Mild matters: trial learnings and importance of community engagement in research for early identified bilateral mild hearing loss.

Introduction: Early identification of mild hearing loss has resulted in early hearing amplification without adequate evidence of effectiveness. This paper describes learnings from a pilot trial, combined with a qualitative study, to highlight the importance of community engagement in designing research studies to determine whether early amplification benefits young children with bilateral mild hearing loss. Methods: PART 1 of the study is a proof-of-concept non-blinded multi-centre randomised controlled trial (RCT) of hearing device fitting vs. no fitting aimed to gather preliminary data and determine its acceptability/feasibility in children <2 years old with bilateral mild hearing loss. Results: PART 2 is a qualitative study to understand the barriers/enablers to RCT participation. Of 40 potentially eligible families, nine (23%) declined, three were uncontactable (7%), 26 (65%) ineligible: of these, nine (35%) did not meet hearing threshold inclusion criteria, 11 (42%) were already fitted or had made decisions on fitting hearing device, two (7%) had conductive loss and four (16%) were ineligible for other reasons. Two of 11 (18%) eligible families were randomised. With the limited sample size, outcome measures were not compared between groups. Both participants completed the trial, reported the RCT to be acceptable, and neither changed group post-enrolment. Discussion: Whilst recruitment uptake could potentially be increased by altering the eligibility criteria, better communication with and reimbursement of clinicians as recruiters, and improving awareness of the study amongst external stakeholders, the RCT methodology does not conform to family-centred practice, and potentially raises ethical concerns regarding potential adverse consequences of not offering early amplification. Parental perception of losing control over choice of management due to randomisation is not an easily modifiable factor. Alternative methodological approaches without randomisation are required to determine whether hearing amplification benefits infants with mild hearing loss.Clinical Trial Registration: identifier [ACTRN12618001608257].

The effect of interdevice interval on speech perception performance among bilateral, pediatric cochlear implant recipients.

OBJECTIVES/HYPOTHESIS: To determine if prolongation of the interdevice interval in children receiving bilateral cochlear implants adversely affects speech perception outcomes. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective review of our pediatric cochlear implant database was performed. Children who had undergone revision surgery or had less than 12 months listening experience with either the first or second implant were excluded. The interdevice interval, best Phonetically Balanced Kindergarten word lists (PBK) score from each ear, and demographic data about each patient were collected. A ratio of PBK was generated (PBK second side/PBK first side) to minimize potential confounding from other individual patient factors that affect speech outcomes. RESULTS: Two hundred forty children met the study criteria. Mean age at first cochlear implantation (CI) was 3.2 years (0.6-17.9), and the second was 6.6 years (0.8-22.4). Mean best PBK score from the first CI side was 83.8% (0-100), and the second was 67.5% (0-100) (P < .001). When the PBK ratio was plotted against interdevice interval, R(2) was 0.47 (P < .001). When analyzed for hearing stability, those with a progressive loss history demonstrated less influence of prolonged interdevice interval on performance. Multivariate analysis did not identify other factors influencing the ratio. A line of best fit for those with stable hearing loss suggested best outcomes were with an interdevice interval less than 3 to 4 years. Beyond 7 to 8 years, very few achieved useful speech recognition from the second CI. CONCLUSIONS: Where possible, the second implant should be received within 3 to 4 years of the first to maximize outcome in those with stable, severe to profound sensorineural hearing loss. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:2389-2394, 2016.

Pre-operative simulation of pediatric mastoid surgery with 3D-printed temporal bone models.

OBJECTIVES: As the process of additive manufacturing, or three-dimensional (3D) printing, has become more practical and affordable, a number of applications for the technology in the field of pediatric otolaryngology have been considered. One area of promise is temporal bone surgical simulation. Having previously developed a model for temporal bone surgical training using 3D printing, we sought to produce a patient-specific model for pre-operative simulation in pediatric otologic surgery. Our hypothesis was that the creation and pre-operative dissection of such a model was possible, and would demonstrate potential benefits in cases of abnormal temporal bone anatomy. METHODS: In the case presented, an 11-year-old boy underwent a planned canal-wall-down (CWD) tympano-mastoidectomy for recurrent cholesteatoma preceded by a pre-operative surgical simulation using 3D-printed models of the temporal bone. The models were based on the child's pre-operative clinical CT scan and printed using multiple materials to simulate both bone and soft tissue structures. To help confirm the models as accurate representations of the child's anatomy, distances between various anatomic landmarks were measured and compared to the temporal bone CT scan and the 3D model. RESULTS: The simulation allowed the surgical team to appreciate the child's unusual temporal bone anatomy as well as any challenges that might arise in the safety of the temporal bone laboratory, prior to actual surgery in the operating room (OR). There was minimal variability, in terms of absolute distance (mm) and relative distance (%), in measurements between anatomic landmarks obtained from the patient intra-operatively, the pre-operative CT scan and the 3D-printed models. CONCLUSIONS: Accurate 3D temporal bone models can be rapidly produced based on clinical CT scans for pre-operative simulation of specific challenging otologic cases in children, potentially reducing medical errors and improving patient safety.

