Efficacy and safety of intravenous tranexamic acid in microscopic modified radical mastoidectomy: a study protocol for a prospective, randomised, double-blind controlled trial.

INTRODUCTION: Radical mastoidectomy is a common procedure for chronic suppurative otitis media, typically performed under a microscope. The smooth operation is closely related to the clarity of the operative field. Our trial is designed to investigate whether the intravenous administration of tranexamic acid (TXA) can improve the clarity of the operative field, reduce the operative time, and increase surgeon satisfaction. METHODS AND ANALYSIS: This study is a prospective, randomised, double-blinded, controlled trial that aims to investigate the effects of TXA on patients with otitis media. The trial will include patients between the ages of 18 and 65 who will be randomly assigned to either the TXA group or the control group. In the TXA group, patients will receive 1 g of TXA diluted to 20 mL of normal saline before anaesthesia induction while the control group will receive 20 mL of normal saline. The primary outcome measure will be the Modena Bleeding Score, which will assess the clarity of the surgical field. Secondary outcomes will include the surgeon's satisfaction with surgical conditions, operation time, laboratory measurements (prothrombin time, activated partial thromboplastin time, fibrin degradation products, D-dimer) and levels of inflammatory factors (such as IL-6) at 24 hours postoperatively. In addition, the incidence of general adverse reactions such as postoperative nausea, vomiting and dizziness; serious adverse events such as arterial and venous thromboembolism, myocardial infarction and epilepsy within 90 days will be compared between the two groups. ETHICS AND DISSEMINATION: The protocol was approved by the Ethics Committee of Peking University People's Hospital (2021PHB173-001), on 19 July 2021. The trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2100049183.

Comparison of the 3D-Exoscope and Operating Microscope in Mastoidectomy.

OBJECTIVES: The operating microscope (OM) commonly used in ear surgeries has several disadvantages, including a low depth of field, a narrow field of view, and unfavorable ergonomic characteristics. The exoscope (EX) was developed to overcome these disadvantages. Herein, we compared OM and EX during mastoidectomy and found out the feasibility of the EX. STUDY DESIGN: Prospective randomized comparative study. SETTING: Tertiary academic medical center. PATIENTS: Patients who had mastoidectomy for chronic otitis media with or without cholesteatoma between January 2022 and April 2022. INTERVENTION: Canal wall-up mastoidectomy (CWUM) or canal wall-down mastoidectomy (CWDM) using OM or EX without endoscope. MAIN OUTCOME MEASURES: Operative setting time (the time between the end of general anesthesia and incision), operative time (from incision to suture), postoperative audiologic outcomes, perioperative complications, and the decision to switch from EX to OM. RESULTS: Of 24 patients who were diagnosed with chronic otitis media or cholesteatoma, 12 each were randomly assigned to the OM or EX group. The mean operation time was 175 ± 26.5 minutes and 172 ± 34.6 minutes in the EX and OM group, respectively, which was not significantly different ( p = 0.843). The procedures in the EX group were successfully completed using a three-dimensional (3D)-EX without conversion to OM. All surgeries were completed without any complications. The postoperative difference in the air and bone conduction was 11.2 and 12.4 dB in the EX and OM groups, respectively, which was not significantly different ( p = 0.551). CONCLUSIONS: EX is comparable to OM in terms of surgical time, complications, and audiologic outcomes following mastoidectomy. The EX system is a potential alternative to OM. However, further improvements are required to overcome some drawbacks (deterioration of image resolution at high magnification, requirement of an additional controller for refocusing).

Outcomes of Soft Versus Bony Canal Wall Reconstruction with Mastoid Obliteration.

