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Sin financiación 4.153 JCR (2019) Q2, 35/138 Cardiac & Cardiovascular Systems 2.902 SJR (2019) Q1, 17/362 Cardiology and Cardiovascular Medicine No data IDR 2019 UEM

Background: Morbidity and mortality in surgical systems in low- and middle-income countries (LMICs) remain high compared to high-income countries. Quality improvement processes, interventions, and structure are essential in the effort to improve peri-operative outcomes. Methods: A systematic review and meta-analysis of interventional studies assessing quality improvement processes, interventions, and structure in developing country surgical systems was conducted according to the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they were conducted in an LMIC, occurred in a surgical setting, and measured the effect of an implementation and its impact. The primary outcome was mortality, and secondary outcomes were rates of rates of hospital-acquired infection (HAI) and surgical site infections (SSI). Prospero Registration: CRD42020171542. Result: Of 38,273 search results, 31 studies were included in a qualitative synthesis, and 28 articles were included in a meta-analysis. Implementation of multimodal bundled interventions reduced the incidence of HAI by a relative risk (RR) of 0.39 (95%CI 0.26 to 0.59), the effect of hand hygiene interventions on HAIs showed a non-significant effect of RR of 0.69 (0.46–1.05). The WHO Safe Surgery Checklist reduced mortality by RR 0.68 (0.49 to 0.95) and SSI by RR 0.50 (0.33 to 0.63) and antimicrobial stewardship interventions reduced SSI by RR 0.67 (0.48–0.93). Conclusion: There is evidence that a number of quality improvement processes, interventions and structural changes can improve mortality, HAI and SSI outcomes in the peri-operative setting in LMICs.

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Background The optimal periprocedural management of direct oral anticoagulants (DOAC), including edoxaban, in patients undergoing catheter-based cardiovascular procedures is unknown, and mainly based on physician opinion and experience. Purpose To assess real-world management of edoxaban in patients undergoing cardiovascular procedures, and to report their clinical events. Methods Global EMIT-AF/VTE is a prospective study of periprocedural management in edoxaban-treated patients undergoing diagnostic and therapeutic procedures. We report the data from patients undergoing cardiovascular procedures. Timing and duration of edoxaban interruption were at the treating physician’s discretion. Outcomes were collected from 5 days before until 30 days post procedure. Primary outcome was the incidence of major bleeding (MB); secondary outcomes included incidence of clinically relevant non-major bleeding (CRNMB) and acute thromboembolic events (ATE). Results Data was collected from 301 and 311 procedures with arterial or venous access, respectively. Baseline characteristics are shown in Table 1. Edoxaban was not interrupted in 36.9% of arterial and 52.7% of venous procedures. Edoxaban was interrupted pre-procedure in 41% of arterial and 32.8% of venous procedures. The median periprocedural interruption was 2 days. The overall incidence of bleeding was very low. Any bleeding was reported in 8 patients undergoing arterial and 10 patients undergoing venous procedures (2.7% and 3.2%). MB or CRNMB occurred in 2 arterial and 3 venous procedures (0.7% and 1.0%) and ATE occurred in 5 arterial and 1 venous procedure (1.7% and 0.3%, Table 1). Conclusions In this study, the periprocedural risks of bleeding and thrombotic events were low. About a third of arterial access procedures and half of venous access procedures were performed without edoxaban interruption. Arterial(n = 301) Venous(n = 311) Baseline characteristics Age, year, mean (SD)Male, n (%)Weight (kg), mean (SD) 71.9 (8.5)211 (70.1%)80.8 (16.7) 64.6 (11.1)215 (69.1%)84.1 (17.4) CrCL (mL/min), mean (SD) CHA2DS2-VASc score, mean (SD)HAS-BLED score, mean (SD) 73.5 (29.8) 3.3 (1.5)2.0 (1.0) 88.9 (35.5) 2.2 (1.5)1.3 (1.0) Edoxaban 60 mg / 30 mg, % 73% / 26% 88% / 26% Coronary heart disease, n (%) Congestive heart failure, n (%) 101 (33.6%) 58 (19.3%) 51 (16.4%) 33 (10.6%) Interruption of edoxaban, n (%) No interruption Pre-procedure only Post-procedure only Pre- and post-procedure 111 (36.9%)125 (41.5%)12 (4.0%)53 (17.6%) 164 (52.7%)102 (32.8%)8 (2.6%)37 (11.9%) Clinical events, n (%) MB or CRNMBACSStroke/Transient ischemic attackCV mortalityAll-cause mortality 2 (0.7%)2 (0.7%)3 (1.0%)1 (0.3%)2 (0.7%) 3 (1.0%) 01 (0.3%)00

