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  • 1
    In: Internal and Emergency Medicine, Springer Science and Business Media LLC, Vol. 18, No. 2 ( 2023-03), p. 449-456
    Abstract: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster-randomized trial showed that a mobile health (mHealth)-implemented ‘Atrial fibrillation Better Care’ (ABC) pathway approach reduced the risk of adverse events in atrial fibrillation (AF) patients. Whether this benefit can be applied to both males and females is unclear, especially given the suboptimal management and poorer cardiovascular outcomes in females with AF. In this post-hoc analysis, we performed a sex-stratified analysis of the mAFA-II trial. Between June 2018 and August 2019, adult AF patients were enrolled across 40 centers in China. The primary outcome was the composite of stroke, thromboembolism, all-cause death, and re-hospitalization. The effect of mAFA intervention according to sex was evaluated through adjusted Cox-regression models. Among the 3,324 patients enrolled in the trial, 2,062 (62.0%) patients were males (mean age: 67.5 ± 14.3 years; 1,021 allocated to mAFA intervention) and 1,262 (38.0%) were females (mean age: 70.2 ± 13.0; 625 allocated to mAFA intervention). A significant risk reduction of the primary composite outcome in patients allocated to mAFA intervention was observed in both males (adjusted hazard ratio [aHR] and 95% confidence interval [CI] 0.30 [0.17–0.52]) and females (aHR [95%CI] 0.50 [0.27–0.92]), without statistically significant interaction ( p  = 0.225). Sex-based interactions were observed for other secondary outcomes, including all-cause death ( p  = 0.026) and bleeding events ( p  = 0.032). A mHealth-technology implemented ABC pathway was similarly effective in reducing the risk of adverse clinical events both in male and female patients. Secondary outcomes showed greater benefits of mAFA intervention in men.
    Type of Medium: Online Resource
    ISSN: 1828-0447 , 1970-9366
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2378342-4
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  • 2
    In: Clinical Research in Cardiology, Springer Science and Business Media LLC, Vol. 112, No. 9 ( 2023-09), p. 1263-1277
    Abstract: Mechanisms of myocardial ischemia in obstructive and non-obstructive coronary artery disease (CAD), and the interplay between clinical, functional, biological and psycho-social features, are still far to be fully elucidated. Objectives To develop a machine-learning (ML) model for the supervised prediction of obstructive versus non-obstructive CAD. Methods From the EVA study, we analysed adults hospitalized for IHD undergoing conventional coronary angiography (CCA). Non-obstructive CAD was defined by a stenosis  〈  50% in one or more vessels. Baseline clinical and psycho-socio-cultural characteristics were used for computing a Rockwood and Mitnitski frailty index, and a gender score according to GENESIS-PRAXY methodology. Serum concentration of inflammatory cytokines was measured with a multiplex flow cytometry assay. Through an XGBoost classifier combined with an explainable artificial intelligence tool (SHAP), we identified the most influential features in discriminating obstructive versus non-obstructive CAD. Results Among the overall EVA cohort ( n  = 509), 311 individuals (mean age 67 ± 11 years, 38% females; 67% obstructive CAD) with complete data were analysed. The ML-based model (83% accuracy and 87% precision) showed that while obstructive CAD was associated with higher frailty index, older age and a cytokine signature characterized by IL-1β, IL-12p70 and IL-33, non-obstructive CAD was associated with a higher gender score (i.e., social characteristics traditionally ascribed to women) and with a cytokine signature characterized by IL-18, IL-8, IL-23. Conclusions Integrating clinical, biological, and psycho-social features, we have optimized a sex- and gender-unbiased model that discriminates obstructive and non-obstructive CAD. Further mechanistic studies will shed light on the biological plausibility of these associations. Clinical trial registration NCT02737982. Graphical abstract
    Type of Medium: Online Resource
    ISSN: 1861-0684 , 1861-0692
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    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2218331-0
