Endoscopic Balloon Dilatation of the Eustachian Tube via the Soft Palate Approach in Miniature Pigs.

The eustachian tube (ET) is one of the most complex organs in the human body, and its dysfunction may lead to a variety of diseases. In recent years, an increasing number of scholars have opted to conduct ET-related studies using large experimental animals such as miniature pigs or sheep, yielding promising results. Typically, conventional endoscopic procedures are performed through the nasal approach for large experimental animals. However, due to the elongated and narrow nasal cavity in these animals, transnasal surgeries are challenging. To address this issue, we explored an ET surgery approach via the soft palate. The animal was placed in a supine position. After endotracheal intubation under general anesthesia, a mouth opener was used to fully expose the upper palate. Local infiltration with diluted adrenal fluid was performed for anesthesia of the area. A sickle knife was then used to make a longitudinal soft palate incision at the junction of the soft and hard palates. After hemostasis, an endoscope was inserted into the nasopharynx cavity, allowing the visualization of the pharyngeal opening of the ET on the posterior lateral wall of the nasal cavity. Subsequently, a specialized pusher was used to insert a balloon into ET. The balloon was inflated, maintained at 10 bar for 2 min, and then removed. The incision in the soft palate was then sutured to ensure proper alignment. The soft palate healed well after the operation. This surgical approach is suitable for ET-related procedures in large experimental animals (e.g., miniature pigs, sheep, and dogs). The surgical procedure is simple, with a short surgical time, and wound healing is rapid. Under endoscopy, the pharyngeal opening of the ET is visible, and it is thus a good choice for procedures such as balloon dilation of the ET.

Reconstruction of an obliterated Eustachian tube: transnasal lighted guidewire catheter stenting.

An obliterated Eustachian tube (ET) is a rare occurrence that can lead to chronic otitis media (OM) and aural fullness even with treatment. Our study presents a review of the literature on methods of stenting the ET. We additionally present a case of a man with mucoepidermoid carcinoma of the ET who underwent a radical nasal pharyngectomy with reconstruction and adjuvant radiation, and who had symptoms of intolerable otorrhea after tympanostomy tube placement to treat aural fullness and mucoid OM. We used a novel method of stenting the ET using a transnasal lighted guidewire catheter and steroid eluting stents placed along the entire medial ET. Previously described methods in the literature were unable to be used due to the complex middle ear anatomy filled with granulation tissue and the lack of a visible nasopharyngeal ET ostium available for straightforward placement of the stent. The procedure was successful, and postoperatively, the patient experienced decreased otorrhea.

Eustachian Tube Balloon Dilation in Children: Short- and Long-Term Outcome.

OBJECTIVE: Eustachian Tube Balloon Dilation (ETBD) represents an innovative therapeutic approach for chronic Eustachian tube dysfunction (CETD), a common disease in children. Some evidence of a benefit of ETBD in the adults exist in contrast to sparse reports in children. The objective was to analyze short- and long-term outcome of ETBD in children with CETD. METHODS: A retrospective chart-review was performed in a cohort of 19 children (mean age 13 years, 7-17) who underwent ETBD. The following parameters were analyzed: tubomanometry (R-value), tympanogram, hearing (CPT-AMA, Air-bone gap [ABG]), Eustachian Tube Score (ETS and ETS-7), and Eustachian Tube Disease questionnaire (ETDQ). RESULTS: Twenty-four ears were dilated (in 5 patients subsequently after successful first intervention) and grouped as A (17) without and B (7) with additional T-tube insertion. Most children suffered from either chronic otitis media with effusion or chronic perforation (12, 63%), the remainder comprising recurrent otitis media, adhesive otitis media and CETD with barotrauma. Mean duration of symptoms were 7/8.2 years and mean follow-up 13.7/11.1 months. Eighty percent of patients reported a subjective benefit. Accordingly, the R-value, ETS, and ETS-7 were significantly (P < .05) improved. Tympanometry, CPT-AMA and ABG showed a positive trend, but the result was not significant. Tympanic retraction remained largely the same; a spontaneous closure of a chronic tympanic perforation was seen in 1 of 3 cases. CONCLUSIONS: The high subjective benefit and some significant objective improvement warrants further analysis of ETBD as part of the therapeutic management in pediatric CETD.

