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Abstract Background Nonpersistence in anticoagulation therapy is common and associated with undesirable clinical outcomes in patients with venous thromboembolism (VTE). Methods We investigated preceding clinical events of treatment nonpersistence (e.g., switching, discontinuing, or restarting) in VTE patients with and without active cancer using Korean claims database. Results Clinically significant events including thromboembolic events, hepatic function change and surgery preceded treatment nonpersistence, but heterogeneous distributions of clinical events were observed in the presence of active cancer. Patients with active cancer had a low rate of clinical events preceding treatment nonpersistence, and new active cancer diagnosis in the nonactive cancer group was most common before the switch to parenteral anticoagulants from warfarin or non‐vitamin K antagonist oral anticoagulants (NOACs). Conclusion These findings suggest that clinically significant events can precede treatment nonpersistence and largely paralleled current guidelines for patients with VTE, whereas heterogeneous distributions of clinical events were observed in the presence of active cancer.

Abstract Background Fabry disease is a rare, progressive X-linked lysosomal storage disorder. It is caused by mutations in the GLA gene resulting in deficiency of α-galactosidase A (α-Gal A), leading to peripheral neuropathy, cardiovascular disease, stroke, end-stage renal disease, gastrointestinal disorders and premature death. Given the long-term nature of disease progression, trials in Fabry disease are often not powered to capture these clinical events. Clinical measures such as estimated glomerular filtration rate (eGFR) and left ventricular mass index (LVMI) are often captured instead. eGFR and LVMI are believed to be associated with long-term Fabry disease clinical events of interest, but the precise relationships are unclear. Objective We aimed to identify published literature exploring the link between eGFR/LVMI and long-term clinical events in Fabry disease. Methods A comprehensive literature search was conducted in Embase® and MEDLINE® (using Embase.com), and a targeted literature review was conducted. Studies reporting a quantitative relationship between eGFR and/or LVMI and clinical events in Fabry disease were extracted, and narrative synthesis was conducted to understand these predictive relationships. Results Eight studies, consisting of seven patient-level retrospective analyses plus one prospective cohort study, met the inclusion criteria. Seven of these studies reported eGFR and six reported LVMI, with five reporting both. All studies presented results for either a composite measure including a range of key Fabry disease clinical events, or a composite outcome that included at least one key Fabry disease clinical event. All studies employed Cox proportional hazards survival modelling. The studies consistently reported that eGFR and LVMI are predictors of key clinical events in Fabry disease, with the findings remaining consistent regardless of the therapy received by patients in the studies. Conclusions The evidence identified suggests that eGFR and LVMI outcomes may be appropriate indicators for long-term clinical events in Fabry disease, and all identified papers implied the same directional relationship. However, additional research is needed to further understand the specific details of these relationships and to quantify them.

Background: In light of the scarcity of evidence, TIGREECE evaluated the clinical management and long-term outcomes of patients at high risk for an atherothrombotic event who have suffered a myocardial infarction (MI), managed by cardiologists/internists in routine hospital and private office settings in Greece. Methods: TIGREECE, a multicenter, 3-year prospective cohort study, enrolled patients ≥50 years old, with a history of MI 1–3 years before enrollment and with at least one of the following risk factors: age ≥65 years, diabetes mellitus requiring medication, second prior MI, multivessel coronary artery disease, and creatinine clearance 15–60 mL/min. The primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death. Results: Between 5 June 2014 and 25 July 2015, 305 eligible consented patients (median age: 67.3 years; 81.3% males; 14.8% active smokers; 80.7% overweight/obese) were enrolled; 52.5% had ≥2 qualifying risk factors. The median time from the index MI [ST-segment elevation myocardial infarction (STEMI) in 51.1%, non-STEMI in 33.1%] to enrollment was 1.7 years. Of the patients, 65.9% had been discharged on dual antiplatelet therapy. At enrollment, 94.4% were receiving antiplatelets: 60.0% single [acetylsalicylic acid (ASA): 43.3%; clopidogrel: 15.7%] and 34.4% dual (ASA + clopidogrel: 31.8%) therapy. The Kaplan–Meier estimated 3-year primary composite event rate was 9.3% [95% confidence interval (CI): 6.4–13.0), and the ischemic composite event rate was 6.7% (95% CI: 4.2–9.9). Conclusions: Study results indicate that in the routine care of Greece one in ten patients experience a recurring cardiovascular event or death, mainly of ischemic origin, 1–3 years post-MI.

