Long-term results of a modified expansion sphincter pharyngoplasty for sleep-disordered breathing.

Our aim was to evaluate the long-term objective and subjective results of a modified expansion sphincter pharyngoplasty (ESP) technique in patients with sleep-disordered breathing. Single center prospective study of 35 patients underwent an ESP as a primary surgical treatment between June 2012 and September 2015 at the hospital AZ Sint-Jan Bruges-Ostend. Patients were divided into non-OSAS and OSAS (AHI >5). Primary outcome parameters were the Epworth Sleeping Scale (ESS, reduction and score less then 10) and the Visual Analogue Score of snoring (VAS, assessed by partner) evaluated at 3 months and 1 year. In addition, the OSAS group underwent a polysomnography after 6 months to calculate the Apneu-Hypopneu Index (AHI) change. Secondary outcome parameters were possible complications and morbidity rate. The overall Epworth Sleepiness Scale showed a steady total reduction of, respectively, 42 and 48% at the two timepoints. All patients had a post-operative score of less than ten points. The Visual Analogue Score improved in 92% of the patients; of these, the snoring was reduced in 86% and disappeared in 6%. In the OSAS group, we noticed a reduction in AHI of more than 50 in 53% of the patients. A considerable reduction was found in the severe OSAS group, where we found a mean pre-operative average AHI of 41.3/h that was reduced 6 months after the operation to 17.4/h. There were no severe complications or increased morbidity rate observed. This first long-term study shows that the modified ESP seems to be a safe and promising technique in palatal surgery for patients with sleep-disordered breathing. Surgical effectiveness is sustained after 1 year, both in OSAS as in snoring pathology. The technique seems as approachable for the basic ENT surgeon as the uvulopalatopharynoplasty.

Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set.

Development and (pre-) clinical assessment were performed of a novel surgical tool for primary and secondary tracheoesophageal puncture (TEP) with immediate voice prosthesis (VP) insertion in laryngectomized patients, the Provox Vega Puncture Set (PVPS). After preclinical assessment in fresh frozen cadavers, a multicenter prospective clinical feasibility study in two stages was performed. Stage-1 included 20 patients, and stage-2 had 27. Based on observations in stage-1, the PVPS was re-designed (decrease in diameter of the dilator from 23.5 to 18 Fr.) and further used in stage-2. Primary outcome measure was immediate VP insertion without requiring additional instruments. Secondary outcome measures for comparison of the new with the traditional TEP procedure were: appreciation, ease of use, time consumption, estimated surgical risks and overall preference. A mini-max two-stage study design was used to establish the required sample size. In stage-1, dilatation forces were considered too high in patients with a fibrotic TE wall. With the final thinner version of the PVPS, VPs were successfully inserted into the TEP in 'one-go' in 24/27 (89%) of TEPs: 20 primary and 7 secondary. Participating surgeons rated appreciation, ease of use, time consumption and estimated surgical risks as better. Related adverse events were few and minor. The new PVPS appeared to be the preferred device by all participating surgeons. This study shows that the novel, disposable PVPS is a useful TEP instrument allowing quick and easy insertion of the VP in the vast majority of cases without requiring additional instruments.

The Semont-Plus Maneuver or the Epley Maneuver in Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Study.

Importance: Questions remain concerning treatment efficacy for the common condition of benign paroxysmal positional vertigo (BPPV). Objective: To compare the effectiveness of the Semont-plus maneuver (SM-plus) and the Epley maneuver (EM) for treatment of posterior canal benign paroxysmal positional vertigo (pcBPPV) canalolithiasis. Design, Setting, and Participants: This prospective randomized clinical trial was performed at 3 national referral centers (in Munich, Germany; Siena, Italy; and Bruges, Belgium) over 2 years, with a follow-up to 4 weeks after the initial examination. Recruitment took place from June 1, 2020, until March 10, 2022. Patients were selected randomly during routine outpatient care after being referred to 1 of the 3 centers. Two hundred fifty-three patients were assessed for eligibility. After consideration of the exclusion criteria as well as informed consent, 56 patients were excluded and 2 declined to participate, with 195 participants included in the final analysis. The analysis was prespecified and per-protocol. Interventions: After being randomized to the SM-plus or the EM group, patients received 1 initial maneuver from a physician, then subsequently performed self-maneuvers at home 3 times in the morning, 3 times at noon, and 3 times in the evening. Main Outcome and Measures: Patients had to document whether they could provoke positional vertigo every morning. The primary end point was the number of days until no positional vertigo could be induced on 3 consecutive mornings. The secondary end point was the effect of the single maneuver performed by the physician. Results: Of the 195 participants included in the analysis, the mean (SD) age was 62.6 (13.9) years, and 125 (64.1%) were women. The mean (SD) time until no positional vertigo attacks could be induced in the SM-plus group was 2.0 (1.6) days (median, 1 [range, 1-8] day; 95% CI, 1.64-2.28 days); in the EM group, 3.3 (3.6) days (median, 2 [range, 1-20] days; 95% CI, 2.62-4.06 days) (P = .01; α = .05, 2-tailed Mann-Whitney test). For the secondary end point (effect of a single maneuver), no significant difference was detected (67 of 98 [68.4%] vs 61 of 97 [62.9%]; P = .42; α = .05). No serious adverse event was detected with both maneuvers. Nineteen patients (19.6%) in the EM group and 24 (24.5%) in the SM-plus group experienced relevant nausea. Conclusions and Relevance: The SM-plus self-maneuver is superior to the EM self-maneuver in terms of the number of days until recovery in pcBPPV. Trial Registration: ClinicalTrials.gov Identifier: NCT05853328.

