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Evidence for clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications among adults with peripheral artery disease: protocol for a systematic review and meta-analysis

Por: de Launay · D. · Paquet · M. · Kirkham · A. M. · Graham · I. D. · Fergusson · D. A. · Nagpal · S. K. · Shorr · R. · Grimshaw · J. M. · Roberts · D. J.
Introduction

International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes.

Methods and analysis

We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty.

Ethics and dissemination

Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications.

PROSPERO registration number

CRD42022362801.

Prescriber decision-making on antithrombotic therapy after endovascular intervention for peripheral artery disease: a protocol for a discrete choice experiment

Por: Zhu · A. · Tang · R. · Rajendran · S. · Hajian · H. · Aitken · S. J.
Introduction

Peripheral artery disease (PAD) is a major risk factor for cardiovascular morbidity and mortality, despite surgical and endovascular treatments. Emerging evidence supports the use of immediate antithrombotic medications after endovascular intervention for PAD, however, there is a lack of consensus regarding choice and duration of antithrombotic therapy. Prescriber decision-making is a complex process, with prior studies demonstrating patient factors can influence variability in antithrombotic therapy for PAD. However, it remains unclear the relative contribution of these factors. This paper describes a planned study that aims to (1) determine the influence of patient factors on clinician preference for antithrombotic therapy following endovascular intervention and (2) compare differences in prescribing preferences between consultant vascular surgeons and trainees.

Methods and analysis

This cross-sectional survey will evaluate antithrombotic prescribing choices using a discrete choice experiment (DCE) that has been developed and piloted for this study. A list of attributes and levels was generated using a mixed-methods approach. This included an extensive literature review and semistructured interviews with prescribing clinicians. Following final selection of included attributes, specialised software was used to construct a D-efficient design for the DCE questionnaire. The electronic questionnaire will be administered to vascular trainees and consultant surgeons across Australia. These data will be analysed using multinomial logistic regression, treating the decision to prescribe antithrombotic therapy as a function of both the attributes of the two alternatives, as well as characteristics of the respondent. Latent class analysis will be used to explore heterogeneity of responses.

Ethics and dissemination

Ethics approval was obtained from the University of Sydney Human Ethics committee (2023/474). The results of this study will be published in peer-reviewed journals and presented at national vascular surgical conferences. These results will be used to improve understanding how clinicians make prescribing decisions and to inform future strategy to enhance guideline-directed prescribing.

Predictive machine learning models for ascending aortic dilatation in patients with bicuspid and tricuspid aortic valves undergoing cardiothoracic surgery: a prospective, single-centre and observational study

Por: Gaye · B. · Vignac · M. · Gadin · J. R. · Ladouceur · M. · Caidahl · K. · Olsson · C. · Franco-Cereceda · A. · Eriksson · P. · Björck · H. M.
Objectives

The objective of this study was to develop clinical classifiers aiming to identify prevalent ascending aortic dilatation in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).

Design and setting

A prospective, single-centre and observational cohort.

Participants

The study involved 543 BAV and 491 TAV patients with aortic valve disease and/or ascending aortic dilatation, excluding those with coronary artery disease, undergoing cardiothoracic surgery at the Karolinska University Hospital (Sweden).

Main outcome measures

Predictors of high risk of ascending aortic dilatation (defined as ascending aorta with a diameter above 40 mm) were identified through the application of machine learning algorithms and classic logistic regression models.

Exposures

Comprehensive multidimensional data, including valve morphology, clinical information, family history of cardiovascular diseases, prevalent diseases, demographic details, lifestyle factors, and medication.

Results

BAV patients, with an average age of 60.4±12.4 years, showed a higher frequency of aortic dilatation (45.3%) compared with TAV patients, who had an average age of 70.4±9.1 years (28.9% dilatation, p

Conclusion and recommendation

Cardiovascular risk profiles appear to be more predictive of aortopathy in TAV patients than in patients with BAV. This adds evidence to the fact that BAV-associated and TAV-associated aortopathy involves different pathways to aneurysm formation and highlights the need for specific aneurysm preventions in these patients. Further, our results highlight that machine learning approaches do not outperform classical prediction methods in addressing complex interactions and non-linear relations between variables.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

Can glycated haemoglobin (HbA1c) be used as a predictor of left ventricular diastolic dysfunction in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus: a cross-sectional study at a tertiary care centre in Eastern India

Por: Porel · R. · Shyama · S. · Ahmad · S. · Kumar · N. · Ahmad · S. · Biswas · R. · Ojha · V. S.
Objectives

This study was conducted to establish the association between glycated haemoglobin (HbA1c) and left ventricular diastolic dysfunction (LVDD) in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus (DM) and determine the cut-off value of HbA1c for detecting LVDD.

