Challenges and advances in device-related thrombus in left atrial appendage occlusion.

Oral anticoagulation therapy (OAC) is a mainstay for mitigating stroke and other embolic events in patients with atrial fibrillation (AF). Despite the demonstrated efficacy of OAC in reducing events, many patients are unable to tolerate OAC due to bleeding risks. Left atrial appendage occlusion (LAAO) devices were developed as implantable technologies to moderate stroke risk in patients with intolerance to OAC. Despite clinical data supporting near-comparable protection against thromboembolic events with OAC, device-related thrombus formation has emerged as a critical complication following LAAO that remains a potential limitation to the safety and efficacy of LAAO. Improved biocompatibility of LAAO devices with fluoropolymers, a well-established stent-coating technology used to reduce thrombus formation and promote endothelialization, may optimize outcomes after LAAO.

[Box: see text].

Body Composition and Energy Expenditure in Youth With Spina Bifida: Protocol for a Multisite, Cross-Sectional Study.

BACKGROUND: Obesity prevalence in youth with spina bifida is higher than in their typically developing peers. Obesity is associated with lifelong medical, psychological, and economic burdens. Successful prevention or treatment of obesity in individuals with spina bifida is compromised by (1) the lack of valid and reliable methods to identify body fat in a clinical setting and (2) limited data on energy expenditure that are necessary to provide daily caloric recommendations. OBJECTIVE: The objectives of this study will be to develop 2 algorithms for use in youth with spina bifida in a clinical setting, one to model body fat and one to predict total daily energy expenditure. In addition, physical activity and dietary intake will be described for the sample. METHODS: This multisite, prospective, national clinical study will enroll 232 youth with myelomeningocele aged 5 to 18 years (stratified by age and mobility). Participants will be enrolled for 1 week. Data obtained include 4 measures of body composition, up to 5 height measures, a ramped activity protocol, and a nutrition and physical activity screener. Participants will wear an accelerometer for the week. On the final study day, 2 samples of urine or saliva, which complete the doubly labeled water protocol, will be obtained. The analysis will include descriptive statistics, Bland-Altman plots, concordance correlation, and regression analysis. RESULTS: The study received extramural federal funding in July 2019. Data collection was initiated in March 2020. As of April 2024, a total of 143 (female participants: n=76, 53.1%; male participants: n=67, 46.9%) out of 232 participants have been enrolled. Data collection is expected to continue throughout 2024. A no-cost extension until November 2025 will be requested for data analysis and dissemination of findings. CONCLUSIONS: This study furthers previous pilot work that confirmed the acceptability and feasibility of obtaining alternate height, body composition, and energy expenditure measures. The findings from this study will enhance screening, prevention, and treatment of abnormal weight status by facilitating the accurate identification of youths' weight status category and recommendations of daily caloric needs for this population that is at higher risk of obesity. Furthermore, the findings have the potential to impact outcomes for youth diagnosed with disabilities other than spina bifida who experience similar challenges related to alterations in body composition or fat distribution or measurement challenges secondary to mobility issues or musculoskeletal problems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52779.

Nanostructure engineering in organic semiconductor devices toward interface matching.

The performance of organic semiconductor devices with heterojunctions between the organic semiconductors and electrodes can be improved by reducing the contact resistance. In this study, we have developed nanopatterned electrodes that gradually change the impedance at the interface between the metal and organic semiconductor in organic devices, which were fabricated in periodic patterns using nanoimprint lithography (NIL). The imprint pattern spacing was changed to control the interface between the metal and organic semiconductor to ensure smooth carrier injection. We analyzed the carrier injection based on the pattern spacing of the electrode interface using electrical current-voltage (I-V) and capacitance-frequency (C-F) measurements in the diode. Subsequently, we analyzed the improved current mechanism through numerical simulation. Therefore, this study suggests the possibility of designing the interface of an organic device using the nanostructure between the organic semiconductor and carrier injection electrode.

Caries lesions diagnosis with deep convolutional neural network in intraoral QLF images by handheld device.

