BACKGROUND: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year.
OBJECTIVE: To evaluate angiographic stability at 1 year.
METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design.
RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.

BACKGROUND: Ventricular septal defect (VSD) is the most common congenital cardiac malformation, accounting for approximately 30% of congenital heart defects. Conventional surgical repair using cardiopulmonary bypass is invasive and associated with morbidities and prolonged hospital stay. With the advent of interventional approaches and availability of different occluding devices, the technique of perventricular device closure is evolving and being implemented successfully in larger groups of patients. We present herein, our initial experience of perventricular device closure for the ventricular septal defects in children to assess risks and benefits.
METHODS: From March, 2023 to February, 2024, we have performed perventricular closure of ventricular septal defects in 13 children, under guidance of transesophageal echocardiography without cardiopulmonary bypass support. The median age at operation was 2 year (range 1.3-10 years) with the median body weight 11 kg (range 8.7-16.6 kg). Sixty-nine percent were males. The ventricular septal defect sizes ranged from 2.7 to 6 mm (mean 4.7 mm). Seven defects were perimembranous, four sub-aortic and two were muscular. One patient also underwent pulmonary artery de-banding with pulmonary artery balloon angioplasty and other one patent ductus arteriosus ligation, concomitantly. For defect closure, we used ventricular septal defect occlusion device (MemoPart™, Lepu Medical Technology Company, China) through a 3-cm skin incision in the lower- third of the sternum. The device sizes ranged from 5 to 8 mm (mean 6.9+-1.8 mm) and all patients except for two required symmetrical devices.
RESULTS: All patients underwent device closure successfully. The procedural duration ranged between 32 and 52 min. None of the patients required cardiopulmonary bypass. The mean ventilation time and intensive care unit stay was 3 and 24 h, respectively. None of the patients required inotropic support or blood transfusions. Moreover, no patients developed any arrhythmias including heart block. The average length of hospital stay was 4.4 days. At the latest follow up, there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications seen in any patients. There was no mortality.
CONCLUSIONS: Perventricular device closure of ventricular septal defects is a less invasive, extremely safe and effective method in children. It is associated with very fast recovery, shorter hospitalization time and better cosmetic incision. Moreover, it avoids cardiopulmonary bypass. The modifications and refinements in the design, material and implantation techniques will help in expanding the indications and prevent complications in the long-term.

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.
BACKGROUND: Clinical trial NCT03845491.

OBJECTIVE: To assess the accuracy of a prototype novel instrument for intra ocular pressure (IOP) measurements not involving corneal pressure application.
METHODS: 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.

UNASSIGNED: Left atrial appendage (LAA) thrombus is a contraindication for LAA closure (LAAC). However, in selected cases, oral anticoagulants are strictly contraindicated because of a history of life-threatening bleeding, and LAAC remains the only possible therapy to avoid systemic and especially cerebral embolization.
UNASSIGNED: We report a case of LAAC despite a massive proximal thrombus in a patient who had an absolute contraindication to anticoagulant therapy, with thorough pre-planning using CT scan, device modelling and thrombus trapping techniques to reduce the risk of systemic embolic events and perform LAAC safely.
UNASSIGNED: Although LAAC remains at high risk in this setting, the use of cautious techniques and tools, from pre-procedure planning to systemic embolization prevention systems associated to a precise transoesopheageal echocardiography guiding throughout the procedure, allows it to be performed as safely as possible when no other option is available.

BACKGROUND: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment.
METHODS: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator.
RESULTS: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2.
CONCLUSIONS: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.

OBJECTIVE: To assess the feasibility and the diagnostic accuracy of the new tool, DEvice© (AI, Rome, Italy), for screening patients with dry eye disease (DED).
METHODS: This study was performed at the University Magna Græcia of Catanzaro. Enrolled patients were classified as affected by DED (group 1) or not (group 2) using an already validated tool (Keratograph 5M, Oculus, Germany), evaluating the noninvasive keratograph breakup time (NIKBUT), tear meniscus height (TMH), meibomian gland loss (MGL), and bulbar redness. All the patients were then examined by means of DEvice©, which allowed the measurement of the relative humidity (RH) and temperature of the ocular surface. Symptoms were scored using the Ocular Surface Disease Index (OSDI) questionnaire.
RESULTS: Overall, 40 patients (17 males and 23 females, mean age 38.0 ± 17.1 years) were included: of these, 20 belonged to group 1 and the remaining 20 to group 2. Using Keratograph 5M, significant differences between groups 1 and 2 were detected for NIKBUT-first (respectively, 4.97 ± 1.85 vs. 13.95 ± 4.8 s; p < 0.0001) and for NIKBUT-average (10.55 ± 4.39 vs. 15.96 ± 4.08 s; p = 0.0003). No statistically significant changes were detected for TMH (p = 0.565), MGL (p = 0.051), and bulbar redness (p = 0.687). Using Device©, a statistically significant higher value of RH was found in group 1 compared to group 2 (respectively, 85.93 ± 10.63 vs. 73.05 ± 12.84%; p = 0.0049). A statistically significant correlation was found between RH and OSDI (r = 0.406; p = 0.009). The value RH showed a discriminating power to detect DED with an AUC = 0.782 (standard error 0.07264; 95% CI 0.6401-0.9249; p = 0.0022).
CONCLUSIONS: The DEvice© can effectively discriminate DED patients from healthy subjects. The parameter RH showed good sensitivity, making this tool ideal for a fast and noninvasive DED screening.

