Publications
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Bergh N, Lindmark K, Lissdaniels J, et al., 2024, Estimating the clinical and budgetary impact of using angiotensin receptor neprilysin inhibitor as first line therapy in patients with HFrEF., ESC Heart Fail, Vol: 11, Pages: 1153-1162
AIMS: Recent updates of international treatment guidelines for heart failure with reduced ejection fraction (HFrEF) differ regarding the use of angiotensin receptor neprilysin inhibitor (ARNI) as first-line treatment. The American Heart Association/American College of Cardiology/Heart Failure Society of America (AHA/ACC/HFSA) 2022 guidelines gives ARNI a Class IA recommendation for HFrEF patients while the European Society of Cardiology's guidelines are less clear when ARNI could be considered as first line treatment option in de novo patients. This study aimed to model the clinical and budgetary outcomes of implementing these guidelines, comparing conservative ARNI prescription patterns with less conservative in Sweden and in the United Kingdom. METHODS AND RESULTS: A health economic model was developed to compare different treatment patterns for HFrEF. Incident cohorts were included on an annual basis and followed over 10 years. The model included treatment specific all-cause mortality and hospitalization rates, as well as drug acquisition, monitoring, and hospitalization costs. Increasing the use of ARNI could lead to about 7000-12 300 life years gained and 2600-4600 hospitalizations prevented in Sweden. These health benefits come with an additional cost of 112-195 million euros. Similar results were estimated for the United Kingdom, albeit on a larger population. CONCLUSIONS: Increasing the proportion of patients receiving ARNI instead of angiotensin converting enzyme inhibitors as first-line treatment of HFrEF will lead to a considerable number of additional life years gained and prevented hospitalizations but with additional cost in terms of health care expenditure in Sweden and in the United Kingdom.
Mullens W, Dauw J, Gustafsson F, et al., 2024, Integration of implantable device therapy in patients with heart failure. A clinical consensus statement from the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC)., Eur J Heart Fail, Vol: 26, Pages: 483-501
Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter-defibrillators and long-term mechanical support. For others, more evidence is still needed before large-scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device-provided therapy and also device-guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care.
Amirova A, Fteropoulli T, Ahmed N, et al., 2024, Framework-based qualitative analysis of free responses of Large Language Models: Algorithmic fidelity., PLoS One, Vol: 19
Today, with the advent of Large-scale generative Language Models (LLMs) it is now possible to simulate free responses to interview questions such as those traditionally analyzed using qualitative research methods. Qualitative methodology encompasses a broad family of techniques involving manual analysis of open-ended interviews or conversations conducted freely in natural language. Here we consider whether artificial "silicon participants" generated by LLMs may be productively studied using qualitative analysis methods in such a way as to generate insights that could generalize to real human populations. The key concept in our analysis is algorithmic fidelity, a validity concept capturing the degree to which LLM-generated outputs mirror human sub-populations' beliefs and attitudes. By definition, high algorithmic fidelity suggests that latent beliefs elicited from LLMs may generalize to real humans, whereas low algorithmic fidelity renders such research invalid. Here we used an LLM to generate interviews with "silicon participants" matching specific demographic characteristics one-for-one with a set of human participants. Using framework-based qualitative analysis, we showed the key themes obtained from both human and silicon participants were strikingly similar. However, when we analyzed the structure and tone of the interviews we found even more striking differences. We also found evidence of a hyper-accuracy distortion. We conclude that the LLM we tested (GPT-3.5) does not have sufficient algorithmic fidelity to expect in silico research on it to generalize to real human populations. However, rapid advances in artificial intelligence raise the possibility that algorithmic fidelity may improve in the future. Thus we stress the need to establish epistemic norms now around how to assess the validity of LLM-based qualitative research, especially concerning the need to ensure the representation of heterogeneous lived experiences.
