Effects of Omalizumab Treatment in Patients With Recalcitrant Nasal Polyposis and Mild Asthma: A Multicenter Retrospective Study.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a clinical entity with specific features that impacts significantly on patient quality of life (QoL). CRSwNP is often associated with asthma and is difficult to control and manage despite pharmacological and/or surgical treatment. Omalizumab, a monoclonal anti-IgE antibody, has emerged as a putative therapeutic option. OBJECTIVE: To evaluate the effects of omalizumab on nasal polyp (NP) size and QoL assessed by Sino-Nasal Outcome Test-22 (SNOT-22) in patients with recalcitrant CRSwNP and mild asthma. METHODS: A multicenter retrospective analysis of patient data from the Community of Valencia (Spain) was performed. Adult patients with recalcitrant CRSwNP and comorbid mild asthma receiving compassionate use of omalizumab were included. NP size measured by total nasal endoscopic polyp score (TPS) and QoL evaluated through the SNOT-22 questionnaire were assessed at baseline and monthly over 12 months. An ordinal regression model was built to analyze the results. RESULTS: A total of 23 CRSwNP patients with a mean age (± SD) of 54.78 ± 9.46 years were included. Nineteen suffered from aspirin-exacerbated respiratory disease (AERD). In all patients, a significant and sustained reduction in TPS was observed over time, accompanied by improvements in QoL reflected in lower SNOT-22 scores. In the ordinal regression model, time but not total IgE, age or tissue eosinophilia impacted on NP size and SNOT-22 outcomes. Additionally, improvements in QoL were not explained by reductions in the size of polyps. CONCLUSION: Omalizumab was effective for the treatment of patients with recalcitrant CRSwNP and mild asthma, even when AERD was present, by reducing NP size and improving QoL; treatment time was a key factor. SNOT-22 improvements were not explained by decreases in TPS, indicating that omalizumab may be effective in all patients, regardless of polyp size.

A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology.

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI -50.33; 219.20), FR €134 (CI -3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI -191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI -117.90; 289.50), and in France to €80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

Effectiveness of a mandibular advancement device in obstructive sleep apnea patients: a prospective clinical trial.

PURPOSE: This study aimed to determine the effectiveness of a mandibular advancement device in a sample of obstructive sleep apnea syndrome patients by the evaluation of respiratory and neurophysiologic parameters and clinical symptoms. Second, the influence of certain predictor factors related with the patient and the intraoral device, were considered in the final response with this treatment option. METHODS: Forty-one patients constituted the final sample. Outcomes were measured using polysomnography, Epworth sleepiness scale and an analogue visual snoring scale, before treatment and once the device was properly titrated. RESULTS: Mean apnea-hypopnea index decreased from 22.5 ± 16.8 to 9.1 ± 11.6 (p ≤ 0.05), influencing only gender and Fujita index as predictor factors. The oxygen saturation, arousal index, percentages of sleep stages and sleep efficiency significantly improved with the mandibular advancement device (MAD) placement. The snoring index improved in absolute terms in 6.1 units and the excessive daytime sleepiness was reduced from 12.2 ± 4.7 to 8.5 ± 3.8 (p ≤ 0.00). CONCLUSIONS: The successful treatment rate with the MAD was 65.8%. The placement and posterior regulation of the intraoral appliance efficiently reduced the apnea-hypopnea index, improved the sleep quality and the clinical symptomatology associated. Obstructive sleep apnea syndrome is a highly prevalent disease. and dentists should be aware of the benefits enhanced by this prosthetic device, considered the first treatment option by certain physicians.

Comparative study between unilateral and bilateral cochlear implantation in children of 1 and 2 years of age. / Estudio comparativo entre implantación coclear uni y bilateral en niños de 1 y 2 años de edad.