OBJECTIVES: This study investigated the effectiveness of a deep convolutional neural network (CNN) in diagnosing and staging caries lesions in quantitative light-induced fluorescence (QLF) images taken by a self-manufactured handheld device. METHODS: A small toothbrush-like device consisting of a 400 nm UV light-emitting lamp with a 470 nm filter was manufactured for intraoral imaging. A total of 133 cases with 9,478 QLF images of teeth were included for caries lesion evaluation using a CNN model. The database was divided into development, validation, and testing cohorts at a 7:2:1 ratio. The accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC) were calculated for model performance. RESULTS: The overall caries prevalence was 19.59%. The CNN model achieved an AUC of 0.88, an accuracy of 0.88, a specificity of 0.94, and a sensitivity of 0.64 in the validation cohort. They achieved an overall accuracy of 0.92, a sensitivity of 0.95 and a specificity of 0.55 in the testing cohort. The model can distinguish different stages of caries well, with the best performance in detecting deep caries followed by intermediate and superficial lesions. CONCLUSIONS: Caries lesions have typical characteristics in QLF images and can be detected by CNNs. A QLF-based device with CNNs can assist in caries screening in the clinic or at home. TRIAL REGISTRATION: The clinical trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2300073487, Date: 12/07/2023).

Tungsten-Doped ZnO as an Electron Transport Layer for Perovskite Solar Cells: Enhancing Efficiency and Stability.

This study delves into enhancing the efficiency and stability of perovskite solar cells (PSCs) by optimizing the surface morphologies and optoelectronic properties of the electron transport layer (ETL) using tungsten (W) doping in zinc oxide (ZnO). Through a unique green synthesis process and spin-coating technique, W-doped ZnO films were prepared, exhibiting improved electrical conductivity and reduced interface defects between the ETL and perovskite layers, thus facilitating efficient electron transfer at the interface. High-quality PSCs with superior ETL demonstrated a substantial 30% increase in power conversion efficiency (PCE) compared to those employing pristine ZnO ETL. These solar cells retained over 70% of their initial PCE after 4000 h of moisture exposure, surpassing reference PSCs by 50% PCE over this period. Advanced numerical multiphysics solvers, employing finite-difference time-domain (FDTD) and finite element method (FEM) techniques, were utilized to elucidate the underlying optoelectrical characteristics of the PSCs, with simulated results corroborating experimental findings. The study concludes with a thorough discussion on charge transport and recombination mechanisms, providing insights into the enhanced performance and stability achieved through W-doped ZnO ETL optimization.

A novel trans-occipital catheter placement guide for ventriculoperitoneal shunts.

We have designed a novel device that facilitates the accurate placement of occipital ventricular catheters in ventriculoperitoneal shunt procedures. After 7 years of clinical use, this device has consistently demonstrated its simplicity, user-friendliness, and effectiveness. It enables both experienced surgeons and novices to confidently and accurately position the ventricular catheter to a satisfactory location.

Infective endocarditis associated with left atrial appendage occlusion device: a contemporary systematic review.

BACKGROUND: Data are limited regarding infective endocarditis (IE) complicating left atrial appendage occlusion (LAAO) device procedures. This systematic review examines the etiology, diagnosis, and management of infective endocarditis (IE) following LAAO. METHODS: A comprehensive search of six databases was performed between 2007 and 2022. In selecting studies, articles were included if they provided information about IE complicating LAAO, with relevant clinical and imaging details. Articles were excluded if they were editorials, study protocols, letters, or abstracts. RESULTS: We identified seven cases of IE complicating LAAO published between 2007 and 2022, from the United States and Europe, highlighting the exceedingly rare reported incidence of the condition. Staphylococcus aureus is the predominant organism implicated in LAAO infections. Echocardiography is a key imaging modality for diagnosing LAAO IE. Both antibiotic therapy and surgical intervention in appropriate patients are important for managing LAAO device-related IE. CONCLUSIONS: The limited data in the current literature regarding LAAO IE underscores the need for prospective clinical trials to establish evidence-based guidelines for infection prophylaxis, diagnosis, and management. Our findings emphasize the importance of vigilance for device-related infections, especially as the use of LAAO devices continues to grow worldwide.

Single center outcomes after temporary mechanical circulatory assist device prior to Heartmate 3 implantation - a retrospective cohort study.