OBJECTIVE: To compare recidivism rates, audiometric outcomes, and postoperative complication rates between soft-wall canal wall reconstruction (S-CWR) versus bony-wall CWR (B-CWR) with mastoid obliteration (MO) in patients with cholesteatoma. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary neurotologic referral center. PATIENTS: Ninety patients aged ≥18 years old who underwent CWR with MO, either S-CWR or B-CWR, for cholesteatoma with one surgeon from January 2011 to January 2022. Patients were followed postoperatively for at least 12 months with or without second-look ossiculoplasty. INTERVENTIONS: Tympanomastoidectomy with CWR (soft vs. bony material) and mastoid obliteration. MAIN OUTCOME MEASURES: Recidivism rates; conversion rate to CWD; pre- versus postoperative pure tone averages, speech reception thresholds, word recognition scores, and air-bone gaps; postoperative complication rates. RESULTS: Middle ear and mastoid cholesteatoma recidivism rates were not significantly different between B-CWR (17.3%) and S-CWR (18.4%, p = 0.71). There was no significant difference in pre- versus postoperative change in ABG (B-CWR, -2.1 dB; S-CWR, +1.6 dB; p = 0.91) nor in the proportion of postoperative ABGs <20 dB (B-CWR, 41.3%; S-CWR, 30.7%; p = 0.42) between B-CWR and S-CWR. Further, there were no significant differences in complication rates between B-CWR and S-CWR other than increased minor TM perforations/retractions in B-CWR (63% vs. 40%, p = 0.03). CONCLUSIONS: Analysis of recidivism rates, audiometric outcomes and postoperative complications between B-CWR with MO versus S-CWR with MO revealed no significant difference. Both approaches are as effective in eradicating cholesteatoma while preserving relatively normal EAC anatomy and hearing. Surgeon preference and technical skill level may guide the surgeon's choice in approach.

External auditory canal reconstruction using a novel mastoidoplasty technique during canal wall down mastoidectomy: how I do it.

BACKGROUND: While mastoid obliteration techniques have received much attention in decreasing the disadvantages associated with the resultant mastoid cavity from canal wall down procedures, techniques for an anatomically normal looking ear canal reconstruction to increase the feasibility of hearing aid fitting are less commonly discussed as an alternative. METHODS: Our mastoidoplasty technique basically utilises an inferiorly based periosteal flap with or without temporalis muscles and fascia to obliterate the epitympanum and reconstruct the external auditory canal (EAC). Stay sutures are used to keep them in place. For larger cavities, demineralized bone matrix (DBM) is used to obliterate the mastoid cavity and support the neo-EAC. CONCLUSIONS: The concept of our mastoidoplasty potentially provides a very useful alternative in recreating a near normal ear canal anatomy avoiding cavity problems as well as facilitating hearing aid fitting with canal type hearing aids after canal wall down mastoidectomy.

Convolutional Neural Network-Based Deep Learning Engine for Mastoidectomy Instrument Recognition and Movement Tracking.

OBJECTIVE: To develop a convolutional neural network-based computer vision model to recognize and track 2 mastoidectomy surgical instruments-the drill and the suction-irrigator-from intraoperative video recordings of mastoidectomies. STUDY DESIGN: Technological development and model validation. SETTING: Academic center. METHODS: Ten 1-minute videos of mastoidectomies done for cochlear implantation by varying levels of resident surgeons were collected. For each video, containing 900 frames, an open-access computer vision annotation tool was used to annotate the drill and suction-irrigator class images with bounding boxes. A mastoidectomy instrument tracking module, which extracts the center coordinates of bounding boxes, was developed using a feature pyramid network and layered with DETECTRON, an open-access faster-region-based convolutional neural network. Eight videos were used to train the model, and 2 videos were used for testing. Outcome measures included Intersection over Union (IoU) ratio, accuracy, and average precision. RESULTS: For an IoU of 0.5, the mean average precision for the drill was 99% and 86% for the suction-irrigator. The model proved capable of generating maps of drill and suction-irrigator stroke direction and distance for the entirety of each video. CONCLUSIONS: This computer vision model can identify and track the drill and suction-irrigator from videos of intraoperative mastoidectomies performed by residents with excellent precision. It can now be employed to retrospectively study objective mastoidectomy measures of expert and resident surgeons, such as drill and suction-irrigator stroke concentration, economy of motion, speed, and coordination, setting the stage for characterization of objective expectations for safe and efficient mastoidectomies.

3-D-Printed Models for Temporal Bone Training: A Validity Study.

