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Literature Review: A Roundup of Important Recent Studies

Patients Need to Be Better Informed About Steroid Complications

What are the medico-legal implications of corticosteroid use in patients with chronic rhinosinusitis and/or allergic rhinitis?

Background: Corticosteroids are a mainstay of treatment for inflammatory disease of the upper airway. Because of their beneficial anti-inflammatory effects, many physicians utilize oral corticosteroids as part of a regimen of “maximal medical therapy” for the treatment of chronic rhinosinusitis. However, in light of their potential complications, uncertainty regarding the use of these agents, as well as informed consent and medico-legal implications, exist for treating physicians.

Study design: Literature review.

Setting: Division of Otolaryngology, Department of Surgery, Zablocki VA Medical Center, Milwaukee, Wisconsin; Department of Otolaryngology-Head and Neck Surgery, Oregon Health and Science University, Portland.

Synopsis: Complications from steroid use can be extensive, ranging from psychiatric reactions to skin changes, loss of bone density and avascular necrosis (AVN) of the bone. AVN is the complication that most often leads to litigation. While this condition typically occurs with longer courses of higher doses of steroids, studies of short-term use with lower doses also exist. One notable study found 15 patients with AVN who had received a single course of steroids over a three-year period. The mean cumulative dose was 850 mg of prednisone (range, 290–3300 mg), and the mean duration was 20.5 days (range, 6–39 days). Litigation related to steroid use, according to the WESTLAW database, identifies 65 percent of cases related to “negligent use of steroids,” while 36 percent allege “lack of informed consent or incomplete/unclear consent.”

Bottom line: Clear explanations regarding the use of steroids and their expected benefits and potential risks, as well as possible alternatives, should be presented to patients. These discussions should be documented.

Reference: Poetker DM, Smith TL. What rhinologists and allergists should know about the medico-legal implications of corticosteroid use: a review of the literature. Int Forum Allergy Rhinol. 2012;2(2):95-103.

—Reviewed by Brent Senior, MD

Major Complications from Endoscopic Sinus Surgery on the Decline

What is the nationwide incidence of major complications from endoscopic sinus surgery?

Background: Although endoscopic sinus surgery is one of the most common surgeries performed in otolaryngology, knowledge of major complications is limited. Early studies with small patient cohorts at academic institutions estimated the occurrence of complications to be 1 to 3 percent of cases. This study is an attempt to determine a more accurate rate by utilizing a large nationwide patient database.

Study design: Retrospective review of a nationwide database of endoscopic sinus surgery procedures. Major post-operative complications, including hemorrhage requiring blood transfusion, CSF leak and orbital injury, were analyzed by searching the database for ICD-9 and CPT codes.

Setting: Department of Otolaryngology, University of Colorado Anschutz Medical Campus, Aurora; Department of Otolaryngology-Head and Neck Surgery, Stanford University, Palo Alto, California; Department of Otolaryngology-Head and Neck Surgery, University of Utah, Salt Lake City.

Synopsis: Data analyses of patients undergoing endoscopic sinus surgery, comprising 62,823 patients, were reviewed for the years 2003 to 2007. The overall major complication rate was found to be 1 percent. CSF leak was encountered in 0.17 percent; orbital injury in 0.07 percent; and hemorrhage requiring transfusion in 0.76 percent. Stratified for age, CSF leak was seen less frequently in the pediatric population, while orbital injury occurred more frequently in children younger than 12 years of age. Meaningful assessment of the impact of image guidance in reducing complications could not be achieved.

Bottom line: Major complications from endoscopic sinus surgery appear to have declined compared with even the best of earlier studies from the late 1990s. The most common complication is post-operative hemorrhage requiring transfusion, followed by CSF leak, then orbital injury—which together comprise fewer than 1 percent of total cases.

Reference: Ramakrishnan VR, Kingdom TT, Nayak JV, et al. Nationwide incidence of major complications in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(1):34-39.

—Reviewed by Brent Senior, MD

First Review of Frontal Sinus Inverted Papilloma Surgical Management

What is the best surgical management of frontal sinus (FS) inverted papilloma (IP), according to a review of the literature?