Background: Nonpersistence in anticoagulation therapy is common and associated with undesirable clinical outcomes in patients with venous thromboembolism (VTE). Methods: We investigated preceding clinical events of treatment nonpersistence (e.g., switching, discontinuing, or restarting) in VTE patients with and without active cancer using Korean claims database. Results: Clinically significant events including thromboembolic events, hepatic function change and surgery preceded treatment nonpersistence, but heterogeneous distributions of clinical events were observed in the presence of active cancer. Patients with active cancer had a low rate of clinical events preceding treatment nonpersistence, and new active cancer diagnosis in the nonactive cancer group was most common before the switch to parenteral anticoagulants from warfarin or non‐vitamin K antagonist oral anticoagulants (NOACs). Conclusion: These findings suggest that clinically significant events can precede treatment nonpersistence and largely paralleled current guidelines for patients with VTE, whereas heterogeneous distributions of clinical events were observed in the presence of active cancer. [ABSTRACT FROM AUTHOR]

Background: Fabry disease is a rare, progressive X-linked lysosomal storage disorder. It is caused by mutations in the GLA gene resulting in deficiency of α-galactosidase A (α-Gal A), leading to peripheral neuropathy, cardiovascular disease, stroke, end-stage renal disease, gastrointestinal disorders and premature death. Given the long-term nature of disease progression, trials in Fabry disease are often not powered to capture these clinical events. Clinical measures such as estimated glomerular filtration rate (eGFR) and left ventricular mass index (LVMI) are often captured instead. eGFR and LVMI are believed to be associated with long-term Fabry disease clinical events of interest, but the precise relationships are unclear. Objective: We aimed to identify published literature exploring the link between eGFR/LVMI and long-term clinical events in Fabry disease. Methods: A comprehensive literature search was conducted in Embase® and MEDLINE® (using Embase.com), and a targeted literature review was conducted. Studies reporting a quantitative relationship between eGFR and/or LVMI and clinical events in Fabry disease were extracted, and narrative synthesis was conducted to understand these predictive relationships. Results: Eight studies, consisting of seven patient-level retrospective analyses plus one prospective cohort study, met the inclusion criteria. Seven of these studies reported eGFR and six reported LVMI, with five reporting both. All studies presented results for either a composite measure including a range of key Fabry disease clinical events, or a composite outcome that included at least one key Fabry disease clinical event. All studies employed Cox proportional hazards survival modelling. The studies consistently reported that eGFR and LVMI are predictors of key clinical events in Fabry disease, with the findings remaining consistent regardless of the therapy received by patients in the studies. Conclusions: The evidence identified suggests that eGFR and LVMI outcomes may be appropriate indicators for long-term clinical events in Fabry disease, and all identified papers implied the same directional relationship. However, additional research is needed to further understand the specific details of these relationships and to quantify them. [ABSTRACT FROM AUTHOR]

Accurate and timely diagnosis is a pillar of effective healthcare. However, the challenge lies in gathering extensive training data while maintaining patient privacy. This study introduces a novel approach using federated learning (FL) and a cross-device multimodal model for clinical event classification based on vital signs data. Our architecture employs FL to train several machine learning models including random forest, AdaBoost, and SGD ensemble models on vital signs data. The data were sourced from a diverse clientele at a Boston hospital (MIMIC-IV dataset). The FL structure trains directly on each client's device, ensuring no transfer of sensitive data and preserving patient privacy. The study demonstrates that FL offers a powerful tool for privacy-preserving clinical event classification, with our approach achieving an impressive accuracy of 98.9%. These findings highlight the significant potential of FL and cross-device ensemble technology in healthcare applications, especially in the context of handling large volumes of sensitive patient data. [ABSTRACT FROM AUTHOR]

We described the clinical, laboratory and molecular characteristics of individuals with Hb S (HBB: c.20A>T)/β-thalassemia (Hb S/β-thal) participating in the Recipient Epidemiology and Donor Evaluation Study (REDS-III) Brazil Sickle Cell Disease cohort. HBB gene sequencing was performed to genotype each β-thal mutation. Patients were classified as Hb S/β0-thal, Hb S/β+-thal-severe or Hb S/β+-thal based on prior literature and databases of hemoglobin (Hb) variants. Characteristics of patients with each β-thal mutation were described and the clinical profile of patients grouped into Hb S/β0-thal, Hb S/β+-thal and Hb S/β+-thal-severe were compared. Of the 2793 patients enrolled, 84 (3.0%) had Hb S/β0-thal and 83 (3.0%) had Hb S/β+-thal; 40/83 (48.2%) patients with Hb S/β+-thal had mutations defined as severe. We identified 19 different β-thal mutations, eight Hb S/β0-thal, three Hb S/β+-thal-severe and eight Hb S/β+-thal. The most frequent β0 and β+ mutations were codon 39 (HBB: c.118C>T) and IVS-I-6 (T>C) (HBB: c.92+6T>C), respectively. Individuals with Hb S/β0-thal had a similar clinical and laboratory phenotype when compared to those with Hb S/β+-thal-severe. Individuals with Hb S/β+-thal-severe had significantly lower total Hb and Hb A levels and higher Hb S, white blood cell (WBC) count, platelets and hemolysis markers when compared to those with Hb S/β+-thal. Likewise, individuals with Hb S/β+-thal-severe showed a significantly higher occurrence of hospitalizations, vaso-occlusive events (VOE), acute chest syndrome (ACS), splenic sequestration, blood utilization, and hydroxyurea (HU) therapy.