Objectives. Temporary mechanical circulatory support (TMCS) has become a component in the therapeutic strategy for treatment of cardiogenic shock as a bridge-to-decision. TMCS can facilitate recovery of cardiopulmonary function, end-organ function, and potentially reduce the surgical risk of left ventricular assist device (LVAD) implantation. Despite the improvements of hemodynamics and end-organ function, post-LVAD operative morbidity might be increased in these high-risk patients. The aim of the study was to compare outcomes after Heartmate 3 (HM3) implantation in patients with and without TMCS prior to HM3 implant. Methods. In this retrospective cohort study of all HM3 patients in the period between November 2015 and October 2021, patients with and without prior TMCS were compared. Patients' demographics, baseline clinical characteristics, laboratory tests, intraoperative variables, postoperative outcomes, and adverse events were collected from patient records. Results. The TMCS group showed an improvement in hemodynamics prior to LVAD implantation. Median TMCS duration was 19.5 (14-26) days. However, the TMCS group were more coagulopathic, had more wound infections, neurological complications, and more patients were on dialysis compared with patient without TMCS prior to HM3 implantation. Survival four years after HM3 implantation was 80 and 82% in the TMCS (N = 22) and non-TMCS group (N = 41), respectively. Conclusion. Patients on TMCS had an acceptable short and long-term survival and comparable to patients receiving HM3 without prior TMCS. However, they had a more complicated postoperative course.

Clinical use of CRT-D devices with left ventricular sensing: Impact of the desynchronization-detection algorithm.

The use of CRT-D devices with left ventricular (LV) sensing has created controversy about programming various parameters especially the left ventricular T wave protection (LVTP) designed to prevent the delivery of a pacing stimulus into the LV vulnerable period. Such devices are available from two manufacturers. This review focuses only on those provided by Biotronik. As the LVTP controls LV sensing, some investigators have advocated turning off the LVTP to prevent episodic desynchronization known a CRT pacing interrupt. However, LVTP off reduces but does not eliminate this type of desynchronization if triggering of an LV stimulus upon right ventricular sensing (RVs) is programmed on. Deactivation of the LVTP incurs loss of diagnostic data provided by CRT pacing interrupt itself. By choice, the occurrence of CRT pacing interrupt can be totally eliminated by appropriate programming of the LV upper rate interval, LVTP and triggering of an LV pacing event upon RVs. Various programmability options are available according to clinical circumstances. As a rule, clinical judgement must weigh the potential diagnostic benefit of preserving the LVTP capable of recording of episodic CRT pacing interrupt against the loss of diagnostic benefit when LVTP is programmed off (with or without triggering of an LV stimulus upon RVs).

Centimeter-Scale Tellurium Oxide Films for Artificial Optoelectronic Synapses with Broadband Responsiveness and Mechanical Flexibility.

Prevailing over the bottleneck of von Neumann computing has been significant attention due to the inevitableness of proceeding through enormous data volumes in current digital technologies. Inspired by the human brain's operational principle, the artificial synapse of neuromorphic computing has been explored as an emerging solution. Especially, the optoelectronic synapse is of growing interest as vision is an essential source of information in which dealing with optical stimuli is vital. Herein, flexible optoelectronic synaptic devices composed of centimeter-scale tellurium dioxide (TeO2) films detecting and exhibiting synaptic characteristics to broadband wavelengths are presented. The TeO2-based flexible devices demonstrate a comprehensive set of emulating basic optoelectronic synaptic characteristics; i.e., excitatory postsynaptic current (EPSC), paired-pulse facilitation (PPF), conversion of short-term to long-term memory, and learning/forgetting. Furthermore, they feature linear and symmetric conductance synaptic weight updates at various wavelengths, which are applicable to broadband neuromorphic computations. Based on this large set of synaptic attributes, a variety of applications such as logistic functions or deep learning and image recognition as well as learning simulations are demonstrated. This work proposes a significant milestone of wafer-scale metal oxide semiconductor-based artificial synapses solely utilizing their optoelectronic features and mechanical flexibility, which is attractive toward scaled-up neuromorphic architectures.

Device-based physical therapies in chronic pruritus: a narrative review.