Background: IP is a benign sinonasal tumor with an estimated incidence of 01.74/100,000 cases a year. Surgical resection is important due to IP’s aggressive nature, propensity for recurrence and potential to harbor squamous cell carcinoma. Between 1 and 16 percent of IPs originate in the frontal sinus. Management of FS IP remains a significant surgical challenge.

Study design: Literature review.

Setting: Department of Otolaryngology-Head and Neck Surgery, Comprehensive Skull Base Program and Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.

Synopsis: In 11 studies, 49 cases were deemed adequate for analysis. The surgical approach to FS included endoscopic frontal sinusotomy (EFS) in 42.9 percent of patients, endoscopic modified Lothrop procedure in 20.4 percent, osteoplastic flap in 26.5 percent and EFS combined with other endoscopic approaches (above/below) in 10.2 percent. There was a high prevalence of secondary disease (51 percent) and frequent involvement of bilateral FSs (16.3 percent). The overall rate of recurrence was 22.4 percent, with no variables found to be statistically significant between recurrence and non-recurrence. The authors said the data in their study represent an aggregate of multiple studies from different surgeons, with inherent biases on the optimal management strategy for FS IP, which is therefore a limitation of this study.

Bottom line: The recurrence rate underscores the surgical challenge, but the authors were unable to identify specific trends to demonstrate the superiority of one surgical approach over others.

Reference: Walgama E, Ahn C, Batra PS. Surgical management of frontal sinus inverted papilloma: a systemic review. Laryngoscope. 2012;122(6):1205-1209.

—Reviewed by Sue Pondrom

Clinical Tests of Peripheral Vestibular Function Are Reviewed

What is the anatomical and physiological evidence underpinning the tests of both canal and otolith function?

Background: The interpretation of vestibular test results depends heavily on basic anatomical and physiological information. New clinical tests of canal and otolith function have been introduced, but the anatomical and physiological evidence for their interpretation is not well known.

Study design: Contemporary review.

Setting: Vestibular Research Laboratory, School of Psychology, University of Sydney, New South Wales, Australia.

Synopsis: The author described tests of semicircular canal function, including the caloric test, head impulse testing and tests of static otolith function. Regarding primary physiological evidence, the author recapitulated the anatomical and physiological evidence about the otoliths. He put forward a hypothesis speculating that measuring oculomotor responses to air-conducted sound (ACS) and bone-conducted vibration (BCV) probes predominately utricular function, whereas measuring neck muscle responses to ACS and BCV mainly probes saccular function. He noted that this differential probing of utricular and saccular function is possible because of their differential neural projections.

In a section titled “Testing Dynamic Otolith Function by Vestibular-Evoked Myogenic Potentials,” the author discussed cervical vestibular-evoked myogenic potential (cVEMP) and ocular vestibular-evoked myogenic potential (oVEMP), noting that these tests are vestibular because patients who are totally deaf show the myogenic potentials to ACS or BCV, and patients after systemic gentamicin with likely absent vestibular function but residual hearing do not show the myogenic potentials. For clinical evidence, the author discussed dissociation and BCV versus ACS, including recent comparisons between the frequency response of oVEMPs to ACS and to BCV.

Bottom line: The overwhelming weight of physiological and clinical evidence supports oVEMP, but the exact mechanism by which BCV and ACS cause hair-cell deflections is not known. Additionally, when the results of oVEMP and cVEMP tests are combined with the results of other vestibular tests, the clinician can obtain a picture of the state of the peripheral vestibular function of each sense organ of the labyrinth.

Reference: Curthoys IS. The interpretation of clinical tests of peripheral vestibular function, Laryngoscope. 2012;122(6):1342-1352.

—Reviewed by Sue Pondrom

Identification of Prognostic Factors for Head and Neck Merkel Cell Carcinoma

What are the prognostic indicators for head and neck Merkel cell carcinoma (HN-MCC), and how do these compare with patients who have non-head and neck (NHN) MCC?

Background: MCC is a rare, aggressive cutaneous neoplasm that occurs most frequently in the head and neck region. Prognostic factors are not well characterized, but prognosis is considered poor. Whether HN-MCC requires separate consideration from MCC that occurs in other regions is uncertain.