Design

Cross-sectional study.

Setting

This study was conducted in General Medicine Department in collaboration with the Cardiology Department at All India Institute of Medical Sciences, Patna.

Participants

The study population comprised patients with newly diagnosed type 2 DM within the past 3 months, aged between 18 years and 80 years, who were not hypertensive and without any systemic diseases and who presented to the General Medicine Department.

Primary and secondary outcome measures

The presence of LVDD was the primary outcome measure.

Results

Among the total of 60 participants, it was observed that age (adjusted odds ratio (AOR): 1.169, 95% CI: 1.066 to 1.283) and HbA1c (AOR: 2.625, 95% CI: 1.264 to 5.450) were found to be independent predictors for the presence of LVDD. Receiver operating characteristic analysis identified a cut-off value of HbA1c at 9.5% (80 mmol/mol) for detecting LVDD, with a specificity of 96.43%, a sensitivity of 37.5% and a positive predictive value (PPV) of 91.62%.

Conclusions

This study demonstrated that age and HbA1c levels are independent predictors of LVDD in patients with newly diagnosed type 2 DM without hypertension. A cut-off value of 9.5% for HbA1c was identified with a high specificity and PPV for predicting LVDD in patients with newly diagnosed type 2 diabetes. This underscores the importance of conducting echocardiography in patients with newly diagnosed asymptomatic type 2 diabetes with HbA1c 9.5% or more to assess LVDD, allowing for prompt interventions if necessary and to decelerate the progression towards heart failure.

Early predictors of bacterial pneumonia infection in children with congenital heart disease after cardiopulmonary bypass: a single-centre retrospective study

Por: Wang · Q. · Liu · H. · Zou · L. · Cun · Y. · Shu · Y. · Patel · N. · Yu · D. · Mo · X.
Objectives

The objective of this study was to evaluate the early predictors of bacterial pneumonia infection in children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB).

Design

Retrospective study.

Setting

A freestanding tertiary paediatric hospital in China.

Participants

Patients admitted to the hospital due to CHD who underwent open-heart surgery.

Outcome measures

We retrospectively reviewed and analysed data from 1622 patients with CHD after CPB from June 2018 to December 2020 at the Children’s Hospital of Nanjing Medical University. Enrolled patients were assigned to an infection group or a non-infection group according to the presence of postoperative bacterial pneumonia infection, and the differences in clinical indicators were compared. Potential predictors were analysed by multivariate logistic regression analysis and area under the curve (AUC) analysis.

Results

Among the 376 patients (23.2%) in the infection group, the three most common bacteria were Streptococcus pneumoniae in 67 patients (17.8%), Escherichia coli in 63 patients (16.8%) and Haemophilus influenzae in 53 patients (14.1%). The infection group exhibited a lower weight (8.0 (6.0–11.5) kg vs 11.0 (7.5–14.5) kg, p

Conclusions

In our study, weight, PCT and CRP were found to be independent predictors of pulmonary bacterial infection after CPB. Moreover, PCT was the most specific predictor, and CRP was the most sensitive independent predictor that might be beneficial for the early diagnosis of pulmonary bacterial infection after CPB in patients with CHD.

Appraising the quality standard of clinical practice guidelines related to central venous catheter-related thrombosis prevention: a systematic review of clinical practice guidelines

Por: Zhang · J. · Wu · Y. · Zhang · S. · Yao · W. · Bu · F. · Wang · A. · Hu · X. · Wang · G.
Objective

To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it.

Design

Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales.

Data sources

Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022.

Eligibility criteria

Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022.

Data extraction and synthesis

Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines.

Results

Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended.

Conclusion

The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.

