262 results on '"Gale, Chris P"'
Search Results
2. Implementing a Medicines at Transitions Intervention (MaTI) for patients with heart failure: a process evaluation of the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial.
- Author
-
Powell C, Ismail H, Breen L, Fylan B, Alderson SL, Gale CP, Gardner P, Silcock J, Cundill B, Farrin A, Mason E, Moreau L, and Alldred DP
- Subjects
- Humans, Male, Qualitative Research, Female, Process Assessment, Health Care, Patient Transfer, Heart Failure drug therapy, Heart Failure therapy, Continuity of Patient Care organization & administration, Patient Discharge
- Abstract
Background: Heart failure is a major global health challenge incurring a high rate of mortality, morbidity and hospitalisation. Effective medicines management at the time of hospital discharge into the community could reduce poor outcomes for people with heart failure. Within the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) programme, the Medicines at Transitions Intervention (MaTI) was co-designed to improve such transitions, with a cluster randomised controlled trial to test effectiveness. The MaTI includes a patient toolkit and transfer of discharge medicines information to community pharmacy. This paper aims to determine the degree to which the intervention was delivered, and identify barriers and facilitators experienced by staff for the successful implementation of the intervention., Methods: The study was conducted in six purposively selected intervention sites. A mixed-methods design was employed using hospital staff interviews, structured and unstructured ward observations, and routine trial data about adherence to the MaTI. A parallel mixed analysis was applied. Qualitative data were analysed thematically using the Framework method. Data were synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research (CFIR)., Results: With limited routines of communication between ward staff and community pharmacy, hospital staff found implementing community pharmacy-related steps of the intervention challenging. Staff time was depleted by attempts to bridge system barriers, sometimes leading to steps not being delivered. Whilst the introduction of the patient toolkit was often completed and valued as important patient education and a helpful way to explain medicines, the medicines discharge log within it was not, as this was seen as a duplication of existing systems. Within the CFIR the most applicable constructs were identified as 'intervention complexity' and 'cosmopolitanism' based on how well hospitals were networked with community pharmacies, and the availability of hospital resources to facilitate this., Conclusion: The MaTI was generally successfully implemented, particularly the introduction of the toolkit. However, implementation involving community pharmacy was more challenging and more effective communication systems are needed to support wider implementation., Trial Registration: 11/04/2018 ISRCTN66212970. https://www.isrctn.com/ISRCTN66212970 ., (© 2024. The Author(s).)
- Published
- 2024
- Full Text
- View/download PDF
3. Standardised and hierarchically classified heart failure and complementary disease monitoring outcome measures: european Unified Registries for heart Care evaluation and randomised trials (EuroHeart).
- Author
-
Bhatty A, Wilkinson C, Batra G, Aktaa S, Smith AB, Wahab A, Chappell S, Alfredsson J, Erlinge D, Ferreira J, Guðmundsdóttir IJ, Hrafnkelsdóttir ÞJ, Ingimarsdóttir IJ, Irs A, Jánosi A, Járai Z, Oliveira-Santos M, Popescu BA, Vasko P, Vinereanu D, Yap J, Bugiardini R, Cenko E, Nadarajah R, Sydes MR, James S, Maggioni AP, Wallentin L, Casadei B, and Gale CP
- Abstract
Aims: The lack of standardised definitions for heart failure outcome measures limits the ability to reliably assess effectiveness of heart failure therapies. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) aimed to produce a catalogue of internationally endorsed data definitions for heart failure outcome measures., Methods: Following the EuroHeart methods for the development of cardiovascular data standards, a working group was formed of representatives from the European Society of Cardiology Heart Failure Association and other leading heart failure experts. A systematic review of observational and randomised clinical trials identified current outcome measures, which was supplemented by clinical practice guidelines and existing registries for contemporary definitions. A modified Delphi process was employed to gain consensus for variable inclusion and whether collection should be mandatory (Level 1) or optional (Level 2) within EuroHeart. In addition, a set of complementary outcome measures were identified by the Working Group as of scientific and clinical importance for longitudinal monitoring for people with heart failure., Results: Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure., Conclusion: We present a structured, hierarchical catalogue of internationally endorsed heart failure outcome measures. This will facilitate quality improvement, high quality observational research, registry-based trials, and post market surveillance of medical devices., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
4. Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts.
- Author
-
Peek N, Hindricks G, Akbarov A, Tijssen JGP, Jenkins DA, Kapacee Z, Parkes LM, van der Geest RJ, Longato E, Sprague D, Taleb Y, Ong M, Miller CA, Shamloo AS, Albert C, Barthel P, Boveda S, Braunschweig F, Johansen JB, Cook N, de Chillou C, Elders P, Faxén J, Friede T, Fusini L, Gale CP, Jarkovsky J, Jouven X, Junttila J, Kautzner J, Kiviniemi A, Kutyifa V, Leclercq C, Lee DC, Leigh J, Lenarczyk R, Leyva F, Maeng M, Manca A, Marijon E, Marschall U, Merino JL, Mont L, Nielsen JC, Olsen T, Pester J, Pontone G, Roca I, Schmidt G, Schwartz PJ, Sticherling C, Suleiman M, Taborsky M, Tan HL, Tfelt-Hansen J, Thiele H, Tomaselli GF, Verstraelen T, Vinayagamoorthy M, Olesen KKW, Wilde A, Willems R, Wu KC, Zabel M, Martin GP, and Dagres N
- Abstract
Background and Aims: Risk stratification of sudden cardiac death after myocardial infarction and prevention by defibrillator rely on left ventricular ejection fraction (LVEF). Improved risk stratification across the whole LVEF range is required for decision-making on defibrillator implantation., Methods: The analysis pooled 20 data sets with 140 204 post-myocardial infarction patients containing information on demographics, medical history, clinical characteristics, biomarkers, electrocardiography, echocardiography, and cardiac magnetic resonance imaging. Separate analyses were performed in patients (i) carrying a primary prevention cardioverter-defibrillator with LVEF ≤ 35% [implantable cardioverter-defibrillator (ICD) patients], (ii) without cardioverter-defibrillator with LVEF ≤ 35% (non-ICD patients ≤ 35%), and (iii) without cardioverter-defibrillator with LVEF > 35% (non-ICD patients >35%). Primary outcome was sudden cardiac death or, in defibrillator carriers, appropriate defibrillator therapy. Using a competing risk framework and systematic internal-external cross-validation, a model using LVEF only, a multivariable flexible parametric survival model, and a multivariable random forest survival model were developed and externally validated. Predictive performance was assessed by random effect meta-analysis., Results: There were 1326 primary outcomes in 7543 ICD patients, 1193 in 25 058 non-ICD patients ≤35%, and 1567 in 107 603 non-ICD patients >35% during mean follow-up of 30.0, 46.5, and 57.6 months, respectively. In these three subgroups, LVEF poorly predicted sudden cardiac death (c-statistics between 0.50 and 0.56). Considering additional parameters did not improve calibration and discrimination, and model generalizability was poor., Conclusions: More accurate risk stratification for sudden cardiac death and identification of low-risk individuals with severely reduced LVEF or of high-risk individuals with preserved LVEF was not feasible, neither using LVEF nor using other predictors., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
5. Phenotypic characterisation of people at risk of atrial fibrillation: Protocol for the FIND-AF longitudinal cohort study.
- Author
-
Wahab A, Nadarajah R, Reynolds C, Bennett S, Ambakederemo E, Harris M, Younsi T, Joesph T, Raveendera K, Smith A, Bhatty A, Lip GYH, Swoboda PP, Wu J, and Gale CP
- Abstract
Aims: The Future Innovations in Novel Detection of Atrial Fibrillation (FIND-AF) longitudinal cohort study is a multi-centre prospective cohort study of patients identified at risk of atrial fibrillation (AF). The aim of the FIND-AF longitudinal cohort study is to provide multi-modal phenotypic characterisation of these patients., Methods and Results: 1955 participants identified as at risk of AF by the FIND-AF algorithm from primary care electronic health (EHR) data, aged 30 years and above and eligible for oral anticoagulation, will be be recruited between October 2023 and November 2024 to receive home-based intermittent ECG monitoring. About 500 participants without diagnosed AF will then undergo cross-sectional phenotypic characterisation including physical examination, symptoms assessment, serum blood biomarkers and echocardiography, and non-stress cardiac magnetic resonance imaging. Longitudinal information about cardio-renal-metabolic-pulmonary outcomes will be ascertained from linkages to EHR data. The study is funded by the British Heart Foundation (CC/22/250026). The study has ethical approval (North West - Greater Manchester South Research Ethics Committee reference 23/NW/0180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder's open access policy., Conclusions: The FIND-AF multi-centre prospective longitudinal cohort study aims to (i) provide evidence for the impact of comorbidities on AF genesis (ii) uncover actionable targets to prevent AF, and (iii) act as a platform for cohort randomised clinical trials that investigate enhanced detection and prevention of AF., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
6. Association of baseline and changes in health-related quality of life with mortality following myocardial infarction: multicentre longitudinal linked cohort study.
- Author
-
Dondo TB, Munyombwe T, Hurdus B, Aktaa S, Hall M, Soloveva A, Nadarajah R, Haris M, West RM, Hall AS, and Gale CP
- Abstract
Background: Health-related quality of life (HRQoL) for patients following myocardial infarction (MI) is frequently impaired. We investigated the association of baseline and changes in HRQoL with mortality following MI., Methods and Results: Nationwide longitudinal study of 9474 patients admitted to 77 hospitals in England as part of the Evaluation of the Methods and Management of Acute Coronary Events study. Self-reported HRQoL was collected using EuroQol EQ-5D-3L during hospitalization and at 1, 6, and 12 months following discharge. The data was analysed using flexible parametric and multilevel survival models. Of 9474 individuals with MI, 2360 (25%) were women and 2135 (22.5%) died during the 9-year follow-up period. HRQoL improved over 12 months (baseline mean, mean increase: EQ-5D 0.76, 0.003 per month; EQ-VAS 69.0, 0.5 per month). At baseline, better HRQoL was inversely associated with mortality [Hazard ratio (HR) 0.55, 95% CI 0.47-0.63], and problems with self-care (HR 1.73, 1.56-1.92), mobility (1.65, 1.50-1.81), usual activities (1.34, 1.23-1.47), and pain/discomfort (1.34, 1.22-1.46) were associated with increased mortality. Deterioration in mobility, pain/discomfort, usual activities, and self-care over 12 months were associated with increased mortality (HR 1.43, 95% CI 1.31-1.58; 1.21, 1.11-1.32; 1.20, 1.10-1.32; 1.44, 1.30-1.59, respectively)., Conclusion: After MI, poor HRQoL at baseline, its dimensions, and deterioration over time are associated with an increased risk of mortality. Measuring HRQoL in routine clinical practice after MI could identify at-risk groups for interventions to improve prognosis., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
7. Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in COPD: A Post-hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS).
- Author
-
Singh D, Martinez FJ, Hurst JR, Han MK, Gale CP, Fredriksson M, Kisielewicz D, Mushunje A, Movitz C, Ojili N, Parikh H, Arya N, Bowen K, and Patel M
- Abstract
Rationale: Chronic obstructive pulmonary disease (COPD) is associated with increased risk of cardiovascular and cardiopulmonary events. In the Phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality versus dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF). However, the effect of BGF on cardiovascular events versus GFF remains unevaluated. Further, the effect of BGF on time to first severe exacerbation has not been reported. Objective: Assess the effects of BGF 320/18/9.6 μg (BGF 320) and other ICS-containing arms on cardiovascular and severe cardiopulmonary endpoints versus GFF in patients with COPD from ETHOS. Methods: Patients with moderate-to-very severe COPD and a history of exacerbations were randomized to twice-daily BGF 320, BGF 160/18/9.6 μg, BFF 320/9.6 μg, or GFF 18/9.6 µg (GFF). Time to first severe COPD exacerbation was a pre-specified endpoint; post-hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event (MACE), time to first cardiovascular adverse event (AE) of special interest (CVAESI), time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event. Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for CVAESI (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate-to-very severe COPD.
- Published
- 2024
- Full Text
- View/download PDF
8. Embracing the promise of Patient Reported Outcome Measures in cardiology.
- Author
-
Wilkinson C, Bhatty A, Smith AB, Dwight J, Sanders J, and Gale CP
- Published
- 2024
- Full Text
- View/download PDF
9. Impact of Chronic Kidney Disease on the Processes of Care and Long-Term Mortality of Non-ST-Segment-Elevation Myocardial Infarction: A Nationwide Cohort Study and Long-Term Follow-Up.