OBJECTIVE: 3-D printing offers convenient and low-cost mastoidectomy training; nonetheless, training benefits using 3-D-printed temporal bones remain largely unexplored. In this study, we have collected validity evidence for a low-cost, 3-D-printed temporal bone for mastoidectomy training and established a credible pass/fail score for performance on the model. STUDY DESIGN: A prospective educational study gathering validity evidence using Messick's validity framework. SETTING: Seven Danish otorhinolaryngology training institutions. PARTICIPANTS: Eighteen otorhinolaryngology residents (novices) and 11 experienced otosurgeons (experts). INTERVENTION: Residents and experienced otosurgeons each performed two to three anatomical mastoidectomies on a low-cost, 3-D-printed temporal bone model produced in-house. After drilling, mastoidectomy performances were rated by three blinded experts using a 25-item modified Welling scale (WS). MAIN OUTCOME MEASURE: Validity evidence using Messick's framework including reliability assessment applying both classical test theory and Generalizability theory. RESULTS: Novices achieved a mean score of 13.9 points; experienced otosurgeons achieved 23.2 points. Using the contrasting groups method, we established a 21/25-point pass/fail level. The Generalizability coefficient was 0.91, and 75% of the score variance was attributable to participant performance, indicating a high level of assessment reliability. Subsequent D studies revealed that two raters rating one performance or one rater rating two performances were sufficiently reliable for high-stakes assessment. CONCLUSION: Validity evidence supports using a low-cost, 3-D-printed model for mastoidectomy training. The model can be printed in-house using consumer-grade 3-D printers and serves as an additional training tool in the temporal bone curriculum. For competency-based training, we established a cut-off score of 21 of 25 WS points using the contrasting groups method.

Modified-modified radical mastoidectomy.

PURPOSE: It is unusual to have communication from the external auditory canal (EAC) directly to the mastoid, totally sparing the tympanum. These patients need a different surgical approach, a modified canal wall-down procedure, to completely clear the disease but fully preserve the tympanum. We present one such exceptional case. CASE PRESENTATION: A 28-year-old lady presented with ear discharge for 1 year. Imaging confirmed the canal-mastoid fistula, but the entire tympanum was normal. We performed a modified-modified radical mastoidectomy. CONCLUSIONS: Canal-mastoid fistula is an infrequent entity and may be idiopathic. Despite being evident on clinical examination, imaging aids in assessing size and location of the defect. Although EAC reconstruction may be attempted, the majority require a canal wall-down procedure.

Use of bonalive in obliterative mastoidectomy: anatomical results and clinical outcome.

PURPOSE: To investigate safety and efficacy of mastoid obliteration in canal-wall-down tympanoplasty performed for cholesteatoma using bioactive glass (BAG). The authors routinely adopt CWD tympanoplasty in case of massive cholesteatoma or revision surgery, performing obliteration with BAG to reduce the mastoid cavity and related disadvantages. We assessed anatomical results, infection control and cholesteatoma recurrence in obliterative mastoidectomy using BAG. METHODS: The authors evaluated 66 patients treated with obliterative mastoidectomy using BAG during the period 2010-2021. 48.5% of the cases had first diagnosis of cholesteatoma, 48.5% had cholesteatoma recidivisms, and two patients underwent obliteration to improve clinical outcome. BAG granules were always moistened with venous blood to enhance their adhesion and reduce the risk of dispersion. Anatomical results were evaluated in otomicroscopy and infection control was assessed during follow-up visits. Periodical otomicroscopy was performed to check recurrent cholesteatoma. MRI-DWI was indicated only in case of clinical suspect of cholesteatoma. RESULTS: Authors followed 66 patients during a mean of 23 months. No post-operative wound infections occured. The mean re-epithelialization time was 45 days. At the last visit, control of infection was achieved in 97% of patients and a clinical stable anatomical cavity in all patients. No clinical suspect for recurrent cholesteatoma was found. CONCLUSIONS: The use of bioactive glass is safe and effective as obliteration material in cholesteatoma surgery. Authors pay a particular attention to obliterate only patients without suspect of epithelial residual, to correctly calibrate the ear canal and to completely cover the granules with graft.

Evolving Management of Acute Mastoiditis: Analysis of the Pediatric Health Information System Database.