Abstract Background and Aim Non‐alcoholic fatty liver disease (NAFLD) can progress in non‐obese patients as in obese patients. Reports on long‐term prognosis in non‐obese NAFLD patients are controversial. Therefore, we aimed to examine the long‐term prognosis of non‐obese patients with NAFLD. Methods This single‐center, retrospective cohort study enrolled biopsy‐proven non‐obese and obese NAFLD patients between January 2002 and December 2011 and followed them up until 31 March 2021, for death and clinical events (cardiovascular and liver‐related events and extrahepatic cancers). Results Of the 223 NAFLD patients, 58 (26.0%) were non‐obese. Compared with obese patients, they had a lower fibrosis stage (0.8 ± 0.80 vs 1.2 ± 0.91; P = 0.004), milder lobular inflammation (0.9 ± 0.7 vs 1.1 ± 0.7; P = 0.02), and significantly lower serum creatinine, total bilirubin, ferritin, and type IV collagen 7S and higher high‐density lipoprotein levels. After a median follow‐up of 8.9 years, no significant difference was noted in mortality between the two groups (2 [3.4%] non‐obese vs 5 [3.0%] obese; log‐rank test, P = 0.63). Twelve patients (20.7%) in the non‐obese group and 32 (19.4%) in the obese group had clinical events. Although the obese group had a higher incidence of clinical events during the first 10 years of follow‐up, the non‐obese group had a higher incidence after that (log‐rank test, P = 0.67). The non‐obese group had a high incidence of malignancy (9 [15.5%] non‐obese vs 14 [8.3%] obese; P = 0.13). Conclusion Non‐obese NAFLD does not necessarily have a good prognosis, and some cases have a poor prognosis such as extrahepatic cancers. Further validation is required in the future.

Background Frailty is associated with adverse outcomes in patients undergoing hemodialysis (HD). However, no study has used various frailty assessments in patients on HD to examine their association with clinical events. In this study, we investigated the association between clinical events and six frailty scales. Methods Outpatients who underwent HD between 2018 and 2020 were retrospectively enrolled. Frailty was defined using the Fried Frailty Phenotype, Study of Osteoporotic Fractures (SOF) Index, Short Physical Performance Battery (SPPB), Frail Screening Index, FRAIL scale and Clinical Frailty Scale. Outcomes were clinical events, including a composite of multiple (i.e. recurrent) all-cause hospitalizations, fractures and/or all-cause mortality. The association of clinical events and the frailty scales were investigated using negative binomial regression analysis. Results Fried Frailty Phenotype [incident rate ratio (IRR), 1.62; 95% confidence interval (CI), 1.49–1.76], SOF Index (IRR, 1.42; 95% CI, 1.10–1.83), SPPB (IRR, 1.79; 95% CI, 1.11–2.88) and Clinical Frailty Scale (IRR, 1.65; 95% CI, 1.04–2.61) were significantly associated with clinical events. However, Frail Screening Index (IRR, 1.38; 95% CI, 0.60–3.18) and FRAIL scale (IRR, 1.30; 95% CI, 0.88–1.92) showed no significant association with clinical events. Conclusions Objective frailty assessments (SPPB) and medical staff impression-based frailty (Clinical Frailty Scale) may be useful prognostic predictors for patients on HD. Questionnaire-based frailty assessment should be carefully considered when used as a measurement of frailty. [ABSTRACT FROM AUTHOR]

Limited research is available on the real-world experiences of patients with dementia with Lewy bodies (DLB). This study evaluated clinical events, healthcare utilization, and healthcare costs of patients with DLB vs other dementia types with psychosis (ODP). Study patients included commercial and Medicare Advantage with Part D enrollees aged ≥40 years with evidence of DLB and ODP from 6/01/2015‒5/31/2019. Compared with patients with ODP, more patients with DLB had clinical events including anticholinergic effects, neurologic effects, and cognitive decline. Patients with DLB used more healthcare resources with greater dementia-related office and outpatient visits and psychosis-related inpatient stays and office, outpatient, and emergency visits compared with their ODP patient counterparts. Patients with DLB also incurred higher healthcare costs for all-cause and dementia-related office visits and pharmacy fills, and psychosis-related total costs. Understanding the clinical and economic impact of DLB and ODP is important to improve care for patients with dementia. [ABSTRACT FROM AUTHOR]

