Tube Balloon Research Articles

MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data

Study designReview of database. SettingTertiary care neurotology center. PatientsPatients undergoing adverse events. InterventionMAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction. Main outcome measuresMedical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates. ResultsThere were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %. ConclusionsETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.

In-office Eustachian Tube Dilation Reduces Symptoms Among Patients With Barometric Challenges.

Balloon dilation of the eustachian tube has gained ground in the treatment of chronic dysfunction. A new indication for a larger group of patients has emerged, which is characterized by barochallenge only, which affects even more patients. Given the recent validation of the balloon dilation, we set out to explore if this procedure could be useful in treating this specific sub-group of patients in an in-office setting. Balloon dilation was performed using inly nasal cottonoids soaked in 2% tretracainephenylephrine combined with xylocaine nasal spray and lidocaine/prilocaine gel and a mild oral sedative. The effect of eustachian tube balloon dilation on the function of the eustachian tube was evaluated by using the eustachian tube dysfunction questionnaire-7 (ETDQ-7) and a VAS score. The questionnaires were completed beforehand and 3 months and 12 months postoperatively to determine subjective surgical success. Two hundred and forty-six balloon dilation were performed in 132 participants. The results from the ETDQ-7 questionnaire and VAS scores showed a significant improvement in symptoms during pressurization after eustachian tube balloon dilation (p = 0.0001). A mean pain score during procedure in local anesthesia was 3.4 on a scale from 1 to 10. Eustachian tube balloon dilation significantly reduced symptoms of eustachian tube dysfunction during non-physiological pressure, which was determined by ETDQ-7 and Vas scores. Additionally, we found that the procedure is well suited for private practice or the outpatient clinic, using local anesthetics and a mild sedative. 4 Laryngoscope, 2024.

The effect of different degrees of Eustachian tube dysfunction on hearing threshold in patients with acquired primary middle ear cholesteatoma after balloon eustachian tuboplasty

Objective:To investigate the changes in hearing threshold of the acquired primary cholesteatoma of the middle ear with different degrees of eustachian tube dysfunction after balloon eustachian tuboplasty. Methods:This retrospective study included forty cases with middle ear cholesteatoma and eustachian tube dysfunction who underwent open mastoidectomy + tympanoplasty + balloon eustachian tuboplasty were enrolled. All patients were admitted from November 2020 to April 2022. The preoperative eustachian tube score of 0-2 were defined as the lower group, and the scores of 3-5 were defined as the higher group. Pure tone audiometry was measured preoperatively and 1, 3, 6 and 12 months postoperatively. The average value of bone conduction threshold and air conduction threshold of 250-4 000 Hz were calculated, and the air-bone gap was calculated simultaneously. SPSS 25.0 was used for statistical analysis. P<0.05 was considered statistically significant. Results:In the lower group, the air conduction threshold and air-bone gap at 3 months postoperatively were significantly decreased in comparison with those preoperatively（P<0.05），as was the air-bone gap at 6 months postoperatively（P<0.05）. In the higher group, the air conduction threshold and air-bone gap were significantly decreased at 3, 6 and 12 months postoperatively（P<0.05）. Conclusion:The air conduction threshold and air-bone gap of patients with the acquired primary cholesteatoma of the middle ear and eustachian tube dysfunction were significantly decreased after eustachian tube balloon dilatation. Hearing improvement lasted longer in patients with slight eustachian tube dysfunction.

Perceived Versus Actual Time of Prehospital Intubation by Paramedics.

