Long-term efficacy of balloon dilation of the pediatric Eustachian tube: A six-year matched cohort study.

PURPOSE: Balloon dilation of the Eustachian tube (BDET) has not been evaluated extensively in children outside of retrospective case series. The purpose of this study is to report the long-term safety and efficacy of this procedure in children with matched controls. MATERIALS AND METHODS: This is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure. RESULTS: Thirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications. CONCLUSIONS: BDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction. LEVEL OF EVIDENCE: 2b.

Patulous Eustachian Tube Dysfunction Symptoms Following Balloon Dilation.

OBJECTIVE: Clinicians increasingly perform balloon dilation of the Eustachian tube (BDET) to treat obstructive Eustachian tube dysfunction (OETD) refractory to medical management. Reported complications have been limited and include patulous Eustachian tube dysfunction (PETD). This multicenter study investigates the incidence of PETD and associated factors. METHODS: Consecutive patients at three academic centers undergoing BDET (January 2014-November 2019) for OETD refractory to medical therapy were included. PETD was diagnosed by patient-reported symptoms of autophony of voice and/or breathing. Associated factors studied include age, sex, comorbidities, balloon size, duration of inflation, repeat BDET, and adjunctive procedures. RESULTS: BDET procedures (n = 295 Eustachian tubes) were performed on 182 patients. Mean age was 38.4 years (SD 21.0; range 7-78) and 41.2% were female. Twenty cases of PETD (6.8% of procedures; 9.3% of patients) occurred following BDET. Risk of PETD did not vary by institution, comorbidities, or adjunctive procedure. Age ≤18 years (adjusted risk ratio [RR] = 3.26; 95% confidence interval [CI]: 1.24, 8.54; p = 0.02), repeat BDET (RR = 3.26; 95% CI: 2.15, 4.96; p < 0.001), and severe preoperative Eustachian tube inflammation (RR = 2.83; 95% CI: 1.10, 7.28; p = 0.03) were associated with increased risk of developing PETD in the multivariable model. Most symptoms were reported as mild or intermittent. CONCLUSION: BDET caused PETD symptoms in approximately 7% of dilated Eustachian tubes in this study with increased risk for younger patients and those with severe inflammation or undergoing repeat dilations. Although most cases were self-limited, symptoms can persist. Awareness of risk factors may aid clinicians in limiting this complication. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:3152-3157, 2023.

Reconstruction of the Obliterated Eustachian Tube: A Pilot Case Series.

OBJECTIVE: To investigate the safety and early efficacy of a procedure for reconstruction of the obliterated Eustachian tube (ET). STUDY DESIGN: Retrospective case series. METHODS: Patients with total obliteration of the cartilaginous ET, with intractable mucoid effusion causing repeated occlusion of tympanostomy tubes were included. Patients underwent endoscopic transnasal/transoral reconstruction of the obliterated ET using transtympanic illuminated guidewire guidance. A temporary stent (angiocatheter filled with bonewax) was placed to maintain patency while healing. In four cases an additional steroid-eluting propel stent was placed in the ET orifice. Main outcome measures were otomicroscopy results, absence of middle ear effusion, and nasopharyngoscopy showing patency of the ET orifice. RESULTS: Nine ETs (seven patients), ages 17-68 years (mean 37.9) underwent ET reconstruction. Follow-up ranged from 4 to 56 months (mean 30.9 months). 89% of operated ears had no effusion at last follow-up. Two patients (three Eustachian tubes) underwent successful reoperation. There were no complications directly related to the procedure. Etiologies of obliteration included scarring after sinus surgery, obstruction after maxillo-mandibular advancement surgery (two patients), bullous pemphigus, gunshot trauma, and previous patulous obliteration (two patients). CONCLUSIONS: Complete occlusion of the cartilaginous ET can be associated with intractable mucoid effusion; endoscopic examination should be considered in such cases. In this pilot study, ET reconstruction was found to be a safe and possibly effective procedure in patients with total obliteration of the ET from various etiologies. Larger studies with long term follow up are indicated. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:1970-1975, 2023.

Comparison of outcomes for balloon dilation of the Eustachian tube under local vs general anesthesia.

Objective: To compare the effectiveness of balloon dilation of the Eustachian tube (BDET) under local versus general anesthesia in the treatment of obstructive Eustachian tube dysfunction (OETD). Study Design: Retrospective review. Methods: Consecutive patients ages ≥18 with persistent OETD having failed adequate medical therapy underwent BDET between 2013 and 2018 under local or general anesthesia. Inclusion criteria were persistent type B or C tympanograms with symptoms or type A with symptoms upon barochallenge. Objective outcome measures were tympanometry, otoscopy and the need for additional subsequent intervention (revision dilation and tympanostomy tube). Primary outcome (failure) was defined as no change or worse in tympanogram. Results: The 191 patients (332 ETs), ages 18-88 years (mean 58.0) underwent BDET. The 112 patients (59%) were female. The 107 procedures (32%) were performed under local anesthesia. Mean duration of follow-up was 3.1 years (SD 1.9). Tympanograms improved to type A in 88% for BDET under local and 74% for general anesthesia at 12 months. Probability of being failure-free at 5 years was 70% (95% confidence interval [CI]: 52%-82%) in the local anesthesia group versus 65% (95% CI: 55%-73%) in the general anesthesia group. Risk of failure did not significantly differ between the groups (HR = 0.60; 95% CI: 0.27-1.31; p = .20). Conclusion: BDET under local anesthesia is effective in treating OETD and results in sustained improvements over 2 years. The procedure was successfully performed in all but one case utilizing a precise anesthesia protocol, and results are comparable with the procedure performed under general anesthesia. Level of evidence: 4.

