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Showing papers in "Laryngoscope in 2004"


Journal ArticleDOI
TL;DR: The objective was to develop an abbreviated voice handicap assessment instrument and compare it with the Voice Handicap Index (VHI).
Abstract: Objectives/Hypothesis: The objective was to develop an abbreviated voice handicap assessment instrument and compare it with the Voice Handicap Index (VHI). Study Design: Item analysis of the VHI in individuals without voice disorders and patients with voice disorders and creation and validation of the abbreviated VHI. Methods: Clinical consensus review of the VHI items was held to prioritize the clinical value of each of the VHI items (30 items in all). Item analysis of the VHI was performed using the VHI responses of 100 patients with voice problems and 159 control subjects. The 10 most robust VHI items were selected using the item analysis and clinical consensus results to form the Voice Handicap Index-10 (VHI-10). Statistical analysis comparing the validity of the VHI-10 with the VHI was performed with 819 patients representing a wide spectrum of voice disorders. Results: Statistical analysis of the VHI and VHI-10 scores from the study group showed no statistically significant differences between the VHI and the VHI-10. Irrespective of diagnosis, the correlation between the VHI and the VHI-10 was greater than .90 (P = .01). The ratios of the VHI-10 to VHI scores for a variety of voice disorder categories were analyzed and found to be consistently greater than the expected value (33%). This suggests that the VHI-10 may be a more robust instrument than the VHI. Conclusion: The VHI-10 is a powerful representation of the VHI that takes less time for the patient to complete without loss of validity. Thus, the VHI-10 can replace the VHI as an instrument to quantify patients' perception of their voice handicap.

923 citations


Journal ArticleDOI
TL;DR: The objectives were to investigate the prevalence of olfactory dysfunction in an adult Swedish population and to relate dysfunction to age, gender, diabetes mellitus, nasal polyps, and smoking habits.
Abstract: Objectives/Hypothesis: Patients with olfactory dysfunction appear repeatedly in ear, nose, and throat practices, but the prevalence of such problems in the general adult population is not known. Th ...

493 citations


Journal ArticleDOI
TL;DR: Evaluated the frequency of olfactory dysfunction in a large representative population without sinonasal complaints and investigated the extent to which general pathological conditions, medications, and aging influence olfaction.
Abstract: Objectives/Hypothesis: Goals of the study were to evaluate the frequency of olfactory dysfunction in a large representative population without sinonasal complaints and to investigate the extent to which general pathological conditions, medications, and aging influence olfaction. Study Design: Prospective. Methods: Results based on an odor identification test (“Sniffin' Sticks”) were reported from 1240 subjects. The subjects presented themselves to an otorhinolaryngology outpatient clinic with relatively mild and transitory complaints unrelated to the upper airways. A detailed otorhinolaryngological examination in combination with a standardized interview further ascertained that these patients had no rhinological problems or symptoms relating to sinonasal disease. Results: Apart from the confirmation of the effects of age, gender, and certain otorhinolaryngological diseases on the sense of smell, the study results revealed that certain general diseases (liver diseases, nonotolaryngological cancers) appear to influence olfactory function, whereas other diseases or disorders have little or no impact on olfaction (hypertension, cardiovascular problems). Conclusion: The data in the study revealed that olfactory dysfunction among subjects under 65 years of age is more frequent than previously reported.

417 citations


Journal ArticleDOI
TL;DR: The value of staging obstructive sleep apnea/hypopnea syndrome patients for the prediction of success for uvulopalatopharyngoplasty (UPPP) on the basis of short‐term follow up is tested.
Abstract: Objective: Early studies by Friedman et al. have demonstrated the value of staging obstructive sleep apnea/hypopnea syndrome (OSAHS) patients for the prediction of success for uvulopalatopharyngoplasty (UPPP) on the basis of short-term follow up. The goal of this study is to test the value of this staging system in a prospective study. Study Design. This is a prospective study of two cohorts of patients: one was treated with the benefit of a clinical staging system and the other without. Methods: Patients with symptoms of OSAHS were assessed by polysomnography and were staged according to a previously described staging system. The staging system is based on palate position, tonsil size, and body mass index (BMI). The control group was treated without the benefit of staging. All patients in the control group were treated with UPPP only. Patients in the experimental group were treated based on their clinical stage. Patients with stage I disease, regardless of the severity of disease, were treated with UPPP only. Selected patients with stage II and stage III disease were treated with UPPP in addition to a staged tongue-base reduction using a radiofrequency technique (TBRF). Results: Follow-up at 6 months showed significant improvement compared with a group of patients treated without the benefit of a staging system. Successful treatment of patients with stage II disease improved from 37.9% to 74.0%. The overall success rate improved from 40% to 59.1%. Conclusion: Clearly, patients with stage I disease had the best success rate, but a selective protocol based on clinical staging improves the overall success rate. In addition, it can eliminate as surgical candidates those patients with whom the procedure is likely to fail.

335 citations


Journal ArticleDOI
TL;DR: The first prospective, randomized, controlled trial evaluating and comparing the medical and surgical treatment of polypoid and nonpolypoid chronic rhinosinusitis (CRS).
Abstract: Objectives: To conduct the first prospective, randomized, controlled trial evaluating and comparing the medical and surgical treatment of polypoid and nonpolypoid chronic rhinosinusitis (CRS). Materials and Methods: Ninety patients with CRS were equally randomized either to medical or surgical therapy. All patients underwent pre- and posttreatment assessments of visual analogue score (VAS), the Sinonasal Outcome Test-20 (SNOT-20), the Short Form 36 Health Survey (SF-36), nitric oxide (NO), acoustic rhinometry, saccharine clearance time (SCT), and nasal endoscopy. Each patient had three assessments: before starting the treatment, after 6 months, and, finally, after 1 year. Results: Both the medical and surgical treatment of CRS significantly improved almost all the subjective and objective parameters of CRS (P .05), except for the total nasal volume in CRS (P < .01) and CRS without polyposis (P < .01) groups, in which the surgical treatment demonstrated greater changes. Conclusion: CRS should be initially targeted with maximal medical therapy (e.g., a 3 month course of a macrolide antibiotic, douche, and topical steroid), with surgical treatment being reserved for cases refractory to medical therapy. The presence of nasal polyps is not a poor prognostic factor for the efficacy of CRS therapy, either surgical or medical.