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  • 3
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. Suppl_3 ( 2020-11-17)
    Abstract: Introduction: Although adverse outcomes from cardiovascular disease (CVD) have been on a linear decline, the burden remains high. Addressing the social determinants of health in the care of CVD patients is emerging as a strategy for improving outcomes. Educational attainment level (EAL), a proxy of socioeconomic status, has been associated with both cardiovascular risk and patient’s ability to self-manage the complex cardiovascular treatment. Objective: To assess the impact of EAL on major adverse cardiovascular events (MACE) and all-cause death in patients with ischemic heart disease (IHD). Methods: Endocrine Vascular disease Approach (EVA) is a prospective observational study recruiting hospitalized patients with IHD undergoing coronary angiography and/or percutaneous coronary interventions. Socio-demographics and clinical data, including the level of multimorbidity defined by a Charlson Comorbidity Index≥ 4, were collected. A low-EAL, assessed through a self-reported questionnaire, was defined if at least elementary/middle school education was completed. The primary outcome was the occurrence of MACE (i.e. cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) and a secondary composite endpoint (i.e. all-cause death, non-fatal myocardial infarction, non-fatal stroke) was also analyzed. Results: Among 460 individuals (mean age 67±11, 30% women) with IHD, 252 (55%) had a low-EAL. Individuals with low-EAL were younger and more likely to have heart failure, vascular encephalopathy, and high multimorbidity. A low-EAL was associated with a higher risk of MACE compared with higher EAL (Log-rank=12.29, p 〈 0.001) with similar results for the secondary outcome (Log-rank=9.45, p=0.002). In the adjusted multivariate regression analysis, low EAL was independently associated with MACE [Hazard Ration (HR): 2.31, 95% Confidence Interval (CI): 1.23-4.34, p=0.010] and secondary outcome [HR: 1.73, 95%CI 1.02-2.92, p=0.042] compared to high-EAL. Conclusion: Individuals with IHD and low-EAL had a higher risk of MACE and all-cause death. Interventions that specifically address health literacy and cognition should be tested among these high-risk patients to improve outcomes.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 1466401-X
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  • 4
    In: Thrombosis and Haemostasis, Georg Thieme Verlag KG
    Abstract: Background The Mobile Health (mHealth) Technology for Improved Screening and Optimized Integrated Care in atrial fibrillation (AF) (mAFA-II) cluster randomized trial assessed the efficacy of an integrated care approach in improving the prognosis of AF patients. In this study, we provide a reanalysis of the trial outcomes using the win ratio (WR) approach. Methods The mAFA-II trial allocated patients to receive a mHealth-technology implemented Atrial Fibrillation Better Care (ABC) pathway (mAFA intervention) or usual care. The primary outcome was the composite of all-cause death, ischemic stroke or systemic thromboembolism, and rehospitalization. The efficacy of the mAFA intervention was analyzed according to the WR method using the unmatched pairs approach, with the components of the primary outcome analyzed hierarchically as follows: (1) all-cause death; (2) ischemic stroke or thromboembolism; (3) rehospitalization. Results were reported as WR and 95% confidence intervals (CIs). In addition, we calculated win odds (WO) and 95% CI. Results A total of 3,324 patients were enrolled in the mAFA-II trial and included in this analysis (1,646 allocated to mAFA intervention and 1,678 to usual care). Among 2,761,988 unmatched pairs comparisons, the number of wins was higher in the mAFA intervention group, with a WR: 2.78 (95% CI: 1.85–4.17). WO confirmed the effect of mAFA intervention, although with a lower magnitude (WO: 1.06; 95% Cl: 1.04–1.08). Conclusions In this posthoc WR analysis of the mAFA-II trial, a mHealth-technology-implemented integrated care approach was effective in reducing the risk of the primary composite outcome of all-cause death, ischemic stroke or thromboembolism, and rehospitalization, even when prioritizing fatal events.