INTRODUCTION: The studies that have evaluated the effectiveness of bilateral cochlear implantation in children suggest an improvement in hearing about sound localization and speech discrimination. In this paper we show the differences in audio-linguistic achievements with early bilateral cochlear implantation versus unilateral, and differences between simultaneous and sequential bilateral implantation. MATERIAL AND METHODS: We present 88 children with bilateral profound sensorineural hearing loss, treated with bilateral cochlear implantation in 32 cases and unilateral in 56 cases, during the first 12 months (27 children) of life and between 12 and 24 months (61 children). We conducted a statistical comparison of both groups in the audiometry, IT-Mais, Nottingham, LittlEars scales and verbal tests. RESULTS: No significant differences in hearing thresholds and questionnaires between unilateral and bilateral implantation were detected in either the first or second year. Verbal tests do show statistically significant differences: children with bilateral cochlear implant obtain 100% recognition of disyllabic and phrases within 2-3 years after implantation whilst children with one implant do not obtain those results at 5 years after surgery. No differences between simultaneous and sequential bilateral implantation were detected. CONCLUSION: We emphasize the importance of ensuring good early audiological screening, to carry out an early and bilateral cochlear implantation with the consequent development of audio-language skills similar to normal hearing children.

Radiosurgery as treatment for acoustic neuroma. Ten years' experience.

INTRODUCTION AND OBJECTIVE: The acoustic neuroma is a benign tumour that usually affects the vestibular portion of the vestibulocochlear nerve. It represents 8% of all intracranial tumours and 80% of those arising at the cerebellopontine angle. There are 3 treatment options: microsurgery (the technique of choice), radiosurgery and observation. The objective of the study was to evaluate the results and side effects obtained using radiosurgery as treatment for acoustic neuroma. MATERIAL AND METHODS: We performed a review of all patients treated with radiosurgery (Gamma Knife and linear accelerator) at doses of 1200-1300 cGy for unilateral acoustic neuroma in our hospital from January 1999 until January 2010. In all patients we evaluated the overall state, tumour growth control rate (tumour smaller or remaining the same size), the involvement of v and vii cranial nerves and central nervous system disorders. We also assessed follow-up time and changes in hearing thresholds after radiosurgery. RESULTS: From a total of 35 patients studied, with a mean age of 58.29 years and lacking statistically significant differences in gender, the tumour growth control rate was over 90%. The main reason for visit (65.71%) was unilateral and progressive hearing loss. After treatment, 34.28% of patients had hearing loss. The involvement of the cranial nerves (v-vii) was transitory in 100% of cases. Gamma Knife radiosurgery was administered in 82.85% of patients. CONCLUSION: Although microsurgery is the treatment of choice for acoustic neuroma, we consider radiosurgery as a valid alternative in selected patients (elderly, comorbidity, small tumour size and sensorineural hearing loss, among others).

[Clinical and radiological evolution of a group of untreated acoustic neuromas]. / Evolución clínica y radiológica de un grupo de neurinomas del acústico no tratados.

INTRODUCTION: The acoustic neuroma is a benign tumour that originates in the vestibular branch of the eighth cranial nerve. The main treatment is surgery, but many authors suggest that with elderly patients or in small neuromas we can opt for watchful waiting. METHODS: This was a retrospective study from 2007 to 2013 that included 27 patients diagnosed of acoustic neuroma that had not been treated due to the size of the tumour, age and comorbidities, or by patient choice. We evaluated overall condition, hearing thresholds, degree of canal paresis and central disorders. RESULTS: After 6 years of follow up, clinical manifestations of 18 patients remained unchanged, 5 patients underwent hearing loss and developed tinnitus, 2 cases had more intense tinnitus and 2 cases had dizziness. The radiological controls by magnetic resonance imaging showed that the initial maximum diameters (5-16mm) increased by 1.7mm on average, with annual growth rates below 0.5mm. CONCLUSION: In selected cases, such as for small neuromas and in elderly patients, the conservative option of close monitoring with magnetic resonance imaging is an important alternative given that, in our cases, clinical features and radiological image did not suffer major changes. If there were any such changes, therapeutic options could be proposed.

Neck lymphadenitis due to silicone granuloma after mammary implants.