316 citations


Journal ArticleDOI
TL;DR: The study hypothesizes that patients with HPV type 11 (HPV‐11) and patients younger than 3 years of age at diagnosis are at risk for more aggressive and extensive disease.
Abstract: Objectives/Hypothesis: A database was developed for prospective, longitudinal study of recurrent respiratory papillomatosis (RRP) in a large population of pediatric patients. Data recorded for each patient included epidemiological factors, human papilloma virus (HPV) type, clinical course, staged severity of disease at each surgical intervention, and frequency of surgical intervention. The study hypothesizes that patients with HPV type 11 (HPV-11) and patients younger than 3 years of age at diagnosis are at risk for more aggressive and extensive disease. Study Design: The 10-year prospective epidemiological study used disease staging for each patient with an original scoring system. Severity scores were updated at each surgical procedure. Methods: Parents of children with RRP referred to the authors' hospital completed a detailed epidemiological questionnaire at the initial visit or at the first return visit after the study began. At the first endoscopic debridement after study enrollment, tissue was obtained and submitted for HPV typing using polymerase chain reaction techniques and in situ hybridization. Staging of disease severity was performed in real time at each endoscopic procedure using an RRP scoring system developed by one of the authors (B.J.W.). The frequency of endoscopic operative debridement was recorded for each patient. Information in the database was analyzed to identify statistically significant relationships between extent of disease and/or HPV type, patient age at diagnosis, and selected epidemiological factors. Results: The study may represent the first longitudinal prospective analysis of a large pediatric RRP population. Fifty-eight of the 73 patients in the study underwent HPV typing. Patients infected with HPV-11 were significantly more likely to have higher severity scores, require more frequent surgical intervention, and require adjuvant therapy to control disease progression. In addition, patients with HPV-11 RRP were significantly more likely to develop tracheal disease, to require tracheotomy, and to develop pulmonary disease. Patients receiving a diagnosis of RRP before 3 years of age had significantly higher severity scores, higher frequencies of surgical intervention, and greater likelihood of requiring adjuvant medical therapy. Patients with Medicaid insurance had significantly higher severity scores and required more frequent surgical debridement. Birth by cesarean section appeared to be a significant risk factor for more severe disease and necessity of more frequent surgical intervention. Conclusion: Statistical analysis of the relationships among epidemiological factors, HPV type, and clinical course revealed that patients with HPV-11 and patients younger than 3 years of age at RRP diagnosis are prone to develop more aggressive disease as represented by higher severity scores at endoscopic debridement, more frequent operative debridement procedures per year, a greater requirement for adjuvant therapy, and greater likelihood of tracheal disease with tracheotomy.

262 citations


Journal ArticleDOI
TL;DR: Cochlear implantation carries with it the potential risk for vestibular system insult or stimulation with resultant dysfunction, and understanding the significance of this risk takes on an increasing importance.
Abstract: Objectives/Hypothesis: Cochlear implantation (CI) carries with it the potential risk for vestibular system insult or stimulation with resultant dysfunction. As candidate profiles continue to evolve and with the recent development of bilateral CI, understanding the significance of this risk takes on an increasing importance. Study Design: Between 1997 to 2001, a prospective observational study was carried out in a tertiary care medical center to assess the effects of unilateral CI on the vestibular system. Methods: Assessment was performed using the dizziness handicap inventory (DHI), vestibulo-ocular reflex (VOR) testing using both alternate bithermal caloric irrigations (ENG) and rotational chair-generated sinusoidal harmonic accelerations (SHA), and computerized dynamic platform posturography (CDP) at preoperative, 1-month, 4-month, 1-year and 2-year postimplantation visits. CI was carried out without respect to the preoperative vestibular function test results. Results: Specifically, 86 patients were entered into the study after informed consent. For the group as a whole, pair wise comparisons revealed few significant differences between preoperative and postoperative values for VOR testing (ENG and SHA) at any of the follow-up intervals. Likewise, DHI testing was also unchanged except for significant reductions (improvements) in the emotional subcategory scores at both the 4-month and 1-year intervals. CDP results demonstrated substantial improvements in postural sway in the vestibular conditions (5 and 6) as well as composite scores with the device “off” and “on” at the 1-month, 4-month, 1-year, and 2-year intervals. Device activation appeared to improve postural stability in some conditions. Excluding those patients with preoperative areflexic or hyporeflexic responses in the implanted ear (total [warm + cool] caloric response ≤ 15 deg/s), substantial reductions (≥21 deg/s maximum slow phase velocity) in total caloric response were observed for 8 (29%) patients at the 4-month interval. These persisted throughout the study period. These changes were accompanied by significant low frequency phase changes on SHA testing confirming a VOR insult. Of interest, no significant changes were detected in the DHI or CDP, and there were no effects of age, sex, device manufacturer, or etiology of hearing loss (HL) for these patients. Conclusions: Unilateral CI rarely results in significant adverse effects on the vestibular system as measured by the DHI, ENG, SHA, and CDP. On the contrary, patients that underwent CI experienced significant improvements in the objective measures of postural stability as measured by CDP. Device activation in music appeared to have an additional positive effect on postural stability during CDP testing. Although VOR testing demonstrated some decreases in response, patients did not suffer from disabling vestibular effects following CI. The mechanism underlying these findings remains speculative. These findings should be considered in counseling patients about CI.

245 citations


Journal ArticleDOI
TL;DR: To determine the role of treatment modality in swallowing outcome after head and neck cancer treatment and to identify potential risk factors for posttreatment dysphagia.
Abstract: Objectives: To determine the role of treatment modality in swallowing outcome after head and neck cancer treatment and to identify potential risk factors for posttreatment dysphagia. Study Design: Cross-sectional survey of patients with no evidence of disease 12 months or more after the treatment of a stage III or IV squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Methods: Potential subjects were stratified by tumor site and tumor T-stage to achieve a balanced comparison between chemoradiation (n = 18) and surgery/radiation (n = 22) groups. Outcome measures included a dysphagia risk factor survey, the MD Anderson Dysphagia Inventory (MDADI), and the Short-Form 36 (SF-36). Results: Patients who received chemoradiation for oropharyngeal primaries demonstrated significantly better scores on the emotional (P = .03) and functional (P = .02) subscales of the MDADI than did patients who underwent surgery followed by radiation. There were no significant differences between chemoradiation and surgery/radiation groups for laryngeal and hypopharyngeal primaries. Additional risk factors for posttreatment dysphagia include prolonged (>2 weeks) nothing by mouth (NPO) status (P =.002) and low SF-36 Mental Health Subscale score (P =.002). Conclusion: The study suggests that chemoradiation may provide superior swallowing outcome to surgery/radiation in patients with oropharyngeal primary. Patients with depressed mental health and prolonged feeding tubes may be at higher risk of long-term dysphagia.