Study design: Retrospective analysis of a large population database.

Setting: College of Medicine, Hollings Cancer Center, the Department of Surgery-Division of Surgical Oncology, and Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston.

Synopsis: The authors identified 2,104 HN-MCC patients and 2,272 NHN-MCC patients using the SEER database. Disease-specific survival was similar between the groups. In comparing differences in clinicopathologic characteristics between the groups, the team identified independent prognostic factors in HN-MCC such as male gender, lip primary site, tumor extension beyond the dermis, histologically confirmed nodal disease, absence of histologic lymph node evaluation and distant metastasis. Male gender and tumor extension limited to the subcutis are factors for poor prognosis that are unique to HN-MCC. In contrast to the current American Joint Committee on Cancer staging system, this study reports that increasing tumor size does not appear to predict survival for patients with HN-MCC; therefore, staging tumors according to size may not be accurate. Patients with tumors on the lip were noted to have the poorest survival. The authors also demonstrated that the five-year survival rate was worse for patients only evaluated clinically compared with those who received pathologically confirmed negative nodal disease. Differences between HN-MCC and NHN-MCC were found with regard to lymph node metastasis. A limitation of the study was that analysis was limited to data collected by the Surveillance, Epidemiology and End Results (SEER) registries.

Bottom line: Factors that predict poorer disease-specific survival for patients with HN-MCC include male gender, lip primary site, subdermal tumor extension, nodal disease and distant metastasis. In contrast to patients with NHN-MCC, sentinel lymph node status was not predictive of survival for those with HN-MCC. However, the authors recommend routine histopathological analysis of the regional nodes for all MCC patients because of its prognostic significance.

Reference: Smith VA, Camp ER, Lentsch EJ. Merkel cell carcinoma: identification of prognostic factors unique to tumors located in the head and neck based on analysis of SEER data. Laryngoscope. 2012;122(6):1326-1330.

—Reviewed by Sue Pondrom

Nomenclature Paradigm for Benign Midmembranous Vocal Fold Lesions

Is there a validated multidimensional nomenclature paradigm for benign midmembranous vocal fold lesions (BVFL)?

Background: There is a significant lack of uniform agreement regarding nomenclature for BVFLs, with confusion resulting in difficulty for clinicians in communicating with their patients and with each other. Additionally, BVFL research and comparison of treatment methods are hampered by the lack of a detailed and uniform BVFL nomenclature.

Study design: Analysis of results from clinical consensus conferences, and video-perceptual analysis of a retrospective review of patients.

Setting: University of Pittsburgh Voice Center, Department of Otolaryngology, University of Pittsburgh School of Medicine, Pennsylvania; Otolaryngology-Head and Neck Surgery, University of Texas Health Science Center, San Antonio; Department of Otolaryngology, MCG Center for Voice and Swallowing Disorders, Georgia Health Sciences Health System, Augusta; University of California San Francisco; Department of Otolaryngology-Head and Neck Surgery, Drexel University College of Medicine, Philadelphia, Pennsylvania.

Synopsis: The authors used multidimensional definitions for each lesion and validated the paradigm developed at clinical consensus meetings by retrospectively applying it to a cohort of patients with BVFL using video-perceptual analysis. A perceptual analysis of vibratory properties of the mucosa on stroboscopy was performed. Additional criteria used included response to voice therapy and operative findings. The team provided nomenclature for nine distinct BVFLs: vocal fold nodules, vocal fold polyps, vocal fold cysts (subepithelial or ligament), vocal fold fibrous mass (subepithelial or ligament), reactive lesion, non-specific vocal fold lesions and pseudocysts.

Bottom line: The study presented a proposal for a clinically based, defined nomenclature paradigm for BVFL that applied multiple criteria.

Reference: Rosen CA, Gartner-Schmidt J, Hathaway B, et al. A nomenclature paradigm for benign midmembranous vocal fold lesions. Laryngoscope. 2012;122(6):1335-1341.

—Reviewed by Sue Pondrom