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Associations of anaemia with bleeding and thrombotic complications in patients with atrial fibrillation treated with warfarin: a registry-based nested case-control study

Por: Helin · T. A. · Raatikainen · P. · Lehto · M. · Haukka · J. · Lassila · R.
Objectives

We studied association of laboratory testing beyond the international normalised ratio (INR) with bleeding and stroke/transient ischaemic attack (TIA) outcomes in patients with atrial fibrillation treated with warfarin.

Design

This was a retrospective nested case–control study from the Finnish Warfarin in Atrial Fibrillation (FinWAF) registry (n=54 568), reporting the management and outcome in warfarin-anticoagulated patients. Associations of blood count test frequency and results were assessed together with risk of bleeding or stroke/TIA during 5-year follow-up.

Setting

National FinWAF registry, with data from all six hospital districts. Follow-up period for complications was 1 January 2007–31 December 2011.

Participants

A total of 54 568 warfarin-anticoagulated patients.

Results

The number of patients with bleeding was 4681 (9%) and stroke/TIA episodes, 4692 (9%). In patients with bleeds, lower haemoglobin (within 3 months) preceded the event compared with the controls (median 126 vs 135 g/L; IQR 111–141 g/L vs 123–147 g/L, p

Conclusions

The deeper the anaemia, the higher the risk of bleeding and stroke/TIA. However, INR remained mainly at its target and only occasionally deviated, failing to detect the complication risk. Repeated low haemoglobin results, compatible with persistent anaemia, refer to suboptimal management and increased the complication risk in anticoagulated patients.

Internal structure validity and internal consistency reliability of the Minnesota Living with Heart Failure Questionnaire: a systematic review protocol

Por: Gowani · A. A. A. · Low · G. · Norris · C. · Hoben · M.
Introduction

The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is one of the most used tools to measure health-related quality of life in heart failure. Despite extensive use in research, evidence on the MLHFQ’s internal structure validity remains heterogeneous and inconclusive. There are no known reviews that systematically summarise the evidence related to the MLHFQ’s factor structure (internal structure validity). This gap highlights a need to critically appraise, summarise and compare the available evidence on the internal structure and internal consistency reliability (ICR) of the MLHFQ.

Methods and analysis

The review will adhere to the reporting guidelines of the Cochrane Handbook for Systematic Reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. We will systematically search eleven electronic databases/search engines (Medline, EMBASE, Cumulative Index for Nursing and Allied Health Literature, PsycINFO, Global Health, Health and Psychosocial Instruments, Scopus, Journals, Web of Science, Google Scholar, and Dissertation and Theses Global) for quantitative studies assessing the MLHFQ’s factor structure and ICR. Two reviewers will then independently screen studies for eligibility and assess the quality of included studies using the COnsensus-based Standards for the selection of health status Measurement Instruments checklist. Throughout the review, discrepancies will be resolved through consensus or by the involvement of the third reviewer. We will analyse and present results using descriptive statistics (frequencies, proportions and ranges) and narrative synthesis. We will include all the relevant studies published within the timeframe covered by the database. We carried out the preliminary search in November 2022 except for Dissertation and Theses Global which was searched in September 2023; however, we will update the entire search right before the review completion in January 2024.

Ethics and dissemination

Ethical approval is not required as no primary data is being collected from individuals. We intend to share the findings of the review at international conferences and publish manuscripts in peer-reviewed journals.

PROSPERO registration number

CRD42023346919.