Dilatation Eustachian tuboplasty with a Eustachian tube video endoscope and supporting balloon.

OBJECTIVE: To evaluate the feasibility and safety of employing a Eustachian tube video endoscope with a supporting balloon as a viable treatment and examination option for patients with Eustachian tube dysfunction. METHODS: A study involving nine fresh human cadaver heads was conducted to investigate the potential of balloon dilatation Eustachian tuboplasty using a Eustachian tube video endoscope and a supporting balloon catheter. The Eustachian tube cavity was examined with the Eustachian tube video endoscope during the procedure, which involved the dilatation of the cartilaginous portion of the Eustachian tube with the supporting balloon catheter. RESULTS: The utilisation of the Eustachian tube video endoscope in conjunction with the supporting balloon catheter demonstrated technical ease during the procedure, with no observed damage to essential structures, particularly the Eustachian tube cavity. CONCLUSION: This newly introduced method of dilatation and examination of the Eustachian tube cavity using a Eustachian tube video endoscope and the supporting balloon is a feasible, safe procedure.

Endoscopic endonasal recanalization of the obliterated eustachian tube via ureteral stent.

KEY POINTS: Eustachian tube recanalization is a feasible procedure but additional studies are needed to determine its safety. Eustachian tube closure can result from different etiologies and can cause severe symptoms. Ureteral stents have appropriate shape and pliability for placement and long-term healing. Multidisciplinary team approach allows for simultaneous endonasal and otologic approaches.

Eustachian tube dysfunction symptoms after endonasal skull base surgery.

KEY POINTS: ETD symptoms are present in 16% patients with underlying skull base pathology. Preoperative ETD symptoms improve following surgical treatment of skull base pathology. ETD symptoms may worsen in patients with central, posterior, or malignant skull base pathology.

Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy.

INTRODUCTION: Balloon Eustachian tuboplasty (BET) is used to treat obstructive Eustachian tube dysfunction (OETD) and recurrent otitis media with effusion (OME). However, there are no indisputable evidence of its efficacy. Here, we present a multicenter, double-blinded, randomized, placebo-controlled trial (MDRCT) design to evaluate the efficacy of BET, and the results of a pilot trial with 3- and 12-months' follow-up. MATERIAL AND METHODS: This was a prospective MDRCT. For a pilot study, OETD (n = 10) and OME (n = 5) patients were recruited and followed. Detailed inclusion and exclusion criteria were used. Participants were randomized at beginning of the operation to active or sham surgery. All procedures were performed under local anesthesia. Controls were performed in double-blinded manner (both patient and physician), at 3 and 12 months after the procedure. RESULTS: Altogether, 20 ears were treated and followed for 12 months, including 14 active BETs and 6 sham surgeries. Both the active and sham surgery were performed under local anesthesia without problems or deviations from the protocol. There were no differences in the preoperative symptoms (ETDQ-7) or objective measures (tympanometry, Valsalva and Toynbee maneuvers, tubomanometry, Eustachian tube score) between active and sham surgery arms. During follow-up, we noticed largely similar reduction in subjective symptoms and improvement in Eustachian tube score both in active and sham surgery arms. CONCLUSIONS: The pilot study demonstrates that our MDRCT protocol is feasible, and that blinded RCTs are dearly needed to objectively measure the efficacy of BET. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:1874-1881, 2024.

Balloon dilation improves both the hearing level and the quality of life in patients suffering from obstructive Eustachian tube dysfunction.