Intraoperative round window electrocochleography and speech perception outcomes in pediatric cochlear implant recipients.

OBJECTIVES: The goal was to measure the magnitude of cochlear responses to sound in pediatric cochlear implant recipients at the time of implantation and to correlate this magnitude with subsequent speech perception outcomes. DESIGN: A longitudinal cohort study of pediatric cochlear implant recipients was undertaken. Intraoperative electrocochleographic (ECoG) recordings were obtained from the round window in response to a frequency series at 90 dB nHL in 77 children totaling 89 ears (12 were second side surgeries) just before device insertion. The increase in intraoperative time was approximately 10 min. An ECoG "total response" metric was derived from the summed magnitudes of significant responses to the first, second, and third harmonics across a series of frequencies. A subset of these children reached at least 9 months of implant use and were old enough for the phonetically balanced kindergarten (PB-k) word test to be administered (n = 26 subjects and 28 ears). PB-k scores were compared to the ECoG total response and other biologic and audiologic variables using univariate and multiple linear regression analyses. RESULTS: ECoG responses were measurable in almost all ears (87 of 89). The range of ECoG total response covered about 60 dB (from ~0.05 to 50 µV). Analyzing individual ECoG recordings in bilaterally implanted children revealed poor concordance between the measured response in the first versus second ear implanted (r = 0.21; p = 0.13; n = 12). In a univariate linear regression, the ECoG total response was significantly correlated with PB-k scores in the subset of 26 subjects who were able to be tested and accounted for 32% of the variance (p = 0.002, n = 28). Preoperative pure-tone average (PTA) accounted for slightly more of the variance (r = 0.37, p = 0.001). However, ECoG total response and PTA were significantly but only weakly correlated (r = 0.14, p = 0.001). Other significant predictors of speech performance included hearing stability (stable versus progressive) and age at testing (22 and 16% of the variance, respectively). In multivariate analyses with these four factors, the ECoG accounted for the most weight (ß = 0.36), followed by PTA (ß = 0.26). In a hierarchical multiple regression analysis, the most parsimonious models that best predicted speech perception outcomes included three variables: ECoG total response, and any two of preoperative PTA, age at testing, or hearing stability. The various three factor models each predicted approximately 50% of the variance in word scores. Without the ECoG total response, the other three factors predicted 36% of variance. CONCLUSIONS: Intraoperative round window ECoG recordings are reliably and easily obtained in pediatric cochlear implant recipients. The ECoG total response is significantly correlated with speech perception outcomes in pediatric implant recipients and can account for a comparable or greater proportion of variance in speech perception than other bio-audiologic factors. Intraoperative recordings can potentially provide useful prognostic information about acquisition of open set speech perception in implanted children.

Effect of cochlear nerve electrocautery on the adult cochlear nucleus.

HYPOTHESIS: Electrocauterization and subsequent transection of the cochlear nerve induce greater injury to the cochlear nucleus than sharp transection alone. BACKGROUND: Some studies show that neurofibromatosis Type 2 (NF2) patients fit with auditory brainstem implants (ABIs) fail to achieve speech perception abilities similar to ABI recipients without NF2. Reasons for these differences remain speculative. One hypothesis posits poorer performance to surgically induced trauma to the cochlear nucleus from electrocautery. Sustained electrosurgical depolarization of the cochlear nerve may cause excitotoxic-induced postsynaptic nuclear injury. Equally plausible is that cautery in the vicinity of the cochlear nucleus induces necrosis. METHODS: The cochlear nerve was transected in anesthetized adult gerbils sharply with or without bipolar electrocautery at varying intensities. Gerbils were perfused at 1, 3, 5, and 7 days postoperatively; their brainstem and cochleas were embedded in paraffin and sectioned at 10 µm. Alternate sections were stained with flourescent markers for neuronal injury or Nissl substance. In additional experiments, anterograde tracers were applied directly to a sectioned eighth nerve to verify that fluorescent-labeled profiles seen were terminating auditory nerve fibers. RESULTS: Cochlear nerve injury was observed from 72 hours postoperatively and was identical across cases regardless of surgical technique. Postsynaptic cochlear nucleus injury was not seen after distal transection of the nerve. By contrast, proximal transection was associated with trauma to the cochlear nucleus. CONCLUSION: Distal application of bipolar electrocautery seems safe for the cochlear nucleus. Application near the root entry zone must be used cautiously because this may compromise nuclear viability needed to support ABI stimulation.