Efficacy of Balloon Tuboplasty for Baro-Challenge-Induced Eustachian Tube Dysfunction: A Systematic Review and a Retrospective Cohort Study of 39 Patients.

OBJECTIVE: Baro-challenge-induced Eustachian tube dysfunction (ETD) manifests due to inadequate Eustachian tube (ET) function during rapid ambient pressure changes, although ET function may be normal in normobaric situations. This systematic review and retrospective cohort study aimed to evaluate the effectiveness of balloon Eustachian tuboplasty (BET) for the treatment of baro-challenge-induced ETD. DATA SOURCES: PubMed, the Cochrane Library, Scopus, and Helsinki University Hospital cohort. METHODS: A systematic literature search was conducted in November 2020 and resulted in 174 articles. Eight articles fulfilled the inclusion criteria. Data was available altogether from 74 adult baro-challenge-induced ETD patients. In addition, we retrospectively evaluated 39 BET operations at Helsinki University Hospital from 2011 to 2020. Data from these 39 patients were collected from medical charts, and a questionnaire was sent to the patients. Meta-analysis was used to evaluate subjective symptom improvement, changes in ETD Questionnaire-7 (ETDQ-7) scores, and Valsalva maneuver performance. RESULTS: In the systematic review, the outcome parameters varied between studies. Improvement was reported in subjective symptoms, Valsalva maneuver, ETDQ-7, tubomanometry, and pressure chamber test. Response rate for the Helsinki University Hospital cohort study was 72% (28/39). Mean follow-up time from the BET to the questionnaire was 4 years 8 months (SD 26months). Of those patients 93% (26/28) found the operation beneficial. Meta-analysis including up to 113 patients showed improvement in Valsalva maneuver, ETDQ-7, and improvement in subjective symptoms. Overall improvement in symptoms was noted in 81% of the patients. CONCLUSION: BET seems to be effective in the majority of patients with baro-challenge-induced ETD.

Facial Paralysis From Post-transplant Lymphoproliferative Disorder.

OBJECTIVE: We report a case of facial paresis and profound hearing loss from post-transplant lymphoproliferative disorder (PTLD) in a pediatric patient with neuroblastoma. PATIENT: Three-year-old boy with rapidly progressive right facial paresis and sensorineural hearing loss. High-risk neuroblastoma had been diagnosed 1 year earlier, treated with chemotherapy and resection of the adrenal primary tumor. Two months after two autologous hematopoietic stem cell transplantations (HSCT), the patient developed facial paralysis. Magnetic resonance imaging (MRI) showed bilateral progressive internal auditory canal (IAC) enhancing lesions with a mass lesion on the right and wispy enhancement on the left and enhancement within the right cochlea. Lumbar puncture (LP) was positive for Epstein-Barr virus (EBV) making the diagnosis of PTLD most probable. Biopsy of the right IAC lesion was deferred because of potential procedural risks including intradural spread of tumor or fungus. The patient was treated with anti-fungal therapy and systemic rituximab without improvement. Subsequent intrathecal rituximab resulted in improvement of lesions on MRI and clearance of EBV from the cerebrospinal fluid (CSF). INTERVENTIONS: Mastoidectomy for biopsies from the mastoid and middle ear. Intrathecal treatment with rituximab. MAIN OUTCOME MEASURES: Imaging assessment of IAC lesion, CSF EBV titers, facial nerve function. RESULTS: Gradual resolution of IAC mass lesions, remission of PTLD, and facial improvement from House-Brackmann score of 4 to 3. CONCLUSIONS: PTLD causing facial paresis after autologous HSCT has not been previously reported and may be considered in the differential diagnosis of lesions causing facial paresis in patients who have received a stem cell or solid organ transplant.

Balloon Dilation for Obstructive Eustachian Tube Dysfunction in Children.

