Design and rationale of DUTCH-AF:a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation

Introduction Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials. Methods and analysis The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire. Ethics and dissemination This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses

The European TeleCheck-AF project on remote app-based management of atrial fibrillation during the COVID-19 pandemic: Centre and patient experiences

Aims: TeleCheck-AF is a multicentre international project initiated to maintain care delivery for patients with atrial fibrillation (AF) during COVID-19 through teleconsultations supported by an on-demand photoplethysmography-based heart rate and rhythm monitoring app (FibriCheck® ). We describe the characteristics, inclusion rates and experiences from participating centres according the TeleCheck-AF infrastructure as well as characteristics and experiences from recruited patients.Methods: Three surveys exploring centre characteristics (n=25), centre experiences (n=23) and patient experiences (n=826) were completed. Self-reported patient characteristics were obtained from the app.Results: Most centres were academic (64%) and specialized public cardiology/district hospitals (36%). Majority of centres had AF outpatient clinics (64%) and only 36% had AF ablation clinics. The time required to start patient inclusion and total number of included patients in the project was comparable for centres experienced (56%) or inexperienced in mHealth use. Within 28 weeks, 1930 AF patients were recruited, mainly for remote AF control (31% of patients) and AF ablation follow-up (42%). Average inclusion rate was highest during the lockdown restrictions and reached a steady state at a lower level after easing the restrictions (188 vs 52 weekly recruited patients). Majority (>80%) of the centres reported no problems during the implementation of the TeleCheck-AF approach. Recruited patients (median age 64 [55-71], 62% male) agreed that the FibriCheck® app was easy to use (94%).Conclusions: Despite different health care settings and mHealth experiences, the TeleCheck-AF approach could be set up within an extremely short time and easily used in different European centres during COVID-19

Refining Clinical Risk Stratification for Predicting Stroke and Thromboembolism in Atrial Fibrillation Using a Novel Risk Factor-Based Approach The Euro Heart Survey on Atrial Fibrillation

Background: Contemporary clinical risk stratification schemata for predicting stroke and thromboembolism (TE) in patients with atrial fibrillation (AF) are largely derived from risk factors identified from trial cohorts. Thus, many potential risk factors have not been included. Methods: We refined the 2006 Birmingham/National Institute for Health and Clinical Excellence (NICE) stroke risk stratification schema into a risk factor-based approach by reclassifying and/or incorporating additional new risk factors where relevant. This schema was then compared with existing stroke risk stratification schema in a real-world cohort of patients with AF (n = 1,084) from the Euro Heart Survey for AF. Results: Risk categorization differed widely between the different schemes compared. Patients classified as high risk ranged from 10.2% with the Framingham schema to 75.7% with the Biramingham 2009 schema. T he classic CHADS(2), (Congestive heart failure, Hypertension, Age > 75, Diabetes, prior Stroke/transient isehemic attack) schema categorized the largest proportion (61.9%) into the intermediate-risk strata, whereas the Birmingham 2009 schema classified 15.1% into this category. The Birmingham 2009 schema classified only 9.2% as low risk, whereas the Framingham scheme categorized 48.3% as low risk. Calculated C-statistics suggested modest predictive value of all schema for TE. The Birmingham 2009 schema fared marginally better (C-statistic, 0.606) than CHADS(2). However, those classified as low risk by the Birmingham 2009 and NICE schema were truly low risk with no TE events recorded, whereas TE events occurred in 1.4% of low-risk CHADS(2) subjects. When expressed as a scoring system, the Birmingham 2009 schema (CHA(2)DS(2)-VASc acronym) showed an increase in TE rate with increasing scores (P value for trend = .003). Conclusion: Our novel, simple stroke risk stratification schema, based on a risk factor approach, provides some improvement in predictive value for TE over the CHADS(2) schema, with low event rates in low-risk subjects and the classification of only a small proportion of subjects into the in(intermediate-risk category. This schema could improve our approach to stroke risk stratification in patients with AF. CHEST 2010; 137(2):263-27

Potential net clinical benefit of population-wide implementation of apixaban and dabigatran among European patients with atrial fibrillation. A modelling analysis from the Euro Heart Survey

