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Literature Review: A Roundup of Important Recent Studies

MRI Cost Justified in Dysosmia

Is magnetic resonance imaging (MRI) warranted for the workup of idiopathic anosmia in today’s climate of cost containment in health care?

Background: Anosmia can result from many causes, both intranasal and intracranial. Failure to diagnose an intracranial cause of anosmia can lead to a poor medical outcome for the patient and a negative medicolegal outcome for the physician.

Study design: Retrospective chart review.

Setting: Tertiary care academic center: Feinberg School of Medicine, Northwestern University, Chicago.

Synopsis: Of the 122 patients included in the study, 44.3 percent of MRIs were normal, and 55.7 percent were abnormal, of which 25.4 percent were dysosmia-related findings and 40.2 percent were incidental findings. The most common dysosmia-related disagnosis was frontoethmoid sinusitis (18.8 percent) and the most common incidental finding was small vessel disease. Nine patients had intracranial causes of dysosmia and six had intracranial neoplasms. MRI cost per dysosmia etiology diagnosis was $9,445. From 1997 to 2003, median medical malpractice settlements and jury awards ranged from $625,616 and $975,000 for misdiagnosis to between $682,500 and $1,550,000 for delay in treatment. In patients with idiopathic anosmia, MRI identified a possible etiology in one-quarter of the cases.

Bottom line: The consequences of missing an intracranial process or neoplasm in a patient with anosmia justify the expense of an MRI.

Citation: Decker JR, Meen EK, Kern RC, Chandra RK. Cost effectiveness of magnetic resonance imaging in the workup of the dysosmia patient. Int Forum Allergy Rhinol. 2013;3:56-61.

—Reviewed by John M. DelGaudio, MD

ESS Superior to Medical Therapy for QOL in CRS

For patients with chronic rhinosinusitis (CRS), does surgery provide better results for symptom control and quality of life (QOL) than medical treatment alone?

Background: Anecdotal evidence supports the effectiveness of endoscopic sinus surgery (ESS) in improving symptoms of chronic sinusitis, but there has been a lack of prospective control studies. This study prospectively compares the results of ESS with medical therapy for CRS patients who are candidates for ESS based on failed maximal medical therapy.

Study design: Prospective nonrandomized cohort.

Setting: Four tertiary academic rhinology practices: Oregon Health and Science University in Portland; Northwestern University in Chicago; Medical University of South Carolina in Charlestown; and the University of Pennsylvania in Philadelphia.

Synopsis: One-year follow up of three cohorts showed significantly better improvement in multiple disease-specific QOL measures in the surgical patients (n = 65) and medically managed patients who crossed over to the surgical arm during the study (n=17) than in medically managed patients (n = 33). Patients who were initially treated medically and switched to the surgical arm did so due to persistence or worsening of disease. This prospective study reports that, at a one-year follow-up, patients electing surgery for CRS showed greater improvement than patients electing medical therapy alone.

Bottom line: In patients who are candidates for ESS, the surgery results in greater disease-specific QOL improvements than medical therapy.

Citation: Smith TL, Kern R, Palmer JN, et al. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2012;3:4-9.

—Reviewed by John M. DelGaudio, MD

First-Line Steroid Therapy Can Improve Outcomes for ISSHL

Is intratympanic steroid therapy an effective first-line therapy for patients with moderate idiopathic sudden sensorineural hearing loss (ISSNHL)?

Background: The causes of moderate ISSNHL are unknown, limiting the ability to find effective treatments. Steroids have become the most widely accepted treatment form; however, previous studies of their effectiveness have lacked a placebo control group, and have shown effectiveness of steroid therapy in treatments for ISSNHL patients in whom previous systemic therapy has failed.

Study design: Prospective, randomized, triple-blind, placebo-controlled trial.

Setting: Patients were referred from the Sapienza University of Rome and four private otolaryngology practitioners.

