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Objective: To analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs)., Methods: We conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken., Results: In total, 93 (16.7%) device malfunctions and 465 (83.3%) patient injuries with 358 subsequent interventions were identified, resulting in 558 AEs. Although the absolute AE number per device cannot be identified, the following trends were detected: Among the 494 AEs associated with OSI200, 55 (11.1%) reported device malfunctions and 454 (88.9%) cited patient injuries. Out of the 64 AEs linked to BCI602, 28 (59.4%) were associated with malfunctions, whereas 26 (40.6%) involved patient injuries. The most frequently reported particular AEs for the OSI200 were infection ( n  = 171, 34.6%), extrusion of the device ( n  = 107, 21.7%), and pain ( n  = 51, 10.3%). Conversely, no device output ( n  = 20, 31.3%) and loss of osseointegration ( n  = 7, 10.9%) were the most reported AEs for the BCI602. Various AEs led to 214 explanations and 77 revision surgeries. Sixty-seven AEs reported conservative treatment., Conclusion: The current study provides an overview of the most commonly reported complications with new active BCIs. Although providing an overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution., Level of Evidence: 4., Competing Interests: L.D.L. receives research funding from Decibel Therapeutics and Amgen and has worked as an independent consultant for Gerson Lehrman Group and Conclave Capital. D.R. is receiving grants from MED‐EL outside the submitted work. No other disclosures were reported., (© 2024 The Author(s). Laryngoscope Investigative Otolaryngology published by Wiley Periodicals LLC on behalf of The Triological Society.)

Objective: The bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss., Data Source: Following the Preferred Reporting items for Systematic Reviews and Meta-analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta-analysis., Review Method: The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences (MDs) between pre- and postoperative performances., Results: In total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2 (3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; P < 0.01), signal-to-noise ratio (n = 96; MD, -6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01)., Conclusion: The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long-term functional outcomes., (© 2024 The Authors. Otolaryngology‐Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology‐Head and Neck Surgery Foundation.)

Objective: Despite multiple studies from high-income countries, reports from low- and middle-income countries on the impact of COVID-19 on head and neck cancer care remain sparse. This study aimed to assess the effects of the COVID-19 pandemic on head and neck cancer patients at a tertiary reference centre in Bosnia and Herzegovina., Methods: We included 228 patients with malignant head and neck tumours evaluated and treated between January 1, 2019, and December 31, 2021. Patient demographics, histological characteristics, and treatment modalities were retrospectively obtained and compared between the pre-pandemic period (pre-COVID-19 group) and the period after the implementation of COVID-19 restrictive measures (COVID-19 group)., Results: Patients were significantly older during the COVID-19 pandemic. In particular, 63 patients (44.7%) were under 65 and 78 (55.3%) were 65 or older, while in the pre-COVID-19 period, 53 patients (60.9%) were under 65 and 34 (39.1%) were 65 or older (p = 0.017). The pre-COVID-19 and COVID-19 groups did not significantly differ regarding other patient- and tumour characteristics, or primary treatment modalities., Conclusions: During the COVID-19 pandemic, significantly fewer patients were under 65 at the time of initial work-up, potentially reflecting the more enhanced disease-related anxiety of the younger population. Future studies are warranted to address this population's specific educational and psychological needs to ensure appropriate cancer care., (Copyright © 2024 Società Italiana di Otorinolaringoiatria e Chirurgia Cervico-Facciale, Rome, Italy.)

The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted the treatment of cancer patients, particularly in terms of treatment choices. This study aimed to assess the effects of the COVID-19 pandemic on the management of surgically treated laryngeal squamous cell carcinoma (LSCC) patients, focusing specifically on changes in treatment modalities. We retrospectively analyzed the data from 102 patients who underwent surgical treatment for LSCC between January 1, 2019, and December 31, 2021, at our tertiary medical center. Patient demographics, histological characteristics, and treatment modalities were extracted from electronic medical records and compared between two time periods: pre-COVID-19 and during COVID-19, marked by the introduction of the hospital entry triage. Of the total patients, 53 (52%) were in the pre-COVID-19 group, and 49 (48%) were in the COVID-19 group. No significant differences in patient characteristics at the initial work-up were observed between the two groups. However, a significant shift in treatment modalities was noted. Fewer patients received postoperative adjuvant therapy in the COVID-19 group (70.5%) compared to the pre-COVID-19 group (95.5%). Importantly, this change did not significantly impact the one-year overall survival (OS) rates. The reduction in the use of postoperative adjuvant therapy during the COVID-19 pandemic may be attributed to efforts to minimize hospital visits due to the risk of COVID-19 infection. Further research is warranted to validate these findings and to investigate the potential effects of such changes in treatment modalities on the long-term survival.

