Atrial Fibrillation and Anticoagulation in Hypertrophic Cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) represents a common inherited cardiac disorder with well-known complications Including stroke and sudden cardiac death. There is a recognised association between HCM and the development of AF. This review describes the epidemiology of AF within the HCM population and analyses the risk factors for the development of AF. It further discusses the outcomes associated with AF in this population, including the evidence in support of higher stroke risk in patients with HCM with AF compared with the general AF population. Finally, the evidence and recommendations for anticoagulation in this patient group are addressed

Managing atrial fibrillation in the global community: The European perspective.

Atrial fibrillation is a common, global problem, with great personal, economic and social burdens. As populations age it increases in prevalence and becomes another condition that requires careful chronic management to ensure its effects are minimised. Assessment of the risk of stroke using well established risk prediction models is being aided by modern computerised databases and the choice of drugs to prevent strokes is ever expanding to try and improve the major cause of morbidity in AF. In addition, newer drugs for controlling rhythm are available and guidelines are constantly changing to reflect this. As well as medications, modern techniques of electrophysiology are becoming more widely embraced worldwide to provide more targeted treatment for the underlying pathophysiology. In this review we consider these factors to concisely describe how AF can be successfully managed

Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants.

Randomised controlled trials (RCTs) provide the reference standard for comparing the efficacy of one therapy or intervention with another. However, RCTs have restrictive inclusion and exclusion criteria; thus, they are not fully representative of an unselected real-world population. Real-world evidence (RWE) studies encompass a wide range of research methodologies and data sources and can be broadly categorised as non-interventional studies, patient registries, claims database studies, patient surveys and electronic health record studies. If appropriately designed, RWE studies include a patient population that is far more representative of unselected patient populations than those of RCTs, but they do not provide a robust basis for comparing treatment strategies. RWE studies can have very large sample sizes, can provide information on treatments in patient groups that are usually excluded from RCTs, are generally less expensive and quicker than RCTs, and can assess a broad range of outcomes. Limitations of RWE studies can include low internal validity, lack of quality control surrounding data collection and susceptibility to multiple sources of bias for comparing outcomes. RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions. RWE studies have been extensively applied in the postmarketing approval assessment of non-vitamin K antagonist oral anticoagulants since 2010. However, the benefits, costs, limitations and methodological challenges associated with the different types of RWE must be considered carefully when interpreting the findings

The year in cardiology: arrhythmias and pacing.

During this last year, there has been much progress with regard to anticoagulant and ablation therapy for atrial fibrillation (AF). Apart from recently issued European Society of Cardiology Guidelines for the management of patients with supraventricular arrhythmias, there has been little progress in research in this field. Ventricular arrhythmias and device therapy have seen modest progress

Leap or lag: left atrial appendage closure and guidelines.

Atrial fibrillation (AF) is associated with life-threatening thromboembolism. Most emboli stem from thrombosis in the left atrial appendage (LAA). The current treatment of choice is oral anticoagulants (OACs), but a small proportion of patients cannot take OACs predominantly because of the so-called unacceptable bleeding risks. However, many who initially accept OACs subsequently stop therapy or reduce the OAC treatment to a potentially non-effective dose leaving them exposed to thromboembolic risk. A relatively simple alternative therapy involves the catheter-based insertion of a LAA closure (LAAC) device to prevent thromboembolism from the LAA. There is a considerable evidence base for this therapy consisting of clinical trials and observational data which suggests comparable therapeutic efficacy with a possible small excess of ischaemic strokes. Although LAAC has been very closely examined by regulators and approved for market release, guidelines from most professional societies give only weak recommendations for use of this device which may be the only known effective therapy available to some at-risk AF patients. Guidance materials from the same societies more enthusiastically endorse LAAC. Clinical practice is running well ahead of the guidelines because equipoise has been lost by physicians faced with patients for whom they have no other effective therapy. Guideline writers are correct in providing recommendations which are less strong for LAAC than for OACs, for those who are able and willing to take OAC treatment, but for those who are not, a stronger recommendation is needed. But, should the guidelines lag behind or leap ahead of the available evidence

XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation.

Atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke. The Phase III ROCKET AF (Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial showed that rivaroxaban, an oral, direct Factor Xa inhibitor, was noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF. Compared with warfarin, rivaroxaban significantly reduced rates of intracranial and fatal hemorrhages, although not rates of bleeding overall. XANTUS (Xarelto(®) for Prevention of Stroke in Patients with Atrial Fibrillation) is a prospective, international, observational, postauthorization, noninterventional study designed to collect safety and efficacy data on the use of rivaroxaban for stroke prevention in AF in routine clinical practice. The key goal is to determine whether the safety profile of rivaroxaban established in ROCKET AF is also observed in routine clinical practice. XANTUS is designed as a single-arm cohort study to minimize selection bias, and will enroll approximately 6,000 patients (mostly from Europe) with nonvalvular AF prescribed rivaroxaban, irrespective of their level of stroke risk. Overall duration of follow-up will be 1 year; the first patient was enrolled in June 2012. Similar studies (XANTUS-EL [Xarelto(®) for Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation, Eastern Europe, Middle East, Africa and Latin America] and XANAP [Xarelto(®) for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific]) are ongoing in Latin America and Asia-Pacific. Data from these studies will supplement those from ROCKET AF and provide practical information concerning the use of rivaroxaban for stroke prevention in AF