Synopsis: Fifty patients presenting with moderate ISSNHL with flat audiograms (250 Hz to 8,000 Hz) were enrolled in the study and randomized into two groups. Inclusion criteria were diagnosis within three days of onset of symptoms, no previous ISSNHL therapy and an age between 15 and 85 years. Twenty-five patients were given 0.3 ml of prednisolone (62.5 mg/mL once per day for three days); 25 control patients were given an IT injection of 0.3 mL of a saline solution once a day for three days. All patients underwent audiometric tests using standardized methods for pure-tone threshold audiometry at study entry, and seven days (T1), 17 days and 37 days after first treatment. Patients who did not show a complete recovery at T1 received oral prednisolone for eight days. Complete recovery, marked improvement, slight improvement and no recovery at T1 were recorded in 19 patients (76 percent), two patients (2 percent), three patients (12 percent) and one patient (4 percent), respectively, in the steroid group; in the control group, numbers were recorded at five patients (20 percent), no patients, no patients and 20 patients (80 percent), respectively. Results suggest that systemic steroid therapy cannot be considered a salvage therapy in case of IT steroid failure, and the lack of a speech discrimination audiometry was a study shortcoming.

Bottom line: The mean improvement recorded in the steroid group at T1 shows a significant therapeutic benefit for first-line intratympanic steroid therapy.

Citation: Filipo R, Attanasio G, Russo FY, Viccaro M, Mancini P, Covelli E. Intratympanic steroid therapy in moderate sudden hearing loss: a randomized, triple-blind, placebo-controlled trial. Laryngoscope. 2013;123:774-778.

—Reviewed by Amy Eckner

TORS Total Laryngectomy Effective for Salvage Surgery

Is transoral robotic surgery a feasible procedure for total laryngectomies to treat advanced larynx cancer?

Background: Procedures for total laryngectomies have remained largely unchanged for more than 100 years, and many physicians now use the procedure primarily as a salvage surgery following chemotherapy and radiology. However, because salvage laryngectomies are often performed on compromised tissues, they are complex and require more resources due to an increase in pharyngocutaneous fistulae. The use of transoral robotic surgery (TORS) has allowed for more complex transoral procedures. Unlike previous studies, this series uses TORS in a salvage setting.

Study design: Multinational, prospective consecutive case series.

Setting: Multinational institutions.

Synopsis: Seven patients underwent the procedure, six of whom had previously received chemotherapy and/or radiation therapy and needed the procedure to manage recurrence or treatment sequelae, and one of whom required a total laryngectomy to manage complications following long-term intubation and multiple surgical failures. Each patient presented with a unique set of circumstances and comorbidities. Two additional patients were unable to participate because proper robotic access to the larynx was limited. This minimally invasive TORS procedure was developed in cadaver models using the daVinci Surgical System (Intuitive Surgical Inc., Sunnyvale, Calif.) and evaluated on an institutional board-approved protocol. Detailed review of surgical technique in the study includes approach to the airway, positioning of equipment and assistant, resection, removal of the larynx and closure. Fistulaes occurred in two patients due to low tracheotomies and distal access issues.

Exact indications and limitations of this procedure are not yet defined, and adequate visualization and high surgical skill are required. Although this series is very limited, it does show TORS feasibility in salvage surgery with standard oncologic results. A larger series is needed to confirm a decreased need for routine flap use. The authors believe this procedure is best used for salvage when there is no need for a concomitant neck dissection.

Bottom line: TORS total laryngectomies are feasible and reproducible across facilities, but the procedure is in its infancy, and exact indications and patient selection remain unclear.

Citation: Smith RV, Schiff BA, Sarta C, Hans S, Brasnu D. Transoral robotic total laryngectomy. Laryngoscope. 2013;123:678-682.

—Reviewed by Amy Eckner

Cidofovir Effective for Recurrent Respiratory Papillomatosis

Is cidofovir a safe, effective treatment for adult and pediatric otolaryngology patients with recurrent respiratory papillomatosis?