Background and Aim: Non‐alcoholic fatty liver disease (NAFLD) can progress in non‐obese patients as in obese patients. Reports on long‐term prognosis in non‐obese NAFLD patients are controversial. Therefore, we aimed to examine the long‐term prognosis of non‐obese patients with NAFLD. Methods: This single‐center, retrospective cohort study enrolled biopsy‐proven non‐obese and obese NAFLD patients between January 2002 and December 2011 and followed them up until 31 March 2021, for death and clinical events (cardiovascular and liver‐related events and extrahepatic cancers). Results: Of the 223 NAFLD patients, 58 (26.0%) were non‐obese. Compared with obese patients, they had a lower fibrosis stage (0.8 ± 0.80 vs 1.2 ± 0.91; P = 0.004), milder lobular inflammation (0.9 ± 0.7 vs 1.1 ± 0.7; P = 0.02), and significantly lower serum creatinine, total bilirubin, ferritin, and type IV collagen 7S and higher high‐density lipoprotein levels. After a median follow‐up of 8.9 years, no significant difference was noted in mortality between the two groups (2 [3.4%] non‐obese vs 5 [3.0%] obese; log‐rank test, P = 0.63). Twelve patients (20.7%) in the non‐obese group and 32 (19.4%) in the obese group had clinical events. Although the obese group had a higher incidence of clinical events during the first 10 years of follow‐up, the non‐obese group had a higher incidence after that (log‐rank test, P = 0.67). The non‐obese group had a high incidence of malignancy (9 [15.5%] non‐obese vs 14 [8.3%] obese; P = 0.13). Conclusion: Non‐obese NAFLD does not necessarily have a good prognosis, and some cases have a poor prognosis such as extrahepatic cancers. Further validation is required in the future. [ABSTRACT FROM AUTHOR]

In 2015, Catalonia introduced sickle cell disease (SCD) screening in its newborn screening (NBS) program along with standard-of-care treatments like penicillin, hydroxyurea, and anti-pneumococcal vaccination. Few studies have assessed the clinical impact of introducing NBS programs on SCD patients. We analyzed the incidence of SCD and related hemoglobinopathies in Catalonia and the change in clinical events occurring after introducing NBS. Screening 506,996 newborns from 2015 to 2022, we conducted a retrospective multicenter study including 100 screened (SG) and 95 unscreened (UG) SCD patients and analyzed SCD-related clinical events over the first six years of life. We diagnosed 160 cases of SCD, with an incidence of 1 in 3169 newborns. The SG had a significantly lower median age at diagnosis (0.1 y vs. 1.68 y, p < 0.0001), and initiated penicillin prophylaxis (0.12 y vs. 1.86 y, p < 0.0001) and hydroxyurea treatment earlier (1.42 y vs. 4.5 y, p < 0.0001). The SG experienced fewer median SCD-related clinical events (vaso-occlusive crisis, acute chest syndrome, infections of probable bacterial origin, acute anemia requiring transfusion, acute splenic sequestration, and pathological transcranial Doppler echography) per year of follow-up (0.19 vs. 0.77, p < 0.0001), a reduced number of annual emergency department visits (0.37 vs. 0.76, p < 0.0001), and fewer hospitalizations (0.33 vs. 0.72, p < 0.0001). SCD screening in Catalonia's NBS program has effectively reduced morbidity and improved affected children's quality of life.

Abstract Aims Recipients of left ventricular assist devices (LVAD) are exposed to increased risk of adverse clinical events. One of the potential contributing factors is non‐pulsatile flow generated by LVAD. We evaluated the association of flow patterns in carotid arteries and of increased arterial stiffness with death and cerebrovascular events in LVAD recipients. Methods and results We analysed data from 83 patients [mean age 54 ± 15 years; 12 women; HeartMate II (HMII), n = 34; HeartMate 3 (HM3), n = 49]. Pulsatile and resistive indexes, atherosclerotic changes in carotid arteries (measured by duplex ultrasound), and arterial stiffness [measured by Endo‐PAT 2000 as the augmentation index standardized for heart rate (AI@75)] were evaluated 3 and 6 months after LVAD implantation. Sixteen patients died during follow‐up (27.3 months; interquartile range 15.7–44.3). After adjusting for the main variables examined, the pulsatility index measured at 3 months was positively associated with increased hazard ratios (HR) for death and cerebrovascular events [HR 9.8, 95% confidence interval (CI) 1.62–59.42], with HR increasing after adding AI@75 to the model (HR 18.8, 95% CI 2.44–145.50). In HM3 recipients, HR was significantly lower than in HMII recipients (HR 0.31, 95% CI 0.11–0.91), but the significance disappeared after adding AI@75 to the model (HR 0.33, 95% CI 0.09–1.18). Conclusions The risk of death and cerebrovascular events in LVAD recipients is associated with increased pulsatility index in carotid arteries and potentiated by increased arterial stiffness. The same risk is attenuated by HM3 LVAD implantation, but this effect is weakened by increased arterial stiffness.

Accurate and timely diagnosis is a pillar of effective healthcare. However, the challenge lies in gathering extensive training data while maintaining patient privacy. This study introduces a novel approach using federated learning (FL) and a cross-device multimodal model for clinical event classification based on vital signs data. Our architecture employs FL to train several machine learning models including random forest, AdaBoost, and SGD ensemble models on vital signs data. The data were sourced from a diverse clientele at a Boston hospital (MIMIC-IV dataset). The FL structure trains directly on each client’s device, ensuring no transfer of sensitive data and preserving patient privacy. The study demonstrates that FL offers a powerful tool for privacy-preserving clinical event classification, with our approach achieving an impressive accuracy of 98.9%. These findings highlight the significant potential of FL and cross-device ensemble technology in healthcare applications, especially in the context of handling large volumes of sensitive patient data.