224 citations


Journal ArticleDOI
TL;DR: This work aims to provide reference information for recurrence rates and need for revision surgery in patients with severe disease with varying degrees of disease severity.
Abstract: Background and objectives: Most studies on outcome after endoscopic sinus surgery (ESS) include patients with varying degrees of disease severity. Recurrence rates cited by those studies may not apply to the subset of patients with severe polyposis. Our aim is to provide reference information for recurrence rates and need for revision surgery in patients with severe disease. Study design, patients, and methods: Review of patients with severe polyposis with a minimum Lund-McKay score of 16 and with a Kennedy computed tomography stage 3 or 4. Data collection included demographics, presence of asthma or documented allergy, history of previous surgery, extent of surgery, preoperative and postoperative management, recurrence rates, revision surgery rates, and follow-up. Results: One hundred and eighteen records were reviewed. Fifty-nine (50%) patients had asthma, and 93 (79%) had documented allergy. All patients required extensive bilateral nasal polypectomy, complete anterior and posterior ethmoidectomy, and maxillary sinusotomy. One hundred (85%) also had frontal or sphenoid sinusotomy. Follow-up ranged from 12 to 168 (median 40) months. Seventy-one (60%) developed recurrent polyposis. Fifty-five (47%) were advised to undergo revision surgery, and 32 (27%) underwent surgery. History of previous sinus surgery or asthma predicted higher recurrence (P <.005, P < .001) and revision surgery rates (P =.02, P <.001). History of allergy also predicted recurrence and need for revision (P <.001, P <.001). Conclusions: Recurrence rates after ESS for severe polyposis are significant. In our study, patients with asthma are at higher risk of recurrence.

223 citations


Journal ArticleDOI
TL;DR: The aim of the study was to evaluate the incidence of short‐ and intermediate‐term postoperative complications after vestibular schwannoma surgery.
Abstract: Objectives/Hypothesis The aim of the study was to evaluate the incidence of short- and intermediate-term postoperative complications after vestibular schwannoma surgery. Study Design Retrospective review in a tertiary referral center. Methods In 400 patients who underwent surgical removal of vestibular schwannoma from 1984 to 2000, symptoms, preoperative evaluation, surgery, and postoperative complications were analyzed using standardized grading systems. Results One hundred ninety-four men and 206 women had an operation. Mean age was 53.9 years (age range, 11–78 y). Tumor size according to Koos stage was stage 1 in 39 cases, stage 2 in 122 cases, stage 3 in 87 cases, and stage 4 in 152 cases. Preoperatively, 7.5% of patients had facial nerve dysfunction. Surgical approaches were translabyrinthine in 229 patients, widened retrolabyrinthine in 128 cases, suboccipital in 42 cases, and transotic in 1 case. Mortality was 0.5%. Facial nerve was transected in 15 cases (3.7%) and immediately repaired in 5 cases. A delayed hypoglossal–to–facial nerve anastomosis was performed in 12 cases. At 1 year, House-Brackmann grade in 70.7% of patients was 1 to 2; in 24.3%, 3 to 4; and in 5%, 5 to 6. Poor facial nerve outcome was correlated with tumor size, preoperative irradiation, and nerve dysfunction and was not correlated with the approach used. Most patients had postoperative dizziness, and 30% still had vestibular disturbances after 1 year. Nine patients (2.2%) had a cerebrospinal fluid rhinorrhea, and 24 had a cerebrospinal fluid wound leak (6%). Twenty-two patients (5.5%) had postoperative meningitis. Two patients had a cerebellopontine angle hemorrhage, and three a brainstem infarct. Conclusion Transpetrosal approaches (translabyrinthine, widened retrolabyrinthine) are safe for vestibular schwannoma removal, and rates of postoperative complications and sequelae are decreasing.

211 citations


Journal ArticleDOI
TL;DR: The objective was to investigate the potential use of pepsin and carbonic anhydrase isoenzyme III (CA‐III) as diagnostic markers for laryngopharyngeal reflux disease.
Abstract: Objectives/Hypothesis: The objective was to investigate the potential use of pepsin and carbonic anhydrase isoenzyme III (CA-III) as diagnostic markers for laryngopharyngeal reflux disease. Study Design: Prospective cell biological investigation was conducted of laryngeal biopsy specimens taken from 9 patients with laryngopharyngeal reflux disease and 12 normal control subjects using antibodies specific for human pepsin (produced in the authors' laboratory within the Department of Otolaryngology at Wake Forest University Health Sciences, Winston-Salem, NC) and CA-III. Methods: Laryngeal biopsy specimens were frozen in liquid nitrogen for Western blot analysis and fixed in formalin for pepsin immunohistochemical study. Specimens between two groups (patients with laryngopharyngeal reflux disease and control subjects) were compared for the presence of pepsin. Further analyses investigated the correlation between pepsin, CA-III depletion, and pH testing data. Results: Analysis revealed that the level of pepsin was significantly different between the two groups (P <.001). Secondary analyses demonstrated that presence of pepsin correlated with CA-III depletion in the laryngeal vocal fold and ventricle (P <.001) and with pH testing data in individuals with laryngopharyngeal reflux disease. Conclusion: Pepsin was detected in 8 of 9 patients with laryngopharyngeal reflux disease, but not in normal control subjects (0 of 12). The presence of pepsin was associated with CA-III depletion in the laryngeal vocal fold and ventricle. Given the correlation between laryngopharyngeal reflux disease and CA-III depletion, it is highly plausible that CA-III depletion, as a result of pepsin exposure during laryngopharyngeal reflux, predisposes laryngeal mucosa to reflux-related inflammatory damage.

Journal ArticleDOI
TL;DR: This review article will highlight the history, physiology, pathophysiology, diagnosis, surgical techniques, and postoperative care relevant to nasal CSF leaks and encephaloceles relevant to anterior skull base defects.
Abstract: Otolaryngologists have assumed a major role in the evaluation and management of anterior skull base defects that result in cerebrospinal fluid (CSF) leaks and meningoencephaloceles. To achieve the best possible results for patients with CSF leaks, a thorough understanding of the underlying pathophysiology and a critical analysis of management principles and treatment options is essential. Surgical and medical management of these patients is highly individualized and depends on a number of factors, including etiology, anatomic site, patient age, and underlying intracranial pressure. This review article will highlight the history, physiology, pathophysiology, diagnosis, surgical techniques, and postoperative care relevant to nasal CSF leaks and encephaloceles.