Background: Recurrent respiratory papillomatosis (RRP) is rare, and there is no known cure. Treatment consists of repeated surgical debulking of papillomata to improve symptoms. Cidofovir is beneficial for severe RRP, but this off-label use comes with a possibility of systemic toxicity. In January 2011, cidofovir’s manufacturer issued a general warning against off-label uses.

Study design: Cross-sectional study from an online survey.

Setting: Selected adult and pediatric laryngeal surgeons worldwide.

Synopsis: One hundred fifteen surgeons received a 21-question online survey; 82 surgeons, representing 3,043 RRP patients, responded. Respondents were asked to identify and rank specific clinical criteria to begin cidovofir treatment. Most respondents use a concentration of 5 mg/mL and administer <4 mL for adults, and a concentration of 5 mg/mL with administration of ≤ 2 mL for children. A majority of respondents use a set administration schedule, with a greater tendency toward scheduled administration for children. Respondents generally allow up to five injections to determine efficacy; there was no clearly preferred action for partial response. After a complete response, the majority of respondents stop cidofovir immediately. In adults and children, most respondents obtain biopsies routinely at each surgery, although this varies more with children. The most common adverse event in adults and children was squamous dysplasia. Despite the warning letter, most respondents indicated they would continue use of cidofovir for RRP. Because this study relied on respondents’ estimates, however, it cannot be compared to a true patient cohort, and the potential for recall bias disallows estimates of prevalence and incidence.

Bottom line: In general, cidofovir is recommended for RRP patients who require surgical debulking at least every two to three months.

Citation: Derkay CS, Volsky PG, Rosen CA, et al. Current use of intralesional cidofovir for recurrent respiratory papillomatosis. Laryngoscope. 2013;123:705-712.

—Reviewed by Amy Eckner

High-Volume Academic Medical Centers Have Lower Complication Rates for Head and Neck Oncologic Surgery

Do patient volume and other variables have an impact on outcomes of head and neck oncologic surgery?

Background: Study authors analyzed the University HealthSystem Consortium (UHC) database, a collection of patient-level UB-04 billing data from 90 percent of U.S. nonprofit academic medical centers, for patients who underwent head and neck surgery (except thyroid and skin cancer) at member centers between Q4 2006 and Q4 2009. Centers were designated high volume (> 50 cases/year), moderate volume (22-49 cases/year) and low volume (< 22 cases/year).

Study design: Cross-sectional ecological study; regression analysis used for some statistics.

Setting: Boston University; University of California, San Diego.

Synopsis: The primary clinical outcomes were mortality, mortality index, length of stay (LOS), LOS index, complication rate, cost and cost index. Results came from 93 hospitals. A majority of patient statistics came from white males aged 52 and older. High-volume medical centers had a higher proportion of patients 65 and older, fewer black and Hispanic patients, more patients with private insurance, a lower mean admission cost, a lower complication rate after controlling for other factors and more comorbidities but a lower use of ICU and substantially lower LOS and LOS index compared with low-volume centers. Moderate-volume centers also had a higher proportion of patients aged 65 and older, saw more severe cases, treated more patients on Medicare and worked with more comorbidities. Low-volume centers had a higher proportion of patients aged 31 to 64, saw more minor cases and had a higher cost index. LOS, cost, mortality rate and mortality index were not significantly different across centers. Study drawbacks included a lack of individual patient data, mortality and morbidity calculated from in-hospital discharge data, unrecorded pre-operative and readmission costs and no long-term follow up data available.

Bottom line: There is evidence of an association between increased volume and lower complications at medical centers that offer head and neck surgery. More physicians, better staffed surgical floors and ICUs and better equipment may contribute to these findings.

Citation: Jalisi S, Bearelly S, Abdillahi A, Truong MT. Outcomes in head and neck oncologic surgery at academic medical centers in the United States. Laryngoscope. 2013;123:689-698.

—Reviewed by Amy Eckner