AimsThe association of low endothelial shear stress (ESS) with high-risk plaque (HRP) has not been thoroughly investigated in humans. We investigated the local ESS and lumen remodelling patterns in HRPs using optical coherence tomography (OCT), developed the shear stress score, and explored its association with the prevalence of HRPs and clinical outcomes.Methods and resultsA total of 35 coronary arteries from 30 patients with stable angina or acute coronary syndrome (ACS) were reconstructed with three dimensional (3D) OCT. ESS was calculated using computational fluid dynamics and classified into low, moderate, and high in 3-mm-long subsegments. In each subsegment, (i) fibroatheromas (FAs) were classified into HRPs and non-HRPs based on fibrous cap (FC) thickness and lipid pool size, and (ii) lumen remodelling was classified into constrictive, compensatory, and expansive. In each artery the shear stress score was calculated as metric of the extent and severity of low ESS. FAs in low ESS subsegments had thinner FC compared with high ESS (89 ± 84 vs.138 ± 83 µm, P < 0.05). Low ESS subsegments predominantly co-localized with HRPs vs. non-HRPs (29 vs. 9%, P < 0.05) and high ESS subsegments predominantly with non-HRPs (9 vs. 24%, P < 0.05). Compensatory and expansive lumen remodelling were the predominant responses within subsegments with low ESS and HRPs. In non-stenotic FAs, low ESS was associated with HRPs vs. non-HRPs (29 vs. 3%, P < 0.05). Arteries with increased shear stress score had increased frequency of HRPs and were associated with ACS vs. stable angina.ConclusionLocal low ESS and expansive lumen remodelling are associated with HRP. Arteries with increased shear stress score have increased frequency of HRPs and propensity to present with ACS.

Abstract Background It is significant to model clinical activities for process mining, which assists in improving medical service quality. However, current process mining studies in healthcare pay more attention to the control flow of events, while the data properties and the time perspective are generally ignored. Moreover, classifying event attributes from the view of computers usually are difficult for medical experts. There are also problems of model sharing and reusing after it is generated. Methods In this paper, we presented a constraint-based method using multi-perspective declarative process mining, supporting healthcare personnel to model clinical processes by themselves. Inspired by openEHR, we classified event attributes into seven types, and each relationship between these types is represented in a Constrained Relationship Matrix. Finally, a conformance checking algorithm is designed. Results The method was verified in a retrospective observational case study, which consists of Electronic Medical Record (EMR) of 358 patients from a large general hospital in China. We take the ischemic stroke treatment process as an example to check compliance with clinical guidelines. Conformance checking results are analyzed and confirmed by medical experts. Conclusions This representation approach was applicable with the characteristic of easily understandable and expandable for modeling clinical activities, supporting to share the models created across different medical facilities.

Background: Marfan syndrome (MFS) is a connective tissue disorder caused by mutations in the Fibrillin-1 gene (FBN1). Here, we undertook the first epigenome-wide association study (EWAS) in patients with MFS aiming at identifying DNA methylation loci associated with MFS phenotypes that may shed light on the disease process. Methods: The Illumina 450 k DNA-methylation array was used on stored peripheral whole-blood samples of 190 patients with MFS originally included in the COMPARE trial. An unbiased genome-wide approach was used, and methylation of CpG-sites across the entire genome was evaluated. Additionally, we investigated CpG-sites across the FBN1-locus (15q21.1) more closely, since this is the gene defective in MFS. Differentially Methylated Positions (DMPs) and Differentially Methylated Regions (DMRs) were identified through regression analysis. Associations between methylation levels and aortic diameters and presence or absence of 21 clinical features of MFS at baseline were analyzed. Moreover, associations between aortic diameter change, and the occurrence of clinical events (death any cause, type-A or -B dissection/rupture, or aortic surgery) and methylation levels were analyzed. Results: We identified 28 DMPs that are significantly associated with aortic diameters in patients with MFS. Seven of these DMPs (25%) could be allocated to a gene that was previously associated with cardiovascular diseases (HDAC4, IGF2BP3, CASZ1, SDK1, PCDHGA1, DIO3, PTPRN2). Moreover, we identified seven DMPs that were significantly associated with aortic diameter change and five DMP's that associated with clinical events. No significant associations at p < 10–8 or p < 10–6 were found with any of the non-cardiovascular phenotypic MFS features. Investigating DMRs, clusters were seen mostly on X- and Y, and chromosome 18–22. The remaining DMRs indicated involvement of a large family of protocadherins on chromosome 5, which were not reported in MFS before. Conclusion: This EWAS in patients with MFS has identified a number of methylation loci significantly associated with aortic diameters, aortic dilatation rate and aortic events. Our findings add to the slowly growing literature on the regulation of gene expression in MFS patients. [ABSTRACT FROM AUTHOR]