- Author
-
Weight N, Moledina S, Ullah M, Wijeysundera HC, Davies S, Chew NWS, Lawson C, Khan SU, Gale CP, Rashid M, and Mamas MA
- Subjects
- Humans, Male, Female, Aged, Middle Aged, United Kingdom epidemiology, Time Factors, Percutaneous Coronary Intervention statistics & numerical data, Percutaneous Coronary Intervention mortality, Follow-Up Studies, Risk Factors, Aged, 80 and over, Risk Assessment, Outcome and Process Assessment, Health Care, Renal Insufficiency, Chronic mortality, Renal Insufficiency, Chronic epidemiology, Renal Insufficiency, Chronic therapy, Renal Insufficiency, Chronic complications, Non-ST Elevated Myocardial Infarction mortality, Non-ST Elevated Myocardial Infarction therapy, Non-ST Elevated Myocardial Infarction diagnosis, Registries
- Abstract
Background: A growing population of patients with chronic kidney disease (CKD) presents with non-ST-segment-elevation myocardial infarction, although little is known about their longer-term mortality., Methods and Results: Using the MINAP (Myocardial Ischaemia National Audit Project) registry, linked to Office for National Statistics mortality data, we analyzed 363 559 UK patients with non-ST-segment-elevation myocardial infarction, with or without CKD. Cox regression models were fitted, adjusting for baseline demographics. Compared with patients without CKD, patients with CKD were less frequently prescribed P2Y12 inhibitors (89% versus 86%, P <0.001) less likely to undergo invasive angiography (67% versus 41%, P <0.001) or percutaneous coronary intervention (41% versus 25%, P <0.001), and were less often referred to cardiac rehabilitation (80% versus 66%, P <0.001). Following non-ST-segment-elevation myocardial infarction, patients with CKD had higher risk of 30-day (adjusted hazard ratio [HR], 1.24 [95% CI, 1.20-1.29], 1-year 1.47 [95% CI, 1.44-1.51]) and 5-year mortality 1.55 (95% CI, 1.53-1.58) than patients without CKD (all P <0.001). Risk of mortality over the entire study period was highest in CKD Stage 5 (HR, 2.98 [95% CI, 2.87-3.10]), even after excluding mortality ≤30 days (HR, 3.03 [95% CI, 2.90-3.17]) ( P <0.001). There was no significant difference in proportion of deaths attributable to cardiovascular disease at 30 days (CKD; 76% versus no CKD; 76%), or 1 -year (CKD; 62% versus no CKD; 62%)., Conclusions: Patients with CKD were significantly less likely to receive invasive investigation or undergo percutaneous coronary intervention and had significantly higher risk of short- and longer-term mortality. Risk of mortality increased with reducing CKD stage. Cardiovascular disease was the main cause of mortality in patients with CKD, but at comparable rates to the general population with non-ST-segment-elevation myocardial infarction.
- Published
- 2024
- Full Text
- View/download PDF
10. Cohort profile: the European Unified Registries On Heart Care Evaluation and Randomized Trials (EuroHeart)-acute coronary syndrome and percutaneous coronary intervention.
- Author
-
Bhatty A, Wilkinson C, Batra G, Alfredsson J, Erlinge D, Ferreira J, Guðmundsdóttir IJ, Hrafnkelsdóttir ÞJ, Ingimarsdóttir IJ, Irs A, Járai Z, Jánosi A, Popescu BA, Santos M, Vasko P, Vinereanu D, Yap J, Maggioni AP, Wallentin L, Casadei B, and Gale CP
- Subjects
- Humans, Female, Male, Europe epidemiology, Aged, Middle Aged, Randomized Controlled Trials as Topic, Percutaneous Coronary Intervention, Acute Coronary Syndrome therapy, Acute Coronary Syndrome surgery, Registries
- Abstract
Aims: The European Unified Registries On Heart Care Evaluation and Randomized Trials (EuroHeart) aims to improve the quality of care and clinical outcomes for patients with cardiovascular disease. The collaboration of acute coronary syndrome/percutaneous coronary intervention (ACS/PCI) registries is operational in seven vanguard European Society of Cardiology member countries., Methods and Results: Adults admitted to hospitals with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) are included, and individual patient-level data collected and aligned according to the internationally agreed EuroHeart data standards for ACS/PCI. The registries provide up to 155 variables spanning patient demographics and clinical characteristics, in-hospital care, in-hospital outcomes, and discharge medications. After performing statistical analyses on patient data, participating countries transfer aggregated data to EuroHeart for international reporting. Between 1st January 2022 and 31st December 2022, 40 021 admissions (STEMI 46.7%, NSTEMI 53.3%) were recorded from 192 hospitals in the seven vanguard countries: Estonia, Hungary, Iceland, Portugal, Romania, Singapore, and Sweden. The mean age for the cohort was 67.9 (standard deviation 12.6) years, and it included 12 628 (31.6%) women., Conclusion: The EuroHeart collaboration of ACS/PCI registries prospectively collects and analyses individual data for ACS and PCI at a national level, after which aggregated results are transferred to the EuroHeart Data Science Centre. The collaboration will expand to other countries and provide continuous insights into the provision of clinical care and outcomes for patients with ACS and undergoing PCI. It will serve as a unique international platform for quality improvement, observational research, and registry-based clinical trials., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
11. Presentation, care, coronary intervention and outcomes of patients with NSTEMI according to age: insights from the international prospective ACVC-EAPCI EORP NSTEMI registry.
- Author
-
Nadarajah R, Ludman P, Laroche C, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, Clegg A, and Gale CP
- Subjects
- Humans, Aged, Male, Female, Prospective Studies, Age Factors, Aged, 80 and over, Hospital Mortality, Treatment Outcome, Middle Aged, Comorbidity, Risk Factors, Percutaneous Coronary Intervention statistics & numerical data, Percutaneous Coronary Intervention mortality, Time Factors, Non-ST Elevated Myocardial Infarction therapy, Non-ST Elevated Myocardial Infarction mortality, Non-ST Elevated Myocardial Infarction diagnosis, Registries, Coronary Angiography statistics & numerical data
- Abstract
Background: Older people less frequently receive invasive coronary angiography (ICA) for NSTEMI than younger patients. We describe care, ICA data, and in-hospital and 30-day outcomes of NSTEMI by age in a contemporary and geographically diverse cohort., Methods: Prospective cohort study including 2947 patients with NSTEMI from 287 centres in 59 countries, stratified by age (≥75 years, n = 761). Quality of care was evaluated based on 12 guideline-recommended care interventions, and data collected on ICA. Outcomes included in hospital acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack, BARC Type ≥3 bleeding and death, as well as 30-day mortality., Results: Patients aged ≥75 years, compared with younger patients, at presentation had a higher prevalence of comorbidities and oral anticoagulation prescription (22.4% vs 7.6%, p < 0.001). Older patients less frequently received ICA than younger patients (78.6% vs 90.6%, p < 0.001) with the recorded reason more often being advanced age, comorbidities or frailty. Of those who underwent ICA, older patients more frequently demonstrated 3-vessel, 4-vessel and/or left main stem coronary artery disease compared to younger patients (49.7% vs 34.1%, p < 0.001) but less frequently received revascularisation (63.6% vs 76.9%, p < 0.001). Older patients experienced higher rates of in-hospital acute heart failure (15.0% vs 8.4%, p < 0.001) and bleeding (2.8% vs 1.3%, p = 0.006), as well as in-hospital and 30-day mortality (3.4% vs 1.3%, p < 0.001; 4.8% vs 1.7%, p < 0.001; respectively), than younger patients., Conclusions: Patients aged ≥75 years with NSTEMI, compared with younger patients, less frequently received ICA and guideline-recommended care, and had worse short-term outcomes., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF
12. European Society of Cardiology quality indicators update for the care and outcomes of adults with heart failure. The Heart Failure Association of the ESC.
- Author
-
Abdin A, Wilkinson C, Aktaa S, Böhm M, Polovina M, Rosano G, Lainscak M, Lund LH, McDonagh T, Metra M, Adamo M, Mindham R, Piepoli M, Abdelhamid M, Störk S, Tokmakova MP, Seferović P, Coats AJS, and Gale CP
- Abstract
Aims: To update the European Society of Cardiology (ESC) quality indicators (QIs) for the evaluation of the care and outcomes of adults with heart failure., Methods and Results: The Working Group comprised experts in heart failure including members of the ESC Clinical Practice Guidelines Task Force for heart failure, members of the Heart Failure Association, and a patient representative. We followed the ESC methodology for QI development. The 2023 focused guideline update was reviewed to assess the suitability of the recommendations with strongest association with benefit and harm against the ESC criteria for QIs. All the new proposed QIs were individually graded by each panellist via online questionnaires for both validity and feasibility. The existing heart failure QIs also underwent voting to 'keep', 'remove' or 'modify'. Five domains of care for the management of heart failure were identified: (1) structural QIs, (2) patient assessment, (3) initial treatment, (4) therapy optimization, and (5) patient health-related quality of life. In total, 14 'main' and 3 'secondary' QIs were selected across the five domains., Conclusion: This document provides an update of the previously published ESC QIs for heart failure to ensure that these measures are aligned with contemporary evidence. The QIs may be used to quantify adherence to clinical practice as recommended in guidelines to improve the care and outcomes of patients with heart failure., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
13. Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association.
- Author
-
Sterliński M, Bunting KV, Boriani G, Boveda S, Guasch E, Mont L, Rajappan K, Sommer P, Mehta S, Sun Y, Gale CP, van Deutekom C, Van Gelder IC, and Kotecha D
- Subjects
- Humans, Female, Male, Aged, Europe, Middle Aged, Stroke prevention & control, Treatment Outcome, Research Design, Cardiology standards, Cardiology education, Anticoagulants therapeutic use, Practice Patterns, Physicians' standards, Anti-Arrhythmia Agents therapeutic use, Atrial Fibrillation therapy, Atrial Fibrillation drug therapy, Atrial Fibrillation diagnosis, Guideline Adherence, Practice Guidelines as Topic
- Abstract
Aims: The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial., Methods and Results: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022-23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers., Conclusion: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care., Clinical Trial Registration: Clinicaltrials.gov, NCT04396418., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
14. Implications of Cardiopulmonary Risk for the Management of COPD: A Narrative Review.
- Author
-
Singh D, Han MK, Hawkins NM, Hurst JR, Kocks JWH, Skolnik N, Stolz D, El Khoury J, and Gale CP
- Subjects
- Humans, Disease Progression, Risk Factors, Heart Disease Risk Factors, Pulmonary Disease, Chronic Obstructive complications, Pulmonary Disease, Chronic Obstructive therapy, Cardiovascular Diseases prevention & control, Cardiovascular Diseases etiology
- Abstract
Chronic obstructive pulmonary disease (COPD) constitutes a major global health burden and is the third leading cause of death worldwide. A high proportion of patients with COPD have cardiovascular disease, but there is also evidence that COPD is a risk factor for adverse outcomes in cardiovascular disease. Patients with COPD frequently die of respiratory and cardiovascular causes, yet the identification and management of cardiopulmonary risk remain suboptimal owing to limited awareness and clinical intervention. Acute exacerbations punctuate the progression of COPD in many patients, reducing lung function and increasing the risk of subsequent exacerbations and cardiovascular events that may lead to early death. This narrative review defines and summarises the principles of COPD-associated cardiopulmonary risk, and examines respiratory interventions currently available to modify this risk, as well as providing expert opinion on future approaches to addressing cardiopulmonary risk., (© 2024. The Author(s).)
- Published
- 2024
- Full Text
- View/download PDF
15. Coronary revascularization and sex differences in cardiovascular mortality after myocardial infarction in 12 high and middle-income European countries.