Very brief intervention for physical activity behaviour change in cardiac rehabilitation: protocol for the 'Measure It! effectiveness-implementation hybrid trial

Por: Freene · N. · McPhail · S. M. · Tyack · Z. · Kunstler · B. · Niyonsenga · T. · Keegan · R. · Gallagher · R. · Abhayaratna · W. · Verdicchio · C. · Davey · R.
Introduction

Physical inactivity is a risk factor for repeat cardiac events and all-cause mortality in coronary heart disease (CHD). Cardiac rehabilitation, a secondary prevention programme, aims to increase physical activity levels in this population from a reported low baseline. This trial will investigate the effectiveness and implementation of a very brief physical activity intervention, comparing different frequencies of physical activity measurement by cardiac rehabilitation clinicians. The Measure It! intervention (

Methods and analysis

This type 1 hybrid effectiveness–implementation study will use a two-arm multicentre assessor-blind randomised trial design. Insufficiently active (

Ethics and dissemination

The study has ethical approval (University of Canberra (ID 11836), Calvary Bruce Public Hospital (ID 14-2022) and the Greater Western Area (ID 2022/ETH01381) Human Research Ethics Committees). Results will be disseminated in multiple formats for consumer, public and clinical audiences.

Trial registration number

ACTRN12622001187730p.

Gender disparities, causes and predictors of immediate and short-term cardiovascular readmissions following COVID-19-related hospitalisations in the USA

Por: Vardar · U. · Shaka · H. · Kumi · D. · Gajjar · R. · Bess · O. · Kanemo · P. · Shaka · A. · Baskaran · N.
Objectives

In this study, we aimed to identify the causes, predictors and gender disparities of 30-day and 90-day cardiovascular readmissions after COVID-19-related hospitalisations using National Readmission Database (NRD) 2020.

Setting

We used the NRD from 2020 to identify hospitalised adults with a principal diagnosis of COVID-19 infection.

Participants

We included subjects who were readmitted within 30 days and 90 days after index admission. We excluded subjects with elective and traumatic admissions. We used a multivariate Cox regression model to identify independent predictors of readmission.

Primary and secondary outcomes measures

Our outcomes were inpatient mortality, 30-day and 90-day cardiovascular readmission rates following COVID-19 infection.

Results

During the study period, there were 1 024 492 index hospitalisations with a primary diagnosis of COVID-19 infection in the 2020 NRD database, 644 903 (62.9%) were included for 30-day readmission analysis, and 418 122 (40.8%) were included for 90-day readmission analysis. Of patients involved in the 30-day analysis, 7140 (1.1%) patients had a readmission within 30 days; of patients involved in the 90-day analysis, 8379 (2.0%) had a readmission within 90 days due to primarily cardiovascular causes. Cox regression analysis revealed that the female sex (aHR 0.89; 95% CI 0.82 to 0.95; p=0.001) was associated with a lower hazard of 30-day cardiovascular readmissions; however, congestive heart failure (aHR 2.45; 95% CI 2.2 to 2.72; p

Conclusion

Our study demonstrates that male gender, heart failure, arrhythmias and valvular disease carry higher hazards of 30-day and 90-day cardiovascular readmissions. Identifying risk factors and common causes of readmission may assist with lowering the burden of cardiovascular disease in patients with COVID-19 infection.

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burde

Por: Zhang · Z. · Sheng · Z. · Che · W. · An · S. · Sun · D. · Zhai · Z. · Zhao · X. · Yang · Y. · Meng · Z. · Ye · Z. · Xie · E. · Li · P. · Yu · C. · Gao · Y. · Xiao · Z. · Wu · Y. · Dong · F. · Ren · J. · Zheng · J.
Introduction

ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.

Methods and analysis

The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.

Ethics and dissemination

The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.

Trial registration number

NCT05554588.

The Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE): protocol for a randomised, double-blind, placebo-controlled trial

Por: Boczar · K. E. · Shin · S. · deKemp · R. A. · Dowlatshahi · D. · Tavoosi · A. · Wiefels · C. · Liu · P. · Lochnan · H. · MacPherson · P. A. · Chong · A. Y. · Torres · C. · Leung · E. · Tawakol · A. · Ahmadi · A. · Garrard · L. · Lefebvre · C. · Kelly · C. · MacPhee · P. · Tilokee · E. · Ragg
Background

Inflammation is a key mediator in the development and progression of the atherosclerotic disease process as well as its resultant complications, like myocardial infarction (MI), stroke and cardiovascular (CV) death, and is emerging as a novel treatment target. Trials involving anti-inflammatory medications have demonstrated outcome benefit in patients with known CV disease. In this regard, colchicine appears to hold great promise. However, there are potential drawbacks to colchicine use, as some studies have identified an increased risk of infection, and a non-significant trend for increased all-cause mortality. Thus, a more thorough understanding of the underlying mechanism of action of colchicine is needed to enable a better patient selection for this novel CV therapy.