Aims Recipients of left ventricular assist devices (LVAD) are exposed to increased risk of adverse clinical events. One of the potential contributing factors is non-pulsatile flow generated by LVAD. We evaluated the association of flow patterns in carotid arteries and of increased arterial stiffness with death and cerebrovascular events in LVAD recipients. Methods and results We analysed data from 83 patients [mean age 54 ± 15 years; 12 women; HeartMate II (HMII), n = 34; HeartMate 3 (HM3), n = 49]. Pulsatile and resistive indexes, atherosclerotic changes in carotid arteries (measured by duplex ultrasound), and arterial stiffness [measured by Endo-PAT 2000 as the augmentation index standardized for heart rate (AI@75)] were evaluated 3 and 6 months after LVAD implantation. Sixteen patients died during follow-up (27.3 months; interquartile range 15.7–44.3). After adjusting for the main variables examined, the pulsatility index measured at 3 months was positively associated with increased hazard ratios (HR) for death and cerebrovascular events [HR 9.8, 95% confidence interval (CI) 1.62–59.42], with HR increasing after adding AI@75 to the model (HR 18.8, 95% CI 2.44–145.50). In HM3 recipients, HR was significantly lower than in HMII recipients (HR 0.31, 95% CI 0.11–0.91), but the significance disappeared after adding AI@75 to the model (HR 0.33, 95% CI 0.09–1.18). Conclusions The risk of death and cerebrovascular events in LVAD recipients is associated with increased pulsatility index in carotid arteries and potentiated by increased arterial stiffness. The same risk is attenuated by HM3 LVAD implantation, but this effect is weakened by increased arterial stiffness. [ABSTRACT FROM AUTHOR]

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Continuous‐flow left ventricular assist devices (LVADs) have gained tremendous acceptance for the treatment of end‐stage heart failure patients. Among different versions, axial flow and centrifugal flow LVADs have shown remarkable potential for clinical implants. It is also very crucial to know which device serves its purpose better to treat heart failure patients. A thorough comparison of axial and centrifugal LVADs, which may guide doctors in deciding before the implant, still lacks in the literature. In this work, an assessment of axial and centrifugal LVADs has been made to suggest a better device by comparing their engineering, clinical, and technological development of design aspects. Hydrodynamic and hemodynamic aspects for both types of pumps are discussed along with their biocompatibility, bearing types, and sizes. It has been observed numerically that centrifugal LVADs perform better over axial LVADs in every engineering aspect like higher hydraulic efficiency, better characteristics curve, lesser power intake, and also lesser blood damage. However, the clinical outcomes suggest that centrifugal LVADs experience higher events of infections, renal, and respiratory dysfunction. In contrast, axial LVADs encountered higher bleeding and cardiac arrhythmia. Moreover, recent technological developments suggested that magnetic type bearings along with biocompatible coating improve the life of LVADs. [ABSTRACT FROM AUTHOR]

Abstract Background (TA) n repeat sequence (rs8175347) of UGT1A1 gene promoter polymorphism is associated with serum bilirubin levels and gallstones among different sickle cell anaemia (SCA) populations. There are no data on UGT1A1 polymorphisms and their impact on Nigerian SCA patients. In this study, we determined the distribution of the UGT1A1 (TA) n genotypes among a group of young Nigerian SCA patients and healthy controls. In addition, the influence of UGT1A1 (TA) n genotypes on the laboratory and clinical events among the patients was determined. Methods The distribution of the UGT1A1 (TA) n genotypes among 101 young Nigerian SCA patients and 64 normal appropriate controls were determined and studied. The UGT1A1 (TA) n genotypes were further classified into subgroups and used to differentiate the clinical events and laboratory parameters of the patients. Results Four (TA) n alleles:(TA)5, 6, 7, and 8 were found. These were associated with 10 genotypes: TA5/5, 5/6, 5/7, 5/8, 6/6, 6/7, 6/8, 7/7, 7/8, 8/8. The normal (wild-type)-(TA) 6/6), low- (TA) 7/7, 7/8, 8/8), intermediate- (TA) 5/7, 5/8, 6/7, 6/8), and high-activity (TA) 5/5, 5/6,) genotypes were found in 24.8, 24.8, 41.5, and 8.9% patients and 20.3, 15.6, 61, and 3.1% controls respectively. The general genotype distribution of the patients and control group were not significantly different. There were significant differences in serum bilirubin and lactate dehydrogenase (LDH) of the patients when differentiated by the UGT1A1 (TA) n genotypes (p

