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JACC. Clinical Electrophysiology Aug 2023Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed...
BACKGROUND
Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device.
OBJECTIVES
The goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM).
METHODS
Canines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin).
RESULTS
Canines implanted with FP-WM exhibited significantly less DRT at 45 days than those implanted with WM (0% vs 50%; P < 0.05). In vitro experiments showed significantly greater albumin adsorption (52.8 [IQR: 41.0-58.3] mm vs 20.6 [IQR: 17.2-26.6] mm; P = 0.03) and significantly less platelet adhesion (44.7% [IQR: 27.2%-60.2%] vs 60.9% [IQR: 39.9%-70.1%]; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% [IQR: 83.4%-92.3%] vs 68.2% [IQR: 47.6%-72.8%]; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM.
CONCLUSIONS
The FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.
Topics: Animals; Dogs; Swine; Fluorocarbon Polymers; Prosthesis Design; Atrial Fibrillation; Atrial Appendage; Treatment Outcome; Thrombosis; Inflammation
PubMed: 37204356
DOI: 10.1016/j.jacep.2023.04.013 -
Materials (Basel, Switzerland) Dec 2023Many designs of anchor cables are currently in use for rock support in civil and mining operations. Because of the exposed surface and weak shear performance of the...
Many designs of anchor cables are currently in use for rock support in civil and mining operations. Because of the exposed surface and weak shear performance of the cable bolt's free section (CBFS) in end-anchored structures, breaking failure frequently occurs. Numerical simulations and laboratory experiments were performed in this study to develop measures to improve CBFS resistance to shear failure. Analysis of shear characteristics of the CBFS showed that higher axial tension weakens the cable bolt's shear resistance, and that shear damage on the cable surface and uneven distribution of shear stress aggravate CBFS tensile-shear failure. A high-strength steel pipe is proposed to protect the shear cable bolt, and the preliminary design of a CBFS-strengthening device (CFSD) is presented. Numerical simulation revealed that the CFSD effectively improved CBFS shear resistance and provided protection from harmful shear damage. The optimal performance of a Q-type (slotted steel pipe) CFSD was confirmed. The mechanism of improvement of the cable's shear resistance to surrounding rock by employing the CFSD was analyzed. Double-shear tests were carried out on a bare cable bolt and a cable bolt with a Q-CFSD. The results revealed that the CFSD increased the peak shear force on the joint plane, cable peak axial force, and ultimate shear displacement by 31%, 18%, and 11%, respectively. The proposed device is effective in improving the shear performance of end-anchored cable bolts and enhancing surrounding rock stability.
PubMed: 38204050
DOI: 10.3390/ma17010197 -
Frontiers in Neurology 2023External ventricular drainage (EVD) is a common emergency neurosurgical procedure, but it is not free of adverse events. The aim of this study is to compare the...
BACKGROUND
External ventricular drainage (EVD) is a common emergency neurosurgical procedure, but it is not free of adverse events. The aim of this study is to compare the complication rate of two frequently used EVD types, namely, tunneled antibiotic-impregnated catheters (Bactiseal) and bolt-connected non-coated devices (Camino).
METHODS
All EVDs placed between 1 March 2015 and 31 December 2017 were registered. Procedures performed with any catheter different from Bactiseal or Camino EVD with incomplete follow-up and those EVDs placed due to infectious disease were excluded. Demographic and clinical variables, as well as the overall complication rate (infection, hemorrhage, obstruction, malposition of the catheter, and involuntary pull-out of the device) and the need for replacement of the EVD, were collected.
RESULTS
A total of 77 EVDs were finally considered for analysis (40 Bactiseal and 37 Camino). There was a statistically significant difference in diagnosis and also in the location of the procedure, as more bolt-connected EVD was placed outside the operating room (97.3 vs. 23.5%, < 0.001) due to emergent pathologies such as vascular diseases and spontaneous hemorrhages. In the univariate analysis, a statistically significantly higher rate of catheter involuntary pull-out (29.7 vs. 7.5%, = 0.012) and the need for EVD replacement (32.4 vs. 12.5%, = 0.035) was found in the Camino cohort. However, those differences could not be confirmed with multivariable analysis, which showed no association between the type of catheter and any of the studied complications. Ventriculostomy duration was identified as a risk factor for infection (OR 1.09, 95% CI 1.02-1.18).
CONCLUSION
No significant differences were observed regarding infection, hemorrhage, obstruction, malposition, involuntary catheter pull-out, and the need for EVD replacement when comparing non-impregnated bolt-connected EVDs (Camino) with tunneled antibiotic-impregnated catheters (Bactiseal). The duration of EVD was associated with an increased risk of infection.
PubMed: 37638173
DOI: 10.3389/fneur.2023.1202954 -
PloS One 2023Traditional tower cranes cannot meet the sustainable development goals as they use the cast-in-place concrete foundation, with large size, long construction period, and...