Situational awareness is essential during emergent procedures such as endotracheal intubation. Previous studies suggest that time distortion can occur during intubation. However, only in-hospital intubations performed by physicians have been studied. We aimed to determine whether time distortion affected paramedics performing intubation by examining the perceived vs actual total laryngoscopy time, defined as time elapsed from the laryngoscope blade entering the mouth until the endotracheal tube balloon passes the vocal cords. For this retrospective study we collected prehospital intubation data from a suburban, fire department-based emergency medical services (EMS) system from January 5, 2021-May 21, 2022. The perceived total laryngoscopy time was queried as a part of the electronic health record. Video laryngoscopy recordings were reviewed by a panel of experts to determine the actual time. Patients >18 years old who underwent intubation by paramedics with video laryngoscopy were included for analysis. The primary outcome was the difference between actual and perceived total laryngoscopy time. Secondary analysis examined the relationship between high time distortion, defined as the highest quartile of the primary outcome, and patient age, paramedic years of experience, perceived presence of difficult anatomy, excess secretions, use of rapid sequence intubation, and multiple intubation attempts. We conducted descriptive analysis followed by logistic regression analysis, chi-square tests, and Fisher exact tests when appropriate. A total of 122 intubations were collected for analysis, and 10 were excluded due to lack of video recording. Final analysis included 112 intubations. Mean actual laryngoscopy time was 50.0 seconds (s) (95% confidence interval [CI] 43.7-56.3). Mean perceived laryngoscopy time was 27.8 s (95% CI 24.7-31.0). The median difference between actual and perceived time was 18 s (interquartile range 6-30). We calculated high time distortion as having a difference greater than 30 s between actual and perceived laryngoscopy time. None of the secondary variables had statistically significant associations with high time distortion. Overall, we show that the paramedic's perception of total laryngoscopy time is significantly underestimated even when accounting for paramedic experience and perceived airway difficulty. This study suggests that time distortion may lead to an unrecognized prolonged procedure time. Limitations include use of a convenience sample, small sample size, and potential uncollected confounding variables.

The impact of sphygmomanometer placement and cuff placement on blood pressure measurements.

Hypertension is the most significant global risk factor for mortality and morbidity, making standardized blood pressure measurement crucial. To investigate whether the location of blood pressure monitors and the positioning of cuffs yield differing results in blood pressure measurements. Patients admitted to the Affiliated Hospital of Jiujiang College between 1 January 2022 and 30 June 2023 were enrolled in this study and randomly allocated into four groups. These groups were defined based on the positioning of monitoring equipment as follows: varied placements of cuffs on automatic blood pressure monitors, different heights for mercury column blood pressure monitors, varied heights for automatic blood pressure monitors, and different orientations for the cuff airbag tubes on electrocardiogram monitors. Blood pressure was measured and recorded for each group, followed by an analysis of the variations in readings across the different setups. In the first cohort of 763 individuals, mean systolic blood pressure measured at the standard upper arm site was 128.8 ± 10.5 mmHg, compared to 125.3 ± 10.4 mmHg at the elbow fossa. The corresponding diastolic pressures were 79.2 ± 10.7 and 75.0 ± 10.6 mmHg, respectively. The difference in systolic pressure between these positions was significant at 3.48 ± 3.22 mmHg (t₁ = 29.91, p₁ < 0.001) and for diastolic pressure at 4.23 ± 1.31 mmHg (t₂ = 88.98, p₂ < 0.001). For the subsequent groups, involving 253, 312, and 225 individuals, respectively, blood pressure measurements were analyzed and compared across different methods within each group. All p-values exceeded 0.05, indicating no statistically significant differences. Blood pressure values measured at the elbow fossa position using an upper arm-type automatic sphygmomanometer were found to be lower than those measured at the upper arm position, with a difference of 3.48 mmHg for systolic and 4.23 mmHg for diastolic pressures. It is therefore essential to position the cuff correctly, specifically 2-3 cm above the elbow fossa, when utilizing an upper arm-type automatic sphygmomanometer for blood pressure monitoring. Conversely, the placement of the mercury column sphygmomanometer and the automated sphygmomanometer at varying heights had no significant effect on blood pressure readings. Similarly, the orientation of the electrocardiogram's cuffed balloon tube, whether facing upward or downward, did not influence blood pressure measurement outcomes.

Thoracoscopic enucleation of an esophageal glomus tumor in the prone position: a case report and literature review