PURPOSE: Chronic obstructive Eustachian tube dysfunction (OETD) can lead to tympanic membrane (TM) retraction and middle ear effusion (MEE) which can cause conductive hearing impairment, which among other ear symptoms can lower the quality of life (QoL). In this prospective study we assess hearing results and subjective changes in QoL following balloon Eustachian tuboplasty (BET) in treatment of OETD. METHODS: Totally 25 ears with TM retraction and 18 ears with MEE due to chronic OETD underwent BET as the sole intervention. Outcomes including otoscopy, ability to perform the Valsalva maneuver, tympanometry, audiometry, Eustachian tube inflammation scale and the Glasgow Benefit Inventory questionnaire (GBI) were obtained on all patients preoperatively and 6 months postoperatively. RESULTS: Hearing thresholds improved statistically significantly (p < 0.05) with means of 3 dB in the TM retraction group and 9 dB in the MEE group. Total GBI results indicated a positive influence on patients' QoL. Valsalva success rate was 80% in patients with TM retraction and 67% in patients with MEE. Tympanometry results improved in 50% of TM retraction patients and in 33% of MEE patients. CONCLUSIONS: Here we demonstrated that the BET has a positive impact on patients' conductive hearing loss and QoL in patients with TM retraction or MEE. Results were better in TM retraction group than in MEE group.

Accessing the Eustachian tube: Conventional nasal spray vs. exhalation delivery system and the impact of targeted endoscopic sinus surgery on topical distribution patterns.

BACKGROUND: Eustachian tube dysfunction (ETD) may occur distinct from, or in conjunction with, chronic rhinosinusitis (CRS+ETD). Intranasal corticosteroid sprays are often prescribed for ETD, although ET distribution may be limited. To date, no anatomic studies compare nasopharynx (NP) distribution between conventional nasal sprays (NS) and exhalation delivery systems (EDS) after surgery. This study utilizes a cadaver model to examine topical NP delivery using EDS vs. NS before and after targeted endoscopic sinus surgery (ESS). METHODS: Sixteen sinonasal cavities were administered fluorescein solution via NS and EDS before and after maxillary antrostomy and anterior ethmoidectomy, followed by nasal endoscopy of the NP and ET orifice. Seven blinded experts submitted staining ratings of endoscopy images on a 0- to 3-point scale, with ratings averaged for analysis. RESULTS: Interrater reliability was excellent (intraclass correlation, 0.956). EDS was associated with significantly greater NP staining vs. NS in a pooled cohort of nonsurgical and ESS specimens (1.19 ± 0.81 vs. 0.78 ± 1.06; p = 0.043). Using a logistic regression model, EDS significantly outperformed NS in nonsurgical (odds ratio [OR], 3.49; 95% confidence interval [CI], 1.21-10.09; p = 0.021) and post-ESS (OR, 9.00; 95% CI, 1.95-41.5; p = 0.005) specimens, with the greatest relative staining observed for EDS after targeted ESS (OR, 18.99; 95% CI, 3.44-104.85; p = 0.001). CONCLUSIONS: EDS is more effective than NS in topical delivery to the NP and ET orifices in cadavers. Targeted ESS may facilitate greater NP penetration by EDS compared with NS, with possible synergism after ESS for augmented delivery. These findings suggest a role for EDS delivery methods for ETD management and in CRS+ETD patients undergoing sinus surgery.

Permanent occlusion of the Eustachian tube: a retrospective study on reopening procedures.