Traditional tower cranes cannot meet the sustainable development goals as they use the cast-in-place concrete foundation, with large size, long construction period, and demolition after construction, resulting in waste of resources and high costs. This paper proposes a bolt-connected prefabricated cross-shaped I-steel tower crane foundation. It offers significant advantages in terms of convenient connection, low amortization cost and recyclability. The split connection point of the foundation is determined through the force analysis of the I-steel. With the ratio of the fixed cross-sectional area to the web height-to-thickness ratio (i.e. total cost) being constant, the inertia moment and bending stiffness of the I-steel are optimized using modern optimization design methods with the ratio of the web plate area to the total section area of the I-steel as the design variable, yielding the ideal strength and stiffness of the I-steel section.
Topics: Bone Plates; Steel
PubMed: 37733764
DOI: 10.1371/journal.pone.0291982 -
Frontiers in Rehabilitation Sciences 2023Outdoor physical activity (PA) contributes to the physical and mental health and well-being of individuals with a mobility impairment. However, individuals are commonly... (Review)
Review
INTRODUCTION
Outdoor physical activity (PA) contributes to the physical and mental health and well-being of individuals with a mobility impairment. However, individuals are commonly excluded from outdoor PA because of accessibility challenges. No reviews summarizing evidence on factors that facilitate/hinder participation and inclusion of individuals with mobility disabilities in adaptive outdoor PA were identified.. This makes it challenging to establish the key components for implementing inclusive outdoor PA interventions. A scoping review was conducted to identify barriers and facilitators to participation in adaptive outdoor PA and identify suggestions for adaptive outdoor PA design.
METHODS
A scoping review of qualitative and quantitative studies was conducted based on the methodological framework of Arksey and O'Malley with modifications by Levac. Barriers and facilitators were categorized into four levels based on a Social Ecological Model (SEM). Suggestions for interventions designed to overcome accessibility issues of outdoor PA were classified based on Universal Design (UD).
RESULTS
Thirty-seven factors regarding barriers and facilitators of outdoor adaptive PA were extracted from 19 studies published between 2002 and 2023. Barriers and facilitators were identified primarily in four levels of the SEM, including intrapersonal, social-environmental, physical-environmental, and policy-related. Eleven design suggestions were identified and categorized according to the seven principles of UD. This study identified gaps in the presented barriers and facilitators and the design suggestions of the included studies, mainly at the social and environmental level, such as a lack of innovation in program delivery and logistics.
CONCLUSION
This study identified gaps in knowledge about facilitators and barriers to outdoor adaptive PA and in the design of interventions addressing them. Future research should focus on the strategies addressing these gaps by involving individuals with mobility disability in designing interventions to gain a better insight into their needs.
PubMed: 38259872
DOI: 10.3389/fresc.2023.1331971 -
Europace : European Pacing,... Jun 2023Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using...
AIMS
Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters.
METHODS AND RESULTS
ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters. Patients with paroxysmal or persistent AF were treated at two centres. Patients were analysed in five cohorts based upon ablation settings, catheter, and mapping system. Pulsed field ablation was performed in 82 patients (74% male, 42 paroxysmal AF). Pulmonary vein isolation was achieved in 100% of pulmonary veins (322/322) with first-pass isolation in 92.2% (297/322). There were four serious adverse events of interest (three vascular access complications and one lacunar stroke). Eighty patients (98%) underwent invasive remapping. Pulsed field ablation development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26% and a per-PV isolation rate of 47% and 53%, respectively. Optimized PFA Cohorts 3-5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively.
CONCLUSION
ECLIPSE AF demonstrated that optimized PFA using the CENTAURI System with three commercial, contact force-sensing, solid-tip focal ablation catheters resulted in transmural lesion formation and high proportion of durable PVI with a favourable safety profile, thus providing a viable treatment option for AF that integrates with contemporary focal ablation workflows.
Topics: Humans; Male; Female; Atrial Fibrillation; Prospective Studies; Focal Adhesions; Treatment Outcome; Catheters; Catheter Ablation; Pulmonary Veins; Recurrence
PubMed: 37335976
DOI: 10.1093/europace/euad147 -
Journal of Vascular Surgery Jan 2024Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to...
OBJECTIVE
Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research.
METHODS
ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year.
RESULTS
Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008).
CONCLUSIONS
Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.
Topics: Female; Humans; Male; Black or African American; Ethnicity; Hispanic or Latino; Prospective Studies; Patient Selection; Racial Groups; Asian; White; Product Surveillance, Postmarketing; Registries; Drug-Eluting Stents; Peripheral Arterial Disease
PubMed: 37742734
DOI: 10.1016/j.jvs.2023.08.131 -
Materials (Basel, Switzerland) Nov 2023In recent decades, low-yielding seismic devices based on the use of friction dampers have emerged as an excellent solution for the development of building structures...