Woodcock T, Matthew D, Palladino R, et al., 2023, Effect of implementing a heart failure admission care bundle on hospital readmission and mortality rates: interrupted time series study, BMJ Quality & Safety, Vol: 33, Pages: 55-65, ISSN: 2044-5423
This study aimed to evaluate the impact of developing and implementing a care bundle intervention to improve care for patients with acute heart failure admitted to a large London hospital. The intervention comprised three elements, targeted within 24 hours of admission: N-terminal pro-B-type natriuretic peptide (NT-proBNP) test, transthoracic Doppler two-dimensional echocardiography and specialist review by cardiology team. The SHIFT-Evidence approach to quality improvement was used. During implementation, July 2015–July 2017, 1169 patients received the intervention. An interrupted time series design was used to evaluate impact on patient outcomes, including 15 618 admissions for 8951 patients. Mixed-effects multiple Poisson and log-linear regression models were fitted for count and continuous outcomes, respectively. Effect sizes are slope change ratios pre-intervention and post-intervention. The intervention was associated with reductions in emergency readmissions between 7 and 90 days (0.98, 95% CI 0.97 to 1.00), although not readmissions between 0 and 7 days post-discharge. Improvements were seen in in-hospital mortality (0.96, 95% CI 0.95 to 0.98), and there was no change in trend for hospital length of stay. Care process changes were also evaluated. Compliance with NT-proBNP testing was already high in 2014/2015 (162 of 163, 99.4%) and decreased slightly, with increased numbers audited, to 2016/2017 (1082 of 1101, 98.2%). Over this period, rates of echocardiography (84.7–98.9%) and specialist input (51.6–90.4%) improved. Care quality and outcomes can be improved for patients with acute heart failure using a care bundle approach. A systematic approach to quality improvement, and robust evaluation design, can be beneficial in supporting successful improvement and learning.
Kouranos V, Khattar RS, Okafor J, et al., 2023, Predictors of outcome in a contemporary cardiac sarcoidosis population: Role of brain natriuretic peptide, left ventricular function and myocardial inflammation., Eur J Heart Fail, Vol: 25, Pages: 2287-2298
AIMS: Cardiac sarcoidosis (CS) is a potentially fatal condition that varies in its clinical presentation. Here, we describe baseline characteristics at presentation along with prognosis and predictors of outcome in a sizable and deeply phenotyped contemporary cohort of CS patients. METHODS AND RESULTS: Consecutive CS patients seen at one institution were retrospectively enrolled after undergoing laboratory testing, electrocardiogram, echocardiography, cardiac magnetic resonance (CMR) imaging and 18 F-flourodeoxyglucose positron emission tomography (FDG-PET) at baseline. The composite endpoint consisted of all-cause mortality, aborted sudden cardiac death, major ventricular arrhythmic events, heart failure hospitalization and heart transplantation. A total of 319 CS patients were studied (67% male, 55.4 ± 12 years). During a median follow-up of 2.2 years (range: 1 month-11 years), 8% of patients died, while 33% reached the composite endpoint. The annualized mortality rate was 2.7% and the 5- and 10-year mortality rates were 6.2% and 7.5%, respectively. Multivariate analysis showed serum brain natriuretic peptide (BNP) levels (hazard ratio [HR] 2.41, 95% confidence interval [CI] 1.34-4.31, p = 0.003), CMR left ventricular ejection fraction (LVEF) (HR 0.96, 95% CI 0.94-0.98, p < 0.0001) and maximum standardized uptake value of FDG-PET (HR 1.11, 95% CI 1.04-1.19, p = 0.001) to be independent predictors of outcome. These findings remained robust for different patient subgroups. CONCLUSION: Cardiac sarcoidosis is associated with significant morbidity and mortality, particularly in those with cardiac involvement as the first manifestation. Higher BNP levels, lower LVEF and more active myocardial inflammation were independent predictors of outcomes.