Objective: Recently, the Bonebridge 602 implant was introduced. Its smaller dimensions facilitate implantation even in surgically demanding cases. However, in extreme anatomical conditions, implant lifts are still required. We intended to report on the medical and audiological outcomes of all patients implanted with the implant with a secondary focus on the safety, efficacy, and feasibility of the use of 1-mm lifts., Study Design: Retrospective cohort study., Setting: Tertiary academic center., Methods: We retrospectively analyzed all patients implanted with the Bonebridge 602. Patient demographics and surgically-specific data were collected from the medical charts. Furthermore, audiological results were assessed. Outcomes were compared between implantations with versus without lifts., Results: Twenty-one devices were implanted during the study period. Satisfactory audiological results were observed, while no intra- or postoperative adverse events occurred. The majority of patients were daily users at the end of the observation period (n = 20/21, 95.2%), and one patient (n = 1/21, 4.8%) was a nonuser after 6 months of use because of subjective dissatisfaction. Due to anatomical considerations, 1-mm lifts were used in 4 implantations (19.0%). The application of lifts did not result in prolonged surgical times, complications, or shorter time of use, nor did it negatively affect audiometric results., Conclusion: Implantations with the new and smaller Bonebridge were associated with gratifying medical and audiological outcomes. Still, in extreme anatomical conditions, 1-mm lifts are necessary. Nonetheless, surgical placement with the help of lifts seems safe, effective, and feasible, and is a viable option in cases with challenging anatomies due to previous surgeries or anomalies., (© 2023 The Authors. Otolaryngology-Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

Surgical simulators are safe and evolving educational tools for developing surgical skills. In particular, virtual and hybrid simulators are preferred due to their detailedness, customization and evaluation capabilities. To accelerate the revolution of a novel class of hybrid simulators, a Smart Artificial Soft Tissue is presented here, that determines the relative position of conductive surgical instruments in artificial soft tissue by inverse resistance mappings without the need for a fixed reference point. This is particularly beneficial for highly deformable structures when specific target regions need to be reached or avoided. The carbon-black-silicone composite used can be shaped almost arbitrarily and its elasticity can be tuned by modifying the silicone base material. Thus, objective positional feedback for haptically correct artificial soft tissue can be ensured. This is demonstrated by the development of a laryngeal phantom to simulate the implantation of laryngeal pacemaker electrodes. Apart from the position-detecting larynx phantom, the simulator uses a tablet computer for the virtual representation of the vocal folds' movements, in accordance with the electrical stimulation by the inserted electrodes. The possibility of displaying additional information about target regions and anatomy is intended to optimize the learning progress and illustrates the extensibility of hybrid surgical simulators.

Less than 20% of patients with sensorineural hearing loss (HL) provided with the Vibrant Soundbridge (VSB) experience a progressive HL and warrant cochlear implantation (CI). The aim of this study was to identify possible predictors of progressive HL prior to VSB implantation. This retrospective study included all consecutive ears with sensorineural HL provided with the VSB between 1998 and 2016. The patient cohort was divided in a study group comprising patients who underwent CI (CI group) after years of VSB usage and those who did not require VSB replacement during the observational time (control group). Pre- and postoperative pure-tone audiometry thresholds were compared among the two groups. Fifteen out of 81 VSB devices (18.5%) required a CI. The CI group had higher preoperative air-conduction (AC) thresholds than the control group (64.3 ± 8.9 dB vs. 56.3 ± 12.9 dB; p = 0.007) at the time of the VSB implantation. On average, the CI group was significantly younger (39.1 ± 12.3 years vs. 52.6 ± 16.2 years; p = 0.003). In conclusion, VSB users with higher preoperative AC thresholds and younger age at the time of VSB implantation might be at risk for progressive HL within the upcoming eight years and need a further CI surgery. Preoperative counseling is particularly advisable in this patient group.

Background: Vitamin D supplementation may be associated with lower cardiovascular (CV) events, but the data are controversial. It remains speculative whether vitamin D supplementation has a direct effect on coronary atherosclerosis. We therefore set out to assess the influence of vitamin D supplementation on the coronary atherosclerosis profile quantified by coronary computed tomography angiography (CTA) in a retrospective case-control cohort study., Methods: 176 patients (age: 62.4 ± 10.4) referred to coronary CTA for clinical indications were included. A total of 88 patients receiving vitamin D supplementation (mean duration 65.3 ± 81 months) were 1:1 propensity score matched with 88 controls for age, gender, smoking, arterial hypertension, positive family history, dyslipidemia, and diabetes. Coronary stenosis severity (CAD-RADS TM ), mixed plaque burden (weighted for non-calcified), high-risk-plaque (HRP) features, and plaque density (HU) were quantified by CTA. Serum 25-hydroxyvitamin D (OH)-levels were measured in 138 patients and categorized into four groups (0: <20 ng/mL; 1: 20-40 ng/mL; 2: 40-60 ng/mL; and 3: >60 ng/mL) and compared with CTA., Results: The prevalence of atherosclerosis by CTA was similar in both groups (75.6% versus 74.3%, p = 0.999), >50% coronary stenosis was slightly higher in controls ( p = 0.046), but stenosis severity score (CAD-RADS) was not different ( p = 0.106). Mixed plaque burden (weighted for non-calcified) was lower in patients receiving vitamin D supplementation ( p = 0.002) and high-risk-plaque prevalence was markedly lower (3.8% versus 32%, p < 0.001). CT plaque density (HU) was higher ( p < 0.001) in the vitamin D group. Patients with serum vitamin D (OH) levels >60 ng/mL had higher plaque density ( p = 0.04), indicating more calcified and less vulnerable plaque., Conclusions: In this retrospective case-control cohort study, vitamin D supplementation was associated with less high-risk plaque, less non-calcified plaque burden, and a higher calcified plaque independent of CV risk factors.