OBJECTIVE: The optimal management of acute mastoiditis remains controversial. Most existing studies are retrospective single-institutional experiences with small cohorts. Our objectives were to analyze the treatment of acute mastoiditis by pediatric centers across the United States and changes in management over time. STUDY DESIGN: Retrospective analysis. SETTING: Administrative database study using Pediatric Health Information System. METHODS: Patients ≤18 years of age who were admitted with a principal diagnosis of acute mastoiditis from January 1, 2010 to December 31, 2019 were included. Trends were assessed by Cochran-Armitage Trend Test. χ2 and Wilcoxon rank sum tests were used to compare outcomes between the surgical and nonsurgical groups. RESULTS: A total of 2170 patients met the inclusion criteria, with 1248 (57.5%) requiring surgical management. The rate of surgical procedures decreased significantly over time. The rate of myringotomy decreased from 64% in 2010 to 47% in 2019 (p < .001), and mastoidectomy decreased from 22% in 2010 to 10% in 2019 (p < .001). On admission, 29% of the cohort presented with mastoiditis-related complications. Patients treated surgically were younger (p < .001), more likely to present with complications (37.5% vs 17.5%, p < .001), required longer length of stay (3.7 vs 2.3 days, p < .001), and had higher intensive care unit utilization (8.6% vs 2.2%, p < .001). However, the rate of 30-day readmission, emergency department return, and in-hospital mortality were all similar. CONCLUSION: Acute mastoiditis has been successfully treated with declining rates of a surgery over time. Younger patients who present with complications are more likely to be managed surgically, and the overall outcomes remain excellent.

Clinical outcomes of revision radical mastoidectomy surgeries to dry ears: A retrospective study.

This study retrospectively investigated the reasons for failure to dry the ear after primary radical mastoidectomy for chronic otitis media. In this retrospective study, we analyzed the main causes of dry ear failure in 43 patients (46 ears) who underwent radical mastoidectomy. We found that inadequate exposure of the mastoid cavity, incomplete removal of pathological tissues, and poor drainage of the surgical cavity were the main reasons for failure of radical mastoidectomy. Lesions in the tympanic ostium of the eustachian tube and incorrect selection of surgical techniques could also cause dry ear failure. Revision surgery based on preoperative temporal bone computed tomography and intraoperative surgical findings could achieve dry ear in 100% of cases and no complications were observed. In patients who underwent tympanoplasty, there was a significant postoperative decrease in the decibel hearing level for the air conduction threshold and air-bone gap ( P  < .05). Based on the reasons for failure, the corresponding treatment was undertaken to achieve dry ears during revision surgery.

Mastoid obliteration with hydroxyapatite vs. bone pâté in mastoidectomy surgery performed on patients with cholesteatoma and chronic suppurative otitis media: a retrospective analysis.

PURPOSE: To compare the efficacy and safety of hydroxyapatite vs. bone pâté as obliteration material in mastoidectomy surgery for patients with chronic suppurative otitis media and cholesteatoma. METHODS: This is a retrospective, multi-center, cohort study. All patients were followed up with micro-otoscopy, audiometry, and, if indicated, MRI with diffusion-weighted imaging. The following outcome parameters were analyzed: procedure safety (wound infections and complications), cholesteatoma recidivism rates (residual/recurrent), control of infection (Merchant's scale), and hearing results (pure-tone averages at 500/1000/2000/4000 Hz). RESULTS: Eighty-three cases were included: 45 obliterated with hydroxyapatite and 38 with bone pâté, with a mean follow-up time of, respectively, 25 and 24 months. Wound infections were only detected in the bone pâté group (4.8%) and successfully treated with oral or intravenous antibiotics and surgical drainage (p = 0.026). No other major surgical complications were observed in both groups. Cholesteatoma recidivism was observed in 15% using hydroxyapatite and 12% using bone pâté (p = 0.471). Complete control of infection (Merchant 0) was achieved in 76.2% using bone pâté and 86.8% using hydroxyapatite at 12 months postoperatively (p = 0.223). All patients showed good postoperative healing without complete failure to manage infection (Merchant 3). Pre- and postoperative audiometry showed significant improvement in hearing results in both groups. No significant difference between the obliteration materials was observed. CONCLUSIONS: Evaluation of mastoid obliteration reveals that hydroxyapatite and bone pâté are safe and effective obliteration materials, with high success rates in achieving a dry ear, low recidivism rates, and good hearing outcome, respecting the short-term limitation. In addition, our study shows that hydroxyapatite results in fewer postoperative wound infections compared to bone pâté.

An endoscopic hydro-mastoidectomy technique for cholesteatoma surgery.