OBJECTIVE: Determine the safety and efficacy of balloon dilation of the Eustachian tube (ET) in pediatric patients. STUDY DESIGN: Retrospective matched cohort study. SETTING: Tertiary medical center. PATIENTS: Pediatric patients (<18 yr) with persistent (>1.5 yr) chronic Eustachian tube dysfunction (ETD) with previous tympanostomy tube (TT) insertion versus matched controls. INTERVENTIONS: Balloon dilation of the cartilaginous ET (BDET) was performed using concomitant myringotomy with/without tube placement and adjunctive procedures if indicated versus controls (TT). MAIN OUTCOME MEASURES: Otitis media with effusion (OME)/retraction with need for additional tube, tympanogram, audiogram, otomicroscopy, ET mucosal inflammation/opening score, and Valsalva maneuver. RESULTS: Forty six ETs (26 patients), ages 7 to 17 years (mean 12.5) underwent BDET. Mean follow-up was 2.3 years (standard deviation [SD], 1.1; range, 6 mo-5 yr). Significant improvements were observed for all measures. Tympanic membranes were healthy in 9% preoperatively, 38% at 6 months, 55% at 12 months, and 93% at 36 months postoperatively. Tympanograms improved to type A in 50% at 6 months, 59% at 12 months, and 85% at 36 months. Mean scores of mucosal inflammation declined from 3.2 (±0.6) preoperatively to 2.5 (±0.7) at 6 months and 1.7 (±0.6) at 36 months postoperatively. BDET had lower risk of failure versus TT insertion (adjusted hazard ratio [HR] 0.26; 95% confidence interval [CI]: 0.10, 0.70; p = 0.007). Probability of being failure free at 2 years was 87% (95% CI: 70, 94%) after BDET and 56% (95% CI: 40, 70%) after TT insertions. CONCLUSIONS: BDET is a safe and possibly effective procedure in selected pediatric patients with chronic ETD.

Scattering of therapeutic radiation in the presence of craniofacial bone reconstruction materials.

PURPOSE: Radiation scattering from bone reconstruction materials can cause problems from prolonged healing to osteoradionecrosis. Glass fiber reinforced composite (FRC) has been introduced for bone reconstruction in craniofacial surgery but the effects during radiotherapy have not been previously studied. The purpose of this study was to compare the attenuation and back scatter caused by different reconstruction materials during radiotherapy, especially FRC with bioactive glass (BG) and titanium. METHODS: The effect of five different bone reconstruction materials on the surrounding tissue during radiotherapy was measured. The materials tested were titanium, glass FRC with and without BG, polyether ether ketone (PEEK) and bone. The samples were irradiated with 6 MV and 10 MV photon beams. Measurements of backscattering and dose changes behind the sample were made with radiochromic film and diamond detector dosimetry. RESULTS: An 18% dose enhancement was measured with a radiochromic film on the entrance side of irradiation for titanium with 6 MV energy while PEEK and FRC caused an enhancement of 10% and 4%, respectively. FRC-BG did not cause any measurable enhancement. The change in dose immediately behind the sample was also greatest with titanium (15% reduction) compared with the other materials (0-1% enhancement). The trend is similar with diamond detector measurements, titanium caused a dose enhancement of up to 4% with a 1 mm sample and a reduction of 8.5% with 6 MV energy whereas FRC, FRC-BG, PEEK or bone only caused a maximum dose reduction of 2.2%. CONCLUSIONS: Glass fiber reinforced composite causes less interaction with radiation than titanium during radiotherapy and could provide a better healing environment after bone reconstruction.

Patient specific glass fiber reinforced composite versus titanium plate: A comparative biomechanical analysis under cyclic dynamic loading.

OBJECTIVES: Free flap fixation with patient specific titanium (TI) plates is commonly performed after oncologic mandible resection, but plate exposure, osseous nonunion and imaging artefacts are associated complications. The aim of this study was to analyze interfragmentary movements and fatigue behaviour of patient specific titanium plates in comparison to a novel glass fiber reinforced composite (GFRC) plate in vitro. METHODS: Two polyurethane fibula segments were fixed to a corresponding mandible (Synbone AG, Malans, CH) with a patient specific 2.0 mm titanium plate (DePuy Synthes, Umkirch, Germany and Materialise, Leuven, Belgium) or one of two patient specific GFRC plates with different glass fiber orientation. Plate fixation to the fibula segments was performed with monocortical non-locking screws in all groups. Plate fixation to the mandible was performed with bicortical locking screws in the titanium group and with bicortical non-locking screws in the GFRC groups. Mastication was simulated via cyclic dynamic loading on the left side at a rate of 1 Hz with increasing peak loading (+0.15 N/cycle, Bionix, MTS, Eden Prairie, USA). A three-dimensional optical measuring system (PONTOS 5 M, GOM, Braunschweig, Germany) was used to determine interfragmentary movements between mandible and fibula segments. RESULTS: Mean plate stiffness of GFRC plates was 431 ±â€¯64 N/mm and 453 ±â€¯70 N/mm versus 560 ±â€¯112 N/mm in the titanium group. No significant differences were found for the number of loading cycles until a vertical displacement of 1.0 mm (p = 0.637) and for vertical displacement over time (p = 0.490). Interosteotomy gap movement differed significantly between titanium and GFRC plates in the right distal (p = 0.001), intermediate (p = 0.006) and left distal gap (p = 0.025). CONCLUSIONS: CAD/CAM titanium plates with locking screws provide increased stiffness and reduced interosteotomy movements in comparison to CAD/CAM glass fiber reinforced composite plates with non-locking titanium screws. Future studies should evaluate the influence of mechanobiologically optimized fixation systems on bone healing in free flap surgery.