Objective

The primary objective of the Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE) trial is to assess the effect of colchicine on vascular inflammation in the carotid arteries and ascending aorta measured with 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT in patients with type 2 diabetes mellitus (T2DM) or pre-diabetes who have experienced a recent vascular event (acute coronary syndrome (ACS)/MI, transient ischaemic attack (TIA) or stroke). Secondary objectives include determining colchicine’s effect on inflammatory biomarkers (high-sensitivity C reactive protein (hs-CRP) and interleukin-6 (IL-6)). Additionally, we will assess if baseline inflammation imaging or biomarkers are associated with a treatment response to colchicine determined by imaging. Exploratory objectives will look at: (1) the difference in the inflammatory response to colchicine in patients with coronary events compared with patients with cerebral events; (2) the difference in the inflammatory response to colchicine in different vascular beds; (3) the relationship of FDG-PET imaging markers with serum biomarkers and (4) assessment of quality-of-life changes.

Methods and design

CADENCE is a multicentre, prospective, randomised, double-blinded, placebo-controlled study to determine the effect of colchicine on arterial inflammation as assessed with imaging and circulatory biomarkers, specifically carotid arteries and aortic FDG uptake as well as hs-CRP and IL-6 among others. Patients with T2DM or pre-diabetes who have recently experienced a CV event (within 30–120 days after an ACS (ie, ST-elevation MI (STEMI) or non-STEMI)) or TIA/stroke with documented large vessel atherosclerotic disease will be randomised to treatment with either colchicine 0.6 mg oral daily or placebo. Participants will undergo baseline clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan of the ascending aorta and left and right carotid arteries. Patients will undergo treatment for 6 months and have repeat clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan at the conclusion of the study. The primary outcome will be the change in the maximum target to background ratio (TBRmax) in the ascending aorta (or carotid arteries) from baseline to follow-up on FDG PET/CT imaging.

Discussion

Colchicine is an exciting potential new therapy for CV risk reduction. However, its use is associated with side effects and greater understanding of its underlying mechanism of action is needed. Importantly, the current study will determine whether its anti-inflammatory action is an indirect systemic effect, or a more local plaque action that decreases inflammation. The results will also help identify patients who will benefit most from such therapy.

Trial registration number

NCT04181996.

Effectiveness of lipid-lowering therapy on mortality and major adverse cardiovascular event outcomes in patients undergoing percutaneous coronary intervention: a network meta-analysis of randomised controlled trials

Por: Deng · C.-J. · Yan · J. · Zheng · Y.-Y. · Wu · T.-T. · Pan · Y. · Hou · X.-G. · Wang · S.-F. · Sirajidin · S. · Aimaitijiang · M. · Xie · X.
Background

Emergency percutaneous coronary intervention (PCI) can quickly restore myocardial perfusion after acute coronary syndrome. Whether and which lipid-lowering regimens are effective in reducing major adverse cardiovascular events (MACEs) and mortality risk after PCI remain unclear.

Objective

This study assessed the benefits of different lipid-lowering regimens on the risk of MACEs and mortality in the post-PCI population by network meta-analysis.

Methods

Public databases, including PubMed, Embase and the Cochrane Library, were searched from inception to August 2022. Randomised controlled trials (RCTs) on lipid-lowering regimens in post-PCI populations were included and analysed. The outcomes were the incidence of all-cause mortality and MACEs, whether reported as dichotomous variables or as HRs.