Journal ArticleDOI
TL;DR: The study describes the author's treatment approach related to the extent of thyroidectomy and adjuvant therapy based on various risk groups and the long‐term survival.
Abstract: Objectives/Hypothesis The outcome in differentiated thyroid cancer generally depends on the stage of the disease at the time of presentation; prognostic factors such as age, grade, size, extension, or distant metastasis; and risk groups (eg, low or high risk). The author has reviewed a large number of patients with differentiated thyroid cancer to analyze their hypothesis and to confirm that various risk groups have a major implication in relation to extent of the treatment and outcome. Differentiated thyroid cancers make up 90% of all thyroid tumors. The prognostic factors are well defined, such as age, size of the tumor, extrathyroidal extension, presence of distant metastasis, histological appearance, and grade of the tumor. The author has previously divided the risk groups into low-, intermediate-, and high-risk categories based on prognostic factors. The study describes the author's treatment approach related to the extent of thyroidectomy and adjuvant therapy based on various risk groups and the long-term survival. Study Design Retrospective. Methods In a retrospective review of 1038 patients with differentiated thyroid carcinoma, various prognostic factors were studied by univariate and multivariate analysis. The significant prognostic factors were studied in detail and, based on these prognostic factors, the patients were divided into low-, intermediate- and high-risk groups. The survival curves were plotted by Kaplan-Meier method. Results The long-term survivals in low-, intermediate- and high-risk groups were 99%, 87%, and 57% respectively. Based on these risk groups, a decision tree was made regarding extent of thyroidectomy and adjuvant treatment. In the high-risk group and selected patients in the intermediate-risk group, aggressive surgery including removal of all gross disease and extrathyroidal extension with postoperative radioactive iodine ablation is recommended. In the low-risk group and selected patients in the intermediate-risk group, lobectomy appears to be satisfactory with excellent long-term outcome. The surgical treatment offers the best long-term results in low-risk patients, and the role of adjuvant treatment in this group is questionable. Conclusion The decisions in the management of well-differentiated thyroid cancer should be based on various prognostic factors and risk groups. The long-term survival in the low-risk group is excellent, and consideration should be given to conservative surgical resection depending on the extent of the disease. In the high-risk group and selected patients in the intermediate-risk group, total thyroidectomy with radioactive ablation is warranted. A consideration may be given to external-beam radiation therapy in selected high-risk patients. It is apparent, based on the author's clinical experience and critical retrospective analysis, that the author's hypothesis that risk groups are extremely important in the long-term outcome of patients with differentiated thyroid cancer is correct. Based on various risk groups, the author currently is able to guide the treatment policies for thyroid cancer.

Journal ArticleDOI
TL;DR: To correlate objective and subjective clinical parameters with molecular, cellular, and histologic markers and to acknowledge the importance of these basic science parameters in a severity classification system for chronic rhinosinusitis (CRS).
Abstract: Objectives: To correlate objective and subjective clinical parameters with molecular, cellular, and histologic markers and to acknowledge the importance of these basic science parameters in a severity classification system for chronic rhinosinusitis (CRS). Study Design: Retrospective analysis of prospectively collected data of consecutive patients undergoing endoscopic sinus surgery for CRS in an academic institution. Methods: The preoperative computed tomography (CT) scans of all patients with CRS scheduled for surgery were graded according to Lund and Mackay. The patients completed a Sino-Nasal Outcome Test (SNOT)-20 questionnaire and had a preoperative nasal endoscopy performed, which was graded by assigning an endoscopy score according to Lanza and Kennedy. Subjects had a medical questionnaire regarding presence of aspirin sensitivity, allergic rhinitis, asthma, and medication usage. Subjects also underwent pulmonary function testing and had skin tests for allergies. At the time of surgery, blood was drawn to determine the level of peripheral eosinophilia and the degree of polymorphisms of the leukotriene C4 synthase gene. Sinus mucosal and polyp tissue was examined pathologically for the number of eosinophils per high-powered filed (HPF) and was stained for EG2 to determine the portion of activated eosinophils. Leukotriene C4 levels (pg/g of tissue) were determined using a sensitive competitive enzyme immunoassay. Endoscopy and SNOT-20 scores were reevaluated 1 year after surgery. Data were analyzed for disease-severity correlation to recommend a severity classification system for CRS that incorporates the contribution of clinical, molecular, cellular, and histologic parameters. Results: The presence of polyps resulted in higher preoperative CT scores and higher preoperative and postoperative symptom scores. Average preoperative CT scores were significantly higher in asthmatics and allergy patients and correlated with endoscopy scores. Patients with more than five eosinophils/HPF of sinus tissue had higher frequency of polyps and asthma and higher CT and endoscopy scores than patients without sinus tissue eosinophilia (less than or equal to 5 cells/HPF sinus tissue). The subgroup of patients with eosinophilic nasal polyps (eosinophilic hyperplastic rhinosinusitis) had more severe disease by CT and endoscopy than the subgroup of patients with nasal polyps (hyperplastic rhinosinusitis) but without eosinophilia. Similarly, patients without polyps but with tissue eosinophilia had more severe disease than patients without polyps and without eosinophilia. Leukotriene C4 levels were elevated in all patient groups. Symptom scores did not correlate with any of the parameters. Conclusion: We suggest the following severity classification system for CRS: 1) eosinophilic chronic hyperplastic rhinosinusitis (ECHRS): patients with polyps and sinus tissue eosinophilia; 2) noneosinophilic chronic hyperplastic rhinosinusitis (NECHRS): patients with polyps but without sinus tissue eosinophilia; 3) eosinophilic chronic rhinosinusitis (ECRS): patients without polyps but with sinus tissue eosinophilia; 4) noneosinophilic chronic rhinosinusitis (NECRS): patients without polyps and without sinus tissue eosinophilia.