PURPOSE: This study retrospectively evaluated the efficacy and versatility of reopening procedures for the permanent occlusion of the cartilaginous Eustachian tube (POET) by analyzing four consecutive cases. METHODS: The study included all patients diagnosed with POET who suffered from Eustachian tube occlusion and glue ear. A combined approach of endoscopic transnasal/transoral laser surgery was utilized to reopen the POET. This was subsequently followed by balloon dilation (BET) and stenting for a duration of six weeks. In one distinct case, the Eustachian tube orifice was approached via a transtympanic method, where a balloon catheter was placed. The primary outcome measures targeted the success rate of reopening, which was quantified using audiological outcomes and Eustachian tube patency verified by a positive Valsalva maneuver. RESULTS: Four patients, with an age range of 14-62 years (mean age of 29.3 years), were subject to Eustachian tube reopening. The duration of follow-up varied between 10 and 24 months, averaging at 16.2 months. Notably, 75% of the surgically treated ears displayed no evidence of glue ear upon their last follow-up and showed restoration of Eustachian tube patency. The procedures were executed without any surgical complications. The causes for POET in these patients were heterogeneous: two were attributed to scarring post adenoidectomy, one to occlusion following orthognathic surgery and the remaining one due to prior radiotherapy treatment for squamous cell carcinoma located at the soft palate. DISCUSSION: Total occlusion of the cartilaginous Eustachian tube may be linked to persistent middle ear diseases. It is imperative to conduct nasopharyngeal endoscopy in these cases. The findings from this study suggest that the Eustachian tube reopening procedure is predominantly effective and safe for patients with POET stemming from a variety of pathologies. Future research should focus on exploring advanced stenting devices and necessitate longer follow-up periods for comprehensive understanding.

Eustachian Tube Function Symptoms in Palatal Surgeries for OSA: 3-Month Postoperative Analysis.

OBJECTIVES: To assess the influence of different soft palate surgeries for obstructive sleep apnea (OSA) on eustachian tube function symptoms, considering various potential factors. METHODS: A prospective, cohort study was conducted on patients who underwent isolated palatal surgeries for OSA at a single academic medical center between 2017 and 2022. Eustachian Tube Dysfunction Questionnaire (ETDQ-7) were assessed at baseline, 1-month, 2-month, and 3-month time points. Patients with retropalatal obstruction underwent tailored surgeries: anterior palatoplasty (AP), expansion sphincter palatoplasty (ESP), or barbed palatoplasty (BP). Baseline OSA severity between baseline and follow-up time points were also examined. RESULTS: In this study, 96 patients with OSA were enrolled and allocated to three surgical groups: AP (n = 30), ESP (n = 32), and BP (n = 34). The mean age was 44.3 ± 10.2 years, with 86% male participants. No significant differences were found between the groups in terms of age, sex, and BMI. A two-way repeated measures ANOVA revealed a significant main effect of time on ETDQ-7 scores (p < 0.001), but no significant main effect of groups (p = 0.109) or interaction between time and groups (p = 0.082). Subgroup analysis showed a significant interaction for the 3-month change in ETDQ-7 scores by OSA severity (p = 0.046). In post hoc analysis, the BP group exhibited a higher mean ETDQ-7 score compared with the AP group at the 3-month follow-up. CONCLUSION: This study highlights the importance of considering individual patient factors, such as OSA severity and eustachian tube function symptoms, when selecting the most appropriate surgical treatment to optimize outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2471-2477, 2024.

Surgical Correction of Nasal Obstruction and Its Effect on Eustachian Tube Dysfunction Symptoms.

OBJECTIVES: To investigate how eustachian tube dysfunction symptoms change following surgical treatment of nonsinusitis-related nasal obstruction. STUDY DESIGN: Retrospective chart review. SETTING: Single academic center. METHODS: We assessed patients who underwent septoplasty, turbinate reduction, or both for nasal obstruction. Chronic sinusitis patients were excluded. Eustachian tube dysfunction (ETD) symptoms were studied using the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), collected preoperatively and postoperatively (1 week, 1 month, 3 months, 6 months postop). Patients with preoperative ETDQ-7 > 14.5 were considered to have clinically significant symptoms. Sinonasal outcomes test scores were also assessed. Pre- and postoperative ETDQ-7 scores were compared using t test. Multivariate linear regression analysis identified factors associated with ETDQ-7 change. RESULTS: We analyzed 259 patients. Preoperatively, 37.5% of patients with nasal obstruction had clinically significant ETD symptoms. These patients exhibited significant improvement in ETDQ-7 at all postoperative timepoints from 23.3 ± 7.6 at baseline to 19.1 ± 9.1 at 1 week, 16.5 ± 8.0 at 1 month, 16.2 ± 7.8 at 3 months, and 16.7 ± 10.4 at 6 months (all P < .01). In patients without baseline ETD symptoms, (baseline ETDQ-7: 9.1 ± 2.3) ETDQ-7 scores did not change significantly at postoperative timepoints, except for an acute worsening at 1 week postoperatively (10.7 ± 5.1, P < .001). Regression analysis showed that higher preoperative ETDQ-7 score (ß = -0.84, 95% confidence interval [CI]: -1.10 to -0.59) and postoperative antihistamine spray usage (ß = -8.70, 95% CI: -14.20 to -3.20) were associated with ETDQ-7 improvement, while comorbid GERD (ß = 7.50, 95% CI: 3.42-11.58) and asthma (ß = 5.62, 95% CI: 0.80-10.45) were negatively associated with improvement. CONCLUSION: Surgical correction of nasal obstruction may improve ETD symptoms.