Results

Thirty-nine RCTs were included. For MACEs, alirocumab plus rosuvastatin (OR: 0.18; 95% CI: 0.07 to 0.44), evolocumab plus ezetimibe and statins (OR: 0.19; 95% CI: 0.06 to 0.59), eicosapentaenoic acid (EPA) plus pitavastatin (HR: 0.67; 95% CI: 0.49 to 0.96) and icosapent ethyl plus statins (HR: 0.73; 95% CI: 0.62 to 0.86) had significant advantages and relatively high rankings. For mortality, rosuvastatin (OR: 0.30; 95% CI: 0.11 to 0.84), ezetimibe plus statins (OR: 0.55; 95% CI: 0.43 to 0.89) and icosapent ethyl plus statins (OR: 0.66; 95% CI: 0.45 to 0.96) had significant advantages compared with the control.

Conclusion

EPA, especially icosapent ethyl, plus statins had a beneficial effect on reducing the risk of MACEs and mortality in post-PCI patients. Proprotein convertase subtilisin/kexin type-9 inhibitors plus statins were able to reduce the risk of MACEs, but the risk of mortality remained unclear.

PROSPERO registration number

CRD42018099600.

The risk factors for and the frequency and outcomes of subsyndromal delirium among patients who have undergone cardiac surgery: a protocol for systematic review and meta-analysis

Por: Gao · Y. · Bai · X. · Zhang · H. · Yang · L. · Wu · T. · Gan · X.
Introduction

Several key symptoms must be present for the accurate diagnosis of patients with postoperative cardiac delirium. Some patients present with symptoms of delirium but do not meet the diagnostic criteria for delirium; such individuals are considered to have having subsyndromal delirium (SSD). SSD is associated with misdiagnosis and poor outcomes. However, to date, no systematic review (SR) has examined the frequency of, risk factors for, and outcomes of SSD among adults who have undergone cardiac surgery.

Methods and analysis

The aim of this SR is to identify those studies that have explored SSD after cardiac surgery. MeSH and free entry terms associated with "subsyndromal delirium" and "subclinical delirium" will be used to search for relevant studies. The PubMed, Web of Science, OVID, Cochrane Library, CINAHL, EMBASE, PsycINFO, China National Knowledge Infrastructure, Wanfang data, VIP database and SinoMed will be searched from inception to the date of retrieval without any restrictions. The primary outcomes will be the frequency of SSD, the risk factors for SSD, and the outcomes of SSD. Analyses will be performed using STATA V.16.0, and descriptive analyses will be performed if the data are not suitable for meta-analysis (ie, data with significant heterogeneity or from different comparisons).

Ethics and dissemination

The SR will examine the frequency of, risk factors for and outcomes of SSD in adults who have undergone cardiac surgery. The results will provide guidance for the identification of knowledge gaps in this field, and areas for further research will be highlighted. The review protocol will be submitted for publication in peer-reviewed journals for dissemination of the findings. Individual patient data will not be included in this protocol, so ethical approval will not be needed.

PROSPERO registration number

CRD42022379211.

Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

Por: Molina Hidalgo · C. · Collins · A. M. · Crisafio · M. E. · Grove · G. · Kamarck · T. W. · Kang · C. · Leckie · R. L. · MacDonald · M. · Manuck · S. B. · Marsland · A. L. · Muldoon · M. F. · Rasero · J. · Scudder · M. R. · Velazquez-Diaz · D. · Verstynen · T. · Wan · L. · Gianaros · P. J
Introduction

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number

NCT03841669.

Sinus node dysfunction and stroke risk: a systematic review and meta-analysis

Por: Dong · H. · Chen · H. · Hidru · T. H. · Xia · Y. · Yang · X.
Objectives

The role of cardiac arrhythmia in ischaemic stroke is widely studied, but the size of the stroke risk in patients with sinus node dysfunction (SND) with and without atrial fibrillation (AF) is unclear. This systematic review and meta-analysis aimed to compare the risk of stroke and its associated factors in patients with SND with and without AF.

Design

A systematic review and meta-analysis was conducted based on the Grading of Recommendations, Assessment, Development and Evaluation approach.

Data sources

PubMed, EMBASE and Cochrane Database were searched until December 2022.

Eligibility criteria for selecting studies

Studies that investigate stroke in patients with SND diagnosed with or without AF/atrial flutter.