- Author
-
Cenko E, Yoon J, Bergami M, Gale CP, Vasiljevic Z, Vavlukis M, Kedev S, Miličić D, Dorobantu M, Badimon L, Manfrini O, and Bugiardini R
- Abstract
Background: Existing data on female sex and excess cardiovascular mortality after myocardial infarction (MI) mostly come from high-income countries (HICs). This study aimed to investigate how sex disparities in treatments and outcomes vary across countries with different income levels., Methods: Data from the ISACS-Archives registry included 22 087 MI patients from 6 HICs and 6 middle-income countries (MICs). MI data were disaggregated by clinical presentation: ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). The primary outcome was 30-day mortality., Results: Among STEMI patients, women in MICs had nearly double the 30-day mortality rate of men (12.4% versus 5.8%; adjusted risk ratio [RR] 2.30, 95% CI 1.98-2.68). This difference was less pronounced in HICs (6.8% versus 5.1%; RR 1.36, 95% CI 1.05-1.75). Despite more frequent treatments and timely revascularization in MICs, sex-based mortality differences persisted even after revascularization (8.0% versus 4.1%; RR 2.05, 95% CI, 1.68-2.50 in MICs and 5.6% versus 2.6%; RR 2.17, 95% CI 1.48-3.18) in HICs. Additionally, women from MICs had higher diabetes rates compared to HICs (31.8% versus 25.1%, standardized difference = 0.15). NSTEMI outcomes were relatively similar between sexes and income groups., Conclusions: Sex disparities in mortality rates following STEMI are more pronounced in MICs compared to HICs. These disparities cannot be solely attributed to sex-related inequities in revascularization. Variations in mortality may also be influenced by sex differences in socioeconomic factors and baseline comorbidities., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
16. Announcing The Lancet Regional Health-Europe commission on inequalities and disparities in cardiovascular health.
- Author
-
Bugiardini R, Gale CP, Gulati M, Anand SS, Maas AHEM, Townsend N, Vaccarino V, Badimon L, Cenko E, Manfrini O, and Jha P
- Abstract
Competing Interests: RB reports participation on the data safety monitoring board of Aptabio Therapeutics. CG reports funding from Horizon 2020, grants or contracts from Alan Turing Institute, British Heart Foundation, National Institute for Health Research, Abbott Diabetes, Bristol Myers Squibb and European Society of Cardiology, consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, CardioMatics, Chiesi, Daiichi Sankyo, GPRI Research B.V., Menarini, Novartis, iRhythm, Organon, The Phoenix Group; fees from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical and Zydus; participation on the data safety monitoring board or advisory board of DANBLCOK trial and TARGET CTCA trial; fiduciary role as Deputy Editor: EHJ Quality of Care and Clinical Outcomes, NICE Indicator Advisory Committee, and Chair ESC Quality Indicator Committee: stock or stock options of CardioMatics; and receipt of other services from Kosmos device. MG reports unpaid leadership or fiduciary role as President of The American Society for Preventive Cardiology. SSA reports leadership or fiduciary role as Associate Vice-President of Global Health; McMaster University and Department of Medicine's Associate Chair of Equity and Diversity; McMaster University; Other financial or non-financial interests: Tier 1 Canada Research Chair in Ethnicity and CVD, Chair in Population Health of Heart & Stroke Foundation and Foundational and grant from Canadian Institutes of Health Research. AHEMM decares consulting fees from Philips and Organon. The other authors have no relevant conflicts of interest to declare related to this manuscript.
- Published
- 2024
- Full Text
- View/download PDF
17. MACE in COPD: addressing cardiopulmonary risk.
- Author
-
Hurst JR and Gale CP
- Subjects
- Humans, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Risk Factors, Pulmonary Disease, Chronic Obstructive epidemiology
- Published
- 2024
- Full Text
- View/download PDF
18. Prediction of incident chronic kidney disease in community-based electronic health records: a systematic review and meta-analysis.
- Author
-
Haris M, Raveendra K, Travlos CK, Lewington A, Wu J, Shuweidhi F, Nadarajah R, and Gale CP
- Abstract
Background: Chronic kidney disease (CKD) is a major global health problem and its early identification would allow timely intervention to reduce complications. We performed a systematic review and meta-analysis of multivariable prediction models derived and/or validated in community-based electronic health records (EHRs) for the prediction of incident CKD in the community., Methods: Ovid Medline and Ovid Embase were searched for records from 1947 to 31 January 2024. Measures of discrimination were extracted and pooled by Bayesian meta-analysis, with heterogeneity assessed through a 95% prediction interval (PI). Risk of bias was assessed using Prediction model Risk Of Bias ASsessment Tool (PROBAST) and certainty in effect estimates by Grading of Recommendations, Assessment, Development and Evaluation (GRADE)., Results: Seven studies met inclusion criteria, describing 12 prediction models, with two eligible for meta-analysis including 2 173 202 patients. The Chronic Kidney Disease Prognosis Consortium (CKD-PC) (summary c-statistic 0.847; 95% CI 0.827-0.867; 95% PI 0.780-0.905) and SCreening for Occult REnal Disease (SCORED) (summary c-statistic 0.811; 95% CI 0.691-0.926; 95% PI 0.514-0.992) models had good model discrimination performance. Risk of bias was high in 64% of models, and driven by the analysis domain. No model met eligibility for meta-analysis if studies at high risk of bias were excluded, and certainty of effect estimates was 'low'. No clinical utility analyses or clinical impact studies were found for any of the models., Conclusions: Models derived and/or externally validated for prediction of incident CKD in community-based EHRs demonstrate good prediction performance, but assessment of clinical usefulness is limited by high risk of bias, low certainty of evidence and a lack of impact studies., Competing Interests: C.P.G. received honoraria for consulting and/or speeches from AstraZeneca, Amgen, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group and Oxford University Press. All the other authors declared no competing interests. The authors had full responsibility for data collection, data interpretation and writing of the report., (© The Author(s) 2024. Published by Oxford University Press on behalf of the ERA.)
- Published
- 2024
- Full Text
- View/download PDF
19. Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial.
- Author
-
Kite TA, Ladwiniec A, Greenwood JP, Gale CP, Anantharam B, More R, Hetherington SL, Khan SQ, O'Kane P, Rakhit R, Chase A, Barber S, Waheed G, Berry C, Flather M, McCann GP, Curzen N, Banning AP, and Gershlick AH
- Subjects
- Humans, Pandemics, Treatment Outcome, Coronary Angiography, Acute Coronary Syndrome diagnosis, Non-ST Elevated Myocardial Infarction, Percutaneous Coronary Intervention adverse effects
- Abstract
Objective: To investigate whether a very early invasive strategy (IS)±revascularisation improves clinical outcomes compared with standard care IS in higher risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS)., Methods: Multicentre, randomised, controlled, pragmatic strategy trial of higher risk patients with NSTE-ACS, defined by Global Registry of Acute Coronary Events 2.0 score of ≥118, or ≥90 with at least one additional high-risk feature. Participants were randomly assigned to very early IS±revascularisation (<90 min from randomisation) or standard care IS±revascularisation (<72 hours). The primary outcome was a composite of all-cause mortality, new myocardial infarction or hospitalisation for heart failure at 12 months., Results: The trial was discontinued early by the funder due to slow recruitment during the COVID-19 pandemic. 425 patients were randomised, of whom 413 underwent an IS: 204 to very early IS (median time from randomisation: 1.5 hours (IQR: 0.9-2.0)) and 209 to standard care IS (median: 44.0 hours (IQR: 22.9-72.6)). At 12 months, there was no significant difference in the primary outcome between the early IS (5.9%) and standard IS (6.7%) groups (OR 0.93, 95% CI 0.42 to 2.09; p=0.86). The incidence of stroke and major bleeding was similar. The length of hospital stay was reduced with a very early IS (3.9 days (SD 6.5) vs 6.3 days (SD 7.6), p<0.01)., Conclusions: A strategy of very early IS did not improve clinical outcomes compared with a standard care IS in higher risk patients with NSTE-ACS. However, the primary outcome rate was low and the trial was underpowered to detect such a difference., Trial Registration Number: NCT03707314., Competing Interests: Competing interests: NC has received unrestricted grants from HeartFlow, Boston Scientific, Haemonetics and Beckman Coulter; speaker fees from Abbott and Boston Scientific; and travel sponsorship from Edwards Lifesciences, Boston Scientific, Abbott and Biosensors., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2024
- Full Text
- View/download PDF
20. Defining the need for cardiovascular event definitions.
- Author
-
Bhatty A, Wilkinson C, Sydes M, and Gale CP
- Subjects
- Humans, Cardiovascular Diseases epidemiology
- Published
- 2024
- Full Text
- View/download PDF
21. Health outcomes after myocardial infarction: A population study of 56 million people in England.
- Author
-
Hall M, Smith L, Wu J, Hayward C, Batty JA, Lambert PC, Hemingway H, and Gale CP
- Subjects
- Humans, Male, Adolescent, Adult, Aged, Female, Cohort Studies, State Medicine, Outcome Assessment, Health Care, Atrial Fibrillation diagnosis, Myocardial Infarction epidemiology, Heart Failure complications, Diabetes Mellitus, Cerebrovascular Disorders, Dementia, Renal Insufficiency complications, Neoplasms complications
- Abstract
Background: The occurrence of a range of health outcomes following myocardial infarction (MI) is unknown. Therefore, this study aimed to determine the long-term risk of major health outcomes following MI and generate sociodemographic stratified risk charts in order to inform care recommendations in the post-MI period and underpin shared decision making., Methods and Findings: This nationwide cohort study includes all individuals aged ≥18 years admitted to one of 229 National Health Service (NHS) Trusts in England between 1 January 2008 and 31 January 2017 (final follow-up 27 March 2017). We analysed 11 non-fatal health outcomes (subsequent MI and first hospitalisation for heart failure, atrial fibrillation, cerebrovascular disease, peripheral arterial disease, severe bleeding, renal failure, diabetes mellitus, dementia, depression, and cancer) and all-cause mortality. Of the 55,619,430 population of England, 34,116,257 individuals contributing to 145,912,852 hospitalisations were included (mean age 41.7 years (standard deviation [SD 26.1]); n = 14,747,198 (44.2%) male). There were 433,361 individuals with MI (mean age 67.4 years [SD 14.4)]; n = 283,742 (65.5%) male). Following MI, all-cause mortality was the most frequent event (adjusted cumulative incidence at 9 years 37.8% (95% confidence interval [CI] [37.6,37.9]), followed by heart failure (29.6%; 95% CI [29.4,29.7]), renal failure (27.2%; 95% CI [27.0,27.4]), atrial fibrillation (22.3%; 95% CI [22.2,22.5]), severe bleeding (19.0%; 95% CI [18.8,19.1]), diabetes (17.0%; 95% CI [16.9,17.1]), cancer (13.5%; 95% CI [13.3,13.6]), cerebrovascular disease (12.5%; 95% CI [12.4,12.7]), depression (8.9%; 95% CI [8.7,9.0]), dementia (7.8%; 95% CI [7.7,7.9]), subsequent MI (7.1%; 95% CI [7.0,7.2]), and peripheral arterial disease (6.5%; 95% CI [6.4,6.6]). Compared with a risk-set matched population of 2,001,310 individuals, first hospitalisation of all non-fatal health outcomes were increased after MI, except for dementia (adjusted hazard ratio [aHR] 1.01; 95% CI [0.99,1.02];p = 0.468) and cancer (aHR 0.56; 95% CI [0.56,0.57];p < 0.001). The study includes data from secondary care only-as such diagnoses made outside of secondary care may have been missed leading to the potential underestimation of the total burden of disease following MI., Conclusions: In this study, up to a third of patients with MI developed heart failure or renal failure, 7% had another MI, and 38% died within 9 years (compared with 35% deaths among matched individuals). The incidence of all health outcomes, except dementia and cancer, was higher than expected during the normal life course without MI following adjustment for age, sex, year, and socioeconomic deprivation. Efforts targeted to prevent or limit the accrual of chronic, multisystem disease states following MI are needed and should be guided by the demographic-specific risk charts derived in this study., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: MH declares research grant income from the Wellcome Trust, British Heart Foundation and Alan Turing Institute. JAB declares research grant income from the Wellcome Trust. CPG has received funding, not in relation to this study, from Abbott Diabetes, Bristol Myers Squibb and the European Society of Cardiology, and consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, CardioMatics, Chiesi, Daiichi Sankyo, GPRI Research B.V., Menarini, Novartis, iRhyth, Organon as well as payment for honoraria or lectures from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical, Zydus. CPG declares participation on Data Safety Monitoring or Advisory boards for the DANBLCOK and TARGET CTCA trials and editorial and committee membership of the NICE Indicator Advisory Committee, EHJ Quality of Care and Clinical Outcomes and ESC Quality Indicator Committee. CH, LS, JW, HH, and PCL have no competing interests to declare., (Copyright: © 2024 Hall et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
- Published
- 2024
- Full Text
- View/download PDF
22. Sex-specific presentation, care, and clinical events in individuals admitted with NSTEMI: the ACVC-EAPCI EORP NSTEMI registry of the European Society of Cardiology.
