Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial.

BACKGROUND: Minimally invasive temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) demonstrated a significant larger treatment effect on the symptom burden of chronic rhinitis patients than a sham control (no energy delivery) at the 3-month primary endpoint of this trial. METHODS: Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage. RESULTS: The mean baseline reflective total nasal symptom score (rTNSS) was 8.2 (95% confidence interval [CI], 7.9-8.6; N = 104). At 2 years (N = 79), the mean change in rTNSS was -5.3 (95% CI, -5.8 to -4.8; p < 0.001; 64.6% improvement). The 2-year responder rate (≥30% improvement in rTNSS) was 87.3% (95% CI, 78.0-93.8). All four components of the rTNSS (rhinorrhea, congestion, sneezing, and nasal itching) showed significant improvement over baseline, with rhinorrhea and congestion showing the most improvement. Postnasal drip and cough symptoms were also significantly improved. At 2 years, 81.0% (95% CI, 70.6-89.0) reported a minimal clinically important difference of ≥0.4-point improvement in the mini-rhinoconjunctivitis quality of life questionnaire score. Of 56 patients using chronic rhinitis medications at baseline, 25 of 56 (44.6%) either stopped all medication use (7/56 [12.5%]) or stopped/decreased (18/56 [32.1%]) use of ≥1 medication class at 2 years. No serious adverse events related to the device/procedure were reported over 2 years. To determine the potential effect of patients who left the trial over 2 years on the responder rate, the responder statuses of the 14 patients with follow-up data who were lost to follow-up/withdrew/died were imputed by the last observation carried forward and the responder statuses of all nine patients who had an additional nasal procedure were imputed to nonresponder, resulting in a 2-year responder rate of 79.4% (95% CI, 70.3-86.8). CONCLUSION: TCRF ablation of the PNN is safe and resulted in a significant and sustained reduction in chronic rhinitis symptom burden through 2 years and a substantial reduction in concomitant medication burden.

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.

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.

Assessment of PIV performance in validating CFD models from nasal cavity CBCT scans.

OBJECTIVE: The aim of our study was to investigate how well Particle Image Velocimetry (PIV) measurements could serve Computational Fluid Dynamics (CFD) model validation for nasal airflow. MATERIAL AND METHODS: For the PIV measurements, a silicone model of the nose based on cone beam computed tomography (CBCT) scans of a patient was made. Corresponding CFD calculations were conducted with laminar and two turbulent models (k-ω and k-ω SST). RESULTS: CFD and PIV results corresponded well in our study. Especially, the correspondence of CFD calculations between the laminar and turbulent models was found to be even stronger. When comparing CFD with PIV, we found that the results were most convergent in the wider parts of the nasal cavities. CONCLUSION: PIV measurements in realistically modelled nasal cavities succeed acceptably and CFD calculations produce corresponding results with PIV measurements. Greater model scaling is, however, necessary for better validations with PIV and comparisons of competing CFD models.

Three-Dimensional Printing of the Nasal Cavities for Clinical Experiments.

3D printing has produced many beneficial applications for surgery. The technique´s applicability in replicating nasal cavity anatomy for clinical use has not been studied. Our aim was to determine whether 3D printing could realistically replicate the nasal cavities and the airflow passing through them from a clinical point of view. We included Cone Beam Computed Tomography (CBCT) scans of five patients with symptoms of chronic nasal congestion. These CBCT scans were used to print plastic 3D prints of the nasal cavities, which were also CBCT scanned and the measurements were compared. The results in vivo were higher than the results in vitro in maxillary sinus volumes with a ratio of 1.05 ± 0.01 (mean ± SD) and in the nasal cavities with a ratio of 1.20 ± 0.1 (mean ± SD). Linear measurements in vitro were very close to those in vivo. Rhinomanometric results showed some differences, but rhinomanometric graphs in vitro were close to the graphs in vivo. 3D printing proved to be a suitable and fast method for replicating nasal cavity structures and for the experimental testing of nasal function. It can be used as a complementary examination tool for rhinomanometry.

In-office balloon dilation of the Eustachian tube under local anesthesia: A retrospective review.

OBJECTIVE: To study the effectiveness and feasibility of in office balloon dilation of the Eustachian tube (BDET) utilizing a novel anesthetic protocol. Study design: retrospective review. METHODS: Retrospective chart review looking at the tolerability and effectiveness of stand-alone BDET in an office setting utilizing a novel topical anesthesia protocol in 33 patients with Eustachian tube dysfunction as defined by an ETDQ-7 score greater than 2.2 and type B or C tympanograms for greater than 3 months despite maximal medical management, including at least 4 weeks of nasal steroids. RESULTS: BDET in the office was well tolerated with 94% (31/33) of patients completing the procedure as planned. No adverse effects or complications were reported; however, the planned dilation time was cut short in one case due to significant discomfort and aborted prior to dilation in another due significant coughing. Tympanograms normalized at six weeks in 87.1% (27/31) of patients who underwent dilation. CONCLUSION: This study demonstrates that performing BDET in an office setting utilizing a local anesthesia protocol is feasible and effective when the unique barometric considerations of BDET are addressed.