Data extraction and synthesis

Two independent authors screened studies for inclusion and extracted data. Literature quality assessment was performed using the Newcastle-Ottawa Scale and the Cochrane Collaboration Tool. The overall risk of stroke was estimated using the random-effects model. The generic inverse variance method was used to calculate the pooled estimates of stroke-associated factors. We performed a sensitivity analysis using a fixed-effects model.

Results

Of the 929 records retrieved, 6 papers (106 163 patients) met the inclusion criteria. The average yearly stroke incidence in patients with SND was 1.542% (95% CI: 1.334% to 1.749%). The stroke incidence was similar between the isolated SND (1.587%; 95% CI: 1.510% to 1.664%) and non-isolated (SND+AF) (1.660%; 95% CI: 0.705% to 2.615%) groups. AF (HR, 95% CI: 1.53 (1.01 to 2.33)), stroke/transient ischaemia attack/other thrombotic events (HR, 95% CI: 2.54 (1.14 to 5.69)), hypertension (HR, 95% CI: 1.51 (1.11 to 2.07)) and heart failure (HR, 95% CI: 1.41 (1.01 to 1.97)) were associated with stroke in the SND population.

Conclusion

Our findings suggest that patients with SND carry a similar risk of stroke to those with combined SND and AF. Future studies are needed to investigate whether interventions targeting stroke prevention, such as anticoagulation therapy, can help to prevent stroke in patients with SND.

PROSPERO registration number

CRD42023408436.

Prognostic significance and clinical determinants of residual dyspnoea at discharge in acute heart failure: a single-centre, prospective observational study

Por: Garus · M. · Jura · M. · Guzik · M. · Zymlinski · R. · Iwanek · G. · Ponikowski · P. · Biegus · J.
Objective

This study aimed to assess the prognostic significance of residual (discharge) dyspnoea in acute heart failure (AHF) patients.

Design

Single-centre, prospective observational study.

Setting

Patients hospitalised for decompensated AHF in a single cardiology centre, in Poland.

Participants

All patients (n=202) who survived the hospitalisation with the primary diagnosis of AHF and were discharged from the hospital.

Primary and secondary outcome measures

1-year all-cause mortality; and the composite endpoint of 1-year all-cause mortality and rehospitalisation for the HF (whichever occurred first).

Results

On admission, 159 (78.7%) AHF patients presented dyspnoea at rest, while residual resting dyspnoea at discharge was present in 16 patients (7.9%). There were 48 (24%) patients with moderate/severe exertional dyspnoea at discharge. In the multivariable model, the resting dyspnoea at discharge was related to a higher risk of both 1-year mortality and composite outcome, with HR (95% CI) 8.0 (3.7 to 17.3) and 5.1 (2.6 to 10.2), respectively, both p

Conclusions

Among AHF patients the residual dyspnoea at discharge was unexpectedly common and was associated with an unfavourable outcome during 1-year follow-up.

PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT): a prospective longitudinal study protocol investigating the prevalence, severity and determinants of atherosclerotic cardiovascular disease in the young adult Pakistani popu

Por: Hanif · B. · Sheikh · S. · Peerwani · G. · Cainzos-Achirica · M. · Javed · W. · Baqar · J. B. · Samad · Z. · Bashir · F. · S Virani · S. · Nasir · K. · Aijaz · S.
Introduction

Atherosclerotic cardiovascular disease (ASCVD) is a major cause of morbidity, mortality and health expenditures worldwide. Despite having higher ASCVD in the Pakistani population, data on subclinical coronary atherosclerosis in young Pakistanis remain scarce. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims to assess the prevalence, severity and determinants of subclinical coronary atherosclerosis among Pakistani men (35–60 years) and women (35–65 years) free of clinically symptomatic ASCVD and will assess 5-year rates of ASCVD events.