- Author
-
Nadarajah R, Ludman P, Laroche C, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, and Gale CP
- Subjects
- Male, Humans, Female, Prospective Studies, Risk Factors, Registries, Non-ST Elevated Myocardial Infarction diagnosis, Non-ST Elevated Myocardial Infarction epidemiology, Non-ST Elevated Myocardial Infarction therapy, Myocardial Infarction, ST Elevation Myocardial Infarction, Cardiology
- Abstract
Aims: Women have historically been disadvantaged in terms of care and outcomes for non-ST-segment elevation myocardial infarction (NSTEMI). We describe patterns of presentation, care, and outcomes for NSTEMI by sex in a contemporary and geographically diverse cohort., Methods and Results: Prospective cohort study including 2947 patients (907 women, 2040 men) with Type I NSTEMI from 287 centres in 59 countries, stratified by sex. Quality of care was evaluated based on 12 guideline-recommended care interventions. The all-or-none scoring composite performance measure was used to define receipt of optimal care. Outcomes included acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack, BARC Type ≥3 bleeding, or death in-hospital, as well as 30-day mortality. Women admitted with NSTEMI were older, more comorbid, and more frequently categorized as at higher ischaemic (GRACE >140, 54.0% vs. 41.7%, P < 0.001) and bleeding (CRUSADE >40, 51.7% vs. 17.6%, P < 0.001) risk than men. Women less frequently received invasive coronary angiography (ICA; 83.0% vs. 89.5%, P < 0.001), smoking cessation advice (46.4% vs. 69.5%, P < 0.001), and P2Y12 inhibitor prescription at discharge (81.9% vs. 90.0%, P < 0.001). Non-receipt of ICA was more often due to frailty for women than men (16.7% vs. 7.8%, P = 0.010). At ICA, more women than men had non-obstructive coronary artery disease or angiographically normal arteries (15.8% vs. 6.3%, P < 0.001). Rates of in-hospital adverse outcomes and 30-day mortality were low and did not differ by sex., Conclusion: In contemporary practice, women presenting with NSTEMI, compared with men, less frequently receive antiplatelet prescription, smoking cessation advice, or are considered eligible for ICA., Competing Interests: Conflict of interest: H.B., K.H., P.L., R.N., and V.K. report no conflict of interest. C.P.G. reports personal fees from AstraZeneca, Amgen, Bayer, Boehrinher-Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group, and Oxford University Press. He has received educational and research grants from BMS, Abbott Inc., the British Heart Foundation, National Institute of Health Research, Horizon 2020, and from the European Society of Cardiology, outside the submitted work. S.B. reports personal fees from Boston Scientific, Insight, Lifetech, iVascular, and Abbott Vascular. D.M. reports personal fees from Abbott, Boston Scientific, Biosensors and Terumo. He has participated on Data Safety Monitoring Boards or Advisory Boards for Abbott and Boston Scientific. A.B. reports personal and institutional investigator fees from AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, Novartis, Amgen, Novo Nordisk, and Bayer. He reports personal fees from AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, Novartis, and Bayer. He has participated in Data Safety Monitoring Boards or Advisory Boards for AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, and Bayer. He has received support for attending meetings by Astra Zeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, and Bayer. S.L. reports personal fees from ICON, Chiesi, AstraZeneca, Daiichi Sankyo, Bayer, Bristol Myers Squibb/Pfizer, and Novo Nordisk. M.L. reports speaker fees from Bristol Myers Squibb/Pfizer, Boehrinher-Ingelheim, Novartis and sanofi, and manuscript writing fees from Edwards Lifesciences. She has also participated as an advisory board member for sanofi, Bristol Myers Squibb/Pfizer, and Boehrinher-Ingelheim. Y.A. reports a research grant from the Dutch Heart Foundation. Signed COIs available for all authors., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF
23. Exacerbating the burden of cardiovascular disease: how can we address cardiopulmonary risk in individuals with chronic obstructive pulmonary disease?
- Author
-
Shrikrishna D, Taylor CJ, Stonham C, and Gale CP
- Subjects
- Humans, Heart, Cardiovascular Diseases prevention & control, Pulmonary Disease, Chronic Obstructive complications
- Published
- 2024
- Full Text
- View/download PDF
24. European Society of Cardiology Quality indicators for the care and outcomes of adults undergoing transcatheter aortic valve implantation.
- Author
-
Ali N, Aktaa S, Younsi T, Beska B, Batra G, Blackman DJ, James S, Ludman P, Mamas MA, Abdel-Wahab M, Borregaard B, Iung B, Joner M, Kunadian V, Modine T, Neylon A, Petronio AS, Pibarot P, Popescu BA, Sabaté M, Stortecky S, Teles RC, Treede H, and Gale CP
- Abstract
Background and Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI)., Methods: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs., Results: We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry., Conclusion: We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
25. Automated external defibrillator location and socioeconomic deprivation in Great Britain.
- Author
-
Burgoine T, Austin D, Wu J, Quinn T, Shurmer P, Gale CP, and Wilkinson C
- Subjects
- Humans, United Kingdom epidemiology, Cross-Sectional Studies, Defibrillators, Socioeconomic Factors, Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest therapy, Emergency Medical Services
- Abstract
Objective: The early use of automated external defibrillators (AEDs) improves outcomes in out-of-hospital cardiac arrest (OHCA). We investigated AED access across Great Britain (GB) according to socioeconomic deprivation., Methods: Cross-sectional observational study using AED location data from The Circuit: the national defibrillator network led by the British Heart Foundation in partnership with the Association of Ambulance Chief Executives, Resuscitation Council UK and St John Ambulance. We calculated street network distances between all 1 677 466 postcodes in GB and the nearest AED and used a multilevel linear mixed regression model to investigate associations between the distances from each postcode to the nearest AED and Index of Multiple Deprivation, stratified by country and according to 24 hours 7 days a week (24/7) access., Results: 78 425 AED locations were included. Across GB, the median distance from the centre of a postcode to an AED was 726 m (England: 739 m, Scotland: 743 m, Wales: 512 m). For 24/7 access AEDs, the median distances were further (991 m, 994 m, 570 m). In Wales, the average distance to the nearest AED and 24/7 AED was shorter for the most deprived communities. In England, the average distance to the nearest AED was also shorter in the most deprived areas. There was no association between deprivation and average distance to the nearest AED in Scotland. However, the distance to the nearest 24/7 AED was greater with increased deprivation in England and Scotland. On average, a 24/7 AED was in England and Scotland, respectively, 99.2 m and 317.1 m further away in the most deprived than least deprived communities., Conclusion: In England and Scotland, there are differences in distances to the nearest 24/7 accessible AED between the most and least deprived communities. Equitable access to 'out-of-hours' accessible AEDs may improve outcomes for people with OHCA., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2024
- Full Text
- View/download PDF
26. Heart Failure Readmission in Patients With ST-Segment Elevation Myocardial Infarction and Active Cancer.
- Author
-
Dafaalla M, Abramov D, Van Spall HGC, Ghosh AK, Gale CP, Zaman S, Rashid M, and Mamas MA
- Abstract
Background: Although numerous studies have examined readmission with heart failure (HF) after acute myocardial infarction (AMI), limited data are available on HF readmission in cancer patients post-AMI., Objectives: This study aimed to assess the rates and factors associated with HF readmission in cancer patients presenting with ST-segment elevation myocardial infarction (STEMI)., Methods: A nationally linked cohort of STEMI patients between January 2005 and March 2019 were obtained from the UK Myocardial Infarction National Audit Project registry and the UK national Hospital Episode Statistics Admitted Patient Care registry. Multivariable Fine-Gray competing risk models were used to evaluate HF readmission at 30 days and 1 year., Results: A total of 326,551 STEMI indexed admissions were included, with 7,090 (2.2%) patients having active cancer. The cancer group was less likely to be admitted under the care of a cardiologist (74.5% vs 81.9%) and had lower rates of invasive coronary angiography (62.2% vs 72.7%; P < 0.001) and percutaneous coronary intervention (58.4% vs. 69.5%). There was a significant prescription gap in the administration of post-AMI medications upon discharge such as an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (49.5% vs 71.1%) and beta-blockers (58.4% vs 68.0%) in cancer patients. The cancer group had a higher rate of HF readmission at 30 days (3.2% vs 2.3%) and 1 year (9.4% vs 7.3%). However, after adjustment, cancer was not independently associated with HF readmission at 30 days (subdistribution HR: 1.05; 95% CI: 0.86-1.28) or 1 year (subdistribution HR: 1.03; 95% CI: 0.92-1.16). The opportunity-based quality indicator was associated with higher rates of HF readmission independent of cancer diagnosis., Conclusions: Cancer patients receive care that differs in important ways from patients without cancer. Greater implementation of evidence-based care may reduce HF readmissions, including in cancer patients., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)
- Published
- 2024
- Full Text
- View/download PDF
27. Diabetes mellitus and presentation, care and outcomes of patients with NSTEMI: the Association for Acute Cardiovascular Care-European Association of Percutaneous Cardiovascular Interventions EURObservational Research Programme NSTEMI Registry of the European Society of Cardiology.
- Author
-
Nadarajah R, Ludman P, Laroche C, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, Ajjan R, Marx N, and Gale CP
- Abstract
Aim: Diabetes mellitus (diabetes) is common amongst patients with NSTEMI. We describe presentation, care and outcomes of patients admitted with NSTEMI by diabetes status., Methods: Prospective cohort study including 2928 patients (1104 with prior diabetes, 1824 without) admitted to hospital with NSTEMI from 287 centres in 59 countries. Quality of care was evaluated based on 12 guideline-recommended care interventions. Outcomes included in-hospital acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack (TIA), BARC Type ≥ 3 bleeding and death, as well as 30-day mortality., Results: Patients with diabetes had higher comorbidity burden and more frequently presented with Killip Class II-IV heart failure (10.2% vs 3.7%, P < 0.001), haemodynamic instability (7.1% vs 3.7%, P < 0.001) and ongoing chest pain (43.1% vs 37.0%, P < 0.001), than those without diabetes. Overall, care quality received was similar by diabetes status (60.0% vs 60.5% received ≥ 80% of eligible care interventions, P = 0.786), but patients with diabetes experienced higher rates of in-hospital acute heart failure (15.3% vs 6.8% P < 0.001), cardiogenic shock (4.5% vs 2.5%, P = 0.002), stroke/TIA (2.0% vs 0.8%, P = 0.006) and death (2.5% vs 1.4%, P = 0.022), and higher 30-day mortality (3.3% vs 2.0%, P = 0.025). Of NSTEMI with diabetes, only 1.9% and 9.0% received prescription for GLP-1 RAs and SGLT2 inhibitors, respectively, on discharge, and only 45.9% were referred for cardiac rehabilitation., Conclusion: NSTEMI patients with diabetes, compared to those without, present more clinically unwell and have worse outcomes despite receiving equal quality of care. Prescription of cardiovascular-protective glycaemic agents is an actionable target to reduce risk of further events., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2024
- Full Text
- View/download PDF
28. Outcomes of ST elevation myocardial infarction in patients with cancer: a nationwide study.
- Author
-
Dafaalla M, Abdel-Qadir H, Gale CP, Sun L, López-Fernández T, Miller RJH, Wojakowski W, Nolan J, Rashid M, and Mamas MA
- Subjects
- Male, Humans, Hospital Mortality, Hemorrhage, ST Elevation Myocardial Infarction epidemiology, ST Elevation Myocardial Infarction surgery, Myocardial Infarction, Lung Neoplasms complications, Lung Neoplasms epidemiology, Colonic Neoplasms
- Abstract
Aims: To assess processes of care and clinical outcomes in cancer patients with ST elevation myocardial infarction (STEMI) according to cancer type., Methods and Results: This is a national population-based study of patients admitted with STEMI in the UK between January 2005 and March 2019. Data were obtained from the National Heart Attack Myocardial Infarction National Audit Project (MINAP) registry and the Hospital Episode Statistics registry. We identified 353 448 STEMI-indexed admissions between 2005 and 2019. Of those, 8581 (2.4%) had active cancer. Prostate cancer (29% of STEMI patients with cancer) was the most common cancer followed by haematologic malignancies (14%) and lung cancer (13%). Cancer patients were less likely to receive invasive coronary revascularization (60.0% vs. 71.6%, P < 0.001] and had higher in-hospital death [odd ratio (OR) 1.39, 95% confidence interval (CI) 1.25-1.54] and bleeding (OR 1.23, 95% CI 1.03-1.46). Cancer patients had higher mortality at 30 days (HR 2.39, 95% CI 2.19-2.62) and 1 year (HR 3.73, 95% CI 3.58-3.89). Lung cancer was the cancer associated with the highest risk of death in the hospital (OR 1.75, 95% CI 1.39-2.22) and at 1 year (OR 8.08, 95% CI 7.44-8.78). Colon cancer (OR 1.98, 95% CI 1.24-3.14) was the main cancer associated with major bleeding. All common cancer types were associated with higher mortality at 1 year. Cardiovascular death (62%) was the main cause of death in the first 30 days, while cancer (52%) was the main cause of death within 1 year., Conclusion: STEMI patients with cancer have a higher risk of short- and long-term mortality, particularly lung cancer. Colon cancer is the main cancer associated with major bleeding. Cardiovascular disease was the main cause of death in the first month, whereas cancer was the main cause of death within 1 year., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
29. Risk of atrial fibrillation and association with other diseases: protocol of the derivation and international external validation of a prediction model using nationwide population-based electronic health records.