BackgroundGlomus tumors (GT) generally occur in the skin. However, esophageal GT, an extremely rare condition, has no established standardized treatment guidelines. Herein, we report the case of an esophageal GT successfully removed by thoracoscopic enucleation in the prone position using intra-esophageal balloon compression.Case presentationA 45-year-old man underwent an annual endoscopic examination and was found to have a submucosal tumor in the lower esophagus. Endoscopic ultrasound (EUS) revealed a hyperechoic mass originating from the muscular layer. Contrast-enhanced computed tomography identified a 2 cm mass lesion with high contrast enhancement in the right side of the lower esophagus. Pathologic findings of EUS-guided fine needle aspiration biopsy (EUS–FNA) revealed round to spindle shaped atypical cells without mitotic activity. Immunohistochemically, the tumor was positive for alpha-smooth muscle actin, but negative for CD34, desmin, keratin 18, S-100 protein, melan A, c-kit, and STAT6. He was diagnosed with an esophageal GT and a thoracoscopic approach to tumor resection was planned. Under general anesthesia, a Sengstaken–Blakemore (SB) tube was inserted into the esophagus. The patient was placed in the prone position and a right thoracoscopic approach was achieved. The esophagus around the tumor was mobilized and the SB tube balloon inflated to compress the tumor toward the thoracic cavity. The muscle layer was divided and the tumor was successfully enucleated without mucosal penetration. Oral intake was initiated on postoperative day (POD) 3 and the patient discharged on POD 9. No surgical complications or tumor metastasis were observed during the 1-year postoperative follow-up.ConclusionsAs malignancy criteria for esophageal GT are not yet established, the least invasive procedure for complete resection should be selected on a case-by-case basis. Thoracoscopic enucleation in the prone position using intra-esophageal balloon compression is useful to treat esophageal GT on the right side of the esophagus.

Sirolimus-coated Eustachian tube balloon dilatation for treating Eustachian tube dysfunction in a rat model

Eustachian tube balloon dilatation (ETBD) has shown promising results in the treatment of ET dysfunction (ETD); however, recurrent symptoms after ETBD frequently occur in patients with refractory ETD. The excessive pressure of balloon catheter during ETBD may induce the tissue hyperplasia and fibrotic changes around the injured mucosa. Sirolimus (SRL), an antiproliferative agent, inhibits tissue proliferation. An SRL-coated balloon catheter was fabricated using an ultrasonic spray coating technique with a coating solution composed of SRL, purified shellac, and vitamin E. This study aimed to investigate effectiveness of ETBD with a SRL-coated balloon catheter to prevent tissue proliferation in the rat ET after ETBD. In 21 Sprague–Dawley rats, the left ET was randomly divided into the control (drug-free ETBD; n = 9) and the SRL (n = 9) groups. All rats were sacrificed for histological examination immediately after and at 1 and 4 weeks after ETBD. Three rats were used to represent the normal ET. The SRL-coated ETBD significantly suppressed tissue proliferation caused by mechanical injuries compared with the control group. ETBD with SRL-coated balloon catheter was effective and safe to maintain ET luminal patency without tissue proliferation at the site of mechanical injuries for 4 weeks in a rat ET model.

Push-PEG or Pull-PEG: Does the Technique Matter? A Prospective Study Comparing Outcomes After Gastrostomy Placement

BackgroundPush-PEG (percutaneous endoscopic gastrostomy) with T-fastener fixation (PEG-T) allows one-step insertion of a balloon tube or button, and avoids contamination of the stoma by oral bacteria. However, PEG-T is a technically more demanding procedure with a significant learning curve. The aim of the present study was to compare outcomes after PEG-T and pull-PEG in a setting where both procedures were well established. Materials and methodsThe study is a prospective cohort study including all patients between 0 and 18 year undergoing PEG-T and pull-PEG between 2017 and 2020 at a combined local and tertiary referral center. Complications and parent reported outcomes were recorded during hospital stay, after 14 days and 3 months postoperatively. Results82 (93%) of eligible PEG-T and 37 (86%) pull-PEG patients were included. The groups were not significantly different with regard to age or weight. Malignant disorders and heart conditions were more frequent in the pull-PEG group, whilst neurodevelopmental disorders were more frequent in the PEG-T group (p < 0.001). 54% in both groups had a complication within 2 weeks. Late complications (between 2 weeks and 3 months postoperatively) occurred in 63% PEG-T vs 62% pull-PEG patients (p = 0.896). More parents in the pull-PEG group (49%) reported that the gastrostomy tube restricted their child's activity, compared to PEG-T (24%) (p = 0.01). At 3 months follow-up, more pull-PEG patients (43%) reported discomfort from the gastrostomy compared to PEG-T (21%) (p = 0.03). ConclusionOverall complication rates were approximately similar, but pull-PEG was associated with more discomfort and restriction of activity. Levels of EvidenceTreatment study level II.