de Gonzalo-Calvo D, Martinez-Camblor P, Belmonte T, et al., 2023, Circulating miR-133a-3p defines a low-risk subphenotype in patients with heart failure and central sleep apnea: a decision tree machine learning approach., J Transl Med, Vol: 21
BACKGROUND: Patients with heart failure with reduced ejection fraction (HFrEF) and central sleep apnea (CSA) are at a very high risk of fatal outcomes. OBJECTIVE: To test whether the circulating miRNome provides additional information for risk stratification on top of clinical predictors in patients with HFrEF and CSA. METHODS: The study included patients with HFrEF and CSA from the SERVE-HF trial. A three-step protocol was applied: microRNA (miRNA) screening (n = 20), technical validation (n = 60), and biological validation (n = 587). The primary outcome was either death from any cause, lifesaving cardiovascular intervention, or unplanned hospitalization for worsening of heart failure, whatever occurred first. MiRNA quantification was performed in plasma samples using miRNA sequencing and RT-qPCR. RESULTS: Circulating miR-133a-3p levels were inversely associated with the primary study outcome. Nonetheless, miR-133a-3p did not improve a previously established clinical prognostic model in terms of discrimination or reclassification. A customized regression tree model constructed using the Classification and Regression Tree (CART) algorithm identified eight patient subphenotypes with specific risk patterns based on clinical and molecular characteristics. MiR-133a-3p entered the regression tree defining the group at the lowest risk; patients with log(NT-proBNP) ≤ 6 pg/mL (miR-133a-3p levels above 1.5 arbitrary units). The overall predictive capacity of suffering the event was highly stable over the follow-up (from 0.735 to 0.767). CONCLUSIONS: The combination of clinical information, circulating miRNAs, and decision tree learning allows the identification of specific risk subphenotypes in patients with HFrEF and CSA.
Abdin A, Anker SD, Cowie MR, et al., 2023, Associations between baseline heart rate and blood pressure and time to events in heart failure with reduced ejection fraction patients: Data from the QUALIFY international registry, EUROPEAN JOURNAL OF HEART FAILURE, ISSN: 1388-9842
Walkley R, Allen AJ, Cowie MR, et al., 2023, The cost-effectiveness of NT-proBNP for assessment of suspected acute heart failure in the emergency department, ESC HEART FAILURE, ISSN: 2055-5822
Zuhlke L, Franke J, Cowie MR, 2023, Roles for cardiologists in government, research councils and regulatory sectors, HEART, ISSN: 1355-6037
Moons P, Norekval TM, Arbelo E, et al., 2023, Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management A statement of the ESC Association of Cardiovascular Nursing and Allied Professions (ACNAP), the Association for Acute CardioVascular Care (ACVC), European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association of Preventive Cardiology (EAPC), Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), European Association of Cardiovascular Imaging (EACVI), ESC Regulatory Affairs Committee, ESC Advocacy Committee, ESC Digital Health Committee, ESC Education Committee, and the ESC Patient Forum, EUROPEAN HEART JOURNAL, ISSN: 0195-668X
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Cowie MR, Thokala P, Ihara Z, et al., 2023, Real-time pulmonary artery pressure monitoring in heart failure patients: an updated cost-effectiveness analysis, ESC HEART FAILURE, ISSN: 2055-5822
Singhal A, Riley J, Cowie M, 2023, Benefits and challenges of telemedicine for heart failure consultations: a qualitative study, BMC Health Services Research, Vol: 23, ISSN: 1472-6963
Background:Prior to the Covid-19 pandemic, heart failure (HF) disease management programmes were predominantly delivered in-person, with telemedicine being uncommon. Covid-19 resulted in a rapid shift to “remote-by-default” clinic appointments in many organisations. We evaluated clinician and patient experiences of teleconsultations for HF.Methods:From 16th March 2020, all HF appointments at a specialist centre in the UK were telemedicine-by-default through a mixture of telephone and video consultations, with rare in-person appointments. HF clinicians and patients with HF were invited to participate in semi-structured interviews about their experiences. A purposive sampling technique was used. Interviews were conducted using Microsoft Teams®, recorded and transcribed verbatim. Narrative data were explored by thematic analysis. Clinicians and patients were interviewed until themes saturated.Results:Eight clinicians and eight patients with HF were interviewed before themes saturated. Five overarching themes emerged: 1) Time utilisation – telemedicine consultations saved patients time travelling to and waiting for appointments. Clinicians perceived them to be more efficient, but more administrative time was involved. 2) Clinical assessment – without physical examination, clinicians relied more on history, observations and test results; video calls were perceived as superior to telephone calls for remote assessment. Patients confident in self-monitoring tended to be more comfortable with telemedicine. 3) Communication and rapport – clinicians experienced difficulty establishing rapport with new patients by telephone, though video was better. Patients generally did not perceive that remote consultation affected their rapport with clinicians. 4) Technology – connection issues occasionally disrupted video consultations, but overall patients and clinicians found the technology easy to use. 5) Choice and flexibility – both patien