- Author
-
Nadarajah R, Wu J, Arbel R, Haim M, Zahger D, Benita TR, Rokach L, Cowan JC, and Gale CP
- Subjects
- Humans, Electronic Health Records, Incidence, Systematic Reviews as Topic, Atrial Fibrillation complications, Atrial Fibrillation epidemiology, Atrial Fibrillation diagnosis, Stroke epidemiology, Stroke prevention & control
- Abstract
Introduction: Atrial fibrillation (AF) is a major public health issue and there is rationale for the early diagnosis of AF before the first complication occurs. Previous AF screening research is limited by low yields of new cases and strokes prevented in the screened populations. For AF screening to be clinically and cost-effective, the efficiency of identification of newly diagnosed AF needs to be improved and the intervention offered may have to extend beyond oral anticoagulation for stroke prophylaxis. Previous prediction models for incident AF have been limited by their data sources and methodologies., Methods and Analysis: We will investigate the application of random forest and multivariable logistic regression to predict incident AF within a 6-month prediction horizon, that is, a time-window consistent with conducting investigation for AF. The Clinical Practice Research Datalink (CPRD)-GOLD dataset will be used for derivation, and the Clalit Health Services (CHS) dataset will be used for international external geographical validation. Analyses will include metrics of prediction performance and clinical utility. We will create Kaplan-Meier plots for individuals identified as higher and lower predicted risk of AF and derive the cumulative incidence rate for non-AF cardio-renal-metabolic diseases and death over the longer term to establish how predicted AF risk is associated with a range of new non-AF disease states., Ethics and Dissemination: Permission for CPRD-GOLD was obtained from CPRD (ref no: 19_076). The CPRD ethical approval committee approved the study. CHS Helsinki committee approval 21-0169 and data usage committee approval 901. The results will be submitted as a research paper for publication to a peer-reviewed journal and presented at peer-reviewed conferences., Trial Registration Number: A systematic review to guide the overall project was registered on PROSPERO (registration number CRD42021245093). The study was registered on ClinicalTrials.gov (NCT05837364)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
30. Temporal analysis of non-ST segment elevation-acute coronary syndrome (NSTEACS) outcomes in 'young' patients under the age of fifty: A nationwide cohort study.
- Author
-
Weight N, Moledina S, Rashid M, Chew N, Castelletti S, Buchanan GL, Salinger S, Gale CP, and Mamas MA
- Abstract
Background: The characteristics and risk factor profile of young patients presenting with non-ST segment elevation acute coronary syndrome (NSTEACS) and how they may have changed over time is not well reported., Methods: We identified 26,708 NSTEACS patients aged under 50 presenting to United Kingdom (UK) hospitals between 2010 and 2017 from Myocardial Ischaemia National Audit Project (MINAP). We calculated incidence of NSTEACS per 100,000 UK population, using Office of National Statistics (ONS) population estimates, prevalence of comorbidities, ethnicity, and in-hospital mortality. We formed biennial groups to enable comparison, 2010-2011, 2012-2013, 2014-2015 and 2016-2017., Results: The incidence of NSTEACS per 100,000 population showed minimal change between 2010 and 2017 (2010: 5.4 per 100,000 and 2017; 4.9 per 100,000). Rates of smoking (2010-11; 58% and 2016-17; 53%), and family history of coronary artery disease (CAD) (2010-11; 51% and 2016-17; 44%) fell, but the proportion of patients from an ethnic minority background (2010-11; 12% and 2016-17; 20%), with diabetes mellitus (DM) (2010-11; 14%, and 2016-17; 18%) and female patients (2010-11; 22% and 2016-17; 24%) increased over the study period. Mortality from NSTEACS remained unchanged (2010-11; 1% and 2016-17; 1%)., Conclusions: The incidence of NSTEACS in patients aged under fifty has not reduced despite reduction in prevalence of risk factors such as smoking hypercholesterolaemia in those admitted to UK hospitals. Despite improved rates of early invasive coronary angiography and percutaneous coronary intervention in 'young' NSTEACS patients, in-hospital mortality remains unchanged., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
31. Clinical Outcomes of Left Bundle Branch Area Pacing Compared with Biventricular Pacing in Patients with Heart Failure Requiring Cardiac Resynchronization Therapy: Systematic Review and Meta-Analysis.
- Author
-
Leventopoulos G, Travlos CK, Anagnostopoulou V, Patrinos P, Papageorgiou A, Perperis A, Gale CP, Gatzoulis KΑ, and Davlouros P
- Abstract
Background: Biventricular pacing (BVP) is recommended for patients with heart failure (HF) who require cardiac resynchronization therapy (CRT). Left bundle branch area pacing (LBBAP) is a novel pacing strategy that appears to ensure better electrical and mechanical synchrony in these patients. Our aim was to systematically review and meta-analyze the existing evidence regarding the clinical outcomes of LBBAP-CRT compared with BVP-CRT., Methods: Medline, Embase, Cochrane Central Register of Controlled Trials and Web of Science databases were searched for studies comparing LBBAP-CRT with BVP-CRT. Outcomes were all-cause mortality, heart failure hospitalizations (HFH) and New York Heart Association (NYHA) class improvement. We included randomized controlled trials (RCTs) and observational studies with participants that had left ventricular ejection fraction (LVEF) ≤ 40% and (i) symptomatic HF or (ii) expected ventricular pacing > 40%. Random and fixed effects models pairwise meta-analysis was conducted. Cochrane Risk of Bias 2 assessment tool (ROB 2.0) and the Newcastle-Ottawa scale (NOS) were used to assess the quality of the studies., Results: Eleven studies (10 observational studies and 1 RCT) with 3141 patients were included in the analysis. Compared with BVP-CRT, LBBAP-CRT was associated with lower risk of all-cause mortality (risk ratio (RR): 0.71, 95% CI: 0.57 to 0.87; p = 0.001), lower risk of HFH (RR: 0.59, 95% CI: 0.50 to 0.71; p < 0.00001) and more improvement in NYHA class (weighed mean difference (WMD): -0.36, 95% CI: -0.59 to -0.13; p < 0.00001) compared with patients who received BVP-CRT., Conclusions: Compared with BVP-CRT, receipt of LBBAP-CRT in patients with HF is associated with a lower risk of mortality, and HFH and greater improvement in NHYA class., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 The Author(s). Published by IMR Press.)
- Published
- 2023
- Full Text
- View/download PDF
32. Temporal trends of cause-specific mortality after diagnosis of atrial fibrillation.
- Author
-
Wu J, Nadarajah R, Nakao YM, Nakao K, Wilkinson C, Cowan JC, Camm AJ, and Gale CP
- Subjects
- Humans, Cause of Death, Comorbidity, Hospitalization, Risk Factors, Atrial Fibrillation epidemiology, Heart Failure, Stroke epidemiology
- Abstract
Background and Aims: Reports of outcomes after atrial fibrillation (AF) diagnosis are conflicting. The aim of this study was to investigate mortality and hospitalization rates following AF diagnosis over time, by cause and by patient features., Methods: Individuals aged ≥16 years with a first diagnosis of AF were identified from the UK Clinical Practice Research Datalink-GOLD dataset from 1 January 2001, to 31 December 2017. The primary outcomes were all-cause and cause-specific mortality and hospitalization at 1 year following diagnosis. Poisson regression was used to calculate rate ratios (RRs) for mortality and incidence RRs (IRRs) for hospitalization and 95% confidence intervals (CIs) comparing 2001/02 and 2016/17, adjusted for age, sex, region, socio-economic status, and 18 major comorbidities., Results: Of 72 412 participants, mean (standard deviation) age was 75.6 (12.4) years, and 44 762 (61.8%) had ≥3 comorbidities. All-cause mortality declined (RR 2016/17 vs. 2001/02 0.72; 95% CI 0.65-0.80), with large declines for cardiovascular (RR 0.46; 95% CI 0.37-0.58) and cerebrovascular mortality (RR 0.41; 95% CI 0.29-0.60) but not for non-cardio/cerebrovascular causes of death (RR 0.91; 95% CI 0.80-1.04). In 2016/17, deaths caused from dementia (67, 8.0%), outstripped deaths from acute myocardial infarction, heart failure, and acute stroke combined (56, 6.7%, P < .001). Overall hospitalization rates increased (IRR 2016/17 vs. 2001/02 1.17; 95% CI, 1.13-1.22), especially for non-cardio/cerebrovascular causes (IRR 1.42; 95% CI 1.39-1.45). Older, more deprived, and hospital-diagnosed AF patients experienced higher event rates., Conclusions: After AF diagnosis, cardio/cerebrovascular mortality and hospitalization has declined, whilst hospitalization for non-cardio/cerebrovascular disease has increased., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
33. Safety and efficacy of left bundle branch area pacing compared with right ventricular pacing in patients with bradyarrhythmia and conduction system disorders: Systematic review and meta-analysis.
- Author
-
Leventopoulos G, Travlos CK, Aronis KN, Anagnostopoulou V, Patrinos P, Papageorgiou A, Perperis A, Gale CP, and Davlouros P
- Subjects
- Humans, Cardiac Pacing, Artificial adverse effects, Cardiac Pacing, Artificial methods, Cardiac Conduction System Disease diagnosis, Cardiac Conduction System Disease therapy, Heart Conduction System, Electrocardiography methods, Treatment Outcome, Bundle of His, Bradycardia diagnosis, Bradycardia therapy, Bradycardia etiology, Atrial Fibrillation
- Abstract
Background: Right Ventricular Pacing (RVP) may have detrimental effects in ventricular function. Left Bundle Branch Area Pacing (LBBAP) is a new pacing strategy that appears to have better results. The aim of this systematic review and meta-analysis is to compare the safety and efficacy of LBBAP vs RVP in patients with bradyarrhythmia and conduction system disorders., Methods: MEDLINE, EMBASE and Pubmed databases were searched for studies comparing LBBAP with RVP. Outcomes were all-cause mortality, atrial fibrillation (AF) occurrence, heart failure hospitalizations (HFH) and complications. QRS duration, mechanical synchrony and LVEF changes were also assessed. Pairwise meta-analysis was conducted using random and fixed effects models., Results: Twenty-five trials with 4250 patients (2127 LBBAP) were included in the analysis. LBBAP was associated with lower risk for HFH (RR:0.33, CI 95%:0.21 to 0.50; p < 0.001), all-cause mortality (RR:0.52 CI 95%:0.34 to 0.80; p = 0.003), and AF occurrence (RR:0.43 CI 95%:0.27 to 0.68; p < 0.001) than RVP. Lead related complications were not different between the two groups (p = 0.780). QRSd was shorter in the LBBAP group at follow-up (WMD: -32.20 msec, CI 95%: -40.70 to -23.71; p < 0.001) and LBBAP achieved better intraventricular mechanical synchrony than RVP (SMD: -1.77, CI 95%: -2.45 to -1.09; p < 0.001). LBBAP had similar pacing thresholds (p = 0.860) and higher R wave amplitudes (p = 0.009) than RVP., Conclusions: LBBAP has better clinical outcomes, preserves ventricular electrical and mechanical synchrony and has excellent pacing parameters, with no difference in complications compared to RVP., (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
34. Illness perceptions and health literacy are strongly associated with health-related quality of life, anxiety, and depression in patients with coronary heart disease: results from the EUROASPIRE V cross-sectional survey.
- Author
-
Jennings CS, Astin F, Prescott E, Hansen T, Gale Chris P, and De Bacquer D
- Subjects
- Humans, Male, Female, Middle Aged, Quality of Life, Cross-Sectional Studies, Depression, Retrospective Studies, Anxiety, Obesity, Health Literacy, Coronary Artery Disease
- Abstract
Aims: To (1) Describe the sociodemographic and risk factor profiles of a sample of patients with coronary disease, (2) Explore associations between illness perceptions and health literacy with sociodemographic characteristics and risk factors, health-related quality of life (HRQoL), anxiety, and depression., Methods and Results: Conducted as part of the ESC Prevention of CVD Project and EUROASPIRE V survey, patients were consecutively and retrospectively identified 6 months to 2 years after an acute event or elective procedure from 12 countries and interviewed. Three thousand four hundred and eight participants (76% male, mean age 64 years) were recruited, 16% were smokers, 38% obese, 60% physically inactive, and 41% hypertensive. Forty percent had attended cardiac rehabilitation. More threatening illness perceptions were associated with female gender (P < 0.0001), lower income (P < 0.0001), lower education (P = 0.02), obesity (P < 0.0001), sedentary behaviour (P < 0.0001), and diabetes (P < 0.0001). Poorer health literacy was associated with obesity (P = 0.02) and sedentary behaviour (P = 0.0001). Threatening illness perceptions were strongly associated with anxiety, depression, and poorer ratings of HRQoL after multivariable adjustment (all P < 0.001). Poor health literacy was associated with anxiety and depression (P < 0.0001) and poorer ratings of HRQoL (HeartQol scores P = 0.03). Results were consistent across regions of Europe, age, gender, and socio-economic strata., Conclusions: Interventions like cardiac rehabilitation should be targeted at vulnerable groups given the strong associations between more threatening illness perceptions, lower health literacy, lower HRQoL, and higher levels of anxiety and depression. The delivery and content of these interventions should be accessible for those with low health literacy., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2023
- Full Text
- View/download PDF
35. Inequalities in care delivery and outcomes for myocardial infarction, heart failure, atrial fibrillation, and aortic stenosis in the United Kingdom.