Outcomes of intubation in difficult airways due to head and neck pathology.

The purpose of this study was to examine the impact of surgical pathology, anesthesiologist experience, and airway technique on surgically relevant outcomes in patients identified by preoperative laryngoscopy to have a difficult airway due to head and neck pathology. We prospectively recorded a series of 152 difficult airway cases due to head and neck pathology out of 2,145 direct laryngoscopies undertaken between November 2005 and June 2008. One of two senior anesthesiologists specializing in head and neck procedures intubated 101 (66.4%) of the 152 patients and did so 3.3 minutes faster (p = 0.51), with better oxygenation (87.3 vs. 81.8%; p = 0.02) and fewer airway plan changes (p = 0.001) than did other, nonspecialist anesthesiologists. Predictors of failure of the first intubation plan included: cancer diagnosis (p = 0.02), previous radiotherapy (p = 0.03), and supraglottic lesions (p = 0.03). Glottic/subglottic lesions required the most intubation attempts (p = 0.02). Awake fiberoptic intubation was the most common method used (44.7%) but resulted in a change in the airway plan in 6 cases (8.8%). Gas induction maintained the best oxygenation (p = 0.01). Awake tracheostomy was infrequent (1.3%) and took the longest (p = 0.006). We concluded that difficult airways due to head and neck pathology require teamwork and a backup plan. An anesthesiologist specializing in head and neck procedures may help to avoid adverse outcomes associated with cancer, especially previously irradiated supraglottic/glottic lesions, leading to a less frequent need for awake tracheostomy.

Prophylactic neck dissection in early oral tongue squamous cell carcinoma 2.1 to 4.0 mm depth.

OBJECTIVE: Regional recurrence is common following surgery for T1/T2 oral tongue squamous cell carcinoma (SCC). Tumor depth >4.0 mm is commonly assigned as an indication for prophylactic neck dissection to improve regional control. Prophylactic neck dissection may detect extracapsular extension, a poor prognostic sign where adjuvant chemotherapy is indicated. The hypothesis in this study is that regional recurrence is a significant problem in 2.1- to 4.0-mm-depth tumors, and detection of extracapsular extension may be important in this group. STUDY DESIGN: Retrospective chart review. SETTING: Australian tertiary referral center. SUBJECTS AND METHODS: Review of all patients with T1/T2 oral tongue SCC treated surgically between January 1991 and January 2009 (n = 81). RESULTS: Twenty-nine prophylactic and 5 therapeutic neck dissections followed for a median 34 months (range, 4-132 months). Tumor depths were 0 to 2.0 mm (n = 15), 2.1 to 4.0 mm (n = 18), 4.1 to 7.0 mm (n = 26), and >7.0 mm (n = 22). Tumors 2.1 to 4.0 mm depth had similar rates of occult nodes as 4.1 to 7.0 mm depth (25% vs 20%). Regional recurrence occurred in 31% overall, 44% in tumors 2.1 to 4.0 mm, and 27% in tumors 4.1 to 7.0 mm depth. Prophylactic neck dissection reduced regional recurrence (17% vs 43%, P = .02). Patients with pathologically negative necks had lower rates of regional recurrence than those with occult nodes (9% vs 50%, P < .01). Extracapsular extension increased regional recurrence (43% vs 7%, P = .02), including 25% of dissected necks with tumor depth 2.1 to 4.0 mm. CONCLUSIONS: Regional recurrence is a significant problem in 2.1- to 4.0-mm-depth T1/T2 tongue tumors. Prophylactic neck dissection may improve regional control in patients with adequate primary resection margins and determine need for adjuvant therapies in 2.1- to 4.0-mm-depth tumors.

Functional outcomes of fibula and osteocutaneous forearm free flap reconstruction for segmental mandibular defects.