Posada-Martinez EL, Cox ZL, Cano-Nieto MM, et al., 2023, Changes in the Inferior Vena Cava Are More Sensitive Than Venous Pressure During Fluid Removal: A Proof-of-Concept Study, JOURNAL OF CARDIAC FAILURE, Vol: 29, Pages: 463-472, ISSN: 1071-9164
Fisser C, Ebert A, Gall L, et al., 2023, Association of apneas and loop gain with intranight variation of ventricular extrasystoles in patients with central sleep apnea and heart failure, Publisher: GEORG THIEME VERLAG KG, Pages: S31-S32, ISSN: 0934-8387
Jankowska EA, Liu PP, Cowie MR, et al., 2023, Personalized care of patients with heart failure: are we ready for a REWOLUTION? Insights from two international surveys on healthcare professionals' needs and patients' perceptions, EUROPEAN JOURNAL OF HEART FAILURE, Vol: 25, Pages: 364-372, ISSN: 1388-9842
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Tamisier R, Pepin J-L, Woehrle H, et al., 2023, Effect of adaptive servo-ventilation for central sleep apnoea in systolic heart failure on muscle sympathetic nerve activity: a SERVE-HF randomised ancillary study, EUROPEAN RESPIRATORY JOURNAL, Vol: 61, ISSN: 0903-1936
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- Citations: 5
Akande R, Brimicombe J, Cowie MR, et al., 2023, Characterising RR Intervals in Atrial Fibrillation Detected Through Screening, ISSN: 2325-8861
Atrial fibrillation (AF) is known to be characterised by increased RR interval variability. However, the characteristics of RR intervals in AF detected through screening have not been extensively studied. The aim of this study was to characterise RR intervals in AF detected in screening of older, community dwelling adults. RR interval characteristics were extracted from 2, 709 ECGs from the SAFER AF Screening Programme, consisting of 671 ECGs exhibiting AF, and 2,038 non-AF ECGs. The characteristics included measures of the mean RR interval, the variability in RR intervals, and the proportion of successive RR intervals differing by at least 50ms (pNN50). All characteristics differed significantly between AF and non-AF ECGs. pNN50 provided the highest performance for discriminating between AF and non-AF, with an AUROC of 96%. In AF the majority of successive RR intervals differed by more than 50ms, although there was large variation in the level of RR interval variability between AF ECGs. This study contributes to furthering our understanding of RR interval characteristics in AF. In the future this could form the basis of an algorithm to automatically identify ECGs exhibiting AF with potential applications in AF screening.
Baumert M, Cowie MR, Redline S, et al., 2022, Sleep characterization with smart wearable devices: a call for standardization and consensus recommendations, SLEEP, Vol: 45, ISSN: 0161-8105
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- Citations: 7
Tamisier R, Pepin J-L, Cowie MR, et al., 2022, Effect of adaptive servo ventilation on central sleep apnea and sleep structure in systolic heart failure patients: polysomnography data from the SERVE-HF major sub study, JOURNAL OF SLEEP RESEARCH, Vol: 31, ISSN: 0962-1105
Benjafield AV, Woehrle H, Vettorazzi E, et al., 2022, NEW TREATMENTS FOR CENTRAL SLEEP APNOEA IN HEART FAILURE: SAMPLE SIZE REQUIRED TO DETECT A SAFETY SIGNAL, Publisher: ELSEVIER, Pages: S259-S260, ISSN: 1389-9457
Fox KAA, Aboyans V, Debus ES, et al., 2022, Patients selected for dual pathway inhibition in clinical practice have similar characteristics and outcomes to those included in the COMPASS randomized trial: The XATOA Registry, EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY, Vol: 8, Pages: 825-836, ISSN: 2055-6837
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- Citations: 7
Bottle A, Newson R, Faitna P, et al., 2022, Risk prediction of mortality for patients with heart failure in England: observational study in primary care, ESC HEART FAILURE, ISSN: 2055-5822
Cowie MR, Bozkurt B, Butler J, et al., 2022, How can we optimise health technology assessment and reimbursement decisions to accelerate access to new cardiovascular medicines?, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 365, Pages: 61-68, ISSN: 0167-5273
Kotecha D, Asselbergs FW, Achenbach S, et al., 2022, CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research, European Heart Journal, Vol: 43, Pages: 3578-3588, ISSN: 0195-668X
Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls. Verification, validation, and data privacy, as well as the social mandate to undertake research are key challenges. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry. We propose the CODE-EHR Minimum Standards Framework as a means to improve the design of studies, enhance transparency and develop a roadmap towards more robust and effective utilisation of healthcare data for research purposes.