INTRODUCTION: A foreign body reaction due to silicone where it is infiltrated or at the places to which it can migrate is known as siliconoma. The use of silicone in breast augmentation procedures can provoke this reaction at the neck level in cases of leakage from mammary implants. METHODS: We reviewed the cases of patients with increased size neck lymph nodes who had previously undergone plastic surgery of the breast with highly cohesive silicone gel implants. RESULTS: In a 10-year period, we identified 12 cases with silicone-infiltrated neck lymphadenopathies, histologically confirmed by fine needle aspiration. They represented 3.5% of patients attended for neck lymph node study. We removed those detected by physical examination and CT in 5 cases, due to pathological characteristics of the node or a previous malignant history. In 2 of these nodes recurred, and node size also increased in 2 of the other 7 non-operated cases. After implant removal, silicone leakage was observed in only 7 cases. CONCLUSIONS: Cohesive gel silicone used for mammary implants can generate increased neck lymphadenopathies as a secondary effect due to systemic reactions against the silicone when it migrates in cases of implant failure. Surgical options for involved nodes usually do not offer good long-term results.

Management of cerebrospinal fluid otorrhea.

INTRODUCTION: Cerebrospinal fluid otorrhea results from an abnormal communication between the subarachnoid space and tympanomastoid compartment; most of them are of traumatic aetiology. They have clinical interest due to the potential risk of meningitis, directly related to the aetiology. Our aim was to show our experience in the management of this process. METHODS: A total of 17 patients diagnosed and treated for cerebrospinal fluid otorrhea from 2003 to 2011. RESULTS: In our study, the highest percentage of cases was spontaneous cerebrospinal fluid otorrhea, with a wide clinical presentation. The diagnosis was based on the determination of beta-2-transferrin and radiological studies, especially important for its locator value. The treatment of choice was surgery. CONCLUSIONS: Cerebrospinal fluid otorrhea is a rare entity in otorhinolaryngological pathology. Its diagnosis is suspected through otorrhea, hearing loss and aural fullness, while computed tomography and magnetic resonance help us to locate the defect. Surgery is the preferred technique, and its success is based on multilayer technology with 2 or more support materials.

Evolution of otosclerosis to cochlear implantation.

INTRODUCTION: Otosclerosis is an osteodystrophy of the labyrinthine capsule producing conductive hearing loss. If the process invades the cochlea, a sensorineural hearing loss usually takes place. The cochlear implant is a good alternative in these patients. OBJECTIVE: To ascertain the behaviour of cochlear implantation in otosclerosis. MATERIAL AND METHODS: We reviewed a database of 250 patients that underwent cochlear implantation, performing a retrospective study of 13 patients with clinical, audiological and/or imaging findings of bilateral otosclerosis. The 26 ears were studied as to their natural history, previous surgeries, evolution to profound hearing loss, computed tomography images, complications and functional results. RESULTS: Of the cases studied, 46% were female and 54% were men, with a mean age of 26 years at the onset of conductive hearing loss. Stapes surgery was performed in 19 ears (73%), with a mean patient age of 29 years, and 53% of them underwent cochlear implantation. Computed tomography results showed that there were signs of different degrees of radiological affectation in 54% of the ears. A total of 3 complications took place (23%): implant failure, overstimulation of the facial nerve and bilateral tinnitus were found. One year after implantation, the average percentages of correct 2-syllable words were 80% and 85% in open sentences. CONCLUSIONS: Patients having profound bilateral sensorineural hearing loss secondary to otosclerosis obtain great benefit from cochlear implantation.

[Hodgkin's lymphoma in otorhinolaryngology]. / Enfermedad de Hodgkin en otorrinolaringología.