Journal ArticleDOI
TL;DR: This study assessed the intracochlear position and the extent of trauma to cochlear structures using a new prototype electrode carrier (Flex EAS) with special emphasis on the practicality for combined electric and acoustic stimulation of the auditory system.
Abstract: Objective: The objective of this study was to assess the intracochlear position and the extent of trauma to cochlear structures using a new prototype electrode carrier (Flex EAS). Special emphasis was placed on the practicality for combined electric and acoustic stimulation of the auditory system. Study Design: Human temporal bones were evaluated histologically after insertion of the electrodes, and insertion forces were measured in an acrylic model of the scala tympani. Methods: 1) Insertion forces with the regular C40+ array and the new electrode prototype were measured in an acrylic model of the scala tympani. 2) Ten human temporal bones were implanted using the same surgical procedure as in vivo. All bones underwent fixation methylmethacrylate embedding to allow cutting of the undecalcified bone with the electrode in situ. In addition, radiography of the implanted devices was performed and correlated to histologic results. Electrode positions and trauma to cochlear structures were then evaluated histologically. Results: All insertions of the new electrode array were performed in the scala tympani of the cochlea. All insertions were atraumatic and covered one cochlear turn. The only effect on cochlear structures that could be observed was a slight lifting of the basilar membrane in the middle turn limited to the tip of the electrode. In three bones, basal trauma, which resulted from the cochleostomy itself, could be observed as well. All neural structures remained intact. Conclusions: The new electrode prototype provides very good mechanical properties for safe and atraumatic implantation. All criteria for the use in hearing-preservation cochlear implantation for electric and acoustic stimulation were fulfilled. Surgical measures to prevent basal trauma appear to be very important Cochlear implant, intracochlear trauma, electric acoustic stimulation.

Journal ArticleDOI
TL;DR: This report evaluates 8 years of experience with transcanal endoscopic management of limited attic cholesteatoma with microscopic postauricular tympanomastoidectomy and the endoscope, allowing for complete removal oflimited attic disease, possibly without interrupting the ossicular chain.
Abstract: Objectives: Microscopic postauricular tympanomastoidectomy provides a limited exposure to the attic, especially anteriorly. In contrast, the endoscope offers wide transcanal access to the attic, allowing for complete removal of limited attic disease, possibly without interrupting the ossicular chain. This report evaluates 8 years of experience with transcanal endoscopic management of limited attic cholesteatoma. Study Design: Case series. Methods: Seventy-three ears with limited attic cholesteatoma underwent endoscopic transcanal tympanotomy and extended atticotomy to access and completely remove the sac. Disease was dissected off the tegmen, the medial and lateral attic walls, and the ossicles. Appropriate ossicular reconstruction was performed. The defect was reconstructed with a composite tragal graft. Results: A transcanal endoscopic approach was adequate for removal of disease in all cases. There were no iatrogenic facial nerve injuries. Bone thresholds were stable. Disease was dissected off the head of the malleus and the body of incus with preservation of both in 24 ears. Mean follow-up was 43 months. Five ears required revision for recurrent disease, and eight were revised for failed ossicular reconstruction or persistent perforation. Moderate to severe retraction in other areas of the tympanic membrane was evident in 28 cases; none of these required further intervention. Conclusion: An endoscopic technique allows transca-nal, minimally invasive, eradication of limited attic cholesteatoma. Preservation of the ossicles coupled with complete removal of disease is more likely with the endoscope.

Journal ArticleDOI
TL;DR: The objectives were to evaluate the clinical relevance of traditional temporal bone radiographic descriptors and to investigate the efficacy of an alternative fracture classification scheme.
Abstract: Objectives/Hypothesis: The objectives were to evaluate the clinical relevance of traditional temporal bone radiographic descriptors and to investigate the efficacy of an alternative fracture classification scheme. Study Design: Retrospective consecutive case series. Methods: Charts and computed tomography scans representing 155 temporal bone fractures at a level I trauma center were reviewed. Fracture types were correlated with clinical presentation and outcomes. Results: The traditional classification system (i.e., longitudinal, transverse, or mixed) correlated poorly with clinical findings such as facial nerve weakness and cerebrospinal fluid leakage. It also had limited utility in predicting conductive hearing loss and sensorineural hearing. An alternative schema distinguishing petrous from nonpetrous involvement demonstrated better correlation with these measures. Cerebrospinal fluid leak was 1.1 times more common in transverse than in longitudinal fractures but was 9.8 times more common in petrous than in nonpetrous fractures. Similarly, facial nerve injury more strongly correlated with fractures through the petrous temporal bone than did the other fracture types. Sensorineural hearing loss did not correlate with the transverse fracture classification but was significantly more prevalent in petrous fractures. Likewise, conductive hearing loss did not correlate with longitudinal fractures but was four times more common in the “middle ear” subcategory of nonpetrous fractures. Conclusion: Traditional temporal bone fracture descriptions correlate poorly with clinical findings. However, simply distinguishing petrous from nonpetrous involvement demonstrates significant correlation with the occurrence of serious sequelae of temporal bone fractures. Subcategories of mastoid and middle ear involvement further refine this classification schema to correlate with minor complications. This simple, radiographically based scheme better focuses clinical resources and attention toward more likely sequelae.

Journal ArticleDOI
TL;DR: The impact of anterior commissure involvement on local control, survival, and laryngeal preservation in patients with early glottic cancer treated with unimodality laser microsurgical resection is analyzed.
Abstract: Objectives: To analyze the impact of anterior commissure involvement on local control, survival, and laryngeal preservation in patients with early glottic cancer (pT1a–pT2a) treated with unimodality laser microsurgical resection. Study Design: Retrospective review of 263 patients with early glottic cancer treated between 1986 and 1996. Methods: Data on local control and overall survival rates were analyzed and calculated by the Kaplan-Meier method; the larynx preservation rates were given absolutely. Results: Among 158 patients presenting with T1a glottic cancer, the anterior commissure was involved in 28 cases; the 5-year local control rate was 84%, and the larynx preservation rate was 93%. In the 130 cases without anterior commissure involvement, the 5-year local control rate was 90.0% and the corresponding larynx preservation rate 99%. In the T1b category consisting of 30 patients, anterior commissure involvement was observed in 16 patients; the 5-year local control rate was 73%, and the larynx preservation rate was 88%. In the 14 cases without anterior commissure involvement, the 5-year local control rate was 92% and the corresponding larynx preservation rate 100%. Seventy-five patients had T2a glottic carcinomas, with normal vocal cord movement. The anterior commissure was involved in 45 cases; the 5-year local control rate was 79%, and the larynx preservation rate was 93%. In the 30 cases without anterior commissure involvement, the 5-year local control rate was 74.0% and the corresponding larynx preservation rate 97%. Conclusions: This study shows the effectiveness of laser microsurgery for early glottic carcinoma regardless of anterior commissure involvement at presentation. This method can be performed as an outpatient procedure, even when conducting reresections.