- Author
-
Nadarajah R, Farooq M, Raveendra K, Nakao YM, Nakao K, Wilkinson C, Wu J, and Gale CP
- Abstract
Cardiovascular diseases are a leading cause of death and disability globally, with inequalities in burden and care delivery evident in Europe. To address this challenge, The Lancet Regional Health-Europe convened experts from a range of countries to summarise the current state of knowledge on cardiovascular disease inequalities across Europe. This Series paper presents evidence from nationwide secondary care registries and primary care healthcare records regarding inequalities in care delivery and outcomes for myocardial infarction, heart failure, atrial fibrillation, and aortic stenosis in the National Health Service (NHS) across the United Kingdom (UK) by age, sex, ethnicity and geographical location. Data suggest that women and older people less frequently receive guideline-recommended treatment than men and younger people. There are limited publications about ethnicity in the UK for the studied disease areas. Finally, there is inter-healthcare provider variation in cardiovascular care provision, especially for transcatheter aortic valve implantation, which is associated with differing outcomes for patients with the same disease. Providing equitable care is a founding principle of the UK NHS, which is well positioned to deliver innovative policy responses to reverse observed inequalities. Understanding differences in care may enable the implementation of appropriate strategies to mitigate differences in outcomes., Competing Interests: CPG reports personal fees from AstraZeneca, Amgen, Bayer, Boehrinher-Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group and 10.13039/501100007723Oxford University Press. He has received educational and research grants from BMS, Abbott inc., the 10.13039/501100000274British Heart Foundation, 10.13039/501100000272National Institute for Health Research, 10.13039/501100007601Horizon 2020, and from the 10.13039/501100000860European Society of Cardiology, outside the submitted work. YMN reports a study grant from Bayer. All other authors declare no competing interests., (© 2023 The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF
36. Prediction models for heart failure in the community: A systematic review and meta-analysis.
- Author
-
Nadarajah R, Younsi T, Romer E, Raveendra K, Nakao YM, Nakao K, Shuweidhi F, Hogg DC, Arbel R, Zahger D, Iakobishvili Z, Fonarow GC, Petrie MC, Wu J, and Gale CP
- Subjects
- Male, Humans, Female, Bayes Theorem, Risk Factors, Heart Failure epidemiology, Atherosclerosis
- Abstract
Aims: Multivariable prediction models can be used to estimate risk of incident heart failure (HF) in the general population. A systematic review and meta-analysis was performed to determine the performance of models., Methods and Results: From inception to 3 November 2022 MEDLINE and EMBASE databases were searched for studies of multivariable models derived, validated and/or augmented for HF prediction in community-based cohorts. Discrimination measures for models with c-statistic data from ≥3 cohorts were pooled by Bayesian meta-analysis, with heterogeneity assessed through a 95% prediction interval (PI). Risk of bias was assessed using PROBAST. We included 36 studies with 59 prediction models. In meta-analysis, the Atherosclerosis Risk in Communities (ARIC) risk score (summary c-statistic 0.802, 95% confidence interval [CI] 0.707-0.883), GRaph-based Attention Model (GRAM; 0.791, 95% CI 0.677-0.885), Pooled Cohort equations to Prevent Heart Failure (PCP-HF) white men model (0.820, 95% CI 0.792-0.843), PCP-HF white women model (0.852, 95% CI 0.804-0.895), and REverse Time AttentIoN model (RETAIN; 0.839, 95% CI 0.748-0.916) had a statistically significant 95% PI and excellent discrimination performance. The ARIC risk score and PCP-HF models had significant summary discrimination among cohorts with a uniform prediction window. 77% of model results were at high risk of bias, certainty of evidence was low, and no model had a clinical impact study., Conclusions: Prediction models for estimating risk of incident HF in the community demonstrate excellent discrimination performance. Their usefulness remains uncertain due to high risk of bias, low certainty of evidence, and absence of clinical effectiveness research., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
37. Disease trajectories following myocardial infarction: insights from process mining of 145 million hospitalisation episodes.
- Author
-
Hayward CJ, Batty JA, Westhead DR, Johnson O, Gale CP, Wu J, and Hall M
- Subjects
- Female, Humans, Retrospective Studies, Risk Factors, Proportional Hazards Models, Hospitalization, Myocardial Infarction diagnosis, Myocardial Infarction epidemiology
- Abstract
Background: Knowledge of post-myocardial infarction (MI) disease risk to date is limited-yet the number of survivors of MI has increased dramatically in recent decades. We investigated temporally ordered sequences of all conditions following MI in nationwide electronic health record data through the application of process mining., Methods: We conducted a national retrospective cohort study of all hospitalisations (145,670,448 episodes; 34,083,204 individuals) admitted to NHS hospitals in England (1st January 2008-31st January 2017, final follow-up 27th March 2017). Through process mining, we identified trajectories of all major disease diagnoses following MI and compared their relative risk (RR) and all-cause mortality hazard ratios (HR) to a risk-set matched non-MI control cohort using Cox proportional hazards and flexible parametric survival models., Findings: Among a total of 375,669 MI patients (130,758 females; 34.8%) and 1,878,345 matched non-MI patients (653,790 females; 34.8%), we identified 28,799 unique disease trajectories. The accrual of multiple circulatory diagnoses was more common amongst MI patients (RR 4.32, 95% CI 3.96-4.72) and conferred an increased risk of death (HR 1.32, 1.13-1.53) compared with matched controls. Trajectories featuring neuro-psychiatric diagnoses (including anxiety and depression) following circulatory disorders were markedly more common and had increased mortality post MI (HR ranging from 1.11 to 1.73) compared with non-MI individuals., Interpretation: These results provide an opportunity for early intervention targets for survivors of MI-such as increased focus on the psychological and behavioural pathways-to mitigate ongoing adverse disease trajectories, multimorbidity, and premature mortality., Funding: British Heart Foundation; Alan Turing Institute., Competing Interests: Declaration of interests CJH, JAB, DRW, OJ, JW, and MH have no conflicts of interest to declare. CPG has received funding from Abbott Diabetes, Bristol Myers Squibb and the European Society of Cardiology, and consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, CardioMatics, Chiesi, Daiichi Sankyo, GPRI Research B.V., Menarini, Novartis, iRhyth, Organon as well as payment for honoraria or lectures from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical, Zydus. CPG declares participation on Data Safety Monitoring or Advisory boards for the DANBLCOK and TARGET CTCA trials and editorial and committee membership of the NICE Indicator Advisory Committee, EHJ Quality of Care and Clinical Outcomes and ESC Quality Indicator Committee., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
38. Associations of health-related quality of life with major adverse cardiovascular and cerebrovascular events for individuals with ischaemic heart disease: systematic review, meta-analysis and evidence mapping.
- Author
-
Soloveva A, Gale CP, Han NT, Hurdus B, Aktaa S, Palin V, Mebrahtu TF, Van Spall H, Batra G, Dondo TB, Bäck M, and Munyombwe T
- Subjects
- Humans, Quality of Life, Myocardial Ischemia diagnosis, Coronary Artery Disease
- Abstract
Objective: To investigate the association between health-related quality of life (HRQoL) and major adverse cardiovascular and cerebrovascular events (MACCE) in individuals with ischaemic heart disease (IHD)., Methods: Medline(R), Embase, APA PsycINFO and CINAHL (EBSCO) from inception to 3 April 2023 were searched. Studies reporting association of HRQoL, using a generic or cardiac-specific tool, with MACCE or components of MACCE for individuals with IHD were eligible for inclusion. Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale to assess the quality of the studies. Descriptive synthesis, evidence mapping and random-effects meta-analysis were performed stratified by HRQoL measures and effect estimates. Between-study heterogeneity was assessed using the Higgins I
2 statistic., Results: Fifty-one articles were included with a total of 134 740 participants from 53 countries. Meta-analysis of 23 studies found that the risk of MACCE increased with lower baseline HeartQoL score (HR 1.49, 95% CI 1.16 to 1.93) and Short Form Survey (SF-12) physical component score (PCS) (HR 1.39, 95% CI 1.28 to 1.51). Risk of all-cause mortality increased with a lower HeartQoL (HR 1.64, 95% CI 1.34 to 2.01), EuroQol 5-dimension (HR 1.17, 95% CI 1.12 to 1.22), SF-36 PCS (HR 1.29, 95% CI 1.19 to 1.41), SF-36 mental component score (HR 1.18, 95% CI 1.08 to 1.30)., Conclusions: This study found an inverse association between baseline values or change in HRQoL and MACCE or components of MACCE in individuals with IHD, albeit with between-study heterogeneity. Standardisation and routine assessment of HRQoL in clinical practice may help risk stratify individuals with IHD for tailored interventions., Prospero Registration Number: CRD42021234638., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare the following: AS has received grant from the European Society of Cardiology, support from AstraZeneca, Bayer, Novartis, Gedeon Richter, Amgen and Servier—outside the submitted work; CPG has received grants or contracts from Alan Turing Institute, British Heart Foundation, National Institute for Health Research, Horizon 2020, Abbott Diabetes, Bristol Myers Squibb, European Society of Cardiology; consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, CardioMatics, Chiesi, Daiichi Sankyo, GPRI Research, Menarini, Novartis, iRhyth, Organon, The Phoenix Group, Payment or honoraria from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical, Zydus, support form AstraZeneca, participation on a Data Safety Monitoring Board or Advisory Board in DANBLCOK trial and TARGET CTCA trial, leadership or fiduciary role in EHJ Quality of Care and Clinical Outcomes as Deputy Editor, NICE Indicator Advisory Committee, Chair ESC Quality Indicator Committee, Stock or stock options CardioMatics Receipt of Kosmos device. SA has received support for attending meetings and/or travel from the European Society of Cardiology and participates on a Data Safety Monitoring Board or Advisory Board of EuroHeart; HVS has received grants from CIHR and Heart and Stroke Foundation; GB has received fees to the institution from Bayer and Pfizer, honoraria for lectures from AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Novo Nordisk, Pfizer and Sanofi—outside of present work. Other authors have nothing to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)- Published
- 2023
- Full Text
- View/download PDF
39. Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).
- Author
-
Batra G, Aktaa S, Camm AJ, Costa F, Di Biase L, Duncker D, Fauchier L, Fragakis N, Frost L, Hijazi Z, Juhlin T, Merino JL, Mont L, Nielsen JC, Oldgren J, Polewczyk A, Potpara T, Sacher F, Sommer P, Tilz R, Maggioni AP, Wallentin L, Casadei B, and Gale CP
- Subjects
- Humans, Treatment Outcome, Randomized Controlled Trials as Topic, Atrial Fibrillation surgery, Atrial Fibrillation epidemiology, Atrial Flutter epidemiology, Atrial Flutter surgery, Catheter Ablation methods
- Abstract
Aims: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation., Methods and Results: We used the EuroHeart methodology for the development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach a consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data., Conclusion: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs, and post-marketing surveillance of devices and pharmacotherapies., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
40. Presentation, care, and outcomes of patients with NSTEMI according to World Bank country income classification: the ACVC-EAPCI EORP NSTEMI Registry of the European Society of Cardiology.
- Author
-
Nadarajah R, Ludman P, Laroche C, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, and Gale CP
- Subjects
- Humans, Prospective Studies, Registries, Non-ST Elevated Myocardial Infarction, Ischemic Attack, Transient, Heart Failure, Cardiology, Stroke epidemiology, Stroke therapy
- Abstract
Background: The majority of NSTEMI burden resides outside high-income countries (HICs). We describe presentation, care, and outcomes of NSTEMI by country income classification., Methods and Results: Prospective cohort study including 2947 patients with NSTEMI from 287 centres in 59 countries, stratified by World Bank country income classification. Quality of care was evaluated based on 12 guideline-recommended care interventions. The all-or-none scoring composite performance measure was used to define receipt of optimal care. Outcomes included in-hospital acute heart failure, stroke/transient ischaemic attack, and death, and 30-day mortality. Patients admitted with NSTEMI in low to lower-middle-income countries (LLMICs), compared with patients in HICs, were younger, more commonly diabetic, and current smokers, but with a lower burden of other comorbidities, and 76.7% met very high risk criteria for an immediate invasive strategy. Invasive coronary angiography use increased with ascending income classification (LLMICs, 79.2%; upper middle income countries [UMICs], 83.7%; HICs, 91.0%), but overall care quality did not (≥80% of eligible interventions achieved: LLMICS, 64.8%; UMICs 69.6%; HICs 55.1%). Rates of acute heart failure (LLMICS, 21.3%; UMICs, 12.1%; HICs, 6.8%; P < 0.001), stroke/transient ischaemic attack (LLMICS: 2.5%; UMICs: 1.5%; HICs: 0.9%; P = 0.04), in-hospital mortality (LLMICS, 3.6%; UMICs: 2.8%; HICs: 1.0%; P < 0.001) and 30-day mortality (LLMICs, 4.9%; UMICs, 3.9%; HICs, 1.5%; P < 0.001) exhibited an inverse economic gradient., Conclusion: Patients with NSTEMI in LLMICs present with fewer comorbidities but a more advanced stage of acute disease, and have worse outcomes compared with HICs. A cardiovascular health narrative is needed to address this inequity across economic boundaries., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
41. European practice patterns for antiplatelet management in NSTE-ACS patients: Results from the REal-world ADoption survey focus on Acute antiPlatelet Treatment (READAPT) survey.