Three Years of Vestibular Infant Screening in Infants With Sensorineural Hearing Loss.

OBJECTIVES: Although vestibular deficits are more prevalent in hearing-impaired children and can affect their development on many levels, a pediatric vestibular assessment is still uncommon in clinical practice. Since early detection may allow for timely intervention, this pioneer project has implemented a basic vestibular screening test for each six-month-old hearing-impaired infant in Flanders, Belgium. This study aims to report the vestibular screening results over a period of three years and to define the most important risk factors for abnormal vestibular screening results. METHODS: Cervical Vestibular Evoked Myogenic Potentials with bone-conduction were used as a vestibular screening tool in all reference centers affiliated to the Universal Newborn Hearing Screening Program in Flanders. From June 2018 until June 2021, 254 infants (mean age: 7.4 months, standard deviation: 2.4 months) with sensorineural hearing loss were included. RESULTS: Overall, abnormal vestibular screening results were found in 13.8% (35 of 254) of the infants. The most important group at risk for abnormal vestibular screening results were infants with unilateral or bilateral severe to profound sensorineural hearing loss (20.8%, 32 of 154) (P < .001, odds ratio = 9.16). Moreover, abnormal vestibular screening results were more prevalent in infants with hearing loss caused by meningitis (66.7%, 2 of 3), syndromes (28.6%, 8 of 28), congenital cytomegalovirus infection (20.0%, 8 of 40), and cochleovestibular anomalies (19.2%, 5 of 26). CONCLUSIONS: The vestibular screening results in infants with sensorineural hearing loss indicate the highest risk for vestibular deficits in severe to profound hearing loss, and certain underlying etiologies of hearing loss, such as meningitis, syndromes, congenital cytomegalovirus, and cochleovestibular anomalies.

BPPV: Comparison of the SémontPLUS With the Sémont Maneuver: A Prospective Randomized Trial.

Objective: To compare the efficacy of the Sémont maneuver (SM) with the new "SémontPLUS maneuver" (SM+) in patients with posterior canal BPPV canalolithiasis (pcBPPVcan). Methods and Patients: In a prospective trinational (Germany, Italy, and Belgium) randomized trial, patients with pcBPPVcan were randomly assigned to SM or SM+; SM+ means overextension of the head by 60+° below earth horizontal line during the movement of the patient toward the affected side. The first maneuver was done by the physician, and the subsequent maneuvers by the patients 9 times/day on their own. Each morning the patient documented whether vertigo could be induced. The primary endpoints were: "How long (in days) does it take until no attacks can be induced?" and "What is the efficacy of a single SM/SM+?" Results: In the 194 patients analyzed (96 SM, 98 SM+), it took 2 days (median, range 1-21 days, mean 3.6 days) for recovery with SM and 1 day (median, range 1-8 days, mean 1.8 days) with SM+ (p = 0.001, Mann-Whitney U-test). There was no difference in the second primary endpoint (chi2-test, p = 0.39). Interpretation: This prospective trial shows that SM+ is more effective than SM when repeated therapeutic maneuvers are performed but not when a single maneuver is performed. It also supports the hypothesis of the biophysical model: overextension of the head during step 2 brings the clot of otoconia beyond the vertex of the canal, which increases the effectivity. Classification of Evidence: This study provides Class I evidence that SM+ is superior to SM for multiple treatment maneuvers of pcBPPVcan.

Vestibular Infant Screening (VIS)-Flanders: results after 1.5 years of vestibular screening in hearing-impaired children.

Due to the close anatomical relationship between the auditory and vestibular end organs, hearing-impaired children have a higher risk for vestibular dysfunction, which can affect their (motor) development. Unfortunately, vestibular dysfunction often goes unnoticed, as vestibular assessment in these children is not standard of care nowadays. To timely detect vestibular dysfunction, the Vestibular Infant Screening-Flanders (VIS-Flanders) project has implemented a basic vestibular screening test for hearing-impaired infants in Flanders (Belgium) with a participation rate of 86.7% during the first year and a half. The cervical Vestibular Evoked Myogenic Potentials (cVEMP) test was applied as vestibular screening tool to map the occurrence of vestibular (mainly saccular) dysfunction in this population. At the age of 6 months, 184 infants were screened. No refers on vestibular screening were observed in infants with permanent conductive hearing loss. In infants with permanent sensorineural hearing loss, a cVEMP refer rate of 9.5% was observed. Failure was significantly more common in infants with severe-profound compared to those with mild-moderate sensorineural hearing loss (risk ratio = 9.8). Since this is the first regional study with a large sample size and successful participation rate, the VIS-Flanders project aims to set an example for other regions worldwide.