Primary intubation of cartilage tympanoplasties.
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OBJECTIVES: To assess the use of an acellular dermal allograft in the repair of chronic tympanic membrane perforations. Chronic tympanic membrane perforations are a common problem in otolaryngology, and although surgical tympanoplasty using either temporalis fascia or rice paper has proven to be highly successful, these materials are not without their own limitations. The search has continued for a simpler, yet equally effective, means of repairing persistent tympanic membrane perforations in an office setting. In this study we experimentally evaluated the use of an acellular dermis (AlloDerm, (LifeCell Corporation, The Woodlands, TX) as an alternative to traditional tympanoplasty materials. STUDY DESIGN: Prospective study using 28 adult chinchillas. METHODS: Subtotal tympanic membrane perforations were created bilaterally in 28 adult chinchillas. Animals with noninfected, stable perforations that showed no signs of epithelial regeneration after 5 to 8 weeks were used to compare the use of rice paper patch with AlloDerm in patch tympanoplasties. RESULTS: Eighteen of 23 tympanoplasties (78%) that were performed using AlloDerm showed no signs of perforation after 5 to 6 weeks. In those performed using rice paper control, 14 of 21 (66%) showed no signs of perforation after 5 to 6 weeks. In addition, histological evaluation of the healed tympanic membranes demonstrated that the acellular dermis had been incorporated within the middle fibrous layer of the tympanic membrane. CONCLUSIONS: The results and histological studies suggest that acellular dermis may be a suitable alternative to traditional materials currently used for patch tympanoplasty. Future studies to evaluate the efficacy of acellular dermis in humans are warranted.
OBJECTIVES/HYPOTHESIS: The objectives of this study are to review the effects of smoking on preoperative middle ear disease severity, long-term surgical outcome, type and extent of surgery required, the need for ossicular chain reconstruction, and the long-term hearing results. STUDY DESIGN: A retrospective chart review. MATERIALS AND METHODS: The charts of 74 smokers and non-smokers who underwent over-under tympanoplasty were reviewed. An analysis of the disease severity (using the Middle Ear Risk Index [MERI]) at presentation and type of surgery was performed. A review of graft take and delayed failure (late perforation or atelectasis after 6 mo) and audiologic data were performed. RESULTS: Fifteen patients smoked a mean of 20 cigarettes daily for a mean of 15 years. The MERI was well matched for both groups. There was a trend toward smokers having a higher incidence of otorrhea preoperatively and requiring a more extensive surgical procedure. All patients had full take of the tympanic membrane graft at 6 months; however, delayed surgical failure was seen in 20% of non-smokers compared with 60% of smokers (P = .050). No statistically significant difference was seen in hearing outcome. CONCLUSIONS: Cigarette smoking is associated with more severe middle ear disease preoperatively. More extensive surgery is often needed in smokers to eradicate the disease. Most significantly, smoking is associated with a threefold increase in the chance of long-term graft failure. Based on the results of this study, the MERI has been revised to include smoking as a risk factor.
BACKGROUND/HYPOTHESIS: Acute otitis media is a major cause of visits to pediatric health care providers. Myringotomy in uncomplicated acute otitis media is debatable today. The study addressed this problem through the otomicroscopic and histopathological observations of the events occurring in the tympanic membrane during the first week after myringotomy. STUDY DESIGN: Randomized study in an experimental animal model. METHODS: Under anesthesia, the left middle ear of 36 Sprague-Dawley rats was inoculated with Streptococcus pneumoniae type 3. Forty-eight hours later, at day 0, four animals were immediately killed and the remaining animals were randomly assigned into a myringotomy group (n = 16, myringotomy on the left ear) and a non-myringotomy group (n = 16, otomicroscopy without myringotomy). Otomicroscopy and killings were performed in series of four animals from each group at days 1, 2, 4, and 7 after myringotomy. Tympanic membranes were collected after fixation and processed for light and electron microscopy. RESULTS: All inoculated ears showed a manifest acute otitis media at day 0. An intense infiltration by inflammatory cells and edema distorted severely the tympanic membrane structure. These findings decreased the following days. However, inflammation as evaluated by the thickness and the cytoarchitecture of the tympanic membrane layers, recovered significantly faster in the membranes in the non-myringotomy group. At day 7, all tympanic membranes in the myringotomy group were closed by a hypertrophic keratinizing epithelium and a remodeling connective tissue layer, whereas the animals in the non-myringotomy group had a residual edema in the lamina propria. CONCLUSIONS: The present infectious model induced an intense inflammatory reaction within the entire structure of the tympanic membrane. Myringotomy provoked a delayed recovery from the inflammatory process within the tympanic membrane. Therefore, if applicable to human conditions, the use of myringotomy in the management of acute otitis media should be restricted to selected cases of acute otitis media.