OBJECTIVE/HYPOTHESIS: To demonstrate that the osteocutaneous radial forearm free flap provides equivalent functional outcomes and improved morbidity compared to the fibular free flap in mandibular reconstruction. STUDY DESIGN: Retrospective review. METHODS: There were 168 patients requiring free flap reconstruction of segmental mandibular defects between January 2001 and December 2008. Mean follow-up was 31 months for fibula free flap (FFF) (n = 117) and 20 months for osteocutaneous radial forearm free flaps (OCRFFF) (n = 51), reflecting an increasing use of forearms. RESULTS: OCRFFF were more commonly used in older patients (mean 63.7 years vs. 59 years, P = .03). The majority (96.2%) of reconstruction was for malignant pathology. Flap failure was 3.4% for the fibula group and 3.9% in the forearm group. Malunion was infrequent (2.0% OCRFFF, 6.0% FFF, P = .26). Donor site complications were higher in the FFF group (4.3%) versus none in the OCRFF group (P = .13). Despite a high rate of long-term survival in this patient population (75% at 5 years for carcinoma), dental implants were rarely placed (2.3% of patients) and were more common in forearm than fibula free flaps. Functional outcomes demonstrated no significant difference between groups with respect to oral diet (FFF 72.6% vs. OCRFFF 79.1%, P = .49) or retained enterogastric feeding tube (20.9% OCRFFF vs. 27.4% FFF, P = .49). CONCLUSIONS: Osteocutaneous radial forearm flaps provide comparable functional outcomes with less morbidity compared to fibula free flaps for selected segmental mandibulectomy defects. The overall dental implantation rate was low and more commonly performed in osteocutaneous radial forearm flaps compared to fibula flaps.

Outcomes of static and dynamic facial nerve repair in head and neck cancer.

OBJECTIVES/HYPOTHESIS: Determine outcomes associated with nerve grafting versus static repair following facial nerve resection. STUDY DESIGN: Retrospective chart review. METHODS: Charts from 105 patients who underwent facial nerve reconstruction between January 1999 and January 2009 were reviewed. The majority had parotid malignancy (78.1%), most commonly squamous cell carcinoma (50.5%). Patients underwent static (n = 72) or dynamic (n = 33) reconstruction with nerve grafting. Facial nerve function was measured using the House-Brackmann (H-B) scale. RESULTS: Patients receiving static reconstruction were on average 10.3 years older (P = .002). Mean overall survival for tumor cases was 61.9 months; parotid squamous cell carcinoma was associated with worse prognosis (P = .10). Median follow-up was 16.1 months (range, 4-96.1 months). Most (97%) patients receiving a nerve graft had some return of function at a median of 6.2 months postoperatively (range, 4-9 months) and the majority (63.6%) had good function (H-B score 6 cm), and prolonged preoperative dysfunction.

Postoperative reirradiation for mucosal head and neck squamous cell carcinomas.

OBJECTIVES: To compare toxic effects and functional outcomes of reirradiation with and without salvage surgery for nonnasopharyngeal mucosal head and neck squamous cell carcinoma. DESIGN: Retrospective review. SETTING: Academic tertiary referral hospital. PATIENTS: Between December 1992 and March 2007, a total of 87 patients underwent reirradiation (64 for cure and 23 for palliation). INTERVENTION: Patients underwent reirradiation with (n = 38) or without salvage surgery (n = 49). After January 2000 there was increased use of concurrent platinum-based chemotherapy (80% vs 5%) and intensity-modulated radiation therapy (82% vs 0%). MAIN OUTCOME MEASURES: Early and late toxic effects of treatment by Radiation Therapy Oncology Group criteria, tracheostomy retention, gastrostomy tube dependence, and survival. RESULTS: The median follow-up among patients alive at last contact was 5.0 years. Compared with reirradiation without surgery, postoperative reirradiation was associated with increased early grade 3 to grade 5 toxic effects (50% [19 of 38] vs 29% [14 of 49], P = .04) and with longer median survival (17.3 vs 8.9 months, P < .001). Free-flap reconstruction decreased early toxic effects in the surgical cohort by 16% (from 60% [9 of 15] to 43% [10 of 23], P = .32). Gastrostomy tube dependence (P = .05) and tracheostomy retention (P = .04) have increased since 2000. The median survival for curative patients was 12.5 months. The estimated 2-year survival was 25%, and the estimated 5-year survival was 8%. CONCLUSIONS: Reirradiation represents the only chance for cure in patients with unresectable disease. After surgery, reirradiation is performed in patients at high risk of locoregional recurrence and may increase acute toxic effects. However, free-flap reconstruction may reduce toxic effects. Functional outcomes have declined since 2000 likely because of the addition of concurrent platinum-based chemotherapy. Future research may define the subpopulation of postoperative patients for whom survival benefits most outweigh reirradiation toxic effects.

Functional outcomes after transoral robotic surgery for head and neck cancer.