Methods and analysis

PAK-SEHAT is an ongoing prospective cohort study with 2000 participants from all provinces of Pakistan who will be interviewed at the baseline along with phlebotomy, measurement of carotid intima-media thickness (CIMT) and coronary CT angiography (CCTA). Phlebotomy will be repeated at 2.5 years, whereas CIMT and CCTA will be repeated at 5 years. We will report the frequency of maximal coronary stenosis ≥50% and ≥70%, number of coronary vessels with plaque and the number of coronary segments affected per participant on CCTA. We will use Cox proportional hazards regression models to evaluate the association between baseline characteristics and incident ASCVD events during follow-up. These associations will be presented as HRs with 95% CIs.

Ethics and dissemination

The study protocol was approved by the Tabba Heart Institute Institutional Review Board (THI/IRB/FQ/22-09-2021/016). All study procedures are consistent with the principles of the Declaration of Helsinki. Findings of the study will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT05156736.

Association of body fat distribution with all-cause and cardiovascular mortality in US adults: a secondary analysis using NHANES

Por: Li · F. · Wang · Z. · Li · S. · Liu · W. · Li · Y. · Jiang · C. · Tian · Y. · Cui · W. · Zhang · X. · Zhang · J. · Xu · Y.
Objective

To investigate the association of fat and lean mass in specific regions with all-cause and cardiovascular-related mortality.

Design

Population based cohort study.

Setting

US National Health and Nutrition Examination Survey (2003–2006 and 2011–2018).

Participants

22 652 US adults aged 20 years or older.

Exposures

Fat and lean mass in specific regions obtained from the whole-body dual-energy X-ray absorptiometry.

Main outcome measures

All-cause and cardiovascular-related mortality.

Results

During a median of 83 months of follow-up, 1432 deaths were identified. Associations between body composition metrics and mortality risks were evident above specific thresholds. For all-cause mortality, Android fat mass showed elevated HRs above 2.46 kg (HR: 1.17, 95% CI 1.02 to 1.34), while Android lean mass (ALM) had similar trends above 2.75 kg (HR: 1.17, 95% CI 1.03 to 1.33), and Android total mass above 5.75 kg (HR: 1.08, 95% CI 1.01 to 1.16). Conversely, lower HRs were observed below certain thresholds: Gynoid fat mass (GFM) below 3.71 kg (HR: 0.72, 95% CI 0.56 to 0.93), Gynoid lean mass below 6.44 kg (HR: 0.77, 95% CI 0.64 to 0.92), and Gynoid total mass below 11.78 kg (HR: 0.76, 95% CI 0.70 to 0.84). Notably, below 0.722 kg, the HR of visceral adipose tissue mass (VATM) was 1.25 (95% CI 1.04 to 1.48) for all-cause mortality, and above 3.18 kg, the HR of total abdominal fat mass was 2.41 (95% CI 1.15 to 5.05). Cardiovascular-related mortality exhibited associations as well, particularly for Android fat mass (AFM) above 1.78 kg (HR: 1.22, 95% CI 1.01 to 1.47) and below 7.16 kg (HR: 0.50, 95% CI 0.36 to 0.69). HRs varied for Gynoid total mass below and above 10.98 kg (HRs: 0.70, 95% CI 0.54 to 0.93, and 1.12, 95% CI 1.02 to 1.23). Android per cent fat, subcutaneous fat mass (SFM), AFM/GFM, and VATM/SFM were not statistically associated with all-cause mortality. Android per cent fat, Gynoid per cent fat, AFM/GFM, and VATM/SFM were not statistically associated with cardiovascular-related mortality. Conicity index showed that the ALM/GLM had the highest performance for all-cause and cardiovascular-related mortality with AUCs of 0.785, and 0.746, respectively.

Conclusions

The relationship between fat or lean mass and all-cause mortality varies by region. Fat mass was positively correlated with cardiovascular mortality, regardless of the region in which they located. ALM/GLM might be a better predictor of all-cause and cardiovascular-related mortality than other body components or body mass index.

