Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The 'Atrial fibrillation Better Care' (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients.From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses.Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58-0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52-0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58-0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56-0.98) and composite outcome (aHR: 0.76, 95%CI 0.60-0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome.An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients.
Abstract Aims Bleeding risk assessment is recommended in guidelines for the management of atrial fibrillation (AF). The HAS-BLED score was proposed prior to non-vitamin K antagonist oral anticoagulants (NOACs) and it has been suggested that the ORBIT score may be superior in predicting bleeds in NOAC users. We aimed to compare the HAS-BLED and ORBIT scores in contemporary AF patients treated with NOACs. Methods and results We analysed patients enrolled in the ESC-EHRA EORP-AF (EURObservational Research Programme in AF) General Long-Term Registry. HAS-BLED and ORBIT scores were computed based on original schemes. The primary outcome was the occurrence of major bleeding (MB). A total of 3018 patients (median age 70; 39.6% females) were included: median [interquartile range (IQR)] HAS-BLED and ORBIT scores were 1 [1–2] and 1 [0–2], respectively; 356 (11.8%) patients were at high risk for MB using HAS-BLED (≥3) and 123 (4.1%) using ORBIT (≥4). Overall, 60 (2.0%) MB events were recorded, with an incidence of 1.1 per 100 patient-years. Both HAS-BLED and ORBIT were associated with outcome, modestly predicting MB [area under the curve (AUC) 0.653, 95% confidence interval (CI) 0.593–0.714 and AUC 0.601, 95% CI 0.526–0.677, respectively]. Calibration plots showed that both scores were poorly calibrated, particularly the ORBIT score, which showed consistent poorer calibration. Time-dependent reclassification analysis showed a trend towards incorrect lower risk reclassification using ORBIT compared with HAS-BLED. Conclusion In this real-life contemporary cohort of AF patients treated with NOACs, the ORBIT score did not provide reclassification improvement, showing even poorer calibration compared with HAS-BLED. Our findings do not support the preferential use of ORBIT in NOAC-treated AF patients.
This editorial refers to ‘Evaluation of SAMe-TT2R2 risk score for predicting the quality of anticoagulation control in a real-world cohort of patients with non-valvular atrial fibrillation on vitamin-K antagonists’ by M. R.R.-Y. Abumuaileq et al. , doi:10.1093/europace/euu353.
Maintaining the therapeutic range in patients treated with vitamin K antagonists (VKAs) had always been challenging whilst the potential consequences of deviating from the optimal average time in therapeutic range(TTR) are deleterious in patients with atrial fibrillation (AF), given the risk for thromboembolic and bleeding events.1,2
Various clinical decision-making tools have been developed to help decision-making in the management of AF patients. In 2013, a new score—with the acronym SAMe-TT2R2—was proposed to help identify those patients who were likely to have a propensity to poor INR control (as reflected by average time in the therapeutic range [TTR] 2).3 This score was derived from a trial cohort and thus independent validation in ‘real-world’ AF cohorts would be needed.
In the current issue of EP-Europace , Abumaileq et al. 4 performed a retrospective analysis of a cohort of outpatients with non-valvular AF and found that SAMe-TT2R2 could indeed represented a useful clinical tool to identify a poor quality of anticoagulation control with VKAs. The predictive ability of SAMe-TT2R2 was acceptable for identifying low TTR and improved when integrated with other clinical characteristics.
A strong relationship …
The prevalence of atrial fibrillation(AF) and diabetes mellitus is rising to epidemic proportions. We aimed to assess the impact of diabetes on the management and outcomes of patients with AF.The EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. Outcomes of interest were as follows: i)rhythm control interventions; ii)quality of life; iii)healthcare resource utilisation; and iv)major adverse events.Of 11,028 patients with AF, the median age was 71 (63-77) years and 2537 (23.0%) had diabetes. Median follow-up was 24 months. Diabetes was related to increased use of anticoagulation but less rhythm control interventions. Using multivariable analysis, at 2-year follow-up, patients with diabetes were associated with greater levels of anxiety (p = 0.038) compared to those without diabetes. Overall, diabetes was associated with worse health during follow-up, as indicated by Health Utility Score and Visual Analogue Scale. Healthcare resource utilisation was greater with diabetes in terms of length of hospital stay (8.1 (±8.2) vs. 6.1 (±6.7) days); cardiology and internal medicine/general practitioner visits; and emergency room admissions. Diabetes was an independent risk factor of major adverse cardiovascular event (MACE; HR 1.26 [95% CI, 1.04-1.52]), all-cause mortality (HR 1.28 [95% CI, 1.08-1.52]), and cardiovascular mortality (HR 1.41 [95% CI, 1.09-1.83]).In this contemporary AF cohort, diabetes was present in 1 in 4 patients and it served as an independent risk factor for reduced quality of life, greater healthcare resource utilisation and excess MACE, all-cause mortality and cardiovascular mortality. There was increased use of anticoagulation therapy in diabetes but with less rhythm control interventions.