Journal ArticleDOI
TL;DR: Localization of dural fistulas in the region of the anterior or lateral skull base may be difficult and a sodium fluorescein solution of 0.5 to 5% (2.5–50 mg) is needed by way of the lumbar space.
Abstract: Background Localization of dural fistulas in the region of the anterior or lateral skull base may be difficult. For many years, a sodium fluorescein solution of 0.5 to 5% (2.5-50 mg) has been administered intrathecally by way of the lumbar space. However, fluorescein is not commercially available for this stated purpose in either Germany or the United States. Methods Retrospectively, 420 fluorescein applications by the authors were retrospectively analyzed. Under the Freedom of Information Act, the United States Federal Drug Administration and the manufactures of fluorescein were queried for adverse reaction reports. Results Four hundred twenty fluorescein applications in 305 patients could be evaluated. Mean age of recipients was 46.9 years, ranging from 1 to 82 years. At a concentration of 5% fluorescein, 26 patients on the day of surgery and 69, 37, 34, and 14 patients on days 2 through 4 suffered from minor side effects that may or may not have been related to this drug. Two of these patients had grand mal seizures, which were attributable to simultaneous intrathecal application of contrast medium. All other side effects were thought to be the result of a postspinal headache and related lumbar puncture. At a concentration of 0.5%, the intraoperative intrathecal administration of 0.5 to 2 mL of fluorescein followed by 4 to 5 days of lumbar drainage resulted in some degree of spinal headache without other complications. In both groups, no patient had sequelae longer than 4 weeks. An additional seven complications were reported to the Federal Drug Administration and the fluorescein manufacturers at doses of 100 to 700 mg. Conclusions Complications from intrathecal application of fluorescein appears to be dose dependent. At concentrations of 5%, or preferably lower, side effects are transient. A grand mal seizure can be minimized when following the general cautions of lumbar puncture and dose. The patient should be supervised for 24 hours. A written informed consent from patients for use of fluorescein is recommended.

Journal ArticleDOI
TL;DR: To compare the auditory abilities and speech performance of children with a profound prelingual bilateral hearing‐impairment when subjected to a cochlear implant before or after 2 years of age and to analyze the complications that arose during or as a result of the implantation process in these groups.
Abstract: Objectives: To compare the auditory abilities and speech performance of children with a profound prelingual bilateral hearing-impairment when subjected to a cochlear implant (CI) before or after 2 years of age. To analyze the complications that arose during, or as a result of, the implantation process in these groups. Design: Prospective cohort single-subject, repeated-measures study of children with profound bilateral hearing impairment subjected to CI. Setting: Tertiary referral center with a program of pediatric CI from 1991. Patients: This study analyzed 130 children subjected to multichannel CI for profound prelingual bilateral hearing-impairment in two age groups: 0 to 2 (n = 36) and 2 to 6 years of age (n = 94). Interventions: The children were evaluated before, and each year after, the intervention (for up to 5 years) with both closed-set and open-set auditory and speech perception tests. Their speech ability was evaluated according to the Peabody Picture Vocabulary and Reynell general oral expression scales. Results: Auditory and speech perception tests improved significantly in all children after CI, regardless of the follow-up time. The infant's performance was better the earlier the implant was performed. Speech tests showed that the development of children treated before 2 years of age was similar to normal children, and no additional complications were observed when compared with CI in older children. Conclusions: When performed before 2 years of age, CI offers a quicker and better improvement of performance without augmenting the complications associated with such an intervention.

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TL;DR: The objective was to assess the effectiveness of three methods of nasal irrigation on distributing saline to the nasal cavity and paranasal sinuses.
Abstract: Objective: To assess the effectiveness of three methods of nasal irrigation on distributing saline to the nasal cavity and paranasal sinuses. Design: A prospective, cross-over study. Materials and Methods: Twelve subjects (9 patients with chronic sinusitis after functional endoscopic sinus surgery and 3 healthy controls) underwent nasal irrigation with normal saline containing Technetium 99m sulfur colloid. The distribution of radioactivity was assessed on each subject after three different irrigation techniques: metered nasal spray, nebulization with RinoFlow, and nasal douching while kneeling with the head on the floor. Results: The nasal cavity was well irrigated by all three techniques. Compared with the other two methods, douching was significantly more effective in penetrating the maxillary sinus (P = .036) and frontal recess (P = .003). The sphenoid and frontal sinuses were poorly irrigated by all three techniques. Conclusion: Nasal douches are more effective in distributing irrigation solution to the maxillary sinus and frontal recess. This should be the method of choice for irrigating these areas.

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TL;DR: The objective was to demonstrate the significance of nasal polyps on the symptoms of chronic rhinosinusitis and their influence on surgical outcomes.
Abstract: Purpose: To demonstrate the significance of nasal polyps on the symptoms of chronic rhinosinusitis (CRS) and their influence on surgical outcomes. Methods: Retrospective analysis of prospectively collected data comparing two groups of patients diagnosed with CRS with and without nasal polyps that underwent surgical management with a minimum 1-year follow-up period. Subjective scoring was performed using the Sino-Nasal Outcome Test (SNOT-20) questionnaire. Computed tomography (CT) scans were compared using the Lund-Mackay scoring system. The two groups were analyzed for the need of revision surgery. Results: Two hundred one patients underwent surgical management of CRS over a 3-year period. One hundred four were male, 97 were female, and the average age was 49 (range 18–80) years. Polyps were present in 78 patients with CRS, whereas 123 patients did not have polyps. The average CT score was 18 for the polyp group and 9.5 for the patients without polyps (P = .0000). Nonpolyp group SNOT-20 scores were 26.5 preoperatively with improvement to 5.1 at 6 months and 5.0 at 12 months postoperatively (85% improvement). Polyp group SNOT-20 preoperative scores averaged 32.2 with improvement to 9.2 at 6 months and 9.1 at 12 months postoperatively (81% improvement, P = .003). Nine patients required revision surgery (4.5%), eight (10%) who had polyps and one (0.8%) who did not (P = .002). Conclusion: The presence of nasal polyps has a significant negative impact on patients with CRS. Patients with nasal polyps have more severe symptoms with less improvement after operative intervention, higher CT scores at presentation, and a significantly higher need for revision surgery.