OBJECTIVE: To evaluate functional outcomes following transoral robotic surgery for head and neck cancer. STUDY DESIGN: Case series with planned data collection. SETTING: Academic hospital. SUBJECTS AND METHODS: Between March 2007 and December 2008, 54 of 62 candidate patients underwent transoral robotic tumor resection. Outcomes include airway management, swallowing (MD Anderson Dysphagia Inventory), and enterogastric feeding. RESULTS: Tumors were most commonly oropharynx (61%) or larynx (22%) and T1 (35%) or T2 (44%). Many received radiotherapy (22% preoperatively, 41% postoperatively) and chemotherapy (31%). Endotracheal intubation was retained (22%) for up to 48 hours, tracheostomy less frequently (9%), and all were decannulated by 14 days. Most commenced oral intake prior to discharge (69%) or within two weeks (83%). A worse postoperative Dysphagia Inventory score was associated with retained feeding tube (P=0.020), age>60 (P=0.017), higher T stage (P=0.009), laryngeal site (P=0.017), and complications (P=0.035). At a mean 12 months' follow-up, 17 percent retained a feeding tube (9.5% among primary cases). Retained feeding tube was associated with preoperative tube requirement (P=0.017), higher T stage (P=0.043), oropharyngeal/laryngeal site (P=0.034), and recurrent/second primary tumor (P=0.008). Complications including airway edema (9%), aspiration (6%), bleeding (6%), and salivary fistula (2%) were managed without major sequelae. CONCLUSION: Transoral robotic surgery provides an emerging alternative for selected primary and salvage head and neck tumors with low morbidity and acceptable functional outcomes. Patients with advanced T stage, laryngeal or oropharyngeal site, and preoperative enterogastric feeding may be at increased risk of enterogastric feeding and poor swallowing outcomes.

Functional outcomes following secondary free flap reconstruction of the head and neck.

OBJECTIVES/HYPOTHESIS: To evaluate head and neck patients undergoing secondary (delayed) free flap reconstructions. STUDY DESIGN: Retrospective chart review. METHODS: Of the 523 free flaps between October 2004 and May 2008, 70 patients underwent 71 secondary free flaps. Outcomes include: hospital stay, complications, flap operative time, enterogastric tube, and tracheostomy requirement. Variables assessed include donor site, indication, prior radiation, and extra-cervical vascular anastomosis. RESULTS: Radial forearm (40.8%) and fibula free flaps (29.6%) were most commonly used. Mean hospital stay was 7.9 days, follow-up 23.5 months, and operative time 323 minutes. Complications occurred in 39.4% in hospital (early) and 31.4% after discharge (late). Many required further surgery (33.8%), tracheostomy at discharge (26.8%), and prolonged enterogastric tube feeding (31%). In-hospital mortality was 1.4%, total flap failure 1.4%, and partial failure 5.6%. The radial forearm required the least operative time (P = .002), and had least tracheostomies at discharge (P = .040). Osteocutaneous fibula took longest (P = .0001), and had the highest tracheostomy rate (P = .047). Early complications were highest with anterolateral thigh flaps (P = .001). Osteoradionecrosis resulted in higher tracheostomy rates at discharge (P = .0001). Osteocutaneous flaps took 111 minutes longer (P = .001), and required more tracheostomies on discharge (P = .031), but with lower fistula rates (P = .046). Previous irradiation and extra-cervical vessels did not significantly impact outcomes. CONCLUSIONS: Secondary free flaps are technically feasible for head and neck reconstruction with low mortality and flap failure rates. The extra-cervical and external carotid vessels were equally effective. Patients considering semi-elective free flap reconstruction for osteoradionecrosis should be cautioned about complication rates and tracheostomy retention.

Concha bullosa: reducing middle meatal adhesions by preserving the lateral mucosa as a posterior pedicle flap.

BACKGROUND: Concha bullosa, an extensively pneumatized middle turbinate, may obstruct the paranasal sinuses. Messerklinger's partial lateral turbinectomy is commonly used to debulk the concha bullosa, leaving a raw surface with the potential for adhesions. MATERIALS AND METHODS: A modified technique of partial lateral turbinectomy is described. A posterior pedicled mucosal flap covers the inferior raw surface of the medial lamella of the middle turbinate. Three-month follow up of a consecutive series is compared with concurrent controls. RESULTS: Two (7 per cent) of 28 posterior pedicled flap and four (21 per cent) of 19 traditional partial lateral turbinectomies developed mild middle meatal adhesions (p = 0.011). Posterior pedicled flap reduced the need for post-operative cleaning of the middle meatus. CONCLUSION: The posterior pedicled mucosal flap is a simple modification to partial lateral turbinectomy that covers the raw surface facing the lateral nasal wall, significantly reducing adhesions and speeding recovery.