Background: It is significant to model clinical activities for process mining, which assists in improving medical service quality. However, current process mining studies in healthcare pay more attention to the control flow of events, while the data properties and the time perspective are generally ignored. Moreover, classifying event attributes from the view of computers usually are difficult for medical experts. There are also problems of model sharing and reusing after it is generated.Methods: In this paper, we presented a constraint-based method using multi-perspective declarative process mining, supporting healthcare personnel to model clinical processes by themselves. Inspired by openEHR, we classified event attributes into seven types, and each relationship between these types is represented in a Constrained Relationship Matrix. Finally, a conformance checking algorithm is designed.Results: The method was verified in a retrospective observational case study, which consists of Electronic Medical Record (EMR) of 358 patients from a large general hospital in China. We take the ischemic stroke treatment process as an example to check compliance with clinical guidelines. Conformance checking results are analyzed and confirmed by medical experts.Conclusions: This representation approach was applicable with the characteristic of easily understandable and expandable for modeling clinical activities, supporting to share the models created across different medical facilities. [ABSTRACT FROM AUTHOR]

• This study aims to assess the key structural modelling approaches applied in published obesity models, and to provide an expert consensus to improve the methodology and consistency of the application of decision-analytic modelling in obesity research. • Focusing on the key structural aspects outlined in the Philips checklist [11], this paper presents the main findings relevant to obesity models that have been identified (systematic literature search), rated (expert interviews) and discussed (expert panel). • The obtained insights, discussion content and consensus can provide valuable guidance for all decision makers, health economists and modellers for developing decision-analytic models to generate high-quality and transparent economic evidence for obesity interventions. This study aims to assess the key structural modelling approaches applied in published obesity models, and to provide an expert consensus to improve the methodology and consistency of the application of decision-analytic modelling in obesity research. Using a previously published systematic literature search as basis, ten individual interviews, and a face-to-face expert panel meeting were conducted. Within the expert panel meeting, the interview findings were presented and discussed, rated and where possible consensus statements were obtained. In particular, five topics of interest were assessed: time horizon, model type, obesity-related clinical events simulated, event simulation approaches and external event validation. In addition to generic modelling standards, several obesity-specific recommendations were generated: Simulating a lifetime horizon was regarded as optimal (100% agreement); Ideally, both short and long-term results should be presented (100%); Using a risk equation approach for simulating the clinical events was the most preferred approach (60%) followed by applying a body mass index (BMI) related relative risk to a base risk estimate (30%); Continuous BMI approaches were preferred (100%); An individual patient/microsimulation state transition model was regarded as preferred modelling approach (90%); Discrete event simulation (DES) was regarded as the most flexible approach for building an obesity model but it was recognised as complex, and more difficult to build, populate and to disseminate; Performing an external validation was rated as important (100%). The obtained insights, discussion and consensus can provide valuable information for developing decision-analytic models to generate high-quality and transparent economic evidence for obesity interventions. [ABSTRACT FROM AUTHOR]

Background Significant coronary artery disease has a well‐known association with long‐term adverse cardiovascular events. In this study, we aimed to evaluate its association with long‐term major adverse clinical events (MACE) up to 5 years in patients who presented with chest pain without significant coronary artery disease. Methods and Results A total of 5890 subjects with chest pain without significant coronary artery disease were prospectively enrolled in this study. The mean follow‐up duration was 3.4 years. Multivariable Cox proportional hazards regression analysis was performed for assessing the independent risk factors for MACE or sustained angina pectoris. MACE was defined as the composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure. Ninety‐one (2.2%) patients developed MACE, and 309 (8.1%) patients developed sustained angina pectoris, both within 5 years. In multivariable Cox proportional hazards regression analysis, the risk of MACE was significantly associated with age (per 5 years; hazard ratio [HR], 1.44; 95% CI, 1.30–1.60) and insignificant coronary stenosis (30%–70%; HR, 2.03; 95% CI; 1.28–3.21). The risk of sustained angina pectoris was significantly associated with age (per 5 years; HR, 1.05; 95% CI, 1.01–1.11), dyslipidemia (HR, 1.34; 95% CI, 1.06–1.70), insignificant coronary stenosis (HR, 2.54; 95% CI, 1.94–3.31), coronary artery spasm (HR, 1.42; 95% CI, 1.11–1.80), and myocardial bridge (HR, 1.37; 95% CI, 1.04–1.81). Conclusions In patients without significant CAD, aging and insignificant coronary stenosis have a strong association with future long‐term MACE. Also, aging, dyslipidemia, insignificant coronary stenosis, coronary artery spasm, and myocardial bridge are strongly associated with future angina pectoris.