Factors influencing in-hospital mortality for salvage percutaneous transjugular intrahepatic portosystemic shunting in cirrhotic patients with recalcitrant variceal bleeding after failed endoscopic intervention

Background. Endoscopic therapy is the first-line treatment of choice for control of acute variceal bleeding (AVB). In high-risk patients with persistent AVB despite pharmacological treatment and endoscopic intervention, percutaneous transjugular intrahepatic portosystemic shunting (TIPS) provides a minimally invasive salvage method to reduce portal pressure and control bleeding. Objectives. To evaluate factors influencing in-hospital mortality after salvage TIPS (sTIPS) in patients with exsanguinating variceal bleeding despite medical treatment and endoscopic intervention. Methods. Clinical and laboratory data were analysed in all patients treated with sTIPS following failed endoscopic therapy for AVB between August 1991 and November 2020. Factors associated with and predictors of death were determined using bivariate analysis and univariate logistic regression analysis. Results. Thirty-four patients (29 men, 5 women), mean age 52 years (range 31 - 80), received sTIPS for uncontrolled (n=11) or refractory (n=23) AVB. The causes of portal hypertension were alcohol-related (n=24) and non-alcohol-related cirrhosis. Salvage TIPS controlled bleeding in 32 patients, with recurrence in 1. Ten patients died in hospital (mean 4.8 days, range 1 - 10) of liver failure (n=4), multiorgan failure (n=3), alcoholic cardiomyopathy (n=2) and uncontrolled gastric variceal bleeding (n=1). On bivariate analysis, factors associated with death were Child-Pugh (C-P) score ≥10 (p=0.006), sodium Model for End-stage Liver Disease (MELD-Na) score ≥22 (p&lt;0.001), ≥8 units of blood transfused (p&lt;0.001), Sengstaken-Blakemore balloon tube placement (p&lt;0.001), endotracheal intubation (p&lt;0.001), inotropic support (p&lt;0.001) and endoscopically uncontrolled bleeding (p&lt;0.001). Univariate logistic regression analysis showed that the most significant predictors of mortality were inotrope dependency (odds ratio (OR) 134; p&lt;0.001), endotracheal intubation (OR 99; p&lt;0.001), endoscopically uncontrolled bleeding (OR 28; p=0.001), grade 3 ascites (OR 20.9; p=0.012) and C-P grade C (OR 8.8; p=0.011). Conclusion. Salvage TIPS controlled variceal bleeding in 94% of patients after failed endoscopic therapy with 29% in-hospital mortality. The most significant predictors of mortality were C-P grade C, grade 3 ascites, inotrope requirement, endotracheal intubation and endoscopically uncontrolled bleeding.

Complications of eustachian tube balloon dilation: Manufacturer and User Facility Device Experience (MAUDE) database analysis and literature review.

To provide an analysis of complications following eustachian tube balloon dilation as well as their treatments and outcomes. PubMed, Ovid Embase, and MAUDE Database. A systematic approach following PRISMA guidelines was used to identify publications pertaining to balloon dilation of the eustachian tube from PubMed and Ovid Embase databases was used. Once these publications were critically reviewed, the primary outcome extracted were reported complications. Additional complications were collected in the Manufacturer and User Facility Device Experience (MAUDE) database using the product class "eustachian tube dilation device" and searching through relevant manufacturers. Complications and outcomes were compared between these sources. Fifty five full-length manuscripts involving 7155 patients were included and 98 complications reported for a 1.4% complication rate. The most frequently reported adverse events were subcutaneous emphysema of the head and neck (19%), epistaxis (12%), and acute otitis media (11%). The MAUDE search returned 18 distinct patient entries, of which 12 (67%) reported complications. The most reported complications in the MAUDE database included subcutaneous emphysema (8, 67%) and pneumomediastinum (3, 25%). The most serious complication was a carotid artery dissection reported in one patient in the MAUDE database. Eustachian tube dilation is rarely associated with complications, which nevertheless may lead to morbidity and medical emergencies. Patients and providers should recognize potential risks associated with this intervention as well as methods to manage complications.