In recent decades, low-yielding seismic devices based on the use of friction dampers have emerged as an excellent solution for the development of building structures with improved reparability and resilience. Achieving an optimal design for such low-yielding seismic devices requires precise control of bolt preloading levels and predictability of the friction coefficient (CoF) between the damper interfaces. While various types of friction devices exist that are capable of providing significant energy dissipation, ongoing research is focused on the development of novel friction materials that exhibit a stable hysteretic response, high CoF values, minimal differences between static and dynamic CoF, and predictable slip resistance. In this context, an experimental campaign was conducted at the STRENGTH Laboratory of the University of Salerno to evaluate the behaviour of new friction shims employing specially developed metal alloys. Specifically, the influence of the characteristics of the contact surfaces in the sliding area on the behaviour and performance of the friction device was analysed. The tests followed the loading protocol recommended by EN12159 for seismic device qualification. Monitored parameters included preloading force values and the evolution of slip resistance. The friction value was determined, along with its degradation over time. Finally, the material's performance in terms of hysteretic behaviour was assessed, providing a comparison of the tested specimens in terms of slip force degradation and energy dissipation capacity.
PubMed: 38068079
DOI: 10.3390/ma16237336 -
PloS One 2024Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH...
BACKGROUND
Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality. IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow® system performs active and controlled intracranial irrigation and aspiration with physiological saline, while simultaneously monitoring and maintaining a stable intracranial pressure (ICP). We addressed important aspects of the device implementation and intracranial lavage.
METHOD
To allow versatile investigation of multiple device parameters, we designed an ex vivo lab setup. We evaluated 1) compatibility between the IRRAflow® catheter and the Silverline f10 bolt (Spiegelberg), 2) the physiological and hydrodynamic effects of varying the IRRAflow® settings, 3) the accuracy of the IRRAflow® injection volumes, and 4) the reliability of the internal ICP monitor of the IRRAflow®.
RESULTS
The IRRAflow® catheter was not compatible with Silverline bolt fixation, which was associated with leakage and obstruction. Design space exploration of IRRAflow® settings revealed that appropriate settings included irrigation rate 20 ml/h with a drainage bag height at 0 cm, irrigation rate 90 ml/h with a drainage bag height at 19 cm and irrigation rate 180 ml/h with a drainage bag height at 29 cm. We found the injection volume performed by the IRRAflow® to be stable and reliable, while the internal ICP monitor was compromised in several ways. We observed a significant mean drift difference of 3.16 mmHg (variance 0.4, p = 0.05) over a 24-hour test period with a mean 24-hour drift of 3.66 mmHg (variance 0.28) in the pressures measured by the IRRAflow® compared to 0.5 mmHg (variance 1.12) in the Raumedic measured pressures.
CONCLUSION
Bolting of the IRRAflow® catheter using the Medtronic Silverline® bolt is not recommendable. Increased irrigation rates are recommendable followed by a decrease in drainage bag level. ICP measurement using the IRRAflow® device was unreliable and should be accompanied by a control ICP monitor device in clinical settings.
Topics: Humans; Reproducibility of Results; Therapeutic Irrigation; Intracranial Pressure; Monitoring, Physiologic; Cerebral Hemorrhage; Hematoma
PubMed: 38626156
DOI: 10.1371/journal.pone.0297131 -
EuroIntervention : Journal of EuroPCR... Feb 2024Outcomes after percutaneous coronary intervention (PCI) for de novo ostial right coronary artery (RCA) lesions are poor.
BACKGROUND
Outcomes after percutaneous coronary intervention (PCI) for de novo ostial right coronary artery (RCA) lesions are poor.
AIMS
We used intravascular ultrasound (IVUS) to clarify the morphological patterns of de novo ostial RCA lesions and their associated clinical outcome.
METHODS
Among 5,102 RCA IVUS studies, 170 de novo ostial RCA stenoses (within 3 mm from the aorto-ostium) were identified. These were classified as 1) isolated ostial lesions (no disease extending beyond 10 mm from the ostium and without a calcified nodule [CN]); 2) ostial CN, typically with diffuse disease (disease extending beyond 10 mm); and 3) ostial lesions with diffuse disease but without a CN. The primary outcome was target lesion failure (TLF: cardiac death, target vessel myocardial infarction, definite stent thrombosis, and ischaemia-driven target lesion revascularisation).
RESULTS
The prevalence of an isolated ostial lesion was 11.8% (n=20), 47.6% (n=81) were ostial CN, and 40.6% (n=69) were ostial lesions with diffuse disease. Compared to ostial lesions with diffuse disease, isolated lesions were more common in women (75.0% vs 42.0%; p=0.01), and CN were associated with older age (median [first, third quartile] 76 [70, 83] vs 69 [63, 81] years old; p=0.002). The Kaplan-Meier rate of TLF at 2 years was significantly higher in patients with CN (21.6%) compared to diffuse lesions (8.2%) (p=0.04), and patients with isolated lesions had no events. A multivariable Cox proportional hazard model revealed that CN were significantly associated with TLF (hazard ratio 6.63, 95% confidence interval: 1.28-34.3; p=0.02).
CONCLUSIONS
Ostial RCA lesions have specific morphologies - detectable by IVUS - that may be associated with long-term clinical outcomes.
Topics: Humans; Female; Aged, 80 and over; Coronary Artery Disease; Percutaneous Coronary Intervention; Drug-Eluting Stents; Treatment Outcome; Risk Factors; Coronary Angiography
PubMed: 38343369
DOI: 10.4244/EIJ-D-23-00406