    Type of Medium: Online Resource
    ISSN: 0340-6245 , 2567-689X
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
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  • 5
    In: European Heart Journal Open, Oxford University Press (OUP), Vol. 3, No. 2 ( 2023-03-02)
    Abstract: Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide. The presence of AF is associated with increased risk of systemic thromboembolism, but with the uptake of oral anticoagulant (OAC) and implementation of a holistic and integrated care management, this risk is substantially reduced. The diagnosis of AF requires a 30-s-long electrocardiographic (ECG) trace, irrespective of the presence of symptoms, which may represent the main indication for an ECG tracing. However, almost half patients are asymptomatic at the time of incidental AF diagnosis, with similar risk of stroke of those with clinical AF. This has led to a crucial role of screening for AF, to increase the diagnosis of population at risk of clinical events. The aim of this review is to give a comprehensive overview about the epidemiology of asymptomatic AF, the different screening technologies, the yield of diagnosis in asymptomatic population, and the benefit derived from screening in terms of reduction of clinical adverse events, such as stroke, cardiovascular, and all-cause death. We aim to underline the importance of implementing AF screening programmes and reporting about the debate between scientific societies’ clinical guidelines recommendations and the concerns expressed by the regulatory authorities, which still do not recommend population-wide screening. This review summarizes data on the ongoing trials specifically designed to investigate the benefit of screening in terms of risk of adverse events which will further elucidate the importance of screening in reducing risk of outcomes and influence and inform clinical practice in the next future.
    Type of Medium: Online Resource
    ISSN: 2752-4191
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 3112907-9
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  • 6
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health)
    Abstract: Clinical risk factors are common among patients with atrial fibrillation (AF), but there are still limited data on their association with oral anticoagulant (OAC) treatment patterns and major outcomes. We aim to analyze the association between clinical risk phenotypes on AF treatment patterns and the risk of major outcomes. Methods and Results The GLORIA‐AF (Global Registry on Long‐Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation) phase 2 and 3 registries enrolled patients with a recent diagnosis of AF between 2011 and 2016. We defined 4 features of clinical risk among patients with CHA 2 DS 2 ‐VASc ≥2: elderly individuals (aged ≥80 years), chronic kidney disease (estimated glomerular filtration rate 〈 45 mL/min), history of stroke, and history of bleeding. We analyzed the odds of receiving OAC and the risk of OAC discontinuation and adverse events at follow‐up according to specific combinations and cumulative burden of these features. Primary outcome was the composite of all‐cause death, thromboembolism, and major bleeding. Among 28 891 (mean±SD age, 70.1±10.5 years; 45.5% women) patients included, 10 797 (37.3%) had at least 1 clinical risk feature. OAC use was lower among patients in the elderly group (odds ratio [OR], 0.85 [95% CI, 0.75–0.96] ), those with history of both stroke and bleeding (OR, 0.45 [95% CI, 0.35–0.56]), and those with multiple features (OR, 0.71 [95% CI, 0.62–0.82] ). Increasing burden of clinical risk features was associated with OAC discontinuation, with highest magnitude in those with ≥3 features (hazard ratio [HR], 1.68 [95% CI, 1.31–2.15] ). Groups with increasingly complex clinical risk phenotypes were associated with the occurrence of the primary composite outcome, with the highest figures observed for groups with a history of both stroke and bleeding (adjusted HR, 2.36 [95% CI, 1.83–3.04]) and multiple features (adjusted HR, 2.86 [95% CI, 2.52–3.25] ). Conclusions In patients with AF, clinical risk phenotypes are multifaceted and heterogenous, and they are associated with differences in stroke prevention and worse prognosis.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2653953-6
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  • 7
    In: Journal of Clinical Medicine, MDPI AG, Vol. 10, No. 11 ( 2021-06-04), p. 2490-
    Abstract: Background: In patients with COVID-19, cardiovascular complications are common and associated with poor prognosis. Among these, an association between atrial fibrillation (AF) and COVID-19 has been described; however, the extent of this relationship is unclear. The aim of this study is to investigate the epidemiology of AF in COVID-19 patients and its impact on all-cause mortality. Methods: A systematic review and meta-analysis were performed and reported according to PRISMA guidelines, and a protocol for this study was registered on PROSPERO (CRD42021227950). PubMed and EMBASE were systematically searched for relevant studies. A random-effects model was used to estimate pooled odds ratios (OR) and 95% confidence intervals (CI). Results: Overall, 31 studies were included in the analysis, with a total number of 187,716 COVID-19 patients. The prevalence of AF was found to be as high as 8% of patients with COVID-19 (95% CI: 6.3–10.2%, 95% prediction intervals (PI): 2.0–27.1%), with a high degree of heterogeneity between studies; a multiple meta-regression model including geographical location, age, hypertension, and diabetes showed that these factors accounted for more than a third of the heterogeneity. AF COVID-19 patients were less likely to be female but more likely older, hypertensive, and with a critical status than those without AF. Patients with AF showed a significant increase in the risk of all-cause mortality (OR: 3.97, 95% CI: 2.76–5.71), with a high degree of heterogeneity. A sensitivity analysis focusing on new-onset AF showed the consistency of these results. Conclusions: Among COVID-19 patients, AF is found in 8% of patients. AF COVID-19 patients are older, more hypertensive, and more likely to have a critical status. In COVID-19 patients, AF is associated with a 4-fold higher risk of death. Further studies are needed to define the best treatment strategies to improve the prognosis of AF COVID-19 patients.