Chronic pruritus is a highly prevalent disease associated with high psychosocial and economic burdens. In addition to pharmacological treatments, device-based physical therapies also offer antipruritic effects. Phototherapy, laser treatment, electrical neurostimulation technologies, acupuncture, cryotherapy, and cold atmospheric plasma are, in part, still experimental but emerging treatment options that augment our repertoire to treat patients with chronic pruritus. In this narrative review, we provided an overview of these physical modalities and their role in itch management.

Accuracy of a novel method for IOP measurement without applying pressure on the cornea.

PURPOSE: To assess the accuracy of a prototype novel instrument for intra ocular pressure (IOP) measurements not involving corneal pressure application. DESIGN: Prospective case control study. METHODS: An institutional study including 16 healthy volunteers without ocular pathology. IOP in both eyes of the participants was measured four times in different body positions with the novel prototype and reference instrument (Goldmann applanation tonometer (GAT) or iCare (iCare Finland OY, Vantaa, Finland)). IOP results were compared between the prototype and the reference instruments in 116 pairs of measurement. RESULTS: Overall no statistically significant difference was found between the presented prototype and the reference instrument. Stratifying measurements by instrument used revealed no significant difference for GAT and statistical significant (yet clinically insignificant) difference for iCare. CONCLUSIONS: The presented prototype demonstrates good clinical agreement of IOP measuring results with reference instruments Further large-scale studies assessing this instrument in glaucoma patients are warranted.

Transitioning from 0.5 to 0.9 mT: Protecting against inadvertent activation of magnet mode in active implants.

The "5 gauss line" is a phrase that is likely to be familiar to everyone working with MRI, but what is its significance, how was it defined, and what changes are currently in progress? This review explores the history of 5 gauss (0.5 mT) as a threshold for protecting against inadvertently putting cardiac pacemakers, implantable cardioverter defibrillators, and other active implantable medical devices into a "magnet mode." Additionally, it describes the background to the recent change of this threshold to 9 gauss (0.9 mT) in the International Standard IEC 60601-2-33 edition 4.0 that defines basic safety requirements for MRI. Practical implications of this change and some ongoing and emerging issues are also discussed.

The impact of the Impeller's hub design on the performance and blood damage in a microaxial mechanical circulatory support device - A numerical study.

This study uses CFD methods to investigate the effects of the impeller's geometry on the hemodynamic characteristics, pump performance, and blood damage parameters, in a percutaneous microaxial Mechanical Circulatory Support (MCS) device. The numerical simulations employ the steady state Reynolds-Averaged Navier-Stokes approximation using the SST k-ω turbulent model. Three different impeller models are examined with different hub conversion angles (α = 0○, 3○ and 5○). The analysis includes 23 cases for different pressure heads (Δp = 60-80 mmHg) and angular velocities (ω = 30-52 kRPM). The obtained flow rate is compared between the cases to assess the effect of the impeller's design and working conditions on the pump performance. The comparative risk of shear-induced platelet activation is estimated using the statistical median of the stress-accumulation values calculated along streamlines. The risk of hemolysis is estimated using the average exposure time to shear stress above a threshold (τ > 425 Pa). The results reveal that the shape of the impeller's hub has a great impact on the flow patterns, performance, and risk of blood damage, as well as the angular velocity. The highest flow rate (Q = 3.7 L/min) and efficiency (η = 11.3 %) were achieved using a straight hub (α = 0○). Similarly, for the same condition of flow and pressure, the straight hub impeller has the lowest blood damage risk parameters. This study shed light on the effect of pump design on the performance and risk of blood damage, indicating the roles of the hub shape and angular velocity as dominant parameters.

Hormone-related side effects in new users of a levonorgestrel 52 mg intrauterine device.