OBJECTIVES/HYPOTHESIS: AlloDerm, an acellular dermal graft, has been used successfully as a material for soft tissue implantation. The authors report their experience with the use of AlloDerm in the reconstruction of the tympanic membrane. STUDY DESIGN: Case review study. METHODS: Charts were reviewed for all patients who underwent tympanoplasty with and without mastoidectomy between June 1999 and June 2002 in whom AlloDerm was used as a grafting material. There were 24 patients, 17 with simple perforations (8 revisions) and 7 with chronic otitis media with cholesteatoma (6 revisions). Success was defined as closure of the tympanic membrane perforation. RESULTS: Closure of the perforation using AlloDerm was achieved in 87.5% of the patients (ie, in all but three patients). Another patient developed serous otitis media and required a myringotomy tube in the postoperative period. CONCLUSIONS: The success rate for AlloDerm in tympanoplasty was similar to that of temporalis fascia in the authors' experience. AlloDerm can provide a suitable grafting material when fascia is not available or when the size of the defect precludes the use of fascia.
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BACKGROUND: The etiology of acute myringitis remains controversial although it is usually encountered in connection with acute otitis media (AOM). In most cases of acute myringitis a bacterial pathogen has been detected in the middle ear fluid, but the role of respiratory viruses has remained unclear. Our objective was to investigate the etiologic role of viruses in the pathogenesis of acute bullous and hemorrhagic myringitis in children <2 years of age. METHODS: A prospective longitudinal cohort study of 2028 children ages 7 to 24 months in primary care in the Finnish Otitis Media Vaccine Trial. Nasopharyngeal aspirate (NPA) and middle ear fluid (MEF) samples taken at the time of the diagnosis were examined by a time-resolved fluoroimmunoassay for antigen detection of adenoviruses; influenza viruses A and B; parainfluenza viruses 1, 2 and 3; and respiratory syncytial virus and by reverse transcription polymerase chain reaction for human rhinovirus and human enterovirus. RESULTS: Eighty-two children with bullous myringitis and 37 children with hemorrhagic myringitis were diagnosed during the 18-month follow-up period. In bullous myringitis a respiratory virus was detected in 70% of NPA samples and in 27% of MEF samples. In hemorrhagic myringitis 57% of NPA samples and 28% of MEF samples were virus-positive. The viral distribution was similar to that of AOM (virus positive 64% of NPA and 37% of MEF). CONCLUSIONS: We could not confirm any specific respiratory virus to be the etiologic agent in acute myringitis. The etiology of acute myringitis is similar to that of AOM in children <2 years of age.
Because of its high density, high tensile strength, and low antigenicity, sclera appears to be an appropriate grafting material for tympanic membrane reconstruction. I have used preserved donor sclera in 100 such cases over a three-year period with an overall success rate for complete closure of the perforation of 96%. Most of the procedures were done without hospitalization. The adults had local anesthesia; the children, general.
PURPOSE: To compare the rates of perioperative morbidity of patients with sickle cell anemia who were randomly assigned to 2 preoperative transfusion regimens and to identify predisposing factors for perioperative complications. PATIENTS AND METHODS: Investigators at 36 centers enrolled 118 patients who were scheduled to have elective surgery and agreed to randomization between 2 preoperative transfusion regimens. Forty-seven subjects were enrolled but not randomized, including 20 who were not transfused before surgery. Perioperative management was based on a prescribed care plan. RESULTS: Tonsillectomy and/or adenoidectomy (TA) were performed on 136 persons, and 29 had myringotomy as their primary procedure. There were no differences in the frequency of complications between the randomized groups. The serious, non-transfusion complication rates for randomized patients were 32% (34 of 107) for TA and 36% (4 of 11) for myringotomy. A history of pulmonary disease was a predictor of postoperative sickle cell-related events for patients undergoing TA surgery. CONCLUSIONS: The more intensive transfusion regimen did not result in fewer perioperative complications. The high frequency of complications emphasizes the need for anticipatory management of persons undergoing TA. A history of pulmonary disease identifies patients at increased risk for sickle cell-related events after TA surgery. Patients undergoing myringotomy have a low frequency of sickle cell-related events but a significant frequency of other serious perioperative complications.