Meta-analysis on inflammation and autonomic nervous system of coronary heart disease combined with depression

Por: Li · G. · Zhang · L. · Liu · M.
Objectives

This meta-analysis aimed to explore the association between inflammatory factors, heart rate variability (HRV) and the coexistence of coronary heart disease (CHD) and depression.

Design

Systematic review and meta-analysis. Complying with the Meta-analysis Of Observational Studies in Epidemiology statement.

Data sources

We searched PubMed, Web of Science and EMBASE for the data from the inception date to 16 March 2023.

Eligibility criteria

We included cross-sectional and cohort studies with inclusion criteria: (1) patients with CHD; (2) depression measurement and (3) including inflammatory factors or cardiac biomarkers or HRV.

Data extraction and synthesis

Two authors searched the databases independently. The effect estimates and heterogeneity were synthesised by Review Manager V.5.3. Sensitivity analysis and publication bias were analysed by STATA software. The quantitative synthesis outcomes were presented by mean difference (MD) or standard MD (SMD) with 95% CI.

Results

By searching the databases, we identified a total of 6750 articles. There were 22 articles left after selection, including 6344 participants. This meta-analysis indicated that patients with CHD with depression had higher levels of C reaction protein (CRP) (SMD 0.50, 95% CI (0.19 to 0.81), p=0.001), high-sensitivity C reactive protein (hs-CRP) (SMD 0.28, 95% CI (0.07 to 0.48), p=0.008), IL-6 (SMD 0.49, 95% CI (0.05 to 0.92), p=0.03) and a lower level of the mean RR interval and the SD of all RR intervals (SMD –0.64, 95% CI (–1.11 to –0.17), p=0.008), SD of the 5 min averages of all normal RR intervals (MD –12.77 ms, 95% CI (–21.20 to –4.33), p=0.003), overage of the SD of all normal RR intervals for each 5 min segment (MD –13.83 ms, 95% CI (–15.94 to –11.72), p50 ms (pNN50) (SMD –0.86, 95% CI (–1.41 to –0.31), p=0.002), than those without depression.

Conclusions

This study underscores the association between elevated CRP, hs-CRP, IL-6 and lower HRV in patients with CHD with depression. It emphasises the importance of clinicians assessing CRP, hs-CRP, IL-6 and HRV in patients with CHD to potentially identify depressive conditions.

Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

Por: Yu · C. · Li · H. · Lei · C. · Wang · Y. · Chen · S. · Zhao · Y. · Zheng · Z.
Introduction

The prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are the primary options for stroke prevention, while it increases risk of bleeding. Left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischaemic stroke, and thoracoscopic LAA clipping procedure provides an alternative option for stroke prevention in high-risk patients. However, high-quality evidence comparing LAA clipping to DOACs in terms of stroke prevention is lacking. This trial is designed to assess whether the efficacy of thoracoscopic LAA clipping is superior to DOACs for stroke prevention in AF patients at high risk of thrombosis (CHA2DS2-VASc≥2 in men and ≥3 in women)[CHA2DS2-VASc stands for "congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)"].

Methods and analysis

This is a prospective, multicentre, open-labelled, randomised controlled study. This trial will randomly assign 290 patients with non-paroxysmal AF to thoracoscopic LAA clipping group or DOAC therapy group in a 1:1 randomisation. The primary endpoint is defined as a composite endpoint event consisting of stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant non-major bleeding events at 24 months after randomisation. The secondary endpoints consist of the components of the primary composite endpoint, surgery-related adverse events and minor bleeding events.

Ethics and dissemination

The central ethics committee at Fuwai Hospital approved the trial entitled "Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP trial)". The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number

NCT06021808.

Study protocol for a cross-sectional online survey investigating patient preferences and experiences of waiting for elective cardiac surgery

Por: Russo · M. · Watson · K. · Richards · K. · Olive · R. R. · Krausova · B. · Kumar · R. · Burridge · J. · Goulding · L. · Chua · K.-C. · Hardy · D. · Vassilios · A. · Kamran · B. · Bhudia · S. · Alia · N. · Habib · K. · Sevdalis · N. · Petrou · M.
Introduction

Being on a waiting list for elective (planned) cardiac surgery can be physically and psychologically challenging for patients. Research suggests that stress associated with waiting for surgery is dependent on different individual and contextual factors. However, most data on patients’ experiences of waiting for surgery and preferences for waiting list management derives from non-cardiac clinical populations. The aim of the current study is to explore patients’ experiences of being on a waiting list for elective cardiac surgery, and their views on how the waiting experience could be improved in the future. This work will inform the patient management strategy during the waiting period for surgery across the four major hospitals in London directly involved in this study, and potentially beyond by transferring learning to other services.