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial

Por: Hu · X. · Xu · H. · Wang · C. · Wang · Y. · Wang · Y. · Zhou · D. · Zhu · Q. · Xu · K. · Yang · J. · Zhang · H. · Jiang · N. · Zhang · J. · Fang · Z. · Fu · G. · Guo · Y. · Li · Y. · Wang · M. · Feng · D. · Niu · G. · Zhang · E. · Chen · Y. · Ye · Y. · Wu · Y.
Introduction

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

Methods and analysis

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

Ethics and dissemination

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

Trial registration number

NCT05375474.

Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial)

Por: Su · X. · Ma · H. · Lin · S. · Dou · K. · Zheng · Z.
Introduction

The implementation of a heart team still faces many challenges which may be facilitated with advanced communication technology. There is a knowledge gap to support the use of an electronic real-time heart team decision-making approach based on communication technology in the real clinical practice and evaluate its safety and feasibility in patients with complex coronary artery disease (CAD).

Methods and analysis

The EHEART (Electronic HEArt team with Real-Time decision-making) trial is a prospective, multicentre, two-arm, randomised controlled trial that will randomise 490 patients with complex CAD to either an electronic real-time heart team group or conventional heart team group. For patients allocated to the real-time electronic group, heart team meetings will be initiated during the coronary angiography and guided by a supporting system based on communication technology to help with information synchronisation, real-time communication between specialists, meeting process recording and assistance and joint decision-making with patients’ families. The primary and safety endpoint is a composite of all-cause death, myocardial infarction, stroke, revascularisation or re-angina hospital admission at 1 year. The primary secondary outcome is the time interval from the coronary angiography to the final treatment, which is the major indicator of feasibility. We will also compare the practical feasibility from the specialist’s and patient’s perspectives (for example, specialist’s workload and patient’s decision results) between the two groups.

Ethics and dissemination

The study was approved by the Institutional Review Board (IRB) of Fuwai Hospital (no. 2022-1749). Informed consent will be obtained from all participants. The results of this trial will be disseminated through manuscript publication and national/international conferences, and reported in the trial registry entry.

Trial registration number

ClinicalTrials.gov Registry (NCT05514210).

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the e

Por: Engdahl · J. · Straat · K. · Isaksson · E. · Rooth · E. · Svennberg · E. · Norrving · B. · Euler · M. v. · Hellqvist · K. · Gu · W. · Ström · J. O. · Själander · S. · Eriksson · M. · Asberg · S. · Wester · P.
Introduction

Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis

AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination

Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number

NCT05134454.

Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey

Por: Yuan · Y. · Jin · A. · Zhao · M.-H. · Wang · H. · Feng · X. · Qiao · Q. · Zhang · R. · Gao · R. · Wu · Y.
Objectives

Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions.

Design

A cross-sectional study conducted from September 2017 to March 2018.

Setting

48 residential elderly care facilities in northern China.

Participants

Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia.

Exposure

Potassium intake is measured by 24-hour urinary potassium.

Outcomes

Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect.

Results

Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted β=0.0040/L; p=0.017) and high (adjusted β=0.0078/L; p=0.003) but not low (adjusted β=0.0018/L; p=0.311) risk of hyperkalaemia.

Conclusions

A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns.

Trial registration number

NCT03290716; Post-results.

Hidden sodium in effervescent-tablet dietary supplements and over-the-counter drugs: a comparative cross-sectional study

Por: Kunz · M. · Götzinger · F. · Jacobs · C. M. · Lauder · L. · Ukena · C. · Meyer · M. R. · Laufs · U. · Schulz · M. · Böhm · M. · Mahfoud · F.
Objective

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Design

Comparative cross-sectional study.