OBJECTIVE: To evaluate the usefulness of cartilage plates as tympanic membranes combined with total middle ear reconstructive surgery for radicalized ears. STUDY DESIGN: Retrospective study between 1994 and 1999. SETTING: Tertiary care referral medical center. PATIENTS: Seven patients had seven ears with severe chronic otorrhea after radical mastoidectomy. All patients had severe to profound sensorineural hearing loss and expected a trouble-free ear rather than improved hearing after surgery. Patients were followed up for 4 years postoperatively. METHODS: After the middle ear space was cleaned, the tympanic membrane was reconstructed using a plate prepared from the tragal cartilage. The major part of the posterior wall was reconstructed using a conchal cartilage plate. Cortical bone segments were inserted to support the cartilage plate. RESULTS: Preoperatively, cultures of ear discharge were positive for various bacteria. Recovery with dry eardrums was noted in six patients, and one patient showed minimal erosion. No postoperative complications were encountered, but the hearing threshold did not improve postoperatively. CONCLUSIONS: Total middle ear reconstructive surgery is suitable for patients with chronic otorrhea complicating radical mastoidectomy. The use of cartilage plates seems to be clinically appropriate, particularly for patients with severe infection who expect a trouble-free ear rather than hearing gain after surgery.
OBJECTIVE: To evaluate the long-term anatomic and functional results after partial and total autologous cartilage palisade type III tympanoplasties to assess the efficacy of cartilage palisades in preventing recurrent cholesteatoma. STUDY DESIGN: Retrospective data bank and patient review. SETTING: Tertiary referral center. PATIENTS: The study population included all patients with more than 36 months follow-up who underwent tympanoplasty or tympanomastoidectomy for previously untreated cholesteatoma using partial or total autologous cartilage palisade graft associated with a reconstruction of the ossicular chain from October 1, 1992, to October 31, 1998. INTERVENTION: Tympanoplasty or tympanomastoidectomy using autologous cartilage palisade graft for partial or total reconstruction of the tympanic membrane and the ossicular chain. MAIN OUTCOME MEASURES: Anatomic results, i.e., closure of the perforation, rate of retraction pockets, recurrent cholesteatoma, and reperforation rate related to the use of autologous cartilage were clinically evaluated. Postoperative speech reception thresholds, speech discrimination scores, and postoperative air-bone gap were compared with preoperative levels. The outcomes of canal wall up and canal wall down procedures were compared. RESULTS: Closure of the tympanic membrane was achieved in 98.3% of patients. Speech reception thresholds did not change significantly. Speech discrimination scores were stable or improved in all patients. Postoperative air-bone gap was less than 10 dB in 29.8% of patients and between 11 and 20 dB in 32.3%. The complication rate of the tympanoplasty in general was 0.67%. The rate of recurrences of cholesteatoma was 2.2%. No complications could be related to the use of cartilage. CONCLUSIONS: The cartilage palisade technique is effective for the reconstruction of the tympanic membrane and also prevents new retractions and recurrences of cholesteatoma. The functional results show that autologous cartilage grafts are able to transmit sound.
OBJECTIVE: To analyze the closure time of diode laser-assisted myringotomies, the incidence of complications, and the hearing results in comparison with the "cold" procedure in adults with otitis media with effusion (OME). STUDY DESIGN: Prospective case-control study. SETTING: Tertiary referral center, university hospital. PATIENTS: Twenty-eight adult patients (39 ears), 13 men and 15 women, age 13 to 76 years (mean, 51.9). Inclusion criteria included 3 months (or more) history of OME resistant to medical therapy. Twenty-two control patients (34 ears) underwent cold myringotomies with knife and ventilation tubes (VT). INTERVENTION: Diode laser myringotomy performed in an office setting under local anesthesia with topical EMLA ointment. MAIN OUTCOME MEASURES: Timing of closure of the myringotomy, hearing results, incidence of complications, recurrence of OME. RESULTS: No intra- or postoperative pain nor complications were observed. Otomicroscopic daily monitoring documented the healing patterns of the tympanostomies, which remained patent for 7 to 25 days (average, 15.6 +/- 4.8 days). Immediate improvement of hearing was achieved in every patient. Recurrence of OME was observed in 36 ears (92.3%) within 1 month from healing. In the control group with VTs, healing of the eardrum was observed between 126 and 301 days (average, 183.2 +/- 44.8 days), and recurrence of OME was observed in 8 ears (23.5%) (p < 0.001). One month after healing, the air-bone gap was retained within 10 dB in 10.3% (4/39) of the diode laser group and in 50% (17/34) of the standard procedure group (p=0.0001). CONCLUSIONS: Diode laser myringotomy is a straightforward, painless procedure simplified by the thin fiberoptic cables available. Functional benefit is comparable to conventional tympanostomies plus VTs, but the duration of patency is too short to achieve long-term clearance of the effusion in "glue" ears of adult patients. Selected indications could be acute or recurrent otitis media or the prevention of barotraumas in tubal dysfunction.