BACKGROUND: Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects. OBJECTIVE: Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years. This analysis evaluated a subset of participants who used combined hormonal or no hormonal contraception in the month prior to device placement. We assessed all non-expulsion, non-bleeding-related events with ≥1% incidence at 180 days with a plan to include weight increase regardless of incidence; we excluded events considered non-hormonal. We computed 180-day side effect frequency rates based on the number of days a side effect was reported during the study period. We created a multivariable model for side effect incidence at 180 days based on age, race, ethnicity, body mass index at enrollment, parity, and contraception use in the month before enrollment. For those side effects with a p-value <0.2 on univariate comparison between combined-hormonal and no-hormonal contraception users, we secondarily evaluated 360-day event rates. RESULTS: Overall, 644 participants used combined hormonal contraception (primarily oral [n=499, 77.5%]) and 855 used no hormonal method before IUD placement. Individual side effect rates over the first 180 days did not differ between prior combined-hormonal and no-hormonal contraception users except for acne (84 [13.0%] versus 73 [8.5%], respectively), p=0.006, OR 1.61 (95% CI 1.15-2.24). However, this association was weaker after adjustment for age, race, ethnicity, obesity status, and parity (aOR 1.40, 95% CI 0.99-1.98) At 360 days, prior combined hormonal contraception users were more likely to report acne (101 [15.7%] vs. 91 [10.6%], respectively, p=0.005) and orgasm/libido problems (20 [3.1%] vs. 12 [1.4%], respectively, p=0.03). Over the first 180 days, all side effects other than acne were reported in less than 3% of days; acne was reported an average of 13 days (7.4%) per prior combined hormonal contraception user and 9 days (5.0%) per prior non-hormonal contraception user (p<0.0001). Discontinuation for evaluated side effects occurred in 83 (5.5%) participants with no difference between those who used combined hormonal (36 [5.6%]) or no hormonal contraception (47 [5.5%]), p=1.0) before study entry. CONCLUSIONS: Using combined hormonal contraception prior to levonorgestrel 52 mg intrauterine device placement is only weakly associated with reporting hormonally related side effects like acne. Only a small percentage of levonorgestrel 52 mg intrauterine device users experienced potentially hormone-related side effects during the initial 6 months of use that resulted in discontinuation.

Hemorrhagic transformation in acute ischemic stroke: hemorrhagic subtypes and symptomatic intracranial hemorrhage.

BACKGROUND: Few clinical studies perform detailed analyses of subtypes of intracranial hemorrhage (ICH) after mechanical thrombectomy (MT) used to treat acute ischemic stroke. Symptomatic intracranial hemorrhage (sICH) is a formidable complication of MT and is widely used in clinical trials as a safety outcome. However, variable definitions of sICH are used across clinical studies. OBJECTIVE: To radiographically subcategorize post-MT ICH development within this large cohort and examine overlap with sICH. Second, to examine the agreement of this definition of sICH with local site-reported occurrences of sICH to see how sICH rates change with modifications of the definitions used. METHODS: A large cohort of patients treated with MT for acute ischemic stroke (n=1395) was analyzed to (1) radiographically characterize hemorrhagic subtypes of intracranial hemorrhage (ICH) occurring after MT; (2) examine associations of hemorrhagic subtypes with sICH; and (3) compare core laboratory-adjudicated occurrences of sICH with site-reported sICH. RESULTS: The overall rate of ICH was 552/1395 patients (39.6%), and the overall rate of sICH was 47/1395 (3.4%). The most common type of ICH was hemorrhagic infarction type 1 (HI1), which represented 45.3% of all ICH cases- followed by HI2 (31.5%) and subarachnoid hemorrhage (SAH, 29.2%). Parenchymal hematoma 2 (PH2) represented only 3.3% of all ICH cases. Of the PH2 hemorrhages, only 33.3% were determined to be symptomatic. Of sICH cases, the most common ICH subtypes were HI2 (48.9%) and SAH (38.3%). Comparison of sICH rates as determined by core laboratory adjudication versus local site-reported results showed that only 14 patients were identified as having sICH with both definitions, with 47 patients total with sICH according to one definition, but not the other. CONCLUSIONS: Results of this analysis demonstrate the radiographic subtypes of ICH and also highlight the limitations of variable criteria used to define sICH, suggesting that it might be appropriate to revisit how sICH is defined post-MT. TRIAL REGISTRATION NUMBER: Clinical trial NCT03845491.

3D printed energy devices: generation, conversion, and storage.