- Author
-
Angiolillo DJ, Erlinge D, Ferreiro JL, Gale CP, Huber K, Musumeci G, and Collet JP
- Subjects
- Humans, Platelet Aggregation Inhibitors, Blood Platelets, Coronary Angiography, Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome drug therapy, Percutaneous Coronary Intervention adverse effects
- Abstract
Background: The 2020 European Society of Cardiology (ESC) guidelines for the diagnosis and management of patients with non-ST elevation-acute coronary syndrome (NSTE-ACS) recommend early invasive coronary angiography in high-risk patients and no routine pre-treatment with oral P2Y12 receptor inhibitor in NSTE-ACS patients prior to defining coronary anatomy., Objective: To assess the implementation of this recommendation in the real-life setting., Methods: A web-survey in 17 European countries collected physician profiles and their perceptions of the diagnosis, medical and invasive management of NSTE-ACS patients at their hospital. A sample size of at least 1100 responders permitted the estimation of proportions with a precision of at least ±3.0%., Results: Among the 3024 targeted participants, 1154 provided valid feedback defined as a 50% response rate of answers to the survey questions. Overall, >60% of the participants declared full implementation of the guidelines at their institution. The time delay from admission to coronary angiography and PCI was reported to be <24 h in over 75% of the hospitals while pre-treatment was intended in >50% of NSTE-ACS patients. Ad-hoc percutaneous coronary intervention (PCI) was performed in >70% of the cases while intravenous platelet inhibition was rarely used (<10%). Between countries differences in practice patterns for antiplatelet management for NSTE-ACS were observed, suggesting heterogeneous implementation of the guidelines., Conclusions: This survey indicates that the implementation of 2020 NSTE-ACS guidelines on early invasive management and pre-treatment is heterogeneous, potentially due by local logistical constraints., Competing Interests: Declaration of Competing Interest Dr. Angiolillo has received payment as an individual for Consulting fee or honorarium from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi-Sankio, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, Sanofi and Vectura. Institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli-Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and the Scott R. MacKenzie Foundation. Jean-Philippe Collet reports grants for the institution or consulting fees from BMS, Pfizer, Medtronic, Boston Scientific, AstraZeneca. David Erlinge has received payment as an individual for Consulting fee or honorarium from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis and Sanofi. José Luis Ferreiro has received payment as an individual for lecture or consulting fee from Daiichi Sankyo, Inc., AstraZeneca, Boston Scientific, Pfizer, Abbott, Ferrer, Rovi, Boehringer Ingelheim, Bristol-Myers Squibb, Biotronik and Terumo. Chris P. Gale has received payment as an individual for Consulting fee or honorarium from AI Nexus, Amgen, AstraZeneca, Bayer, Boston Scientific, Bristol Myers Squibb, Boehringer Ingelheim, CardioMatics, Chiesi, Daiichi-Sankyo, GPRI Research B.V., Menarini, iRhyth, Novartis, Organon, Raisio Group, Wondr Medical and Zydus. Institutional payments for grants from Alan Turing Institute, British Heart Foundation, National Institute for Health Research, Horizon 2020, Abbott Diabetes, Bristol Myers Squibb and European Society of Cardiology. Support for attending meetings and/or travel from AstraZeneca. Participation on a Data Safety Monitoring or Advisory Board from DANBLCOK trial and TARGET CTCA trial. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Deputy Editor: EHJ Quality of Care and Clinical Outcomes, NICE Indicator Advisory Committee, Chair ESC Quality Indicator Committee. Stock options in CardioMatics. Receipt of equipment, materials, drugs, medical writing, gifts or other services from Kosmos device. Kurt Huber has received lecture and consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Novartis, and Sanofi. Giuseppe Musumeci has received payment as an individual for honorarium from Amgen, AstraZeneca, Chiesi, Edwards and Novartis., (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
42. Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): pilot study of an electronic health record machine learning algorithm-guided intervention to identify undiagnosed atrial fibrillation.
- Author
-
Nadarajah R, Wahab A, Reynolds C, Raveendra K, Askham D, Dawson R, Keene J, Shanghavi S, Lip GYH, Hogg D, Cowan C, Wu J, and Gale CP
- Subjects
- Humans, Pilot Projects, Electronic Health Records, Anticoagulants adverse effects, Algorithms, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Stroke prevention & control
- Abstract
Introduction: Atrial fibrillation (AF) is associated with a fivefold increased risk of stroke. Oral anticoagulation reduces the risk of stroke, but AF is elusive. A machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation (FIND-AF)) developed to predict incident AF within 6 months using data in primary care electronic health records (EHRs) could be used to guide AF screening. The objectives of the FIND-AF pilot study are to determine yields of AF during ECG monitoring across AF risk estimates and establish rates of recruitment and protocol adherence in a remote AF screening pathway., Methods and Analysis: The FIND-AF Pilot is an interventional, non-randomised, single-arm, open-label study that will recruit 1955 participants aged 30 years or older, without a history of AF and eligible for oral anticoagulation, identified as higher risk and lower risk by the FIND-AF risk score from their primary care EHRs, to a period of remote ECG monitoring with a Zenicor-ECG device. The primary outcome is AF diagnosis during ECG monitoring, and secondary outcomes include recruitment rates, withdrawal rates, adherence to ECG monitoring and prescription of oral anticoagulation to participants diagnosed with AF during ECG monitoring., Ethics and Dissemination: The study has ethical approval (the North West-Greater Manchester South Research Ethics Committee reference 23/NW/0180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder's open access policy., Trial Registration Number: NCT05898165., Competing Interests: Competing interests: CPG reports personal fees from AstraZeneca, Amgen, Bayer, Boehrinher-Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group and Oxford University Press. He has received educational and research grants from BMS, Abbott, the British Heart Foundation, National Institute of Health Research, Horizon 2020, and from the European Society of Cardiology, outside the submitted work. AJC reports personal fees from Abbott, Bayer, BMS, Sanofi, Milestone, Boston Scientific, InCarda and Menarini. YMN reports a study grant from Bayer. GYHL is consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Anthos. No fees are received personally. GYHL is corincipal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899871., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
43. Using routinely collected health record data for the earlier detection of heart failure with preserved ejection fraction: FIND-HFpEF.
- Author
-
Nadarajah R, Nakao YM, Wu J, and Gale CP
- Subjects
- Humans, Stroke Volume, Ventricular Function, Left, Prognosis, Heart Failure diagnosis
- Published
- 2023
- Full Text
- View/download PDF
44. Prognosis, characteristics, and provision of care for patients with the unspecified heart failure electronic health record phenotype: a population-based linked cohort study of 95262 individuals.
- Author
-
Nakao YM, Nakao K, Nadarajah R, Banerjee A, Fonarow GC, Petrie MC, Rahimi K, Wu J, and Gale CP
- Abstract
Background: Whether the accuracy of the phenotype ascribed to patients in electronic health records (EHRs) is associated with variation in prognosis and care provision is unknown. We investigated this for heart failure (HF, characterised as HF with preserved ejection fraction [HFpEF], HF with reduced ejection fraction [HFrEF] and unspecified HF)., Methods: We included individuals aged 16 years and older with a new diagnosis of HF between January 2, 1998 and February 28, 2022 from linked primary and secondary care records in the Clinical Practice Research Datalink in England. We investigated the provision of guideline-recommended diagnostic investigations and pharmacological treatments. The primary outcome was a composite of HF hospitalisation or all-cause death, and secondary outcomes were time to HF hospitalisation, all-cause death and death from cardiovascular causes. We used Kaplan-Meier curves and log rank tests to compare survival across HF phenotypes and adjusted for potential confounders in Cox proportional hazards regression analyses., Findings: Of a cohort of 95,262 individuals, 1271 (1.3%) were recorded as having HFpEF, 10,793 (11.3%) as HFrEF and 83,198 (87.3%) as unspecified HF. Individuals recorded as unspecified HF were older with a higher prevalence of dementia. Unspecified HF, compared to patients with a recorded HF phenotype, were less likely to receive specialist assessment, echocardiography or natriuretic peptide testing in the peri-diagnostic period, or receive angiotensin-converting enzyme inhibitors, beta blockers or mineralocorticoid receptor antagonists up to 12 months after diagnosis (risk ratios compared to HFrEF, 0.64, 95% CI 0.63-0.64; 0.59, 0.58-0.60; 0.57, 0.55-0.59; respectively) and had significantly worse outcomes (adjusted hazard ratios compared to HFrEF, HF hospitalisation and death 1.66, 95% CI 1.59-1.74; all-cause mortality 2.00, 1.90-2.10; cardiovascular death 1.77, 1.65-1.90)., Interpretation: Our findings suggested that absence of specification of HF phenotype in routine EHRs is inversely associated with clinical investigations, treatments and survival, representing an actionable target to mitigate prognostic and health resource burden., Funding: Japan Research Foundation for Healthy Aging and British Heart Foundation., Competing Interests: YMN reports a study grant from Bayer, outside the submitted work. CPG reports personal fees from AstraZeneca, Amgen, Bayer, Boehrinher-Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group and Oxford University Press. He has received educational and research grants from BMS, Abbott inc., the British Heart Foundation, National Institute of Health Research, Horizon 2020, and from the European Society of Cardiology, outside the submitted work. MCP reports grants from Boehringer Ingelheim, Roche, SQ Innovations, Astra Zeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, and Pharmacosomos. He reports consulting fees and payments from Boehringer Ingelheim, AstraZeneca, Novartis, Novo Nordisk, Pharmacosomos, Abbvie, Bayer, Takeda, Corvia, Cardorentis, Seimens, and Vifor. He has participated on Data Safety Monitoring Boards and Advisory Boards for Teikoku and AstraZeneca and is Director of Global Clinical Trials Partners. AB reports a grant from AstraZeneca. GCF reports consulting fees from Abbott, Amgen, AstraZeneca, Bayer, Eli Lilly, Janssen, Medtronic, Merck, Novartis, Pfizer and Cytokinetics. All other authors declare no competing interests., (© 2023 The Authors.)
- Published
- 2023
- Full Text
- View/download PDF
45. Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).
- Author
-
Aktaa S, Batra G, James SK, Blackman DJ, Ludman PF, Mamas MA, Abdel-Wahab M, Angelini GD, Czerny M, Delgado V, De Luca G, Agricola E, Foldager D, Hamm CW, Iung B, Mangner N, Mehilli J, Murphy GJ, Mylotte D, Parma R, Petronio AS, Popescu BA, Sondergaard L, Teles RC, Sabaté M, Terkelsen CJ, Testa L, Wu J, Maggioni AP, Wallentin L, Casadei B, and Gale CP
- Subjects
- Humans, Aortic Valve surgery, Registries, Randomized Controlled Trials as Topic, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods
- Abstract
Aims: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI)., Methods and Results: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform., Conclusion: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies., One-Sentence Summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
46. Cohort profile: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) Longitudinal Cohort.
- Author
-
Munyombwe T, Dondo TB, Hall M, Nadarajah R, Hurdus B, Aktaa S, Haris M, Keeley A, West R, Hall A, Norman P, and Gale CP
- Subjects
- Humans, Hospitalization, Longitudinal Studies, Prospective Studies, Myocardial Infarction epidemiology, Myocardial Infarction therapy, Quality of Life
- Abstract
Aims: The Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) longitudinal cohort study aims to investigate health trajectories of individuals following hospitalization for myocardial infarction (MI)., Methods and Results: EMMACE is a linked multicentre prospective cohort study of 14 899 patients with MI admitted to 77 hospitals in England who participated in the EMMACE-3 and -4 studies between 1st November 2011 and 24th June 2015. Long-term follow-up of the EMMACE cohorts was conducted through the EMMACE-XL (27th September 2020 to 31st March 2022) and EMMACE-XXL (1st July 2021 to 1st July 2023) studies. EMMACE collected individual participant data for health-related quality of life (HRQoL) measured by three-level EuroQol five-dimension and visual analogy scale at admission, 1 month, 6 months, 12 months, and 10 years follow-up, as well as medications, medication adherence, beliefs about medicines, Satisfaction with Information about Medicines Scale, and illness perceptions. Participant data were deterministically linked to the Myocardial Infarction National Audit Project (MINAP) for information on baseline treatments and comorbidities, Hospital Episode Statistics Admitted Patient Care (for cause-specific hospitalization data), and the Office for National Statistics (for mortality data) up to 2020., Conclusion: EMMACE is a nationwide prospective cohort that will provide unique insights into fatal and non-fatal outcomes, medication adherence, and HRQoL following MI.Trial registration: ClinicalTrials.gov NCT01808027 and NCT01819103., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