Deep learning models are efficient in learning the features that assist in understanding complex patterns precisely. This study proposed a computerized process of classifying skin disease through deep learning based MobileNet V2 and Long Short Term Memory (LSTM). The MobileNet V2 model proved to be efficient with a better accuracy that can work on lightweight computational devices. The proposed model is efficient in maintaining stateful information for precise predictions. A grey-level co-occurrence matrix is used for assessing the progress of diseased growth. The performance has been compared against other state-of-the-art models such as Fine-Tuned Neural Networks (FTNN), Convolutional Neural Network (CNN), Very Deep Convolutional Networks for Large-Scale Image Recognition developed by Visual Geometry Group (VGG), and convolutional neural network architecture that expanded with few changes. The HAM10000 dataset is used and the proposed method has outperformed other methods with more than 85% accuracy. Its robustness in recognizing the affected region much faster with almost 2× lesser computations than the conventional MobileNet model results in minimal computational efforts. Furthermore, a mobile application is designed for instant and proper action. It helps the patient and dermatologists identify the type of disease from the affected region’s image at the initial stage of the skin disease. These findings suggest that the proposed system can help general practitioners efficiently and effectively diagnose skin conditions, thereby reducing further complications and morbidity.

Trauma mortality in low- and middle-income countries (LMICs) remains high compared to high-income countries. Quality improvement processes, interventions, and structure are essential in the effort to decrease trauma mortality.A systematic review and meta-analysis of interventional studies assessing quality improvement processes, interventions, and structure in developing country trauma systems was conducted from November 1989 to August 2020 according to the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they were conducted in an LMIC population according to World Bank Income Classification, occurred in a trauma setting, and measured the effect of implementation and its impact. The primary outcome was trauma mortality.Of 37,575 search results, 30 studies were included from 15 LMICs covering five WHO regions in a qualitative synthesis. Twenty-seven articles were included in a meta-analysis. Implementing a pre-hospital trauma system reduced overall trauma mortality by 45% (risk ratio (RR) 0.55, 95% CI 0.4 to 0.75). Training first responders resulted in an overall decrease in mortality (RR 0.47, 95% CI 0.28 to 0.78). In-hospital trauma training with certified courses resulted in a reduction of mortality (RR 0.71, 95% CI 0.62 to 0.78). Trauma audits and trauma protocols resulted in varying improvements in trauma mortality.There is evidence that quality improvement processes, interventions, and structure can improve mortality in the trauma systems in LMICs.

Annually 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated.Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality.Of the 1442 patients, 280 (19%) were 65, 550 (38%) were 65-74, 514 (36%) 75-84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those 65, and seven in patients aged 75 years.Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed.NCT# 02950168, October 31, 2016.

Privacy protection in electronic healthcare applications is an important consideration, due to the sensitive nature of personal health data. Internet of Health Things (IoHT) networks that are used within a healthcare setting have unique challenges and security requirements (integrity, authentication, privacy, and availability) that must also be balanced with the need to maintain efficiency in order to conserve battery power, which can be a significant limitation in IoHT devices and networks. Data are usually transferred without undergoing filtering or optimization, and this traffic can overload sensors and cause rapid battery consumption when interacting with IoHT networks. This poses certain restrictions on the practical implementation of these devices. In order to address these issues, this paper proposes a privacy-preserving two-tier data inference framework solution that conserves battery consumption by inferring the sensed data and reducing data size for transmission, while also protecting sensitive data from leakage to adversaries. The results from experimental evaluations on efficiency and privacy show the validity of the proposed scheme, as well as significant data savings without compromising data transmission accuracy, which contributes to energy efficiency of IoHT sensor devices.

