The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association ...(EHRA) in order to identify the safety and efficacy of the current practice of TLE.
European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV ≥ 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% 95% CI 1.3-2.1% (58/3510 pts) including a mortality of 0.5% 95% CI 0.3-0.8% (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% 95% CI 1.0-1.8%). Complete clinical and radiological success rates were 96.7% 95% CI 96.1-97.3% and 95.7% 95% CI 95.2-96.2%, respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% 95% CI 1.9-3.0% vs. 4.1% 95% CI 2.7-6.0%, P = 0.0146; and 1.2% 95% CI 0.8-1.6% vs. 2.5% 95% CI 1.5-4.1% P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres.
The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres.
Abstract
Aims
The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether ...time-to-treatment initiation (TTI) influences the beneficial impact of colchicine.
Methods and results
In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4–7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32–0.84, in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53–1.75) or > Day 8 (HR = 0.82, 95% CI 0.61–1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05).
Conclusion
Patients benefit from early, in-hospital initiation of colchicine after MI.
Trial Registration
COLCOT ClinicalTrials.gov number, NCT02551094.
Graphical Abstract
Abstract Objective Atrial fibrillation is often asymptomatic, but outcomes require further characterization. The study objective was to investigate the clinical presentation, management, and outcomes ...in asymptomatic and symptomatic patients with atrial fibrillation who were prospectively enrolled in the EurObservational Research Programme – Atrial Fibrillation (EORP-AF) Pilot General Registry. Methods A total of 3119 patients were enrolled, and 1237 (39.7%) were asymptomatic (European Heart Rhythm Association EHRA score I). Among symptomatic patients, 963 (51.2%) had mild symptoms (EHRA score II) and 919 (48.8%) had severe or disabling symptoms (EHRA III-IV). Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients. Results On multivariate analysis, male gender (odds ratio OR, 1.630; 95% confidence interval CI, 1.384-1.921), older age (OR, 1.019; 95% CI, 1.012-1.026), previous myocardial infarction (OR, 1.681; 95% CI, 1.350-2.093), and limited physical activity (OR, 1.757; 95% CI, 1.495-2.064) were associated significantly with asymptomatic (EHRA I) atrial fibrillation. Fully asymptomatic atrial fibrillation (absence of current and previous symptoms) was present in 520 patients (16.7%) and was associated independently with male gender, age, and previous myocardial infarction. Appropriate guideline-based prescription of oral anticoagulants was lower in these patients, and aspirin was prescribed more frequently. Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients (9.4% vs 4.2%, P < .0001) and was associated independently with older age and comorbidities, including chronic kidney disease and chronic heart failure. Conclusions Asymptomatic atrial fibrillation is common in daily cardiology practice and is associated with elderly age, more comorbidities, and high thromboembolic risks. A higher 1-year mortality was found in asymptomatic patients compared with symptomatic patients.
Aims
Co‐morbidities frequently accompany heart failure (HF), contributing to increased morbidity and mortality, and an impairment of quality of life. We assessed the prevalence, determinants, ...regional variation, and prognostic implications of co‐morbidities in patients with chronic HF in Europe.
Methods and results
A total of 3226 European outpatients with chronic HF were included in this analysis of the European Society of Cardiology (ESC) Heart Failure Pilot Survey. The following co‐morbidities were considered: diabetes, hyper‐ and hypothyroidism, stroke, COPD, sleep apnoea, chronic kidney disease (CKD), and anaemia. Prognostic implications of co‐morbidities were evaluated using population attributable risks (PARs), and patients were divided into geographic regions. Clinical endpoints were all‐cause mortality and HF hospitalization. The majority of patients (74%) had a least one co‐morbidity, the most prevalent being CKD (41%), anaemia (29%), and diabetes (29%). Co‐morbidities were independently associated with higher age (P < 0.001), higher NYHA functional class (P < 0.001), ischaemic aetiology of HF (P < 0.001), higher heart rate (P = 0.011), history of hypertension (P < 0.001), and AF (P < 0.001). Only diabetes, CKD, and anaemia were independently associated with a higher risk of mortality and/or HF hospitalization. There were marked regional differences in prevalence and prognostic implications of co‐morbidities. Prognostic implications of co‐morbidities (PARs) were: CKD = 41%, anaemia = 37%, diabetes = 14%, COPD = 10%, and <10% for all other co‐morbidities.
Conclusion
In this pilot survey, co‐morbidities are prevalent in patients with chronic HF and are related to the severity of the disease. The presence of diabetes, CKD, and anaemia was independently related to increased mortality and HF hospitalization, with the highest PAR for CKD and anaemia.
Aims
To identify differences in clinical epidemiology, in‐hospital management and 1‐year outcomes among patients hospitalized for acute heart failure (AHF) and enrolled in the European Society of ...Cardiology Heart Failure Long‐Term (ESC‐HF‐LT) Registry, stratified by clinical profile at admission.