- Full Text
- View/download PDF
47. The detection and management of attempted fraud during an online randomised trial.
- Author
-
Willis TA, Wright-Hughes A, Skinner C, Farrin AJ, Hartley S, Walwyn R, Weller A, Althaf M, Wilson S, Gale CP, and Foy R
- Subjects
- Humans, Surveys and Questionnaires, United Kingdom, Feedback, Motivation, Electronic Mail
- Abstract
Background: Online studies offer an efficient method of recruiting participants and collecting data. Whilst delivering an online randomised trial, we detected unusual recruitment activity. We describe our approach to detecting and managing suspected fraud and share lessons for researchers., Methods: Our trial investigated the single and combined effects of different ways of presenting clinical audit and feedback. Clinicians and managers who received feedback from one of five United Kingdom national clinical audit programmes were emailed invitations that contained a link to the trial website. After providing consent and selecting their relevant audit, participants were randomised automatically to different feedback versions. Immediately after viewing their assigned feedback, participants completed a questionnaire and could request a financial voucher by entering an email address. Email addresses were not linked to trial data to preserve participant anonymity. We actively monitored participant numbers, questionnaire completions, and voucher claims., Results: Following a rapid increase in trial participation, we identified 268 new voucher claims from three email addresses that we had reason to believe were linked. Further scrutiny revealed duplicate trial completions and voucher requests from 24 email addresses. We immediately suspended the trial, improved security measures, and went on to successfully complete the study. We found a peak in questionnaires completed in less than 20 seconds during a likely contamination period. Given that study and personal data were not linked, we could not directly identify the trial data from the 268 duplicate entries within the 603 randomisations occurring during the same period. We therefore excluded all 603 randomisations from the primary analysis, which was consequently based on 638 randomisations. A sensitivity analysis, including all 961 randomisations over the entire study except for questionnaire completions of less than 20 seconds, found only minor differences from the primary analysis., Conclusion: Online studies offering incentives for participation are at risk of attempted fraud. Systematic monitoring and analysis can help detect such activity. Measures to protect study integrity include linking participant identifiers to study data, balancing study security and ease of participation, and safeguarding the allocation of participant incentives., Trial Registration: International Standard Randomised Controlled Trial Number: ISRCTN41584028. Registration date is August 17, 2017., (© 2023. BioMed Central Ltd., part of Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
48. Activation of telomerase by TA-65 enhances immunity and reduces inflammation post myocardial infarction.
- Author
-
Bawamia B, Spray L, Wangsaputra VK, Bennaceur K, Vahabi S, Stellos K, Kharatikoopaei E, Ogundimu E, Gale CP, Keavney B, Maier R, Hancock H, Richardson G, Austin D, and Spyridopoulos I
- Subjects
- Aged, Humans, C-Reactive Protein, Inflammation, T-Lymphocytes, Double-Blind Method, Myocardial Infarction, Telomerase
- Abstract
Myocardial infarction (MI) accelerates immune ageing characterised by lymphopenia, expansion of terminally differentiated CD8
+ T-lymphocytes (CD8+ TEMRA ) and inflammation. Pre-clinical data showed that TA-65, an oral telomerase activator, reduced immune ageing and inflammation after MI. We conducted a double blinded randomised controlled pilot trial evaluating the use of TA-65 to reduce immune cell ageing in patients following MI. Ninety MI patients aged over 65 years were randomised to either TA-65 (16 mg daily) or placebo for 12 months. Peripheral blood leucocytes were analysed by flow cytometry. The pre-defined primary endpoint was the proportion of CD8+ T-lymphocytes which were CD8+ TEMRA after 12 months. Secondary outcomes included high-sensitivity C-reactive protein (hsCRP) levels. Median age of participants was 71 years. Proportions of CD8+ TEMRA did not differ after 12 months between treatment groups. There was a significant increase in mean total lymphocyte count in the TA-65 group after 12 months (estimated treatment effect: + 285 cells/μl (95% CI: 117-452 cells/ μ l, p < 0.004), driven by significant increases from baseline in CD3+ , CD4+ , and CD8+ T-lymphocytes, B-lymphocytes and natural killer cells. No increase in lymphocyte populations was seen in the placebo group. At 12 months, hsCRP was 62% lower in the TA-65 group compared to placebo (1.1 vs. 2.9 mg/L). Patients in the TA-65 arm experienced significantly fewer adverse events (130 vs. 185, p = 0.002). TA-65 did not alter CD8+ TEMRA but increased all major lymphocyte subsets and reduced hsCRP in elderly patients with MI after 12 months., (© 2023. The Author(s).)- Published
- 2023
- Full Text
- View/download PDF
49. Trajectories in chronic disease accrual and mortality across the lifespan in Wales, UK (2005-2019), by area deprivation profile: linked electronic health records cohort study on 965,905 individuals.
- Author
-
Lyons J, Akbari A, Abrams KR, Azcoaga Lorenzo A, Ba Dhafari T, Chess J, Denaxas S, Fry R, Gale CP, Gallacher J, Griffiths LJ, Guthrie B, Hall M, Jalali-Najafabadi F, John A, MacRae C, McCowan C, Peek N, O'Reilly D, Rafferty J, Lyons RA, and Owen RK
- Abstract
Background: Understanding and quantifying the differences in disease development in different socioeconomic groups of people across the lifespan is important for planning healthcare and preventive services. The study aimed to measure chronic disease accrual, and examine the differences in time to individual morbidities, multimorbidity, and mortality between socioeconomic groups in Wales, UK., Methods: Population-wide electronic linked cohort study, following Welsh residents for up to 20 years (2000-2019). Chronic disease diagnoses were obtained from general practice and hospitalisation records using the CALIBER disease phenotype register. Multi-state models were used to examine trajectories of accrual of 132 diseases and mortality, adjusted for sex, age and area-level deprivation. Restricted mean survival time was calculated to measure time spent free of chronic disease(s) or mortality between socioeconomic groups., Findings: In total, 965,905 individuals aged 5-104 were included, from a possible 2.9 m individuals following a 5-year clearance period, with an average follow-up of 13.2 years (12.7 million person-years). Some 673,189 (69.7%) individuals developed at least one chronic disease or died within the study period. From ages 10 years upwards, the individuals living in the most deprived areas consistently experienced reduced time between health states, demonstrating accelerated transitions to first and subsequent morbidities and death compared to their demographic equivalent living in the least deprived areas. The largest difference were observed in 10 and 20 year old males developing multimorbidity (-0.45 years (99% CI: -0.45, -0.44)) and in 70 year old males dying after developing multimorbidity (-1.98 years (99% CI: -2.01, -1.95))., Interpretation: This study adds to the existing literature on health inequalities by demonstrating that individuals living in more deprived areas consistently experience accelerated time to diagnosis of chronic disease and death across all ages, accounting for competing risks., Funding: UK Medical Research Council, Health Data Research UK, and Administrative Data Research Wales., Competing Interests: RKO is a member of the National Institute for Health and Care Excellence (NICE) Technology Appraisal Committee, member of the NICE Decision Support Unit (DSU), and associate member of the NICE Technical Support Unit (TSU). She has served as a paid consultant providing unrelated methodological advice to AstraZeneca, Cogentia Healthcare Ltd., Daiichi Sankyo, NICE, Norwegian Institute of Public Health, Roche, and Vifor Pharma. She reports teaching fees from the Association of British Pharmaceutical Industry (ABPI) and the University of Bristol. KRA is a member of the National Institute for Health and Care Excellence (NICE) Diagnostics Advisory Committee, the NICE Decision and Technical Support Units, and is a National Institute for Health Research (NIHR) Senior Investigator Emeritus [NF-SI-0512-10159]. He has served as a paid consultant, providing unrelated methodological and strategic advice, to the pharmaceutical and life sciences industry generally, as well as to DHSC/NICE, and has received unrelated research funding from Association of the British Pharmaceutical Industry (ABPI), European Federation of Pharmaceutical Industries & Associations (EFPIA), Pfizer, Sanofi and Swiss Precision Diagnostics/Clearblue. He has also received course fees from ABPI and is a Partner and Director of Visible Analytics Limited, a health technology assessment consultancy company. CMC has received previous funding from Medical Research Council, National Institute for Health and Care Research, Wellcome Trust, and Chief Scientists Office. JR has received previous funding from Medical Research Council, and NHS England for an internship programmed collaboration. CPG has received funding from Abbott Diabetes, National Institute for Health and Care Research, BMS, and BHF. He has served as paid consultant for Amgen, AINexus, AstraZeneica, Bayer, BMS, Cardiomatics, Chessi, Diachii Sankyo, iRhythm, and Organon. He has also received payment from AstraZeneca, Bayer, Novartis, WomdrMedical, and Zydos, and received materials from Echonous and Kosmos. All other authors report no conflicts of interest., (Crown Copyright © 2023 Published by Elsevier Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
50. Association of beta-blockers beyond 1 year after myocardial infarction and cardiovascular outcomes.
- Author
-
Ishak D, Aktaa S, Lindhagen L, Alfredsson J, Dondo TB, Held C, Jernberg T, Yndigegn T, Gale CP, and Batra G
- Subjects
- Humans, Female, Middle Aged, Male, Cohort Studies, Hospitalization, Adrenergic beta-Antagonists therapeutic use, Myocardial Infarction drug therapy, Myocardial Infarction complications, Heart Failure etiology, Ventricular Dysfunction, Left etiology
- Abstract
Objective: Beta-blockers (BB) are an established treatment following myocardial infarction (MI). However, there is uncertainty as to whether BB beyond the first year of MI have a role in patients without heart failure or left ventricular systolic dysfunction (LVSD)., Methods: A nationwide cohort study was conducted including 43 618 patients with MI between 2005 and 2016 in the Swedish register for coronary heart disease. Follow-up started 1 year after hospitalisation (index date). Patients with heart failure or LVSD up until the index date were excluded. Patients were allocated into two groups according to BB treatment. Primary outcome was a composite of all-cause mortality, MI, unscheduled revascularisation and hospitalisation for heart failure. Outcomes were analysed using Cox and Fine-Grey regression models after inverse propensity score weighting., Results: Overall, 34 253 (78.5%) patients received BB and 9365 (21.5%) did not at the index date 1 year following MI. The median age was 64 years and 25.5% were female. In the intention-to-treat analysis, the unadjusted rate of primary outcome was lower among patients who received versus not received BB (3.8 vs 4.9 events/100 person-years) (HR 0.76; 95% CI 0.73 to 1.04). Following inverse propensity score weighting and multivariable adjustment, the risk of the primary outcome was not different according to BB treatment (HR 0.99; 95% CI 0.93 to 1.04). Similar findings were observed when censoring for BB discontinuation or treatment switch during follow-up., Conclusion: Evidence from this nationwide cohort study suggests that BB treatment beyond 1 year of MI for patients without heart failure or LVSD was not associated with improved cardiovascular outcomes., Competing Interests: Competing interests: JA reports, outside the submitted work, honoraria for lectures from Boehringer Ingelheim, AstraZeneca, MSD and Bayer; advisory board from AstraZeneca and Novartis. CH reports, outside the submitted work, institutional research grants from Pfizer, GlaxoSmith Kline, AstraZeneca, Bristol Myers Squibb; advisory board from AstraZeneca, Bayer, Boehringer Ingelheim, Novo Nordisk and Coala Life; personal fees from event adjudication for Uppsala Clinical Research Center. CPG reports, outside the submitted work, consultancy/advisory (AstraZeneca, AINexus, Bayer, Bristol Myers Squibb, Boehringer-Ingelheim, Chiesi, Daiichi Sankyo, GPRI Research B.V., iRhythm Menarini, Novartis, Organon), international advisory board member (BMJ Heart), speaker fees (AstraZeneca, Bayer, Menarini, Raisio Group, Wondr Medical, Zydus), editorship (Deputy Editor: European Heart Journal Quality of Care and Clinical Outcomes, Oxford University Press), grants (British Heart Foundation, National Institute for Health Research, Horizon 2020, Abbott Diabetes, Bristol Myers Squibb), leadership (NICE Indicator Advisory Committee, Chair ESC Quality Indicator Committee). GB reports, outside the submitted work, institutional research grants from Pfizer; expert committee and consulting fees to his institution from Bayer; honoraria for lectures and scientific advice from AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Pfizer and Sanofi., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.