European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus on risk assessment in cardiac arrhythmias: use the right tool for the right outcome, in the right population

Patients with cardiac diseases or conditions with high risk of developing cardiac diseases undergo risk assessment by cardiologists, primary care physicians, and scientists based on referral for more advanced risk assessment strategies, institution of preventive treatments, counselling of patients and their relatives, and selection of patients for scientific trials. The various methods used for risk assessment differ with respect to availability, complexity, and usefulness in different patient populations. Parameters associated with increased risk of e.g. death may also be associated with higher risk of other adverse outcomes. However, risk assessment strategies including specific methods for risk assessment and risk scores should be used only for the purposes for which they are validated. This expert consensus statement of the European Heart Rhythm Association (EHRA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS) summarizes the consensus of the international writing group based on a thorough review of the medical literature regarding risk assessment in cardiac arrhythmias. To create a tool for clinicians to perform rational and evidence-based risk stratification, this task force was set down by EHRA, HRS, LAHRS, and APHRS, including representatives from each of the four societies. With this document, we intend to describe and review status of performing risk assessment in different patient populations with cardiac diseases or conditions with high risk of developing such. Our objectives are to raise awareness of using the right risk assessment tool for a given outcome in a given population, and to provide physicians with practical proposals that may lead to improvement of patient care in this regard. For quick reference, sub-chapters start with a short section on consensus statements. The document concludes with a summary of consensus statements. Members of the Task Force were asked to perform a detailed literature review using PubMed and EMBASE, weigh the strength of evidence for or against a particular treatment or procedure, and include estimates of expected health outcomes for which data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that might influence the choice of particular tests are considered, as are frequency of follow-up and cost-effectiveness. In controversial areas, or with regard to issues without evidence other than usual clinical practice, consensus was achieved by agreement of the expert panel after thorough deliberations. This document was prepared by the Task Force and peer-reviewed by official external reviewers representing EHRA, HRS, APHRS, and LAHRS. Consensus statements are evidence-based and derived primarily from published data or determined through consensus opinion if no data available. Current systems of ranking level of evidence are becoming complicated in a way that might compromise their practical utility.1 In contrast to guidelines, we opted for an easier user-friendly system of ranking using 'coloured hearts' that should allow physicians to easily assess the current status of the evidence and consequent guidance (Table 1). This EHRA grading of consensus statements does not have separate definitions of the level of evidence. The categorization used for consensus statements must not be considered directly similar to the one used for official society guideline recommendations which apply a classification (Class I-III) and level of evidence (A, B, and C) to recommendations used in official guidelines. Thus, a green heart indicates a 'should do this' consensus statement or indicated risk assessment strategy based on at least one randomized trial or supported by strong observational evidence that it is beneficial and effective. A yellow heart indicates general agreement and/or scientific evidence favouring a 'may do this' statement or the usefulness/efficacy of a risk assessment strategy or procedure. A 'yellow heart' symbol may be supported by randomized trials based on a small number of patients or not widely applicable. Risk assessment strategies for which there is scientific evidence of no benefit or potential harm and should not be used ('do not do this') are indicated by a red heart. Finally, this consensus document includes evidence and expert opinions from several countries. The risk assessment approaches discussed may therefore include tests not approved by governmental regulatory agencies in all countries. All members of the writing group, as well as reviewers, have disclosed any potential conflicts of interest. Details are available in Supporting Information online. All consensus statements were voted upon by the writing committee independently and reached the predefined level of ≥75% consensus for inclusion in consensus statement tables. Each partner society officially reviewed the document, and all reviewer comments were addressed. Each partner society approved the final document and consensus statements. Clinical assessment of the patient with cardiac arrhythmias starts with a good clinical history and basic investigations for an underlying aetiological factor for the arrhythmia or its associated complication(s). In addition, an assessment of the risks and benefits of any therapeutic intervention should be made, and appropriate management initiated. Following on from clinical history and assessment, there is a proposal toward a more integrated and holistic approach to arrhythmia management, as evident in guidelines. Such an integrated approach requires multidisciplinary teams of healthcare professionals, patient involvement, access to treatment options, and decision-support tools to optimize the patient journey. Many proposals have been made towards the operationalization of such an integrated approach to risk assessment and practical management in cardiac arrhythmias, which has been of varying complexity. As an example, the management of atrial fibrillation (AF) has been simplified into the ABC pathway ('A' Avoid stroke with Anticoagulation; 'B' Better symptom management, with patient-centred and symptom-directed decisions on rate or rhythm control; 'C' Cardiovascular and comorbidity risk management), which has been shown to be associated with improved clinical outcomes and reduced healthcare costs.2-6 This makes a strong argument for using the right approaches and clinical tools for patient assessment, but using them appropriately for the reasons they were first proposed (e.g. stroke risk scores to assess stroke risk, and not other outcomes). Taking AF as an illustrative example with regard to using the right score for the right reason there are many risk factors for stroke (but the more common and validated ones have been used to formulate risk stratification tools).7 The most common in use is the CHA2DS2-VASc score8 but it is not meant to include every possible stroke risk factor, and was designed to be simple, reductionist and practical to help decision-making for stroke risk. As with all clinical scores based on clinical factors, the CHA2DS2-VASc score only performs modestly for predicting high-risk patients who sustain events. The use of more clinical factors and biomarkers improves prediction (at least statistically) but the practical added value is marginal, and less impressive in real-world cohorts.9, 10 Use of simplified scores to artificially categorize patients into low-, moderate- and high-risk strata can be problematic, as in the real-world patients do not necessarily fall into three neat categories of risk. Also, not all risk factors carry equal weight, hence, the move to focus the initial decision-making on identifying low-risk patients who do not need antithrombotic therapy first, following which stroke prevention can be offered to AF patients with ≥1 stroke risk factors.9 Stroke risk is also highly dynamic, and although logistically challenging, a clinical reassessment may be needed every 4-6 months to optimize risk re-assessment.11-13 As the CHA2DS2-VASc is a cluster of common cardiovascular risk factors, it is predictive of death, cardiovascular hospitalizations, and other adverse outcomes that the CHA2DS2-VASc score was not designed for. Also, given that many components of the CHA2DS2-VASc score are associated with incident AF, the CHA2DS2-VASc score is used to predict new onset AF, again something it was not designed for. Another misuse of the CHA2DS2-VASc score is the prediction of bleeding risk. Nevertheless, formal comparisons show that the CHA2DS2-VASc (and older CHA2DS2) score are inferior to a formal bleeding risk score such as the HAS-BLED score, for the prediction of major bleeding in AF patients.14 Indeed, bleeding risk is also highly dynamic, and the appropriate use of bleeding risk scores such as HAS-BLED is to address modifiable bleeding risk factors (e.g. uncontrolled hypertension, labile INR, concomitant aspirin, or NSAID use) then to schedule the 'high risk' patients for early and more frequent follow-up visits (e.g. 4 weeks rather than 4 months).15 Only focusing on modifiable bleeding risk factors is an inferior strategy for bleeding risk assessment, compared to the HAS-BLED score.8 We should use the scores only for the purposes they were designed for. Attention to appropriate methodology, statistics, etc.—as well as other clinical states merits consideration e.g. sudden death prediction (or failed ablation, device infection, etc.), Charlson Comorbidity Index, frailty etc.—but using the right score designed for that purpose. If appropriately used, some of these (simplified) tools help with clinical management. Indeed, the value of a medical test is measured by its accuracy as well as how it impacts medical decisions and ultimately patient health. As medical tests are considered and new ones emerge, they should be considered and evaluated in a framework of accuracy and patient impact.16 A test must not only be accurat

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