OBJECTIVES: To evaluate the implication of Hodgkin's lymphoma (HL) in Otorhinolaryngology. PATIENTS AND METHODS: A longitudinal retrospective study on patients with HL diagnosed, treated and followed-up in our Centre from 1996 to 2010. RESULTS: From 413 individuals having lymphoma, 120 were labelled as HL (29%). Patients were males in 76% and greater incidence was observed in ages between 15 and 30 years old, as well as between 45 and 60. Samples for biopsy from adenopathies were obtained in 84 cases (61 from the neck), and in 15 its origin was extranodal. The most usual finding at physical exploration was the presence of cervical (86%) and axillary nodes (68%), followed by B symptoms (37%). Waldeyer's ring was affected in 4%. The most frequent histopathological variety was classic HL with nodular sclerosis (50%) and mixed cellularity (28%). Patients were usually diagnosed at stages I (28%) and II (47%). Recurrence of disease in the neck after conventional oncologic therapies was detected in 17 patients, in 7 of which the pathologic study had varied. Mortality was 8%. The main unfavourable prognostic factors for neoplasm recurrence were lymphocyte depletion variety, lymphadenopathy larger than 10 cm and B symptoms. CONCLUSIONS: Clinical HL findings are strongly associated with the head and neck area, making its suspicion obligatory in differential diagnosis on cervical nodes.

[Double second branchial cleft anomaly]. / Doble anomalía de la segunda hendidura branquial.

Second branchial cleft anomalies are the most common of this type of neck masses. They can be classified in four types (Bailey/Proctor classification) according to their location. Type II is the most common, and related to vital neck structures such as the carotid artery and jugular vein. Cysts are the most frequent among them. Management consists of surgical excision of the cyst and tract by cervicotomy to avoid recurrence. We present an extremely rare case of a 32-year-old male who presented a sudden appearance of a right lateral neck mass that was identified by an image study as a double branchial cleft cyst. A review of simultaneous branchial cleft cyst in the literature is also made.

[Use of imaging criteria to identify cervical metastases using CT scans in head and neck tumours]. / Empleo de patrones de imagen en la identificación de metástasis cervical mediante tomografía computarizada en tumores de cabeza y cuello.

OBJECTIVE: To assess the diagnostic certainty of CT images to identify regional spread of head and neck tumours. PATIENTS AND METHOD: A CT study was performed on 86 patients with neoplasms in the larynx and/or pharynx. After this, surgical dissection was performed for 142 neck sides. In the imaging study the following parameters were considered for all patients before suspecting malignant nodes: size of adenopathy bigger than 10-11 mm, irregular borders, central necrosis, spherical shape, capsular enhancement and presence of groups with three or more lymphadenopathies. RESULTS: 48.5 % of dissections were N+. Sensitivity and specificity for physical examination were 59 % and 82 %, respectively, against 73 % and 86 % for CT. Lymph node necrosis was the pattern with the greatest sensitivity and specificity (35.8 % and 100 %, respectively) and its accuracy was 69.7 %. Accuracy was 60.5 % for spherical shape, 59.8 % for node size, and between 54 % and 58 % for the other three criteria. In the histopathological findings, 25 % of neck dissections were N+ when only one pattern had been detected on CT, whereas those neck sides in which four patterns were identified simultaneously showed regional spread in 100 %. CONCLUSIONS: The presence of specific morphological imaging criteria for head and neck tumours in cervical lymph nodes and their concomitance increase the accuracy of imaging to predict regional spread.

[Radiosurgery treatment of acoustic neuromas. Our experience]. / Tratamiento del neurinoma del acústico con radiocirugía. Nuestra experiencia.

OBJECTIVE: To evaluate the results and side effects obtained using radiosurgery to treat acoustic neuromas. MATERIAL AND METHOD: Between 1999 and 2004 we treated 30 patients with unilateral acoustic neuromas with a mean age of 54 years old (31-76), a mean follow-up of 34 months (12-54), and tumour size between 4 and 38 millimetres (mean, 16.5). All of them were treated with radiosurgery (24 Gamma Knife and 6 LINAC) with doses of 1200-1300 cGy. RESULTS: Tumour growth control rate (smaller or same size) was 93 % (28/30). In 11 patients there was a post-treatment hearing loss (36.6 %). Trigeminal (3/30) and facial (2/30) neuropathy was transient. CONCLUSIONS: Although microsurgery is the treatment of choice for acoustic neuromas, we consider radiosurgical treatment a valid alternative for selected patients (the elderly, co-morbid conditions, small size, contralateral hearing loss...).