Abstract Background Frailty is a medical syndrome characterised by reduced physiological reserve and increased vulnerability to stressors. Data regarding the relationship between frailty and atrial fibrillation (AF) are still inconsistent. Objectives We aim to perform a comprehensive evaluation of frailty in a large European cohort of AF patients. Methods A 40-item frailty index (FI) was built according to the accumulation of deficits model in the AF patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Association of baseline characteristics, clinical management, quality of life, healthcare resources use and risk of outcomes with frailty was examined. Results Among 10,177 patients [mean age (standard deviation) 69.0 (11.4) years, 4,103 (40.3%) females], 6,066 (59.6%) were pre-frail and 2,172 (21.3%) were frail, whereas only 1,939 (19.1%) were considered robust. Baseline thromboembolic and bleeding risks were independently associated with increasing FI. Frail patients with AF were less likely to be treated with oral anticoagulants (OACs) (odds ratio 0.70, 95% confidence interval 0.55–0.89), especially with non-vitamin K antagonist OACs and managed with a rhythm control strategy, compared with robust patients. Increasing frailty was associated with a higher risk for all outcomes examined, with a non-linear exponential relationship. The use of OAC was associated with a lower risk of outcomes, except in patients with very/extremely high frailty. Conclusions In this large cohort of AF patients, there was a high burden of frailty, influencing clinical management and risk of adverse outcomes. The clinical benefit of OAC is maintained in patients with high frailty, but not in very high/extremely frail ones.
Abstract Background Risk stratification in patients with atrial fibrillation (AF) is important to facilitate guideline-directed therapies. The Calculator of Absolute Stroke Risk (CARS) scheme enables an individualized estimation of 1-year absolute risk of stroke in AF. We aimed to investigate the predicted and absolute risks of ischaemic stroke, and evaluate whether CARS (and CHA2DS2-VASc score) may be useful for identifying high risk patients with AF despite contemporary treatment. Methods We utilized the EORP-AF General Long-Term Registry which prospectively enrolled patients with AF from 250 centres across 27 participating European countries. Patients with sufficient data to determine CARS and CHA2DS2-VASc score, and reported outcomes of ischaemic stroke were included in this analysis. The primary outcome of ischaemic stroke was recorded over a 2-year follow-up period. Results A total of 9444 patients were included (mean age 69.1 [±11.4] years; 3776 [40.0%] females). There was a high uptake (87.9%) of anticoagulation therapy, predominantly with vitamin K antagonist (50.0%). Over a mean follow-up period of 24 months, there were a total of 101 (1.1%) ischaemic stroke events. In the entire cohort, the median CARS and absolute annual risks of ischaemic stroke were 2.60 (IQR 1.60–4.00) and 0.53% (95%CI 0.43–0.64%), respectively. There was no statistical difference between the predictive performance of CARS and CHA2DS2-VASc score (0.621 [95%CI 0.563–0.678] vs. 0.626 [95%CI 0.573–0.680], P = 0.725). Conclusion Contemporary management of AF was associated with a low risk of ischaemic stroke. CARS and CHA2DS2-VASc score may be useful to identify high risk patients despite treatment who may benefit from more aggressive treatment and follow-up.
Abstract Aim To investigate the association of anthropometric parameters [height, weight, body mass index (BMI), body surface area (BSA), and lean body mass (LBM)] with outcomes in atrial fibrillation (AF). Methods and results Ten-thousand two-hundred twenty patients were enrolled [40.3% females, median age 70 (62–77) years, followed for 728 (interquartile range 653–745) days]. Sex-specific tertiles were considered for the five anthropometric variables. At the end of follow-up, survival free from all-cause death was worse in the lowest tertiles for all the anthropometric variables analyzed. On multivariable Cox regression analysis, an independent association with all-cause death was found for the lowest vs. middle tertile when body weight (hazard ratio [HR] 1.66, 95%CI 1.23–2.23), BMI (HR 1.65, 95%CI 1.23–2.21), and BSA (HR 1.49, 95%CI 1.11–2.01) were analysed in female sex, as well as for body weight in male patients (HR 1.61, 95%CI 1.25–2.07). Conversely, the risk of MACE was lower for the highest tertile (vs. middle tertile) of BSA and LBM in males and for the highest tertile of weight and BSA in female patients. A higher occurrence of haemorrhagic events was found for female patients in the lowest tertile of height [odds ratio (OR) 1.90, 95%CI 1.23–2.94] and LBM (OR 2.13, 95%CI 1.40–3.26). Conclusions In AF patients height, weight, BMI, BSA, and LBM were associated with clinical outcomes, with all-cause death being higher for patients presenting lower values of these variables, i.e. in the lowest tertiles of distribution. The anthropometric variables independently associated with other outcomes were also different between male and female subjects.
The implantable cardioverter defibrillator (ICD) is now an integral therapy for cardiac patient care. More than 20 years have passed since the first ICD implant. Sudden cardiac death from arrhythmia (ventricular tachycardia and fibrillation) has been significantly decreased because of the use of ICD therapy. Primary treatment trials have shown ICD therapy to be superior to drug therapy. Most of these trials compared ICD therapy with amiodarone or sotalol. Prevention trials have also been completed. Patients with nonsustained ventricular tachycardia, low left ventricular ejection fraction, and coronary artery disease were evaluated with electrophysiology studies. Patients with inducible ventricular arrhythmias were treated with ICD or drug suppression therapy. ICD therapy was superior to drug therapy for prevention of fatal arrhythmias. Ongoing trials include evaluation of ICD therapy for patients with high-risk substrates: congestive heart failure, dilated cardiomyopathy, hypertrophic cardiomyopathy, and repolarization syndromes. Factors such as medication inefficacy/side effects, transvenous ICD implantation and overwhelming mortality benefits have expanded ICD usage beyond the original restrictive guidelines.