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 (e.g., 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 (e.g., 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.
OBJECTIVES/HYPOTHESIS: Animal experiments and human studies show that autologous fascia lata and temporal fascia change their dimensions during first 5 days of healing. Poor dimensional stability of the temporal fascia grafts may be responsible for the residual perforation sometimes seen in clinical practice. STUDY DESIGN: Retrospective. METHODS: Tympanoplasties performed for large perforations or granular myringitis using either fascia lata or temporal fascia as graft material are included. The ears are divided into two groups. Group I includes ears with fascia lata, and group II includes ears with temporal fascia as graft material. Ears with minimum 1-year follow-up are included in the study. RESULTS: The results are studied in terms of 1) rate of primary closure of perforation, 2) rate of recurrent perforation, and 3) hearing improvement. It is noted that the ears with very large or subtotal perforations fared better (alpha = 0.05) in group I than similar ears in group II with respect to rate of primary closure of perforations. Similarly, ears in group I also have a lesser rate of recurrent perforation on long-term follow-up than ears in group II. No significant difference is noted in hearing improvement between the two groups. CONCLUSION: Shrinkage of graft during healing phase appears to have significant relevance in the clinical situation. Ears having large perforations have high chances of residual perforations caused by limited margin of remnant tympanic membrane overlapping the graft. It seems logical to use fascia lata as graft material for large perforations because it has better dimensional stability.
OBJECTIVE/HYPOTHESIS: Autogenous fascia is a material popularly applied as a connective tissue graft for reconstruction of the tympanic membrane. The objective was to establish how an underlaid fascia graft can form the middle layer of a reconstructed tympanic membrane. STUDY DESIGN: In the underlaid technique, the graft is laid on the medial surface of the tympanic remnant without removal of the mucous membrane, which is covered with entodermal epithelium. Interestingly earlier authors have regarded this fact as natural, though, if it is really so, it must be a result of an unexpected, special mechanism that apparently contradicts the general rules of transplantation. METHODS: Experimental operations were performed on one ear of 114 adult, male guinea pigs. The posterior quadrants of the tympanic membrane were removed, and the perforation was closed with an underlaid temporal fascia graft. Examinations were made after different survival times. The temporal bones were removed immediately, and specimens were processed histologically. RESULTS: The graft proved to be well adapted to the margin of the tympanic membrane. The epithelium of the outer surface grew both from the meatal skin and from the margin of the tympanic remnant. In connection with the regeneration of the mucous membrane of the inner surface, unexpected, special events were observed. The originally intact epithelium of the mucous membrane was annihilated, and disappeared completely. Consequently, the fibrous layer of the tympanic remnant and the graft came into direct contact and grew together. The regeneration of the mucous membrane started at the margin of the graft. CONCLUSIONS: The histologic observations described have clarified the problem of the underlaid technique.
As an alternative to the mean regression model, the quantile regression model has been studied extensively with independent failure time data. However, due to natural or artificial clustering, it is common to encounter multivariate failure time data in biomedical research where the intracluster correlation needs to be accounted for appropriately. For right-censored correlated survival data, we investigate the quantile regression model and adapt an estimating equation approach for parameter estimation under the working independence assumption, as well as a weighted version for enhancing the efficiency. We show that the parameter estimates are consistent and asymptotically follow normal distributions. The variance estimation using asymptotic approximation involves nonparametric functional density estimation. We employ the bootstrap and perturbation resampling methods for the estimation of the variance-covariance matrix. We examine the proposed method for finite sample sizes through simulation studies, and illustrate it with data from a clinical trial on otitis media.
In an attempt to assess the value of preoperative tubal testing in the selection of cases most likely to respond favourably to surgery, 100 ears with a central perforation following chronic otitis media were investigated. Tubal function was tested manometrically with different known tests. Postoperatively the healing and hearing results were correlated with the preoperative test results. No positive correlation was found between healing or hearing and tubal function. Postoperatively 50 ears were re-tested in a pressure chamber with a flow volume technique. It was found that the tubal function improves postoperatively in spite of no visible pathological changes in the aural end of the tube. Possible explanations are offered.