Background: Intravenous thrombolysis for ischaemic stroke remains underused worldwide. We aimed to assess whether our statewide comprehensive stroke management programme would improve thrombolysis use and clinical outcome in patients., Methods: In 2008-09, we designed the Tyrol Stroke Pathway, which provided information campaigns for the public and standardised the entire treatment pathway from stroke onset to outpatient rehabilitation. It was commenced in Tyrol, Austria, as a long-term routine-care programme and aimed to include all patients with stroke in the survey area. We focused on thrombolysis use and outcome in the first full 4 years of implementation (2010-13)., Findings: We enrolled 4947 (99%) of 4992 patients with ischaemic stroke who were admitted to hospitals in Tyrol; 675 (14%) of the enrollees were treated with alteplase. Thrombolysis administration in Tyrol increased after programme implementation, from 160 of 1238 patients (12·9%, 95% CI 11·1-14·9) in 2010 to 213 of 1266 patients (16·8%, 14·8-19·0) in 2013 (ptrend 2010-13<0·0001). Differences in use of thrombolysis in the nine counties of Tyrol in 2010 (range, 2·2-22·6%) were reduced by 2013 (12·1-22·5%). Median statewide door-to-needle time decreased from 49 min (IQR 35-60) in 2010 to 44 min (29-60) in 2013; symptomatic post-thrombolysis intracerebral haemorrhages occurred in 28 of 675 patients (4·1%, 95% CI 2·8-5·9) during 2010-13. In four Austrian states without similar stroke programmes, thrombolysis administration remained stable or declined between 2010 and 2013 (mean reduction 14·4%, 95% CI 10·9-17·9). Although the 3-month mortality was not affected by our programme (137 [13%] of 1060 patients in 2010 vs 143 [13%] of 1069 patients in 2013), 3-month functional outcome significantly improved (modified Rankin Scale score 0-1 in 375 [40%] of 944 patients in 2010 vs 493 [53%] of 939 in 2013; score 0-2 in 531 [56%] patients in 2010 and 615 [65%] in 2013; ptrend 2010-13<0·0001)., Interpretation: During the period of implementation of our comprehensive stroke management programme, thrombolysis administration increased and clinical outcome significantly improved, although mortality did not change. We hope that these results will guide health authorities and stroke physicians elsewhere when implementing similar programmes for patients with stroke., Funding: Reformpool of the Tyrolean Health Care Fund., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Local velocity and direction of cardiac excitation spread can be estimated from four extra-cellular electric potential waveforms recorded simultaneously by closely-spaced electrodes. In this work, three methods for the determination of these parameters in case of non-fractionated electrograms were compared. Waveforms recorded during in-vitro experiments were analyzed in terms of their noise components. Noise according to the experimental environment was generated and added to noise-free waveforms obtained from computer simulations. For each of the three investigated methods the accuracy of the determined parameters velocity and direction was evaluated for three different noise levels and three types of propagation.

Wave fronts of cardiac activation, when propagating oblique to the fiber axis, reveal small fractionations and distortions in extracellular potential waveforms Phi(e) as well as in parameters derived from Phi(e) like dPhi(e)/dt and the gradient of Phi(e), the cardiac near field E. dPhi(e)/dt shows multiple deflections and E changes its morphology forming abnormal or even two or multiple subsequent loops. We analyze segments of such irregular loops of E obtained from in-vitro experiments and from computer simulation of a 2D-tissue sheet with a longitudinal oriented obstacle. In computer simulations we found that the individual sections of E reflect fairly well individual pathways of activation separated and delayed by the presence of a structural obstacle similar to connective tissue embedded longitudinally in heart tissue. Electrophysiological experiments with papillary muscles confirm this near field behavior.

Three cases of ruptured aneurysm of the aortic sinus of Valsalva (one each into the right atrium, right ventricle and pulmonary artery) are reported and clinical as well as haemodynamic features described. It is pointed out that the right sinus is most frequently involved, the non-coronary one only rarely, and the left one only quite exceptionally. The clinical findings depend on the size, site and direction of the rupture and its haemodynamic consequences. Rupture occurs most frequently into the right attrium or ventricle, much more rarely into the pulmonary artery or left ventricle. Cardinal clinical signs are retrosternal pain, marked shock with dyspnoea and tachycardia or rapidly progressive cardiac failure. Auscultation reveals either a continuous systolic-diastolic murmur or a holosystolic crescendo-decrescendo murmur followed by a high-frequency diastolic murmur, maximal parasternally in the second to fourth left intercostal spaces. As effective surgical treatment is available, early diagnosis is essential.