Methods and analysis

This is a mixed-methods study that will collect quantitative and qualitative data using a cross-sectional online survey. Patients who are on waiting lists for elective surgery across four major cardiac surgery departments in London hospitals, and are at least 18 years old, will be invited by their healthcare team via text message or letter to complete the survey. The target sample size of non-randomly selected participants will be 268. Bivariable and multivariable regression models will be used to assess associations between survey items measuring the impact of the cardiac condition on specific life domains (eg, daily activities, social and family relationships, hobbies, sexual life), anxiety and depression symptoms as measured by the Patient Health Questionnaire-4 and survey items evaluating experiences of health services. Data on experience and preferences for improvements to the waiting experience will be analysed with qualitative content analysis using an inductive approach.

Ethics and dissemination

This study was reviewed and granted ethical approval by the East of England—East Cambridge Research Ethics Committee. Findings from this study will be disseminated through peer-reviewed journals, a research website and social media and with an online event engaging patients, members of the public, healthcare professionals and other relevant stakeholders.

Trial registration numb

NCT05996640

Snoring Survivors: the impact of obstructive sleep apnoea and continuous positive airway pressure use on in-hospital mortality, length of stay and costs among patients hospitalised with acute cardiovascular disease - A retrospective analysis of 2016-2019

Por: Ogbu · I. · Hakobyan · B. · Sossou · C. · Levisman · J. · Obiagwu · C. · Danielian · A.
Background

The routine administration of supplemental oxygen to non-hypoxic patients with acute myocardial infarction (AMI) has been abandoned for lack of mortality benefit. However, the benefits of continuous positive airway pressure (CPAP) use in patients hospitalised with acute cardiovascular disease and concomitant obstructive sleep apnoea (OSA) remain to be elucidated.

Methods

In this retrospective case–control analysis, using 10th International Classification of Diseases, Clinical Modification (ICD-10) codes, we searched the 2016–2019 Nationwide Inpatient Sample for patients diagnosed with unstable angina (UA), AMI, acute decompensated heart failure (ADHF) and atrial fibrillation with rapid ventricular response (AFRVR), who also carried a diagnosis of OSA. We identified in-hospital CPAP use with ICD-10-Procedure Coding System codes. In-hospital death, length of stay (LOS) and hospital charges were compared between patients with and without OSA, and between OSA patients with and without CPAP use.

Results

Our sample included 2 959 991 patients, of which 1.5% were diagnosed with UA, 30.3% with AMI, 37.5% with ADHF and 45.8% with AFRVR. OSA was present in 12.3%. Patients with OSA were more likely to be younger, male, smokers, obese and have chronic obstructive pulmonary disease, renal failure and heart failure (p

Conclusion

Our study showed that patients with recognised OSA hospitalised for AMI, ADHF and AFRVR had significantly lower mortality regardless of CPAP use, while CPAP treatment among these patients was associated with significantly higher in-hospital mortality and resource utilisation. The routine use of CPAP during acute cardiovascular encounters could neutralise the impact of chronic intermittent ischaemic preconditioning.

Association between perioperative glucose profiles assessed by the continuous glucose monitoring (CGM) system and prognosis in patients with ST-segment elevation myocardial infarction (STEMI): protocol for a cohort study

Por: Shi · J. · Wang · X. · Zhang · H. · Ding · Y. · Wu · J. · Luo · S. · Hu · H. · Zheng · X.
Introduction

ST-segment elevation myocardial infarction (STEMI) presents a serious cardiovascular condition requiring prompt intervention. Dysglycaemia has been identified as a significant risk factor impacting STEMI prognosis. However, limited research has focused on comprehensively examining the association between glucose dynamics during the perioperative period and patient outcomes. This study aims to address this gap by leveraging continuous glucose monitoring (CGM) technology to gain real-time insights into glucose fluctuations and their potential impact on STEMI prognosis.