Methods and results
The ESC‐HF‐LT Registry is a prospective, observational study collecting hospitalization and 1‐year follow‐up data from 6629 AHF patients. Among AHF patients enrolled in the registry, 13.2% presented with pulmonary oedema (PO), 2.9% with cardiogenic shock (CS), 61.1% with decompensated heart failure (DHF), 4.8% with hypertensive heart failure (HT‐HF), 3.5% with right heart failure (RHF) and 14.4% with AHF and associated acute coronary syndromes (ACS‐HF). The 1‐year mortality rate was 28.1% in PO, 54.0% in CS, 27.2% in DHF, 12.8% in HT‐HF, 34.0% in RHF and 20.6% in ACS‐HF patients. When patients were classified by systolic blood pressure (SBP) at initial presentation, 1‐year mortality was 34.8% in patients with SBP <85 mmHg, 29.0% in those with SBP 85–110 mmHg, 21.2% in patients with SBP 110–140 mmHg and 17.4% in those with SBP >140 mmHg. These differences tended to diminish in the months post‐discharge, and 1‐year mortality for the patients who survived at least 6 months post‐discharge did not vary significantly by either clinical profile or SBP classification.
Conclusion
Rates of adverse outcomes in AHF remain high, and substantial differences have been found when patients were stratified by clinical profile or SBP. However, patients who survived at least 6 months post‐discharge represent a more homogeneous group and their 1‐year outcome is less influenced by clinical profile or SBP at admission.
Abstract
Aims
The 2019 report from the European Society of Cardiology (ESC) Atlas provides a contemporary analysis of cardiovascular disease (CVD) statistics across 56 member countries, with ...particular emphasis on international inequalities in disease burden and healthcare delivery together with estimates of progress towards meeting 2025 World Health Organization (WHO) non-communicable disease targets.
Methods and results
In this report, contemporary CVD statistics are presented for member countries of the ESC. The statistics are drawn from the ESC Atlas which is a repository of CVD data from a variety of sources including the WHO, the Institute for Health Metrics and Evaluation, and the World Bank. The Atlas also includes novel ESC sponsored data on human and capital infrastructure and cardiovascular healthcare delivery obtained by annual survey of the national societies of ESC member countries. Across ESC member countries, the prevalence of obesity (body mass index ≥30 kg/m2) and diabetes has increased two- to three-fold during the last 30 years making the WHO 2025 target to halt rises in these risk factors unlikely to be achieved. More encouraging have been variable declines in hypertension, smoking, and alcohol consumption but on current trends only the reduction in smoking from 28% to 21% during the last 20 years appears sufficient for the WHO target to be achieved. The median age-standardized prevalence of major risk factors was higher in middle-income compared with high-income ESC member countries for hypertension {23.8% interquartile range (IQR) 22.5–23.1% vs. 15.7% (IQR 14.5–21.1%)}, diabetes 7.7% (IQR 7.1–10.1%) vs. 5.6% (IQR 4.8–7.0%), and among males smoking 43.8% (IQR 37.4–48.0%) vs. 26.0% (IQR 20.9–31.7%) although among females smoking was less common in middle-income countries 8.7% (IQR 3.0–10.8) vs. 16.7% (IQR 13.9–19.7%). There were associated inequalities in disease burden with disability-adjusted life years per 100 000 people due to CVD over three times as high in middle-income 7160 (IQR 5655–8115) compared with high-income 2235 (IQR 1896–3602) countries. Cardiovascular disease mortality was also higher in middle-income countries where it accounted for a greater proportion of potential years of life lost compared with high-income countries in both females (43% vs. 28%) and males (39% vs. 28%). Despite the inequalities in disease burden across ESC member countries, survey data from the National Cardiac Societies of the ESC showed that middle-income member countries remain severely under-resourced compared with high-income countries in terms of cardiological person-power and technological infrastructure. Under-resourcing in middle-income countries is associated with a severe procedural deficit compared with high-income countries in terms of coronary intervention, device implantation and cardiac surgical procedures.
Conclusion
A seemingly inexorable rise in the prevalence of obesity and diabetes currently provides the greatest challenge to achieving further reductions in CVD burden across ESC member countries. Additional challenges are provided by inequalities in disease burden that now require intensification of policy initiatives in order to reduce population risk and prioritize cardiovascular healthcare delivery, particularly in the middle-income countries of the ESC where need is greatest.
Abstract
Background and Aims
Cardiovascular disease (CVD) impacts significantly health and social care systems as well as society through premature mortality and disability, with patients requiring ...care from relatives. Previous pan-European estimates of the economic burden of CVD are now outdated. This study aims to provide novel, up-to-date evidence on the economic burden across the 27 European Union (EU) countries in 2021.
Methods
Aggregate country-specific resource use data on morbidity, mortality, and health, social and informal care were obtained from international sources, such as the Statistical Office of the European Communities, enhanced by data from the European Society of Cardiology Atlas programme and patient-level data from the Survey of Health, Ageing and Retirement in Europe. Country-specific unit costs were used, with cost estimates reported on a per capita basis, after adjustment for price differentials.