Introduction: The aim of the study was to evaluate the effects of cytochrome P450 2C19*2 (CYP2C19*2) on ischemic and bleeding events in the Chinese Han population.Material and Methods: Patients after coronary artery stenting were enrolled for genotyping CYP2C19*2. Platelet reactivity 4 weeks after stent implantation was compared between different genotype groups. Ischemic and bleeding events were compared after 6 months' follow-up.Results: A total of 255 patients were enrolled and 57.7% and 42.3% of patients presented with stable angina and acute coronary syndrome, respectively. The prevalence of homozygous (AA) and heterozygous (GA) CYP2C19*2 variants was 3.5% and 24.7% respectively, and the prevalence of wild type (GG) was 71.8%. Compared to GG and GA genotype groups, the absolute platelet activity reduction was significantly lower in AA genotype (GG 43.6 ±7.8%, GA 31.9 ±6.5%, and AA 24.8 ±5.3%, p < 0.01 for trend). After 6 months' follow-up, 3.3%, 4.8% and 11.1% of patients experienced ischemic events in GG, GA and AA genotype groups, respectively (p = 0.003 for trend). After adjusting for traditional risk factors, AA genotype was significantly associated with ischemic events, with hazard ratio 1.19 and 95% confidence interval 1.08-1.30 (p = 0.013). Also, 2.2%, 1.6% and 0% of patients experienced bleeding events in GG, GA and AA genotype groups (p = 0.153 for trend). No independent association of CYP2C19*2 genotype and bleeding events was observed.Conclusions: Genotyping of CYP2C19*2 may be useful to guide antiplatelet treatment in the Chinese Han population. Randomized controlled trials are warranted to investigate whether genotype-guided antiplatelet treatment could reduce ischemic events. [ABSTRACT FROM AUTHOR]

Background: Socioeconomic status (SES) is a social determinant of both health and receipt of health care services, but its impact is under-studied in acute coronary syndrome (ACS). The aim of this study was to examine the influence of SES on in-hospital care, and clinical events for patients presenting with an ACS to public hospitals in Australia.Methods: Data from 9064 ACS patient records were collected from 41 public hospitals nationwide from 2009 as part of the Cooperative National Registry of Acute Coronary Syndrome Care (CONCORDANCE) registry. For this analysis, we divided the cohort into four socioeconomic groups (based on postcode of usual residence) and compared the in-hospital care provided and clinical outcomes before and after adjustment for both patient clinical characteristics and hospital clustering.Results: Patients were divided into four SES groups (from the most to the least disadvantaged: 2042 (23%) vs. 2104 (23%) vs. 1994 (22%) vs. 2968 (32%)). Following adjustments for patient characteristics, there were no differences in the odds of receiving coronary angiogram, revascularisation, prescription of recommended medication, or referral to cardiac rehabilitation across the SES groups (p=0.06, 0.69, 0.89 and 0.79, respectively). After adjustment for clinical characteristics, no associations were observed for in-hospital and cumulative death (p=0.62 and p=0.71, respectively). However, the most disadvantaged group were 37% more likely to have a major adverse cardiovascular event (MACE) than the least disadvantaged group (OR (95% CI): 1.37 (1.1, 1.71), p=0.02) driven by incidence of in-hospital heart failure.Conclusions: Although there may be gaps in the delivery of care, this delivery of care does not differ by patient's SES. It is an encouraging affirmation that all patients in Australian public hospitals receive equal in-hospital care, and the likelihood of death is comparable between the SES groups. [ABSTRACT FROM AUTHOR]

Introduction: This study aims to determine methodological variations in the event simulation approaches of published health economic decision models, in the field of obesity, and to investigate whether their predictiveness and validity were investigated via external event validation techniques, which investigate how well the model reproduces reality.Areas Covered: A systematic review identified a total of 87 relevant papers, of which 72 that simulated obesity-associated events were included. Most frequently simulated events were coronary heart disease (≈ 83%), type 2 diabetes (≈ 74%), and stroke (≈ 66%). Only for ten published model-based health economic assessments in obesity an external event validation was performed (14%; 10 of 72), and only for one the predictiveness and validity of the event simulation was investigated in a cohort of obese subjects.Expert Commentary: We identified a wide range of obesity related event simulation approaches. Published obesity models lack information on the predictive quality and validity of the applied event simulation approaches. Further work on comparing and validating these event simulation approaches is required to investigate their predictiveness and validity, which will offer guidance future modelling in the field of obesity. [ABSTRACT FROM AUTHOR]

Background: The dynamic effects of duty events on the blood pressure (BP) and heart rate variability (HRV) of physicians on duty are unknown. Methods: A study was conducted among 12 physicians on night duty. BP and HRV with and without the effect of a duty event were compared. The risk of higher BP and impaired HRV after a phone call were calculated. Results: Physicians had higher mean BP (122.4 ± 11.1; 76.9 ± 7.1 mmHg) within 30 min after a phone calls than without a phone call (113.5 ± 5.3; 69.0 ± 3.8) and higher sympathetic tone (low frequency normalized units (LFnu) 68.5 ± 8.9; high frequency normalized units (HFnu) 27.7 ± 8.7) within 10 min of a phone call than without a phone call (62.9 ± 8.51; 33.5 ± 8.4). Elevated BP and sympathetic tone recovered to baseline levels 30 min after a phone call. Conclusions: Among physicians on night duty, sympathetic tone and BP might be elevated by clinical events, and these effects last for 30 min. [ABSTRACT FROM AUTHOR]

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