Methods and analysis

This is a multicentre, prospective, 3-year follow-up cohort study. Between May 2023 and May 2024, 550 eligible STEM patients who underwent percutaneous coronary intervention are expected to be recruited. Using the CGM system, continuous glucose levels will be collected throughout the perioperative phase. Key clinical parameters, including cardiac biomarkers, angiographic findings and major adverse cardiovascular events, will be assessed in relation to glucose profile.

Ethics and dissemination

The study was approved by the Medical Research Ethics Committee of The First Affiliated Hospital of University of Science and Technology of China and will be conducted in accordance with the moral, ethical and scientific principles of the Declaration of Helsinki. Written informed consent will be obtained from all participants before any study-related procedures are implemented. Study results will be disseminated through conferences and peer-reviewed scientific journals.

Trial registration number

ChiCTR2300069662.

Early ICD implantation following out-of-hospital cardiac arrest: a retrospective cohort study from the Swedish Registry for Cardiopulmonary Resuscitation

Por: Sultanian · P. · Lundgren · P. · Rawshani · A. · Möller · S. · Jafari · A. H. · David · L. · Yassinson · S. · Myredal · A. · Rorsman · C. · Taha · A. · Ravn-Fischer · A. · Martinsson · A. · Herlitz · J. · Rawshani · A.
Background

It is unclear whether an implantable cardioverter-defibrillator (ICD) is generally beneficial in survivors of out-of-hospital cardiac arrest (OHCA).

Objective

We studied the association between ICD implantation prior to discharge and survival in patients with cardiac aetiology or initial shockable rhythm in OHCA.

Design

We conducted a retrospective cohort study in the Swedish Registry for Cardiopulmonary Resuscitation. Treatment associations were estimated using propensity scores. We used gradient boosting, Bayesian additive regression trees, neural networks, extreme gradient boosting and logistic regression to generate multiple propensity scores. We selected the model yielding maximum covariate balance to obtain weights, which were used in a Cox regression to calculate HRs for death or recurrent cardiac arrest.

Participants

All cases discharged alive during 2010 to 2020 with a cardiac aetiology or initial shockable rhythm were included. A total of 959 individuals were discharged with an ICD, and 2046 were discharged without one.

Results

Among those experiencing events, 25% did so within 90 days in the ICD group, compared with 52% in the other group. All HRs favoured ICD implantation. The overall HR (95% CI) for ICD versus no ICD was 0.38 (0.26 to 0.56). The HR was 0.42 (0.28 to 0.63) in cases with initial shockable rhythm; 0.18 (0.06 to 0.58) in non-shockable rhythm; 0.32 (0.20 to 0.53) in cases with a history of coronary artery disease; 0.36 (0.22 to 0.61) in heart failure and 0.30 (0.13 to 0.69) in those with diabetes. Similar associations were noted in all subgroups.

Conclusion

Among survivors of OHCA, those discharged with an ICD had approximately 60% lower risk of death or recurrent cardiac arrest. A randomised trial is warranted to study this further.

Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >= 65 years: CONSIDERING-AF study design

Por: Etminani · F. · Sandgren · E. · Holm · J. · Magnusson · P. · Modica · A. · Moberg · K. · Davidsson · T. · Stalpe · L. · Kiflemariam · S. · Younan · N. · Parikh · P. · Wadhwa · M. · Sundin · A. · Engdahl · J.
Introduction

Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.

Methods and analysis

CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.

Ethics and dissemination

This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.

Trial registration number

NCT05838781.

Effect of methylene blue on outcomes in patients with distributive shock: a meta-analysis of randomised controlled trials

Por: Huang · X. · Yan · W. · Chen · Z. · Qian · Y.
Objective

This meta-analysis aimed to demonstrate the effect of methylene blue (MB) in patients with distributive shock.

Design

Meta-analysis.

Methods

According to the Prospective International Register of Systematic Reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the relevant randomised controlled trials (RCTs) via PubMed, Embase and Cochrane Library from the date of database inception to 19 April 2023. The primary outcome was mortality during follow-up, and secondary outcomes included mean arterial pressure (mm Hg), mechanical ventilation time (hours), intensive care unit (ICU) length of stay (LOS) (days), hospital LOS (days) and heart rate (times/min).