Setting and methods

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

Results

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Conclusion

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

Cohort profile: a large EHR-based cohort with linked pharmacy refill and neighbourhood social determinants of health data to assess heart failure medication adherence

Por: Adhikari · S. · Mukhyopadhyay · A. · Kolzoff · S. · Li · X. · Nadel · T. · Fitchett · C. · Chunara · R. · Dodson · J. · Kronish · I. · Blecker · S. B.
Purpose

Clinic-based or community-based interventions can improve adherence to guideline-directed medication therapies (GDMTs) among patients with heart failure (HF). However, opportunities for such interventions are frequently missed, as providers may be unable to recognise risk patterns for medication non-adherence. Machine learning algorithms can help in identifying patients with high likelihood of non-adherence. While a number of multilevel factors influence adherence, prior models predicting non-adherence have been limited by data availability. We have established an electronic health record (EHR)-based cohort with comprehensive data elements from multiple sources to improve on existing models. We linked EHR data with pharmacy refill data for real-time incorporation of prescription fills and with social determinants data to incorporate neighbourhood factors.

Participants

Patients seen at a large health system in New York City (NYC), who were >18 years old with diagnosis of HF or reduced ejection fraction (

Findings to date

Among 39 963 patients in the cohort, the average age was 73±14 years old, 44% were female and 48% were current/former smokers. The common comorbid conditions were hypertension (77%), cardiac arrhythmias (56%), obesity (33%) and valvular disease (33%). During the study period, 33 606 (84%) patients had an active prescription of beta blocker, 32 626 (82%) had ACEi/ARB/ARNI, 11 611 (29%) MRA and 7472 (19%) SGLT2i. Ninety-nine per cent were from urban metropolitan areas.

Future plans

We will use the established cohort to develop a machine learning model to predict medication adherence, and to support ancillary studies assessing associates of adherence. For external validation, we will include data from an additional hospital system in NYC.

Effect of preinitiated glucose-insulin-potassium strategy for patients with undergoing planned percutaneous coronary intervention: a systematic review and meta-analysis

Por: Liu · H. · Liu · R. · Yang · Z. · Xu · F. · Li · C.
Objectives

Whether the glucose-insulin-potassium (GIK) should be used as an adjuvant therapy for ischaemic myocardial disease remains controversial nowadays reperfusion era. This meta-analysis aimed to assess the effects of preinitiated GIK for patients undergoing planned percutaneous coronary intervention (PCI).

Design

Systematic review and meta-analysis.

Data sources

PubMed, Web of science, MEDLINE, Embase, Cochrane Library and ClinicalTrials.gov were searched through 27 November 2022.

Eligibility criteria

Only randomised controlled trials involving participants preinitiated with GIK or placebo before planned PCI were included.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included trials. Risk of bias was assessed with the Cochrane tool. Pooled analysis was conducted using random or effects models according to the heterogeneity. Subgroup analyses were carried out for dosage of GIK and if with ongoing myocardial ischaemia.

Results

13 randomised controlled trials (RCTs) including 3754 participants were evaluated. We found patients preconditioned with GIK before PCI showed a significant increase in Thrombolysis in Myocardial Infarction 3 flow events after angioplasty (OR 1.59, 95% CI 1.03 to 2.46, p=0.04), also revealed improved in-hospital left ventricular ejection fraction (weighed mean difference, WMD 1.62, 95% CI 0.21 to 3.03, p=0.02) and myocardial salvage index (WMD 0.09, 95% CI 0.01 to 0.16, p=0.03). Nevertheless, no benefit was observed in all-cause mortality neither on 30-day (OR 0.81, 95% CI 0.59 to 1.11, p=0.18) nor 6 months (OR 1.02, 95% CI 0.42 to 2.46, p=0.97). Furthermore, GIK intervention was associated with higher occurrences of complications such as phlebitis (OR 10.13, 95% CI 1.74 to 59.00, p=0.01) and hypoglycaemia (OR 10.43, 95% CI 1.32 to 82.29, p=0.03), but not hyperkalaemia (OR 9.36, 95% CI 0.50 to 175.27, p=0.13), liquid overload (OR 1.02, 95% CI 0.25 to 4.13, p=0.98) or in-hospital heart failure (OR 0.42, 95% CI 0.06 to 2.96, p=0.39).

Conclusions

Our study shows preconditioning GIK exhibits myocardial reperfusion and cardiac function benefits for patients planning to receive PCI intervention, while also some complications such as phlebitis and hypoglycaemia accompany.

PROSPERO registration number

CRD42022326334.

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