Results of Eustachian tube balloon dilation measured using the nine-step test

Suggested several decades ago, the nine-step test is an intuitive test of Eustachian tube function. However, studies employing the nine-step test to assess the results of Eustachian tube balloon dilation (EBD) are limited. We aimed to objectively evaluate the efficacy of EBD in opening failure patients with decreased maximal peak pressure difference (MPD) using the nine-step test. Patients who had MPD values ≤ 13 daPa in the nine-step test were enrolled. The patients were categorized into two groups according to treatment decisions after discussion with a clinician: an EBD group (N = 26) and a medication group (N = 30). One month after treatment, the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ7) and the nine-step test were administered to all participants and subgroups of symptomatic participants (ETDQ7 > 15). MPD improved (increased) in both the EBD group and the medication group. ETDQ7 values improved (decreased) in the EBD group, but not in the medication group. In subgroup analysis, MPD and ETDQ7 values improved only in the symptomatic EBD group. According to the nine-step test, EBD can normalize 53.8% of decreased MPD. Posttreatment MPD and ETDQ7 scores were significantly better in the EBD group than in the medication group. However, EBD in patients with abnormal nine-step test results seemed less efficacious when the treatment results of the medication group were considered.

S2164 One Size Does Not Fit All: A Case of a PEG Tube Balloon Causing Biliary Obstruction and Pancreatitis

S2164 One Size Does Not Fit All: A Case of a PEG Tube Balloon Causing Biliary Obstruction and Pancreatitis

Letter to the Editor: "Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation".

Letter to the Editor: "Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation".

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

Eustachian tube balloon dilation

Eustachian tube dysfunction is a frequent pathology of middle-ear ventilation, leading to many more or less disabling otologic symptoms. Severity varies from simple otitis media with effusion to aggressive chronic otitis or cholesteatoma. First-line treatment is medical, but surgery can also be proposed. It consists in balloon dilation of the Eustachian tube, in order to increase ventilation and improve symptoms. It is performed in second-line in patients with Eustachian tube dysfunction confirmed by tubomanometry, after failure of local drug treatment. It can be performed under general or local anesthesia but it is mandatory to use a medical device with market authorization for this indication. The main aim of this surgical note is to describe the technique of balloon dilation in the treatment of Eustachian tube dysfunction and the three balloon models with CE label and market authorization currently available in France and in Europe. Balloon dilation of the Eustachian tube appears to be a promising option to restore natural middle-ear ventilation in patients with chronic obstructive Eustachian tube dysfunction.

Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation.

Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management. Case series. FDA Manufacturer and User Facility Device Experience(MAUDE) database. Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management. A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported. Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.

CT Imaging of Eustachian Tube Balloon Dilation: Method Development on Cadaver Heads.

Objective: To develop a methodology for the measurement of balloon dilation (BD) effects on Eustachian Tube (ET) structure using Computerized Tomography (CT) images. Methods: The BD of the ET was performed on three cadaver heads (five ears) through the nasopharyngeal orifice. The axial CT images of the temporal bones were obtained before dilation, while an inflated balloon was in the lumen of ET, and after balloon removal in each ear. Utilizing Dicom images captured by the ImageJ software 3D volume viewer function, the anatomical landmark coordinates of the ET were matched with their pre- and post-dilation counterparts, and the longitudinal axis of the ET was captured with serial images. The histograms of the regions of interest (ROI) and three different lumen width and length measurements were obtained from captured images. The densities of air, tissue, and bone were determined with histograms as a baseline to determine the BD rate as a function of increased air in the lumen. Results: The small ROI box included the area of prominently dilated ET lumen after BD and best represented the visually obvious changes in the lumen, compared to the ROIs that extended the wider areas (longest and longer). Air density was the outcome measure for comparison with each corresponding baseline value. The average increase in air density in the small ROI was 64%, while the longest and long ROI boxes showed 44 and 56% increases, respectively. Conclusion: This study describes a method to image the ET and quantify the outcomes of BD of the ET using anatomical landmarks.