Despite an increase in approved cancer-targeting antibody drugs over the last decade, the process of identifying novel therapeutic antibodies is routinely hampered by limitations in the discovery process. Such barriers include immune tolerance of highly homologous genes, antibody sequence humanization, clone selection and models for drug efficacy/safety evaluation. To overcome these challenges and increase the diversity of antibody paratopes and sequences that recognize functional epitopes, we developed the RenMice™ HiTS (Hyperimmune Target Specific) Platform, which consists of chromosome engineered mice with fully human immunoglobulin variable domains replacing the mouse loci, each with a specific target gene knocked out. Immunization of target-specific RenMice™ generates a sizeable diversity of antibodies, including those that recognize conserved regions between the antigen and the endogenous proteins of the immunized species. The platform is ideal for challenging targets, such as proteins with high homology across species, or multi-pass transmembrane proteins, such as GPCRs/ion channels, and can be used to generate antibodies that cross-react with human, monkey, dog, and mouse targets using a hybrid immunization strategy with both human and mouse/dog antigen. Generation of these species cross-reactive antibodies can be used for high-throughput in vivo efficacy screening in wild-type mice, and the preliminary response and toxicity can be assessed in dogs. Altogether, the RenMice™ HiTS platform facilitates the generation of antibodies that recognize novel epitopes and challenging targets while simultaneously allowing for a streamlined and successful preclinical phase based on in vivo efficacy and safety.

Biometric-based authentication has come into recent prevalence in competition to traditional password- and/or token-based authentication in many applications, both for user convenience and the stability/uniqueness of biometric traits. However, biometric template data, uniquely linking to a user's identity, are considered to be sensitive information. Therefore, it should be secured to prevent privacy leakage. In this paper, we propose a homomorphic encryption-based fingerprint authentication system to provide access control, while protecting sensitive biometric template data. Using homomorphic encryption, matching of biometric data can be performed in the encrypted domain, increasing the difficulty for attackers to obtain the original biometric template without knowing the private key. Moreover, the trade-off between the computational overload and authentication accuracy is studied and experimentally verified on a publicly available fingerprint database, FVC2002 DB2.

Background In ENSURE-AF study, edoxaban had similar efficacy and safety profile versus enoxaparin–warfarin (enox–warf) in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. Objectives To evaluate the efficacy and safety of edoxaban versus enox–warf in patients who were vitamin K antagonists (VKA) naïve or experienced at time of randomisation into ENSURE-AF trial. Methods The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during the overall study period, 28 days on study drug after cardioversion and 30 days follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding during the on-medication period from time of first dose to last dose of study drug taken + 3 days. Results Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox–warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox–warf irrespective of whether VKA experienced or naïve (0.5% vs. 0.9%, 0.3% vs. 1.4%, respectively). There were no significant differences in the primary safety endpoint [odds ratio (OR) 2.09, 95% confidence interval (CI) 0.72–6.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15–3.60 in anticoagulant naïve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06–6.04, OR 0.48, 95% CI 0.01–9.25, respectively). Conclusions Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox–warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.

Additional file 1:. SPIRIT 2013 Checklist: Recommended items to address in this clinical trial protocol and related documents. It is strongly recommended that this checklist is read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items. Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons “Attribution-NonCommercialNoDerivs 3.0 Unported” license.

Background EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation evaluated use of nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin‐warfarin in patients with nonvalvular atrial fibrillation undergoing electrical cardioversion. Hypothesis To assess clinical factors related to successful or unsuccessful cardioversion. To evaluate whether differences in adverse events based on anticoagulation strategy may exist. Methods In this multicenter prospective randomized open‐label blinded end‐point evaluation trial, 2199 patients were randomized to edoxaban 60 mg once daily (30 mg for creatinine clearance 15‐50 mL/min, weight ≤ 60 kg, and/or concomitant use of P‐glycoprotein inhibitor) or enoxaparin‐warfarin. Successful cardioversion was confirmed by 12‐lead electrocardiography‐documented sinus rhythm. Results Cardioversion was successful in 1578 patients; in 355 patients, cardioversion was unsuccessful. Male, high body weight, high body mass index (BMI), coronary artery disease, concomitant aspirin, or prior statins use were more common in patients with unsuccessful cardioversion; international normalized ratio control did not differ by cardioversion success. On multivariate analysis, gender (P