Journal ArticleDOI
TL;DR: Assessment of the audiologic and surgical outcomes for pediatric cochlear implant patients with inner ear malformations with inner hearing loss finds no clear trends in either audiologic or surgical outcomes.
Abstract: Objective/Hypothesis: To assess the audiologic and surgical outcomes for pediatric cochlear implant patients with inner ear malformations. Study Design: Retrospective review of 315 pediatric cochlear implant cases from 1994 to 2002. Methods: Twenty-eight pediatric cochlear implant patients with known inner ear malformations determined on high-resolution computed tomography (HRCT) of the temporal bone were the subjects of review. Results ofHRCTfindings, intraoperative findings, postoperative complications, and objective measures of both closed- and open-set testing of speech perception were analyzed. Results: Patients with the constellation of an incompletely partitioned (IP) cochlea, enlarged vestibular aqueduct (EVA), and a dilated vestibule (i.e., Mondini's malformation) as well as those with an isolated EVA or partial semicircular canal aplasia have relatively good levels of speech perception. Patients with total semicircular canal aplasia, isolated IP, cochlear hypoplasia, or common cavity demonstrated lower levels of performance. Poor performance may be related to associated developmental delays rather than labyrinthine anatomy alone. Complications of surgery were relatively limited. Conclusions: Cochlear implantation can be successfully performed in children with inner ear malformations. These children and their parents can expect significant auditory benefits from this intervention. The various types of inner ear malformations may have quite different prognoses for good auditory performance.

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TL;DR: The present Progress Report has summarized the key otitis media clinical trials and laboratory studies conducted since 1969 by investigators at the Children's Hospital of Pittsburgh–University of Pittsburgh (Pittsburgh, PA).
Abstract: Objectives/Hypothesis: The present Progress Report has summarized the key otitis media clinical trials and laboratory studies conducted since 1969 by investigators at the Children's Hospital of Pittsburgh–University of Pittsburgh (Pittsburgh, PA) Study Design: Review Methods: Included in the discussion are the following: 1) studies of the epidemiology and risk factors; 2) anatomy and pathology of the eustachian tube–middle ear from human temporal bone histopathological specimens; 3) physiology and pathophysiology of the eustachian tube–middle ear in humans and animal models; 4) pathogenesis; 5) otitis media in special populations (eg, patients with cleft palate, Native Americans, patients with Down syndrome); 6) microbiology; 7) diagnosis; 8) outcomes of randomized clinical trials that evaluated efficacy of nonsurgical and surgical methods of treatment and prevention; 9) studies of certain complications and sequelae (eg, effect of middle-ear effusion on hearing, early child development, and the vestibular system; chronic suppurative otitis media) Also included are relevant summary tables and 256 references

Journal ArticleDOI
TL;DR: Evaluation of the treatment outcomes of sleep disordered breathing in prepubertal children 3 months following surgical intervention finds no significant difference between children with and without surgical intervention.
Abstract: Objective To evaluate the treatment outcomes of sleep disordered breathing (SDB) in prepubertal children 3 months following surgical intervention. Study Design Retrospective investigation of 400 consecutively seen children with SDB who were referred to otolaryngologists for treatment. Method After masking the identities and conditions of the children, the following were tabulated: clinical symptoms, results of clinical evaluation and polysomnography at entry, the treatment chosen by the otolaryngologists, and clinical and polysomnographic results 3 months after surgery. Results Treatment ranged from nasal steroids to various surgical procedures. Adenotonsillectomy was performed in only 251 of 400 cases (68%). Four cases included adenotonsillectomy in conjunction with pharyngoplasty (closure of the tonsillar wound by suturing the anterior and posterior pillar to tighten the airway). Persistent SDB was seen in 58 of 400 children (14.5%), and an additional 8 had persistent snoring. Best results were with adenotonsillectomy. Conclusion SDB involves obstruction of the upper airway, which may be partially due to craniofacial structure involvement. The goal of surgical treatment should be aimed at enlarging the airway, and not be solely focused on treating inflammation or infection of the lymphoid tissues. This goal may not be met in some patients, thus potentially contributing to residual problems seen after surgery. The possibility of further treatment, including collaboration with orthodontists to improve the craniofacial risk factors, should be considered in children with residual problems.

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TL;DR: The published experience on intratympanic gentamicin treatment for intractable Menière's disease is reviewed to systematically review the published experience.
Abstract: Objectives: To systematically review the published experience on intratympanic gentamicin treatment for intractable Meniere's disease. Study Design: Meta-analysis using a random effect model. Methods: A comprehensive literature search was performed for articles using intratympanic gentamicin as a sole treatment modality with reporting of results according to the American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS) guidelines for Meniere's disease. Two reviewers independently assessed trial quality and extracted data. Results: Fifteen trials with 627 patients met the inclusion criteria. All trials reported “before-after” outcome measures, using patients as their own controls. No double-blind or blinded prospective control trials were identified. Complete (class A) vertigo control was achieved in 74.7% (confidence interval [CI]95% 67.8–81.5%) of patients, and complete or substantial (class B) control was achieved in 92.7% (CI95% 89.5–96.0%). The success rate was not affected by gentamicin treatment regimen (fixed vs. titration). Hearing level and word recognition were not adversely affected, regardless of gentamicin treatment regimen. Analysis of functional level was not performed because of lack of data in the selected articles. Conclusions: Intratympanic gentamicin treatment for intractable Meniere's disease appears to be effective in the relief of vertigo. Cochleotoxicity and ototoxicity is unlikely to be a major side effect. However, the level of evidence reflected from the eligible articles is insufficient, especially because of relatively poor study design. Therefore, it is prudent that patients eligible for this type of treatment should be selected carefully and titrated with low-dose gentamicin. Further investigation with this treatment modality with control subjects is warranted.