OBJECTIVE: Endoscopic hydro-mastoidectomy, in which mastoidectomy is performed underwater, can be employed during transcanal endoscopic ear surgery for cholesteatoma removal. It was hypothesised that endoscopic hydro-mastoidectomy might take less time than endoscopic non-underwater mastoidectomy because the endoscope does not need to be removed for cleaning. METHODS: This study compared the mastoidectomy and total operative durations between the endoscopic hydro-mastoidectomy (n = 25) and endoscopic non-underwater drilling (control, n = 8) groups. Moreover, it compared the size of resected areas of the external auditory canal between the two groups. RESULTS: The mastoidectomy time of the endoscopic hydro-mastoidectomy group was significantly shorter than that of the control group (p < 0.01). The total operative time did not differ significantly between the endoscopic hydro-mastoidectomy and control groups (p = 0.17). The resected area was significantly larger in the endoscopic hydro-mastoidectomy group than in the control group (p < 0.05). CONCLUSION: Endoscopic hydro-mastoidectomy enables more extensive bone resection within a shorter period.

Transcanal Endoscopic Retrograde Mastoidectomy for Cholesteatoma: A Prospective Study.

OBJECTIVES: To evaluate the feasibility, morphological, and functional outcomes of endoscopic retrograde transcanal mastoidectomy. STUDY DESIGN: Prospective study. SETTINGS: Tertiary Referral Hospital. MATERIALS AND METHODS: We analyzed 31 patients with a diagnosis of chronic otitis media with cholesteatoma that extended to the mastoid cavity who underwent endoscopic transcanal retrograde canal wall down mastoidectomy under general anesthesia. The tympanic membrane and posterior canal wall reconstruction were done using the tragal cartilage palisade technique reinforced with perichondrium. Morphological and functional results were reported in the follow-up of a minimum of 1 year. The graft uptake was also compared with the presence of granulations and discharge status. RESULTS: Graft uptake and disease-free conditions were achieved in 21 of 24 patients, that is, 87.5%, and 3 patients required revision surgery. The graft uptake rate was not affected by the presence of granulation tissues and discharge. The hearing was improved after the surgery, which was statistically significant. CONCLUSION: Endoscopic retrograde mastoidectomy is a new technique to deal with cholesteatoma with excellent results. It is more functional, ideal for sclerotic mastoid, allows faster wound healing, has excellent outcomes, and is a minimally invasive procedure that avoids postauricular incision and tissue dissection. Because the set up for the surgery costs less, it holds a promising future for the developing countries.

Cholesteatoma surgery in the pediatric population: remaining challenges in the era of mastoid obliteration.

PURPOSE: To present the first pediatric study on the safety and efficacy of mastoid obliteration using S53P4 bioactive glass (BAG) for cholesteatoma surgery. METHODS: A single-center retrospective cohort study was conducted. Inclusion criteria were pediatric cases (≤ 18 years) and at least at least one year of follow-up including non-echo planar diffusion-weighted MRI to assess cholesteatoma recidivism. Both canal wall up (CWU) and canal wall down (CWD) procedures were evaluated. RESULTS: A total of 61 cases (56 patients) were included. Most cases had an otologic history before the development of the cholesteatoma. CWU procedure was performed in 18 cases (30%) and CWD procedure in 43 cases (70%). The cholesteatoma recidivism rate was 33% after a mean follow-up period of 58 months. Kaplan-Meier curve estimated a 5-year recidivism rate of 40%. Few complications were seen that were all minor and resolved spontaneously or after local or systemic treatment. Control of the infection (merchant grade 0-1) was achieved in 98% of the cases. Closure of the air-bone gap within 20 dB was achieved in 22% of the cases with complete audiometric evaluation. CONCLUSION: In this MRI-controlled study, we show the safety and efficacy of S53P4 BAG for mastoid obliteration in a pediatric cholesteatoma cohort. Postoperative complications were both rare and minor, and a dry ear was achieved in almost all patients. Nevertheless, persistent hearing loss and the apparent high recidivism rate reflect the challenging nature of pediatric cholesteatoma.

Numerical analysis of the effects of canal wall-up and canal wall-down mastoidectomy on the sound transmission characteristics of human ears.