Results

This study included six RCTs with 265 participants. The study showed no significant difference in mortality between the MB and placebo groups (ORs: 0.59; 95% CI 0.32 to –1.06). However, MB reduced the duration of mechanical ventilation (mean difference (MD): –0.68; 95% CI –1.23 to –0.14), ICU LOS (MD: –1.54; 95% CI –2.61 to –0.48) and hospital LOS (MD: –1.97; 95% CI –3.92 to –0.11).

Conclusions

The use of MB may not reduce mortality in patients with distributive shock, but may shorten the duration of mechanical ventilation, ICU LOS and hospital LOS. More clinical studies are needed to confirm these findings in the future.

Trial registration number

CRD42023415938.

Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide

Por: Chen · Y. · Shah · A. · Jani · Y. · Higgins · D. · Saleem · N. · Chafer · K. · Sydes · M. R. · Asselbergs · F. W. · Lumbers · R. T.
Introduction

Acute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct to pharmacological therapy with loop diuretics, but there is a lack of evidence from traditional randomised controlled trials (RCTs) to support the safety and effectiveness of this intervention in the acute setting.

This study aims to explore the feasibility of using computer alerts within the electronic health record (EHR) system to invite clinical care teams to enrol patients into a pragmatic RCT at the time of clinical decision-making. It will additionally assess the effectiveness of using an alert to help address the clinical research question of whether oral fluid restriction is a safe and effective adjunct to pharmacological therapy for patients admitted with fluid overload.

Methods and analysis

THIRST (Randomised Controlled Trial within the electronic Health record of an Interruptive alert displaying a fluid Restriction Suggestion in patients with the treatable Trait of congestion) Alert is a single-centre, parallel-group, open-label pragmatic RCT embedded in the EHR system that will be conducted as a feasibility study at an National Health Service (NHS) hospital in London. The clinical care team will be invited to enrol suitable patients in the study using a point-of-care alert with a target sample size of 50 patients. Enrolled patients will then be randomised to either restricted or unrestricted oral fluid intake. Two primary outcomes will be explored (1) the proportion of eligible patients enrolled in the study and (2) the mean difference in oral fluid intake between randomised groups. A series of secondary outcomes are specified to evaluate the effectiveness of the alert, adherence to the randomised treatment allocation and the quality of data generated from routine care, relevant to the outcomes of interest.

Ethics and dissemination

This study was approved by Riverside Research Ethics Committee (Ref: 22/LO/0889) and will be published on completion.

Trial registration number

NCT05869656.

Non-pharmacological interventions to support coronary artery bypass graft (CABG) patient recovery following discharge: protocol for a scoping review

Por: Billard · J. N. · Wells · R. · Farrell · A. · Curran · J. A. · Sheppard · G.
Background

In Canada, approximately 15 000 people undergo coronary artery bypass grafting (CABG) each year. However, 9.5% of these patients are urgently readmitted to hospital within 30 days of surgery. Postoperative interventions following discharge play an important role in reducing readmissions and improving CABG patient outcomes. Therefore, it is important to determine effective interventions available to enhance CABG patient recovery following postoperative discharge.

Objectives

Our scoping review aims to identify non-pharmacological interventions available to support recovery of patients who are discharged after CABG in the community setting.

Methods

The methodological framework described by Arksey and O’Malley will be applied to this review. Our search strategy will include electronic databases (Medline, Embase, Cochrane Library and CINAHL), and studies will be screened and reviewed by two independent reviewers. Studies looking at non-pharmacological interventions targeting patients who are discharged after CABG will be included. Preliminary searches were conducted March 2022 and following abstract screening, full-text screening was completed May 2023. Data extraction is planned to begin September 2023 with an expected finish date of October 2023. The study is expected to be completed by January 2024.

Ethics and dissemination

This scoping review will retrieve and analyse previously published studies in which informed consent was obtained by primary investigators. Therefore, no ethical review or approval will be required. This scoping review aims to enumerate available non-pharmacological interventions to support recovery of patients who are discharged after CABG and identify gaps in postoperative recovery after discharge to support the development of innovative and targeted interventions. On completion of this review, we will ensure broad dissemination of our findings through peer-reviewed, open-access journals, conference presentations and hold meetings to engage stakeholders, including clinicians, policy makers and others.

RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands

Por: van Eijk · J. · Luijken · K. · Jaarsma · T. · Reitsma · J. B. · Schuit · E. · Frederix · G. W. J. · Derks · L. · Schaap · J. · Rutten · F. H. · Brugts · J. · de Boer · R. A. · Asselbergs · F. W. · Trappenburg · J. C. A. · RELEASE-HF Investigators · Jan Borleffs · Dalen · Erol-Yilmaz
Introduction

Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.

Methods and analysis

The RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.

Ethics and dissemination

The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.

Trial registration number

NCT05654961.

Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk--protocol of a prospective study

Por: Hou · J. · Li · M. · Han · J. · Yu · S. · Jia · X. · Sun · F. · Zhang · Y.
Introduction

Cardiovascular diseases are the leading cause of death and disease burden in China. However, there is a lack of prospective cohort studies suitable for evaluating early organ damage and its role in preventing and reducing cardiovascular risk among Chinese residents. This study intends to establish the first database based on the phenotypes of all early structural and functional damage of cardiovascular organs in Chinese population. Moreover, a digital follow-up mechanism will be formed, a prospective population cohort will be established, a biological sample bank for early cardiovascular organ damage will be established, and an intervention and management system for early damage of cardiovascular organs will be explored.

Methods and analysis

This study is a prospective cohort study built on the foundation of the Northern Shanghai Study I. People aged 18–75 years are enrolled. After the recruitment, first, corresponding physical measurements and clinical examinations are conducted to collect cardiovascular risk factors and establish the demographic baseline of the study population. Next, the latest equipment is used to evaluate early structural and functional cardiovascular organ damage including heart, macrovessels, microcirculation, renal function and fundus. Meanwhile, the blood, urine, faeces and other biological samples of participants are collected to establish the cardiometabolic and gut microbiota analysis databases. The population is followed up every 2 years. Comprehensive assessment of early organ damage will be used to predict cardiovascular risk, guide people to change lifestyles to achieve early prevention and provide corresponding treatment recommendations.

Ethics and dissemination

This study was approved by the Shanghai Tenth People’s Hospital Institutional Review Board. All participants signed a written consent form. The results of this study will be disseminated in peer-reviewed journals. Ethics approval: SHYS-IEC-5.0/22k148/P01.

Trial registration number

NCT05435898.

Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries

Por: Brouckaert · J. · Dellgren · G. · Wallinder · A. · Rega · F.
Introduction

Ischaemic cold static storage (ICSS) is the gold standard in donor heart preservation. This ischaemic time frame renders a time constraint and risk for primary graft dysfunction. Cold oxygenated heart perfusion, known as non-ischaemic heart preservation (NIHP), theoretically limits the ischaemic time, while holding on to the known advantage of hypothermia and cardioplegia, a low metabolic rate.

Methods and analysis

The NIHP 2019 study is an international, randomised, controlled, open, multicentre clinical trial in 15 heart transplantation centres in 8 European countries and includes 202 patients undergoing heart transplantation, allocated 1:1 to NIHP or ICSS. Enrolment is estimated to be 30 months after study initiation. The patients are followed for 12 months after transplantation.

The primary objective is to evaluate the effect of NIHP on survival, allograft function and rejection episodes within the first 30 days after transplantation. The secondary objectives are to compare treatment groups with respect to survival, allograft function, cardiac biomarkers, rejection episodes, allograft vasculopathy, adverse events and adverse device effects within 12 months.

Ethics and dissemination

This protocol was approved by the Ethics Committee (EC) for Research UZ/KU Leuven, Belgium, the coordinating EC in Germany (Bei Der LMU München), the coordinating EC in the UK (West Midlands—South Birmingham Research), the EC of Hospital Puerta de Hierro, Madrid, Spain, the EC of Göteborg, Sweden, the coordinating EC in France, the EC of Padova, Italy and the EC of the University of Vienna, Austria. This study will be conducted in accordance with current local regulations and international applicable regulatory requirements according to the principles of the Declaration of Helsinki and ISO14155:2020. Main primary and secondary outcomes will be published on modified intention-to-treat population and per-protocol population.

Trial registration number

NCT03991923.

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