Mid-term evaluation of the surgical management of patulous Eustachian tube dysfunction: a STROBE observational study.

INTRODUCTION: Patulous Eustachian tube (PET) is a condition affecting approximately 0.3% to 6.6% of the population, with autophony being the predominant complain. The management of PET lacks a well-defined standard in the literature as no effective medical treatments have been documented but various surgical options are available. This study aims to report mid-term outcomes following surgical management of PET. MATERIALS AND METHODS: All patients who underwent surgical intervention for PET between September 2017 and June 2022 were enrolled. Data encompassing general demographics, quality of life (GBI), and procedure-specific data were collected. RESULTS: A total of 30 PET cases (in 19 patients) underwent surgical intervention including 9 injections of hyaluronic acid, 13 fat injections, 6 endoscopic shim insertions, 1 cartilage graft, and 1 injection of hydroxy apatite. After an average follow-up of 22 ± 14 months, 16 cases (53%) achieved complete symptom relief, while 8 cases (26.6%) reported partial relief. Additionally, 11(36%) cases required multiple surgeries. No specific surgical technique demonstrated superiority. Quality of life improved in 77% of cases based on 10 out of 13 GBI collected. Recurrence of PET symptoms occurred on average 10.6 ± 9.7 months after initial surgery, with an estimated global risk of 75% at 3 years. Transient serous otitis media was observed in only 4 cases (13.3%). CONCLUSION: Surgical intervention for PET was found to be effective, achieving complete symptom relief in 53% of cases and significantly improving quality of life 2 years post-surgery. However, a substantial portion of cases necessitated one or more re-interventions. The durability of effectiveness appears to diminish over time.

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.

Autologous Fat Injection for the Treatment of Patulous Eustachian Tube.

BACKGROUND: Patulous eustachian tube is a disorder that leads to disturbing symptoms such as autophony, respiratory noise, and aural fullness. There has not been an established treatment found for this disorder. This study aims to assess the efficacy of autologous fat injection for a novel treatment of patients with patulous eustachian tube. METHODS: Twenty-eight patients with refractory patulous eustachian tube were recruited for the study. Endoscopic autologous fat injection was performed submucosally into the anterior and posterior portion of the pharyngeal orifice of the eustachian tube. The outcomes were quantitatively assessed by comparing the difference between pre- and postoperative scores with the visual analog scale on 4 criteria: aural fullness, respiratory noise, tinnitus, and autophony. RESULTS: Autologous fat injection was performed successfully in all patients without major complications. According to the combined visual analog scale scores, after the treatments, 20 patients showed significant improvement and 6 showed moderate improvement. The overall success rate of the treatment was 92.9%. CONCLUSION: Autologous fat injection is an effective and safe procedure for the treatment of patulous eustachian tube.

Complication of Ear Impression: Foreign Body in the Eustachian Tube Eroding the Carotid Canal.

