontal sinus underwent surgery to repair the leaks. The leaks were in the superomedial and superolateral locations within the sinus. One leak (in the superolateral location) was secondary to iatrogenic surgical trauma during craniotomy. The second leak (in the superomedial location) was secondary to congenital encephalocele. Surgical approach to ensure adequate exposure was via endoscopic modified Lothrop procedure. Successful repair was undertaken via underlay technique. At follow-up (27 and 7 months, respectively), frontal sinuses remained patent without evidence of CSF leak. CONCLUSION: CSF leaks located in medial and lateral areas of the frontal sinus may be successfully repaired via endonasal approach with endoscopic modified Lothrop. Repair in this manner requires that attention be paid both to achieving a complete repair and to maintaining a patent sinus drainage pathway.

Revisiting the interpretation of positive sinus CT findings: a radiological and symptom-based review.

OBJECTIVE: It is widely believed that a high percentage of normal, healthy patients without sinusitis symptoms have abnormal findings on sinus CT. Experiences of the authors of this study suggest otherwise. STUDY DESIGN: Cross-sectional survey. SUBJECTS AND METHODS: Head/sinus CT scans of 50 consecutive patients from each of three study groups were reviewed. Group 1 consisted of patients without any sinus symptoms. Group 2 consisted of patients with acute headache symptoms. Group 3 consisted of patients with complaints consistent with chronic sinusitis. CT scans were evaluated with the Lund-Mackay scoring system. RESULTS: In the asymptomatic patient group (group 1), six (3%) patients had positive sinus CT scan findings, compared with 11 (5.5%) in the acutely symptomatic group (group 2), and 32 (64%) in the chronically symptomatic group (group 3). In the chronically symptomatic group (group 3), 64 percent of patients were allergic compared with 18% of the acute headache group (group 2) and 8 percent of the asymptomatic patient group (group 1). CONCLUSION: Results of this study suggest that symptomatic sinus patients are much more likely to have positive sinus CT scan findings than asymptomatic patients. Conversely, normal healthy patients should not be expected to have abnormal sinus CT scans.

Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis.

OBJECTIVE: The purpose of this study was to review use of balloon sinuplasty for surgical treatment in critically ill patients with acute sinusitis. STUDY DESIGN: Case series with chart review. SUBJECTS AND METHODS: Patients who underwent balloon sinuplasty between October 2007 and March 2008 were identified. Medical records of the subset of patients who were immunocompromised or otherwise critically ill were analyzed. RESULTS: Thirty-one patients underwent balloon sinuplasty at our institution between October 2007 and March 2008. We identified five critically ill patients with sinus disease within this group. Patient ages ranged from 15 to 51 years with no sex preponderance. All patients had focal findings on a sinus CT scan. In all cases, purulent drainage was noted intraoperatively. All patients returned to baseline health meeting discharge criteria after treatment. CONCLUSION: Balloon sinuplasty represents a potentially less invasive surgical option than standard Functional Endoscopic Sinus Surgery (FESS) and should be considered in the treatment of critically ill or immunocompromised patients.

Surgery of the inferior and middle turbinates.

For over a century, surgical management of the inferior and middle turbinates has been an ongoing topic of discourse and disagreement. Treatment, either medical or surgical, of the inferior turbinate is required in cases of turbinate hypertrophy where the goals of therapy are to maximize the nasal airway, to preserve nasal mucosal function, and to minimize complications. Middle turbinate management, more controversial than inferior turbinate management, still lacks definitive consensus. This article reviews the anatomy, physiology, and pathology involving these two structures. Advantages, disadvantages, complications, and controversies surrounding the surgical management of the turbinates are discussed.

Current issues in the management of sinonasal methicillin-resistant Staphylococcus aureus.

PURPOSE OF REVIEW: Staphylococcus aureus is an important pathogen, contributing to both pediatric and adult infections in the USA. In recent years, methicillin-resistant Staphylococcus aureus (MRSA) has become a source of public fear and outcry. In this article, we review facts and fiction of sinonasal MRSA. RECENT FINDINGS: Although the exact role of bacteria in chronic rhinosinusitis continues to be debated, the role of MRSA in these patients is even less apparent. When MRSA is involved, there are few to guide treatment. Oral, parenteral, and topical antibiotics are all used in the treatment of sinonasal MRSA. MRSA eradication has been advocated by some; however, there are few data to support the efficacy of eradication. Current treatment regimens by the authors are reviewed. SUMMARY: There is much that is not known about the role of MRSA in sinonasal infection, and the impact of sinonasal MRSA on the health quality of the community also remains undefined. Treatment outlines are presented; however, with the current state of data, these treatment preferences lack a solid, evidence-based foundation that is favored. Future studies will lay the foundation for more rigorously supported treatment algorithms.