Guasti L, Dilaveris P, Mamas MA, et al., 2022, Digital health in older adults for the prevention and management of cardiovascular diseases and frailty. <i>A clinical consensus statement from the ESC Council for Cardiology Practice</i>/<i>Taskforce on Geriatric Cardiology</i>, <i>the ESC Digital Health Committee and the ESC Working Group on e</i>-<i>Cardiology</i>, ESC HEART FAILURE, Vol: 9, Pages: 2808-2822, ISSN: 2055-5822
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Kotecha D, Asselbergs FW, Achenbach S, et al., 2022, CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research, LANCET DIGITAL HEALTH, Vol: 4, Pages: E757-E764
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- Citations: 7
Cowie MR, Mourilhe-Rocha R, Chang H-Y, et al., 2022, The impact of the COVID-19 pandemic on heart failure management: Global experience of the OPTIMIZE Heart Failure Care network, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 363, Pages: 240-246, ISSN: 0167-5273
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- Citations: 4
Vaas V, Fisser C, Gall L, et al., 2022, Prevalence and risk factors of atrial fibrillation-Collective of the SERVE-HF Major Substudy, Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD, ISSN: 0903-1936
Dilaveris PE, Antoniou CK, Caiani EG, et al., 2022, ESC Working Group on e-Cardiology Position Paper: accuracy and reliability of electrocardiogram monitoring in the detection of atrial fibrillation in cryptogenic stroke patients : In collaboration with the Council on Stroke, the European Heart Rhythm Association, and the Digital Health Committee., Eur Heart J Digit Health, Vol: 3, Pages: 341-358
The role of subclinical atrial fibrillation as a cause of cryptogenic stroke is unambiguously established. Long-term electrocardiogram (ECG) monitoring remains the sole method for determining its presence following a negative initial workup. This position paper of the European Society of Cardiology Working Group on e-Cardiology first presents the definition, epidemiology, and clinical impact of cryptogenic ischaemic stroke, as well as its aetiopathogenic association with occult atrial fibrillation. Then, classification methods for ischaemic stroke will be discussed, along with their value in providing meaningful guidance for further diagnostic efforts, given disappointing findings of studies based on the embolic stroke of unknown significance construct. Patient selection criteria for long-term ECG monitoring, crucial for determining pre-test probability of subclinical atrial fibrillation, will also be discussed. Subsequently, the two major classes of long-term ECG monitoring tools (non-invasive and invasive) will be presented, with a discussion of each method's pitfalls and related algorithms to improve diagnostic yield and accuracy. Although novel mobile health (mHealth) devices, including smartphones and smartwatches, have dramatically increased atrial fibrillation detection post ischaemic stroke, the latest evidence appears to favour implantable cardiac monitors as the modality of choice; however, the answer to whether they should constitute the initial diagnostic choice for all cryptogenic stroke patients remains elusive. Finally, institutional and organizational issues, such as reimbursement, responsibility for patient management, data ownership, and handling will be briefly touched upon, despite the fact that guidance remains scarce and widespread clinical application and experience are the most likely sources for definite answers.
Williams K, Modi RN, Dymond A, et al., 2022, Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial, BMJ OPEN, Vol: 12, ISSN: 2044-6055
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- Citations: 4
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