Results
CVD is estimated to cost the EU €282 billion annually, with health and long-term care accounting for €155 billion (55%), equalling 11% of EU-health expenditure. Productivity losses accounted for 17% (€48 billion), whereas informal care costs were €79 billion (28%). CVD represented a cost of €630 per person, ranging from €381 in Cyprus to €903 in Germany. Coronary heart disease accounted for 27% (€77 billion) and cerebrovascular diseases for 27% (€76 billion) of CVD costs.
Conclusions
This study provides contemporary estimates of the wide-ranging impact of CVD on all aspects of the economy. The data help inform evidence-based policies to reduce the impact of CVD, promoting care access and better health outcomes and economic sustainability.
Structured Graphical Abstract
Structured Graphical Abstract
Cardiovascular disease costs €282 billion annually across the 27 European Union countries, representing a cost of €630 per EU citizen. CVD-related costs were estimated using country-specific national data on morbidity, mortality, and health, social and informal care.
Aims
Patients with heart failure (HF) randomized in controlled trials are generally selected and do not fully represent the ‘real world’. The purpose of this study is to better describe the ...characteristics of HF by analysing administrative data of a population of nearly 2 500 000 subjects.
Methods and results
Data came from the ARNO Observatory including inhabitants of five Local Health Units of the Italian National Health Service (INHS). Patients were selected when discharged for HF (1 January 2008–31 December 2012) and prescribed at least one HF treatment. Clinical characteristics, pharmacological treatments, rehospitalization, and direct costs for the INHS were described during 1‐year follow‐up (FU). Of the 2 456 739 subjects included in the database, 54 059 (2.2%) were hospitalized for HF: 41 413 were discharged alive and prescribed HF treatments. Mean age was 78 ± 11 years and 51.4% were females. Just 26.6% were managed in a cardiology setting. The most frequent co‐morbidities were diabetes (30.7%), COPD (30.5%), and depression (21%). ACE inhibitors/ARBs, beta‐blockers, and mineralocorticoid antagonists were prescribed in 65.8, 49.7, and 42.1% of patients, respectively. During 1‐year FU, at least one rehospitalization occurred in 56.6% of patients, 49% of them due to non‐cardiovascular causes. The direct cost per patient per year to the INHS was €11 867, of which 76% was related to hospitalizations.
Conclusions
Real‐world evidence provides a description of patient characteristics and treatment patterns that are different from those reported by randomized clinical trials. Costs for the INHS are mainly driven by hospitalizations, which are often due to non‐cardiovascular reasons.
Abstract Background Current guidelines strongly recommend that oral anticoagulation should be offered to patients with atrial fibrillation and ≥1 stroke risk factors. The guidelines also recommend ...that oral anticoagulation still should be used in the presence of stroke risk factors irrespective of rate or rhythm control. Methods In an analysis from the dataset of the EURObservational Research Programme on Atrial Fibrillation Pilot Survey (n = 3119), we examined antithrombotic therapy prescribing, with particular focus on the risk factors determining oral anticoagulation or antiplatelet therapy use. Results When oral anticoagulation was used among admitted patients in whom no pharmacologic cardioversion, electrical cardioversion, or catheter ablation was performed or planned, vitamin K antagonist therapy was prescribed in the majority (72.2%), whereas novel oral anticoagulants were used in the minority (7.7%). There was no significant difference in bleeding risk factors among the patients treated with the different types of antithrombotic therapies, except for those with chronic kidney disease, in whom oral anticoagulation was less commonly used ( P = .0318). Antiplatelet therapy was more commonly used in patients with a high Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (>65 years), Drugs/alcohol concomitantly score (≥2) ( P < .0001). More oral anticoagulation use was associated with female gender ( P = .0245). Less novel oral anticoagulant use was associated with valvular heart disease ( P < .0001), chronic heart failure ( P = .0010), coronary artery disease ( P < .0001), and peripheral artery disease ( P = .0092). Coronary artery disease was the strongest reason for combination therapy with oral anticoagulation plus antiplatelet drug (odds ratio, 8.54; P < .0001). When the Congestive heart failure, Hypertension, Age ≥75 Doubled, Diabetes, Stroke Doubled-Vascular disease, Age 65-74, and Sex category female score was used, 95.6% of patients with a score ≥1 received antithrombotic therapy, with 80.5% of patients with a score ≥1 receiving oral anticoagulation. Of note, 83.7% of those with a score ≥2 received antithrombotic therapy. Of the latter, 70.9% of those with a score ≥2 received oral anticoagulation, vitamin K antagonists were used in 64.1%, and novel oral anticoagulants were used in 6.9%. Conclusions The EURObservational Research Programme on Atrial Fibrillation Pilot Survey provides contemporary data on oral anticoagulation prescribing by European cardiologists for atrial fibrillation. Although the uptake of oral anticoagulation (mostly vitamin K antagonist therapy) has improved since the Euro Heart Survey a decade ago, antiplatelet therapy is still commonly prescribed, with or without oral anticoagulation, whereas elderly patients are commonly undertreated with oral anticoagulation.
The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.
We enrolled in our ...study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death).
The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval CI, 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased.
Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)
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