An integrated and high-throughput device for pathogen detection is crucial in point-of-care testing (POCT), especially for early diagnosis of infectious diseases and preventing the spread of infection. We developed an on-site testing platform that utilizes a centrifugal microfluidic chip and automated device to achieve high-throughput detection. The low-power (<32 W), portable (220 mm × 220 mm × 170 mm, 4 kg) device can complete bacterial lysis, nucleic acid extraction and purification, loop-mediated isothermal amplification (LAMP) reaction, and real-time fluorescence detection. Magnetic beads for nucleic acid adsorption can be mixed by applying electromagnetic fields and centrifugal forces, and the efficiency of nucleic acid extraction is improved by 60% compared to the no-mixing group. The automated nucleic acid extraction process achieves equivalent nucleic acid extraction efficiency in only 40% of the time consumed using the kit protocol. By designing the valve system and disc layout, the maximum speed required for the centrifugal microfluidic chip is reduced to 1500 rpm, greatly reducing the equipment power consumption and size. In detecting E. coli, our platform achieves a limit of detection (LOD) of 102 CFU/mL in 60 min. In summary, our active centrifugal microfluidic platform provides a solution for the integration of complex biological assays on turntables, with great potential in the application of point-of-care diagnosis.

BACKGROUND: Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States (US).
METHODS: This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (mRS), aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS, and length of stay were also collected.
RESULTS: Some 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery (35%) followed by the middle cerebral artery bifurcation (31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2 mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels <2 mm. All (100%) cases had successful deployment and the stent was repositioned in 10% of cases. A single stent was utilized in 91% of cases. Coils were placed in 48 cases (87.2%) and a microcatheter was jailed in 98% of those cases. Immediate Raymond Roy (RR) Class I occlusion was obtained in 33%, Class II in 22%, Class IIIa in 37%, and Class IIIb in 8% of cases. There were no delayed thromboembolic or hemorrhagic complications.
CONCLUSIONS: The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (DFT) technology results in improved visibility of the stent, allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.

BACKGROUND: Adoption of 3D imaging systems in humanitarian settings requires accuracy comparable with manual measurement notwithstanding additional constraints associated with austere settings.
OBJECTIVE: This study aimed to evaluate the accuracy of child stature and mid-upper arm circumference (MUAC) measurements produced by the AutoAnthro 3D imaging system (third generation) developed by Body Surface Translations Inc.
METHODS: A study of device accuracy was embedded within a 2-stage cluster survey at the Malakal Protection of Civilians site in South Sudan conducted between September 2021 and October 2021. All children aged 6 to 59 months within selected households were eligible. For each child, manual measurements were obtained by 2 anthropometrists following the protocol used in the 2006 World Health Organization Child Growth Standards study. Scans were then captured by a different enumerator using a Samsung Galaxy 8 phone loaded with a custom software, AutoAnthro, and an Intel RealSense 3D scanner. The scans were processed using a fully automated algorithm. A multivariate logistic regression model was fit to evaluate the adjusted odds of achieving a successful scan. The accuracy of the measurements was visually assessed using Bland-Altman plots and quantified using average bias, limits of agreement (LoAs), and the 95% precision interval for individual differences. Key informant interviews were conducted remotely with survey enumerators and Body Surface Translations Inc developers to understand challenges in beta testing, training, data acquisition and transmission.
RESULTS: Manual measurements were obtained for 539 eligible children, and scan-derived measurements were successfully processed for 234 (43.4%) of them. Caregivers of at least 10.4% (56/539) of the children refused consent for scan capture; additional scans were unsuccessfully transmitted to the server. Neither the demographic characteristics of the children (age and sex), stature, nor MUAC were associated with availability of scan-derived measurements; team was significantly associated (P<.001). The average bias of scan-derived measurements in cm was -0.5 (95% CI -2.0 to 1.0) for stature and 0.7 (95% CI 0.4-1.0) for MUAC. For stature, the 95% LoA was -23.9 cm to 22.9 cm. For MUAC, the 95% LoA was -4.0 cm to 5.4 cm. All accuracy metrics varied considerably by team. The COVID-19 pandemic-related physical distancing and travel policies limited testing to validate the device algorithm and prevented developers from conducting in-person training and field oversight, negatively affecting the quality of scan capture, processing, and transmission.
CONCLUSIONS: Scan-derived measurements were not sufficiently accurate for the widespread adoption of the current technology. Although the software shows promise, further investments in the software algorithms are needed to address issues with scan transmission and extreme field contexts as well as to enable improved field supervision. Differences in accuracy by team provide evidence that investment in training may also improve performance.