Post-Intubation Tracheal Stenosis: Multicenter Study from 2010 to 2022

Objective: To study the epidemiological, clinical, paraclinical, therapeutic and evolutionary aspects of post-intubation tracheal stenosis occurring in patients admitted to intensive care units. Patients and methods: This is a multicenter, retrospective and descriptive study conducted from November 1, 2010 to June 1, 2022 in 7 intensive care units and 3 ENT departments. From medical records, we collected epidemiological data (frequency, age, sex), medical history, data relating to tracheal intubation (indication, duration, inflation pressure of the intubation tube balloon), data on post-intubation (PI) tracheal stenosis (symptoms and time to onset), paraclinical data, treatment and evolution modalities. The data collected were expressed as averages with their standard deviation. Results: During the study period, 19 patients presented with PI tracheal stenosis. The frequency ranged from 0.03% to 0.1%. The average age of the patients was 25.7 years 11.07 14-38 years. Patients had been intubated in a traumatic context in 47.37% of cases. The average duration of ventilatory support was 10.37 days  03.03 4-15 days No intubation tube cuff pressure monitoring was done for any patient. Dyspnea was the main telltale sign. Its average time to onset was 33.21  days 12.07 1h-3months. Endoscopically, the average degree of tracheal stenosis was 72.63% 50-99% . Therapeutically, in intensive care, 5 patients (26.31%) who presented with acute respiratory failure underwent a life-saving surgical tracheostomy. Curative surgery resulted in a tracheal resection-anastomosis (73.68%) and enlargement tracheoplasty (26.32%). The outcome was favorable for 9 patients (47.37%). The recurrence of the stenosis after curative surgery was observed in 31.58% of cases. Death occured in 3 patients (15.79%). Conclusion: Over-inflation of the intubation tube cuff is the leading cause of PI tracheal stenosis. Prevention is based on the systematic monitoring of its inflation pressure.

In-office Eustachian tube balloon dilation under local anesthesia as a response to operating room restrictions associated with the COVID-19 pandemic.

To evaluate the feasibility of local anesthesia for Eustachian tube balloon dilation as an in-office procedure for the treatment of Eustachian tube dilatory dysfunction as a response to the restriction measures of the coronavirus disease 2019 pandemic. Patients with Eustachian tube dilatory dysfunction refractory to nasal steroids undergoing Eustachian tube balloon dilation in local anesthesia were enrolled in a prospective observational cohort between May 2020 and April 2022. The patients were assessed by using the Eustachian tube dysfunction questionnaire (ETDQ-7) score and Eustachian tube mucosal inflammation scale. They underwent clinical examination, tympanometry, and pure tone audiometry. Eustachian tube balloon dilation was performed in-office under local anesthesia. The perioperative experience of the patients was recorded using a 1-10 visual analog scale (VAS). Thirty patients (47 Eustachian tubes) underwent the operation successfully. One attempted dilation was aborded because the patient displayed anxiety. Local anesthesia was performed by using topical lidocaine and nasal packing for all patients. Three patients required an infiltration of the nasal septum and/or tubal nasopharyngeal orifice. The mean time of the operation was 5.7 min per Eustachian tube dilation. The mean level of discomfort during the intervention was 4.7 (on a 1-10 VAS scale). All patients returned home immediately after the intervention. The only reported complication was a self-limiting subcutaneous emphysema. Eustachian tube balloon dilation can be performed under local anesthesia and is well tolerated by most patients. In the patients reported in this study, no major complications occurred. In order to free operation room capacities, the intervention can be performed in an in-office setting with satisfactory patient feedback.

The role of Eustachian tubography and Valsalva CT in Eustachian tube balloon dilation.

Not many imaging techniques have been reported in Eustachian tube imaging. To investigate the role of selective Eustachian tubography (SET) and Valsalva computed tomography (CT) in patients who underwent Eustachian tube balloon dilation (ETBD). Eligible patients were aged 18 years and older with chronic Eustachian tube dysfunction who had failed medical treatment. On the day of the procedure, Valsalva CT and SET were performed. Participants underwent fluoroscopic ETBD with a 6×20-mm balloon catheter. Clinical examinations to check for the ability to perform the Valsalva maneuver and ETDQ-7 score change were conducted at one week and then at one, two, and six months. Follow-up Valsalva CT was performed in the one-month follow-up. A total of 30 ears in 23 patients (16 right ears, 14 left ears; 10 women, 13 men) underwent ETBD from August 2018 to November 2019. Positive CT patency was higher in follow-up Valsalva CT than baseline Valsalva CT (40% and 23.3%, respectively) (P = 0.006). In SET, positive patency was observed in 13 of 25 ears. Response to balloon dilation was observed in 18 of 25 patients. Clinical success was achieved in 16 of 27 ears. Response to balloon dilation was the only significant predictor of clinical success (P = 0.012). SET depicted the lumen of the Eustachian tube; thereby, it could be a potentially valuable tool in ETBD. Valsalva CT provides additional information about the cartilaginous portion of the Eustachian tube.