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TL;DR: The purpose of this comprehensive retrospective study is to assess issues related to the management of skull base defects associated with CSF rhinorrhea involving the nose and paranasal sinuses.
Abstract: Introduction: The management of cerebrospinal fluid (CSF) rhinorrhea has evolved in recent years. The purpose of this comprehensive retrospective study is to assess issues related to the management of skull base defects associated with CSF rhinorrhea involving the nose and paranasal sinuses. Methods: A retrospective review of CSF leak management was conducted. This study included patients with CSF rhinorrhea managed by the Department of Otolaryngology, Medical College of Wisconsin, Milwaukee, WI, front 1992 to 2002. Data collected included site of leak, surgical approach, and any recurrence of leak. Resuits: Fifty-seven CSF leaks occurred in 53 patients with CSF rhinorrhea originating from the nose or paranasal sinuses. Twenty-eight of the 53 had iatrogenic injuries resulting in CSF rhinorrhea, 16 had leaks from trauma, and 13 developed spontaneous CSF leaks. Ten patients responded to nonoperative management with bed rest with or without lumbar drain placement. Forty-three patients with 47 leaks underwent surgical repair of CSF rhinorrhea, of which 38 resolved after initial repair. Five of these patients developed recurrent CSF leaks at the repair site but resolved with subsequent surgery. Of these, two initially presented with spontaneous CSF leaks, one patient had a gunshot wound with massive skull base injury, and two recurred after repair of an iatrogenic injury. Factors associated with failure included lateral sphenoid leaks and elevated body mass index (BMI). Discussion: Multiple approaches to the management of CSF rhinorrhea can be successful. An endoscopic repair results in resolution of CSF rhinorrhea in the majority of cases. Patients with spontaneous CSF rhinorrhea, elevated BMI, lateral sphenoid leaks, and extensive skull base defects are at increased risk for recurrence. Alternative management options may need to be considered in these cases.

Journal ArticleDOI
TL;DR: The role for postoperative radiation for adenoid cystic carcinoma of the head and neck as it relates to tumor site, T‐stage, and surgical margin status is clarified.
Abstract: Objective: Clarify the role for postoperative radiation for adenoid cystic carcinoma (ACC) of the head and neck as it relates to tumor site, T-stage, and surgical margin status. Study Design: Retrospective cohort study at an academic tertiary care hospital. Methods: A review of 129 patients with biopsy-proven ACC was performed. Previous treatment failures and nonoperative candidates were excluded, with 75 patients considered eligible for further study. Patients were grouped according to treatment modality and Kaplan-Meier estimates of overall survival, locoregional control, and distant control were compared using log-rank tests. Patients were also stratified according to tumor site, T-stage, and surgical margin status, and pair-wise comparisons of treatment outcome within each group were performed using Wald tests from Cox proportional hazards models. Results: Twenty-five patients were treated with surgery alone, and 50 were treated with surgery and postoperative radiation. There was no significant difference in outcome between treatment groups when correlated with tumor site (P = .89). However, postoperative radiation was associated with improved overall survival for advanced T-stage (T4) tumors (P = .019) and greater locoregional control for patients with microscopically positive margins (P = .018). There was no demonstrated benefit of postoperative radiation for patients with microscopically negative margins (P = .93). Conclusions: The findings of this study suggest that advanced T-stage and positive microscopic margins are important factors in determining the necessity for postoperative radiation therapy for ACC of the head and neck and that radiation therapy may not be necessary for patients with early T-stage tumors and negative surgical margins.

Journal ArticleDOI
TL;DR: Nine cases of spontaneous CSF leak to the ear in adult patients from four medical centers are presented and analyzed to provide collective information about a disorder that can be difficult to diagnose and manage.
Abstract: Objectives/Hypothesis: Spontaneous leak of cerebrospinal fluid (CSF) into the middle ear can occur in adults without a history of temporal bone trauma or fracture, meningitis, or any obvious cause. Therefore, clues may be lacking that would alert the otolaryngologist that fluid medial to an intact eardrum, or fluid emanating from an eardrum perforation, is likely to be CSF fluid. A review of relevant medical literature reveals that herniation of the arachnoid membrane through a tegmen defect may be congenital, or CSF leak may occur when dynamic factors (i.e., brain pulsations or increases in intracranial pressure) produce a rent in the arachnoid membrane. Because tegmen defects may be multiple rather than single, identifying only one defect may not be sufficient for achieving definitive repair. Data on nine cases of spontaneous CSF leak to the ear in adult patients from four medical centers are presented and analyzed to provide collective information about a disorder that can be difficult to diagnose and manage. Study Design: Retrospective review of nine cases of spontaneous CSF middle ear effusion/otorrhea. Results: The majority of patients presented with symptoms of aural fullness and middle ear effusion. Many developed suspicious clear otorrhea only after insertion of a tympanostomy tube. Two patients had multiple defects in the tegmen and dura, and five patients had meningoencephaloceles confirmed intraoperatively. Five patients underwent combined middle cranial fossa/transmastoid repair. Materials used in repair included temporalis fascia, free muscle graft, Oxycel cotton, calvarial bone, pericranium, bone wax, and fibrin glue. Conclusions: CSF middle ear effusion/otorrhea can develop in adults without a prior history of meningitis or head trauma or any apparent proximate cause. Although presenting symptoms can be subtle, early suspicion and confirmatory imaging aid in establishing the diagnosis. Because surgical repair by way of a mastoid approach alone can be inadequate if there are multiple tegmen defects, a middle fossa approach alone, or in combination with a transmastoid approach, should be considered in most cases.

Journal ArticleDOI
TL;DR: To determine how frequently the use of ‐interferon (‐IFN) is associated with the development of spastic diplegia, a large number of studies have used IFN as a treatment for central giant cell granuloma.
Abstract: Objective: To determine how frequently the use of -interferon (-IFN) is associated with the development of spastic diplegia. Study Design and Methods: Meta-analysis of 600 English manuscripts published January 1991 to June 2002 reporting -IFN use in infants/children. We identified 3,113 children 18 years of age or younger and an estimated 3,055 children 12 years of age or younger who received -IFN therapy. Sixty-nine percent were treated for chronic hepatitis and 14% for vascular neoplasms. Outcome Measure: Neurologic examination to confirm spastic diplegia or a motor developmental disturbance other than spastic diplegia such as hyperactive deep tendon reflexes, gait disturbances, or impaired fine motor control. Results: Including our index case, 11 of 441 children with vascular lesions developed spastic diplegia and an additional 16 of 441 developed a motor developmental disturbance. All of these children were less than 1 year of age at initiation of therapy. Mean age of initiation and duration of -IFN therapy were not significantly different between groups (P > .05); however, motor developmental disturbances improved with cessation of therapy, whereas spastic diplegia did not. No child receiving treatment for chronic hepatitis developed neurologic complications; however, only 49 children were less than 1 year of age at initiation of therapy. Conclusion: -IFN should not be used in infants under 1 year of age unless life-threatening conditions do not respond to any other form of treatment. If -IFN must be used, children should have monthly neurologic examinations. If a motor developmental disturbance is detected and -IFN therapy can be discontinued, it should be.