In-Office Balloon Dilation of the Eustachian Tube under Local Anesthesia.

Balloon dilation of the Eustachian tube (BDET) is an effective treatment of Eustachian tube dysfunction. This procedure can be performed under local anesthesia in the office. This article outlines the evolution of BDET under local anesthesia, describes the techniques of in-office BDET and provides an algorithm to identify suitable patients for this procedure.

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group.

OBJECTIVE: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. STUDY DESIGN: Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. SETTING: Twenty-one investigational sites across the United States. SUBJECTS AND METHODS: Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. RESULTS: Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire-7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). CONCLUSIONS: The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial.

OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. STUDY DESIGN: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. METHODS: The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. RESULTS: Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. CONCLUSIONS: This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:1200-1206, 2018.

Transnasal Endoscopic Eustachian Tube Surgery.

The purpose of this article is to give a contemporary review of transnasal endoscopic surgery for Eustachian tube disorders. The authors' perspective of the relevant anatomy, pathophysiology, and evaluation of Eustachian tube disorders as related to surgical intervention also is provided.

Eustachian Tube Dilation via a Transtympanic Approach in 6 Cadaver Heads: A Feasibility Study.

The goal of this study was to evaluate the feasibility of endoscopic transtympanic balloon dilation of the cartilaginous eustachian tube. To accomplish this, transtympanic balloon dilation of the cartilaginous eustachian tube was performed on 11 eustachian tubes (6 cadaver heads). The balloon catheter was introduced and passed through the protympanic orifice of the eustachian tube transtympanically under endoscopic view and cannulated without incident in all cadavers. Computed tomography was then performed postprocedure to evaluate for inadvertent dilation of the bony eustachian tube, adverse placement of the balloon, or any bony fractures. The balloon was seen to be successfully inflated in the cartilaginous portion without damage to surrounding structures in all cases. This demonstrates that under endoscopic guidance, the protympanic orifice of the eustachian tube can be feasibly cannulated and reliably traversed, allowing for targeted dilation of the cartilaginous eustachian tube from a transtympanic approach.

Intraoperative parathyroid hormone assay: a necessary tool for multiglandular disease.

OBJECTIVES: The aims were to: (1) evaluate whether failure of intraoperative parathyroid hormone (ioPTH) to decrease by the Miami criterion is a more specific indicator of multiglandular disease (MGD) than sestamibi scan and (2) determine an adequate cutoff value for decrease in ioPTH in MGD. STUDY DESIGN: Case series with chart review. SETTING: Louisiana State University Health Sciences Center- Shreveport. SUBJECTS AND METHODS: Review of subjects undergoing parathyroidectomy using ioPTH and sestamibi for suspected parathyroid adenoma between 2005 and 2009. Patients with MGD were identified by pathology and operative reports. RESULTS: Eighty-three subjects were identified (68 single adenomas, 11 double adenomas, and 4 multiple-gland hyperplasias). Sestamibi predicted MGD in only 4 of 15 cases (27%). Five of the 11 double adenomas (DAs) were identified during initial surgery; the rest required reoperation for cure. ioPTH was useful in predicting MGD in 7 of 10 cases (70%) when a postexcisional value was drawn after removal of the first enlarged gland. Using the Miami criterion of 50% decrease in ioPTH over 15 minutes would have resulted in 1 unnecessary neck exploration and 3 missed DAs. Requiring both a 50% decrease in ioPTH over 15 minutes and normalization of the postexcisional value would have missed only 1 DA and resulted in a single unnecessary neck exploration. CONCLUSION: Sestamibi alone fails to identify MGD 73% of the time, but the success rate increases significantly when combined with ioPTH. The "50% and normal" criterion worked best to increase the success rate in our study population, but larger trials are needed to confirm the utility of this criterion.

Intracerebral metastasis of a sinonasal teratocarcinosarcoma: a case report.

Sinonasal teratocarcinosarcoma (SNTCS) is a rare, malignant neoplasm that contains both mesenchymal and epithelial components. The mortality rate for this tumor is ∼60% within 3 years, with the average survival rate being 1.7 years. Usually, this neoplasm presents with symptoms of nasal obstruction and epistaxis. Neurological symptoms from intracranial extension and dural invasion are rare presentations for this neoplasm. We present the first known case of an intracerebral metastasis of a previously resected SNTCS.