PURPOSE: The aim of this work was to study the effect of canal wall-up (CWU) and canal wall-down (CWD) and mastoid obliteration in conjunction with CWD (CWD-MO) mastoidectomy on the sound transmission characteristics of the human ear. METHODS: Three mastoidectomy surgical methods, CWU, CWD and CWD-MO, were simulated on the freshly dissected cadaver heads. Then, the finite element (FE) models corresponding to these surgical methods were established by micro-computed tomography (Micro-CT) and reverse engineering technology, and the accuracy of the models was verified. Finally, the FE Models were used to analyze the effects of different surgical methods on the sound transmission characteristics of the human ear. RESULTS: For CWU, since the integrity of the outer wall of the ear canal is ensured, the sound pressure (SP) gain of the ear canal and the stapes footplate displacement (FPD) gain after this operation are close to normal values. For CWD, due to severe damage to the outer wall of the ear canal, a negative gain of the ear canal SP occurs in the high-frequency range, and the resonance frequency is significantly reduced. For CWD-MO, the frequency range of SP negative gain in the ear canal is reduced due to the addition of fillers in the ear canal to reduce the degree of damage, and the resonance frequency is increased compared to CWD. CONCLUSIONS: The impact of three types of mastoidectomy, including CWU, CWD, and CWDMO, on the sound transmission characteristics of the human ear after surgery is relatively small.

Concordancia entre hallazgos radiológicos y quirúrgicos en pacientes sometidos a mastoidectomía / Concordance between radiological and surgical findings in patients undergoing mastoidectomy

Introducción: Existe gran controversia acerca de los signos radiológicos de la patología de oído medio y su relación con la extensión real de la patología que nos sugiera decidir un comportamiento determinado. Objetivo: establecer la concordancia entre los hallazgos radiológicos y quirúrgicos encontrados en pacientes sometidos a mastoidectomía. Material y Método: Diseño observacional descriptivo de corte transversal de prueba diagnóstica. Se revisó fichas clínicas y se especificó el tipo de cirugía junto con los hallazgos intra-quirúrgicos. Resultados: se observó erosión de la cadena osicular intraoperatoria en 75 pacientes, 63 predichos correctamente por tomografía computada (TC), con sensibilidad del 84% y especificidad del 94% (k = 0,625). Se detectó erosión del tegmen tympani en nueve pacientes por TC de los 10, con un VPP = 90% y un VPN = 95% (k = 0,809). Hubo sospecha de erosión del canal semicircular lateral en cinco pacientes y se encontró dehiscencias intraoperatorias en 12, sin falsos positivos (k = 0,554). La TC detectó dehiscencia del canal del nervio facial con sensibilidad del 55% y especificidad del 98% (k = 0,636). Conclusión: Los resultados sugieren que la TC preoperatoria con evidencia radiológica de erosión osicular tiene una buena a muy buena concordancia con los hallazgos intraoperatorios.

Introduction: There is a great controversy about the radiological signs of middle ear pathology and its relation with the real extension of the pathology that suggests us to decide a certain medical choice. Aim: To establish concordance between radiological and surgical findings in patients submitted to mastoidectomy. Material and Method: An observational and descriptive design of retrospective cross-sectional diagnostic test. Clinical records were reviewed to specify the type of surgery and intraoperative findings. Results: Intraoperative ossicular chain erosion was observed in 75 patients, 63 were correctly predicted by computed tomography (CT), with a sensitivity of 84% and specificity of 94% (k = 0.625). Tegmen tympani erosion was detected by CT in 9 patients out of 10, with a PPV = 90% and NPV = 95% (k = 0.809). There was suspected lateral semicircular canal erosion in 5 patients and intraoperative dehiscence was found in 12, with no false positives (k = 0.554). CT detected facial nerve canal dehiscence with sensitivity of 55% and specificity of 98% (k = 0.636). Conclusion: The results suggest that preoperative CT with radiological evidence of ossicular erosion has good to very good agreement with intraoperative findings.

Mastoid Obliteration Using S53P4 Bioactive Glass in Cholesteatoma Surgery: A 10-Year Single-Center Experience in 173 Adult Patients with Long-Term Magnetic Resonance Imaging Controlled Follow-up.