Vitamin K antagonists (e.g. warfarin) are commonly underutilised, due to limitations such as the need for monitoring, in high-risk atrial fibrillation (AF) patients. We therefore aimed to model the potential impact on clinical outcomes in patients with AF with the use of the novel oral anticoagulant (OAC) drugs, apixaban and dabigatran. We identified all high-risk (CHA(2)DS(2)-VASc score >= 2) patients with non-valvular AF and known one-year follow-up from the EuroHeart Survey on AF (EHS-AF). We modelled the expected numbers of clinical events on the novel OACs using published hazard ratios from their respective phase 3 clinical trials and calculated the numbers needed to treat and the mathematical net clinical benefit. Our analysis included 3,400 patients [39% females; mean (SD) age 67 (12) years; CHA(2)DS(2)-VASc score 3.0 (1.8)] of which 330 were excluded from the modelling analysis due to concomitant use of OAC and antiplatelet drugs. During one-year follow-up, 108 (3.2%) patients experienced thromboembolism, 51 (1.5%) major bleeds and 146 (4.3%) died. Compared to current treatments (i.e. warfarin, aspirin or nothing) the use of apixaban in high-risk patients would have potentially prevented an additional 17 deaths, 27 strokes and eight major bleeds within this cohort. With use of dabigatran 150 mg BID, 34 strokes could have been prevented and for dabigatran110 mg BID, 16 strokes and six major bleeds would be avoided. Extrapolation of the data from the EHS-AF to the whole of Europe would translate into the prevention of an additional 64,573 major cardiovascular events and deaths each year among patients with a CHA(2)DS(2)-VASc >= 2, by the use of apixaban, 43,235 with the use of dabigatran 150 mg bid and 27,272 with the use of dabigatran 110 mg bid. In conclusion, based on this modelling exercise, the utilisation of apixaban and dabigatran for thromboprophylaxis could provide a profound annual mathematical net clinical benefit on stroke and major bleeds, in European AF patients

Major adverse cardiac events after elective infrarenal endovascular aortic aneurysm repair

Objective: There is a significant cardiac morbidity and mortality after endovascular aneurysm repair (EVAR). However, information about long-term risk of cardiac events after EVAR and potential predictors is lacking. Therefore, the aim of this study was to determine incidence and predictors of major adverse cardiac events (MACE) at 1 and 5 years after elective EVAR for infrarenal abdominal aortic aneurysms. Methods: Baseline, perioperative, and postoperative information of 320 patients was evaluated. The primary outcome was the incidence of MACE after EVAR, which was defined as acute coronary syndrome, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, mitral valve insufficiency, revascularization (including percutaneous coronary intervention and coronary artery bypass grafting), as well as cardiovascular and noncardiovascular death. Kaplan-Meier analyses were performed to determine incidences of MACE, MACE excluding noncardiovascular death and cardiac events by excluding noncardiovascular and vascular death from MACE. Predictors of MACE were identified using univariate and multivariate binary regression analysis. Results: Through 1 and 5 years of follow-up after EVAR, freedom from MACE was 89.4% (standard error [SE], 0.018) and 59.8% (SE, 0.033), freedom from MACE excluding noncardiovascular death was 94.7% (SE, 0.013) and 77.5% (SE, 0.030) and freedom from cardiac events was 96.0% (SE, 0.011) and 79.1% (SE, 0.030), respectively. Predictors for MACE within 1 year were American Society of Anesthesiologists (ASA) score of III or IV (odds ratio [OR], 3.17; 95% confidence interval [CI], 1.52-6.59) and larger abdominal aortic diameter (OR, 1.04; 95% CI, 1.01-1.08). A history of atrial fibrillation (OR, 0.14; 95% CI, 0.03-0.60) was a negative predictor factor. Predictors for MACE through 5 years were a history of heart failure (OR, 4.10; 95% CI 1.36-12.32) and valvular heart disease (OR, 2.31; 95% CI, 0.97-5.51), American Society of Anesthesiologists score of 3 or 4 (OR, 1.66; 95% CI, 0.96-2.88), and older age (OR, 1.04; 95% CI, 1.01-1.08). Conclusions: MACE is a common complication during the first 5 years after elective EVAR. Cardiac diseases at baseline are strong predictors for long-term MACE and potentially helpful in optimizing future postoperative long-term follow-up

Contra-indicaties voor DOAC’s bij atriumfibrilleren

Sometimes there is doubt as to whether or not anticoagulants should be initiated, and if so which ones, in patients with atrial fibrillation and advanced age, increased frailty, or fall risk, kidney, or liver impairment, alcohol abuse, uncontrolled hypertension, or a history of major bleeding. These subgroups have increased risk of haemorrhage as well as thromboembolism. Treatment with anticoagulants is indicated in the vital elderly, preferably with direct oral anticoagulants as demonstrated by robust data. The available study results for the other subgroups may not be (fully) generalisable to clinical practice. In such patients, a comprehensive risk assessment is therefore advised; as is discussing the pros and cons of (not) using anticoagulants and of both type of anticoagulants. Only in exceptional cases is it justified not to use anticoagulants