The energy devices for generation, conversion, and storage of electricity are widely used across diverse aspects of human life and various industry. Three-dimensional (3D) printing has emerged as a promising technology for the fabrication of energy devices due to its unique capability of manufacturing complex shapes across different length scales. 3D-printed energy devices can have intricate 3D structures for significant performance enhancement, which are otherwise impossible to achieve through conventional manufacturing methods. Furthermore, recent progress has witnessed that 3D-printed energy devices with micro-lattice structures surpass their bulk counterparts in terms of mechanical properties as well as electrical performances. While existing literature focuses mostly on specific aspects of individual printed energy devices, a brief overview collectively covering the wide landscape of energy applications is lacking. This review provides a concise summary of recent advancements of 3D-printed energy devices. We classify these devices into three functional categories; generation, conversion, and storage of energy, offering insight on the recent progress within each category. Furthermore, current challenges and future prospects associated with 3D-printed energy devices are discussed, emphasizing their potential to advance sustainable energy solutions.

Prospective multicenter study of continuous tonic-clonic seizure monitoring on Apple Watch in epilepsy monitoring units and ambulatory environments.

OBJECTIVE: Evaluate the performance of a custom application developed for tonic-clonic seizure (TCS) monitoring on a consumer-wearable (Apple Watch) device. METHODS: Participants with a history of convulsive epileptic seizures were recruited for either Epilepsy Monitoring Unit (EMU) or ambulatory (AMB) monitoring; participants without epilepsy (normal controls [NC]) were also enrolled in the AMB group. Both EMU and AMB participants wore an Apple Watch with a research app that continuously recorded accelerometer and photoplethysmography (PPG) signals, and ran a fixed-and-frozen tonic-clonic seizure detection algorithm during the testing period. This algorithm had been previously developed and validated using a separate training dataset. All EMU convulsive events were validated by video-electroencephalography (video-EEG); AMB events were validated by caregiver reporting and follow-ups. Device performance was characterized and compared to prior monitoring devices through sensitivity, false alarm rate (FAR; false-alarms per 24 h), precision, and detection delay (latency). RESULTS: The EMU group had 85 participants (4,279 h, 19 TCS from 15 participants) enrolled across four EMUs; the AMB group had 21 participants (13 outpatient, 8 NC, 6,735 h, 10 TCS from 3 participants). All but one AMB participant completed the study. Device performance in the EMU group included a sensitivity of 100 % [95 % confidence interval (CI) 79-100 %]; an FAR of 0.05 [0.02, 0.08] per 24 h; a precision of 68 % [48 %, 83 %]; and a latency of 32.07 s [standard deviation (std) 10.22 s]. The AMB group had a sensitivity of 100 % [66-100 %]; an FAR of 0.13 [0.08, 0.24] per 24 h; a precision of 22 % [11 %, 37 %]; and a latency of 37.38 s [13.24 s]. Notably, a single AMB participant was responsible for 8 of 31 false alarms. The AMB FAR excluding this participant was 0.10 [0.07, 0.14] per 24 h. DISCUSSION: This study demonstrates the practicability of TCS monitoring on a popular consumer wearable (Apple Watch) in daily use for people with epilepsy. The monitoring app had a high sensitivity and a substantially lower FAR than previously reported in both EMU and AMB environments.

Multimodality imaging for the evaluation and management of patients with long-term (durable) left ventricular assist devices A Clinical Consensus Statement of the European Association of Cardiovascular Imaging (EACVI) of the ESC.

Left ventricular assist devices (LVADs) are gaining increasing importance as therapeutic strategy in advanced heart failure (HF), not only as bridge to recovery or to transplant, but also as destination therapy. Even though long-term LVADs are considered a precious resource to expand the treatment options and improve clinical outcome these patients, these are limited by peri-operative and post-operative complications, such as device-related infections, haemocompatibility-related events, device mispositioning and right ventricular failure. For this reason, a precise pre-operative, peri-operative and post-operative evaluation of these patients is crucial for the selection of LVADs candidates and the management LVADs recipients. The use of different imaging modalities offers important information to complete the study of patients with LVADs in each phase of their assessment, with peculiar advantages/disadvantages, ideal application and reference parameters for each modality. This clinical consensus statement sought to guide the use of multimodality imaging for the evaluation of patients with advanced HF undergoing LVADs implantation.