OBJECTIVE: To present the long-term outcomes of mastoid obliteration in cholesteatoma surgery using S53P4 bioactive glass (BAG) in an adult population. STUDY DESIGN: Retrospective cohort study. SETTING: Single-center study. PATIENTS: All 173 adult patients who underwent primary or revision surgery for cholesteatoma with mastoid obliteration using S53P4 BAG with at least 1 year of follow-up including nonecho planar diffusion-weighted magnetic resonance imaging (MRI) (non-EP DWI MRI) and/or second-look surgery to evaluate recidivism. Both canal wall up (CWU) and canal wall down (CWD) procedures were included. INTERVENTIONS: Patients underwent CWU or CWD mastoidectomy using S53P4 BAG. MAIN OUTCOME AND MEASURES: Cholesteatoma recidivism, postoperative complications, Merchant grade, hearing outcome. RESULTS: Cholesteatoma recidivism was assessed by MRI in 97% of all cases and second-look surgery look surgery in 3% of cases. After a mean follow-up period of 53 months, cholesteatoma recidivism was seen in 10% of the cases (n = 18). Using the Kaplan-Meier curve to extrapolate, a 5-year recidivism rate of 12% was estimated. Only minor complications occurred, all resolving spontaneously or after minor treatment. Merchant grade of 0 to 1 was achieved 95% of the patients, no persistently wet ears were observed. Closure of the air-bone gap within 20 dB was possible in 32%. CONCLUSION: In this long-term (up to 10 yr) follow-up study, we demonstrated the safety of S53P4 BAG. Minimal and only minor postoperative complications were observed. The effectiveness of BAG was indicated by the low rate of recidivism, even when using non-EP DWI MRI, a sensitive and specific noninvasive technique to detect cholesteatoma recidivism.

Implantation of two generations of Bonebridge after mastoid obliteration with bioactive glass S53P4.

PURPOSE: After radical surgery for chronic cholesteatoma (CWD mastoidectomy), patients have the option to have the posterior wall of their external auditory canal surgically reconstructed with S53P4 bioactive glass. The procedure eliminates some of the restrictions related to having a postoperative cavity and extends the options for a hearing prosthesis. If classic reconstruction is not possible and a hearing aid is not used, we suggest use of a Bonebridge implant. METHODS: This study describes, over 18 months of follow-up, 16 patients after a two-stage surgical procedure: obliteration of the mastoid cavity with bioactive glass followed by Bonebridge implantation. There were 7 patients who received the first generation implant (BCI 601) and 9 who used the second (BCI 602). Before and after implantation, pure tone audiometry, sound field thresholds, and free-field audiometry were performed. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: During the observation period, no serious complications were found. The study demonstrated the safety and validity of the procedures and confirmed the safety of using S53P4 bioactive glass in otosurgery (antibacterial effect, nonrecurrence of cholesteatoma, and no effect on the inner ear). The audiological benefits expected from using the Bonebridge implant processor were also confirmed. CONCLUSION: It is concluded that, after reconstructing the posterior wall of the external auditory canal with bioactive glass, two-stage implantation of a Bonebridge implant in a typical site is a safe solution for patients who have difficult anatomical conditions following their CWD mastoidectomy.

Giant Cholesteatoma: A Case Report and Review of the Literature.

OBJECTIVE: To present a case of giant cholesteatoma and review of the contemporary literature. PATIENTS: A 61-year-old male presented with foul-smelling discharge from his right ear in the setting of a previous canal wall down mastoidectomy. Otomicroscopy demonstrated a mastoid cavity filled with infected keratinous debris. Neuro-imaging revealed soft tissue inflammatory changes in the mastoid cavity, with involvement of the temporomandibular joint (TMJ) and parotid gland and tegmen erosion. Biopsies showed evidence of desquamated epithelium consistent with cholesteatoma, with no malignant cells identified. Audiogram demonstrated a mean hearing loss of 65 dB on the right ear and an air-bone gap of 45 dB. Review of literature was also performed on giant cholesteatoma. INTERVENTIONS: He underwent a modified Fisch Type B infratemporal fossa approach to completely remove the cholesteatoma and a vascularized free flap was utilized to fill the surgical defect. MAIN OUTCOME MEASURES: Complete extirpation of choles-teatoma and resolution of otorrhoea. RESULTS: Repeat imaging showed complete removal of cholesteatoma and clinically there was resolution of the otorrhea. Review of the literature has shown a lack of consensus around the definition of giant cholesteatoma. Most cases in the literature demonstrated extensive involvement of anatomical spaces beyond the confines of the temporal bone to qualify for the diagnosis of giant cholesteatoma. CONCLUSIONS: Giant cholesteatoma should be suspected in cases of recurrent ear discharge following canal wall down mastoidectomy. The case we report add to the literature to benefit future patients in preoperative counseling and better inform management.