    Type of Medium: Online Resource
    ISSN: 2077-0383
    Language: English
    Publisher: MDPI AG
    Publication Date: 2021
    detail.hit.zdb_id: 2662592-1
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  • 8
    Online Resource
    Online Resource
    Future Medicine Ltd ; 2021
    In:  Future Cardiology Vol. 17, No. 2 ( 2021-03), p. 215-226
    In: Future Cardiology, Future Medicine Ltd, Vol. 17, No. 2 ( 2021-03), p. 215-226
    Abstract: During the last decade, non-vitamin K antagonist oral anticoagulants (NOACs) revolutionized the thromboprophylaxis management of several medical conditions, including atrial fibrillation and venous thromboembolism. Dabigatran etexilate was the first NOAC widely available worldwide, and it is currently the only one that directly inhibits thrombin. More recently, the availability of idarucizumab, a specific reversal agent, has increased the safety of dabigatran use in clinical practice, especially for those patients with severe and life-threatening bleeding. This review aims to summarize current evidence on dabigatran, starting from its pharmacological characteristics, and providing an updated overview of pivotal randomized controlled trials and real-world data on its efficacy and safety.
    Type of Medium: Online Resource
    ISSN: 1479-6678 , 1744-8298
    Language: English
    Publisher: Future Medicine Ltd
    Publication Date: 2021
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  • 9
    In: Journal of Personalized Medicine, MDPI AG, Vol. 12, No. 4 ( 2022-03-30), p. 547-
    Abstract: Background: New-onset atrial fibrillation (NOAF) is a common complication in patients with sepsis, although its prevalence and impact on outcomes are still unclear. We aim to provide a systematic review and meta-analysis on the prevalence of NOAF in patients with sepsis, and its impact on in-hospital mortality and intensive care unit (ICU) mortality. Methods: PubMed and EMBASE were systematically searched on 26 December 2021. Studies reporting on the prevalence of NOAF and/or its impact on in-hospital mortality or ICU mortality in patients with sepsis or septic shock were included. The pooled prevalence and 95% confidence intervals (CI) were calculated, as well as the risk ratios (RR), 95%CI and 95% prediction intervals (PI) for outcomes. Subgroup analyses and meta-regressions were performed to account for heterogeneity. Results: Among 4988 records retrieved from the literature search, 22 articles were included. Across 207,847 patients with sepsis, NOAF was found in 13.5% (95%CI: 8.9–20.1%), with high heterogeneity between studies; significant subgroup differences were observed, according to the geographical location, study design and sample size of the included studies. A multivariable meta-regression model showed that sample size and geographical location account for most of the heterogeneity. NOAF patients showed an increased risk of both in-hospital mortality (RR: 1.69, 95%CI: 1.47–1.96, 95%PI: 1.15–2.50) and ICU mortality (RR: 2.12, 95%CI: 1.86–2.43, 95%PI: 1.71–2.63), with moderate to no heterogeneity between the included studies. Conclusions: NOAF is a common complication during sepsis, being present in one out of seven individuals. Patients with NOAF are at a higher risk of adverse events during sepsis, and may need specific therapeutical interventions.
    Type of Medium: Online Resource
    ISSN: 2075-4426
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2662248-8
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  • 10
    In: Internal and Emergency Medicine, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2023-01), p. 127-135
    Type of Medium: Online Resource
    ISSN: 1828-0447 , 1970-9366
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2378342-4
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