Background: The optimal interruption schedule for NOACs in patients undergoing invasive procedures has not been determined. This analysis describes periprocedural interruption of edoxaban in real world EMIT AF/VTE study. Methods: EMIT AF/VTE was a prospective, non-interventional study conducted in 7 European countries that collected detailed information on periprocedural management of edoxaban from 5 days before to 30 days after procedure in patients with AF or VTE. Results: Among 1155 patients, pre-procedural interruption occurred in 781 (68%) patients (median 2 days, IQR 1.0-2.0) and post-procedural interruption in 308 (27%) patients (median 3 days, IQR 1.0-8.0); 279 (24.2%) patients had both pre- and post-procedural interruption. Edoxaban interruption in some patients differed from 2018 EHRA Recommendations for NOAC use in AF. Of 294 patients receiving minor risk procedures, for whom no interruption is recommended, 173 (58.8%) had preprocedural interruption (median 1 day). Of 581 patients with low bleeding risk procedures, for whom ≥24h preprocedural interruption is recommended, 188 (32.4%) had no interruption. Of 280 patients receiving high bleeding risk procedures, for whom ≥48h interruption is recommended, 46 (16.4%) had no interruption. Clinical events are shown in Table. Conclusion: Edoxaban interruption schedules in routine practice were not always consistent with EHRA guidelines; nevertheless, rates of clinically significant bleeding or acute thromboembolic events or coronary syndromes were low in the EMIT study. Table Disclosures Colonna: Boehringer Ingelheim: Honoraria; Daiichi Sankyo: Honoraria; BayerAG: Honoraria; Italian Cardiology Association: Other: Non-financial support; European Society of Cardiology: Other: Non-financial support; Pfizer/BMS: Honoraria. von Heymann:Daiichi Sankyo: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria; Bayer AG: Honoraria; Pfizer GmBH: Honoraria; CSL Behring: Honoraria; NovoNordisk Pharma: Honoraria; EACTA and EACTS: Other; DGGG: Other; Mitsubishi Pharma: Honoraria; Ferring GmbH: Honoraria; Biotest GmbH: Honoraria; Leo Pharma GmBH: Honoraria; German Society of Anaesthesiology and Intensive Care Medicine: Other. Saxena:Daiichi Sankyo: Honoraria, Research Funding. Vanassche:Boehringer Ingelheim: Honoraria; 367 Leo Pharma: Honoraria; Bayer: Honoraria; Daiichi Sankyo: Honoraria, Research Funding. Jin:Daiichi Sankyo: Current Employment. Wilkins:Daiichi Sankyo: Honoraria. Chen:Daiichi Sankyo: Current Employment. Unverdorben:Daiichi Sankyo: Current Employment.

Affordable and expandable low power networks such as 5G and Low Power Wide Area Networks (LPWAN) in the public and private network areas have improved network bandwidth capacities and processing performance. Internet of Things (IoT) technologies are increasing in popularity with numerous applications and devices being developed for smart environments and health-related applications. This raises security concerns in these networks, as many IoT devices handle confidential information such as IP/MAC addresses, which could be used to identify a user's location. As a result, there is vulnerability to data tampering by man-in-the-middle (MITM) attacks, which feature two observable characteristics: (1) there is a measurable delay in the session and (2) has unusual travel times compared to prior normal transactions. To improve the detection of these attacks, this paper proposes a novel scheme using a hybrid routing mechanism, which involves appointing dedicated nodes for enforcing routing between IoT devices and users with minimal intervention and workload to the network. The function of dedicated devices with more computational and battery power can provide three advantages: (1) determine secured paths within the network by avoiding suspicious nodes and networks, (2) provide stable travel times (less fluctuations) for a trusted time server (TTS) to improve the accuracy of estimated travel times, and (3) provide packet inspection for security checks. This proposed solution contributes towards increasing the security of IoT networks by enabling the real-time detection of intruders.