The realization of customized earing plugs and earmolds for hearing aids requires an impression of the external auditory canal to obtain a siliconized mold. Silicone used for ear impressions is known to be safe and inert but deposition of silicone in the middle ear can middle and inner ear damages. We present a case of accidental injection of silicone in the middle ear and the Eustachian tube resulting in an erosion of the carotid canal. Laryngoscope, 133:3358-3360, 2023.

Outcomes of Spontaneous Cerebrospinal Fluid Leak Repair With Concurrent Eustachian Tube Dysfunction.

OBJECTIVE: To compare the presentation and outcomes of patients with and without obstructive eustachian tube dysfunction (oETD) undergoing repair of lateral skull base spontaneous cerebrospinal fluid (sCSF) leaks. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: Adults with lateral skull base sCSF leaks who underwent repairs from January 1, 2011, to December 31, 2020, were collected. MAIN OUTCOME MEASURE: Comparative statistics and effect sizes were used to compare clinical features, operative findings, and outcomes between groups. RESULTS: Of 92 ears from 89 patients included, 51.1% (n = 47) had oETD. There were no differences in demographics between patients with and without oETD. Mean age was 60.7 ± 13.1 versus 58.5 ± 12.8 years ( d = -0.17 [-0.58 to 0.24]), mean body mass index was 33.8 ± 8.5 versus 36.0 ± 8.0 kg/m 2 ( d = 0.27 [-0.14 to 0.68]), and female sex preponderance was 59.6% (n = 28) versus 68.8% (n = 31; Φ = -0.09), respectively. There were no differences in the radiologic number, size, and locations of defects. Patients with oETD had less pneumatized mastoids than those without oETD ( p = 0.001; Φ = 0.43). Mean change from preoperative to postoperative air pure-tone average for those with and without oETD was -1.1 ± 12.6 versus 0.1 ± 17.2 dB ( d = 0.09 [-0.04 to 0.58]), respectively. Six ears (6.5%; three with and three without oETD) underwent revisions for rhinorrhea/otorrhea between 5 and 28 months postoperatively, during which four leaks were found, the two patients without leaks had oETD. CONCLUSIONS: The presentation of sCSF leaks and outcomes of repairs in patients with oETD do not differ from those without oETD. Although postoperative otorrhea might represent an inflammatory or infectious process in patients with oETD, reexploration is warranted if patients do not improve with conservative treatment.

Qualification of Pilots with Aero-Otitis Media After Balloon Eustachian Tuboplasty.

BACKGROUND: Aero-otitis media (AOM), also known as aural barotrauma or barotitis media, is categorized into primary AOM and secondary AOM. Because conservative treatment was ineffective, primary AOM was one of the main reasons for grounding. In 2014, the team successfully treated a pilot with primary AOM using balloon Eustachian tuboplasty (BET). Now, this case is reported.CASE REPORT:The patient was a 40-yr-old male transport pilot who joined a flight after catching a cold. During the descent, the right ear appeared to have stuffiness and hearing loss, accompanied by tinnitus and ear pain. The local hospital's acoustic immittance test showed an "A" curve in the left ear and a "B" curve in the right ear. According to "secretory otitis media", right tympanic membrane puncture and drugs were performed. After he recovered, he continued to fly, and the symptoms reappeared again. Then he was transferred to our hospital, and right BET was performed. Equalization of ear pressure in the hypobaric chamber returned to normal 2 mo after the operation. The pilot was found fit to fly. The pilot is still qualified, with more than 6000 h of flight time.DISCUSSION: AOM is linked to Eustachian tube dysfunction. BET has been a minimally invasive treatment of Eustachian tube lesions in recent years. If conservative treatments for primary AOM are ineffective, BET can be selected. While the postoperative symptoms disappeared, pure tone audiometry, tympanometry, and ear pressure function tests met the standards for the physical examination of pilots, allowing the determination of flight qualification.Zhang M, Liu X, Wang B, Jin Z, Xu X. Qualification of pilots with aero-otitis media after balloon Eustachian tuboplasty. Aerosp Med Hum Perform. 2023; 94(8):629-633.