ATRIAL FIBRILLATION IN PRIMARY CARE (AFIP)

Transcription

1 ATRIAL FIBRILLATION IN PRIMARY CARE (AFIP) BRINGING ATRIAL FIBRILLATION PRACTICE CLOSER TO GUIDELINES A Tool for Primary Care Physicians INTERNATIONAL

2 CONTENTS: Introducing the AFIP Tool Impact of atrial fibrillation (AF) Why is primary care so important? A typical AF patient profile Goals of AF management Diagnosis Referral to specialist care Emergency referral An overview of AF management Anticoagulation therapy Rate and rhythm control Empowering patients References

3 INTRODUCING THE AFIP TOOL Dear colleagues, Atrial Fibrillation (AF) is a growing and urgent public health concern. It is the most common sustained abnormal heart rhythm worldwide and places a huge burden on individuals, their families, and healthcare systems. Primary Care Physicians (PCPs) play a critical role in the first steps of discovering and managing atrial fibrillation. However, time-limited settings and lengthy guidelines may contribute to a difficulty in diagnosing AF and in the ongoing management of the condition. The AF AWARE (Atrial Fibrillation AWareness And Risk Education) campaign, which is dedicated to reducing the burden of the condition, convened a group of experts to explore the challenges in adhering to AF management guidelines and identify methods for intervention. We recognized a need, especially at primary care level, to assist physicians with the first steps of discovering and managing AF. This simple, practical tool, AFIP, for use in primary care, is intended to complement existing European and North American guidelines, making them more accessible to physicians. It is not meant to be all-encompassing, but rather to provide an overview of the latest guidelines and to highlight the main goals in AF management. We hope you find the AFIP tool a useful guide. The AF AWARE AFIP Steering Committee Dr Carlos Brotons, Head of the Research Unit, Sardenya Primary Health Care Centre, Sant Pau Biomedical Research Institute, Barcelona, Spain Professor John Camm, Professor of Clinical Cardiology, St George s University, London, UK Professor Gregory Lip, Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK Professor Kathryn Taubert, Chief Science Officer, World Heart Federation, Geneva, Switzerland The AF Aware campaign is concluded and the three partner organizations are distributing materials through their own channels. The World Heart Federation s AF-related activities operate under the Global AF Action (GAFA) programme as part of the 25x25 campaign. 1

4 The AFIP tool is endorsed by: Günter Breithardt, MD, EFESC, FACC, FHRS, Professor (emer.) of Medicine (Cardiology), University of Münster, Germany Bernard J. Gersh, MB, ChB, D.Phil, FRCP Professor of Medicine, Mayo Clinic College of Medicine Consultant in Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Minnesota, USA Professor Dr. med. Paulus Kirchhof, Chair in Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, City Hospital, UK, and Department of Cardiology and Angiology, University of Münster, Germany Dr Jonas Oldgren, Associate Professor of Cardiology, Uppsala Clinical Research Center, Uppsala University, Sweden Henry Purcell MB PhD, Senior Fellow in Cardiology, Department of Cardiology, Royal Brompton Hospital, London, UK; Editor, British Journal of Cardiology Mellanie True Hills, Founder and CEO, American Foundation for Women's Health and StopAfib.org, Dallas-Fort Worth, USA The AFIP tool is also endorsed by the following organizations: INTERNATIONAL 2

5 IMPACT OF ATRIAL FIBRILLATION (AF) AF is the most common sustained abnormal heart rhythm worldwide with an estimated nine million people currently affected in Europe and the US and numbers set to increase. 1,2 It carries a four- to five-fold increased risk of stroke 3 and is associated with a high risk of cardiovascular (CV) events and hospitalization. 1 Patients with AF also suffer from a considerably impaired quality of life (QoL). 4 The incidence of AF at age 50 years has been estimated as 0.5 per cent, whereas it is as high as nine per cent in those aged 80 years. 5 Strokes associated with AF are more severe than ischaemic strokes of other causes, and in consequence, the risk of death from AF-related stroke is doubled and the cost of care is increased 1.5-fold. 1 The cost of AF to healthcare systems has been estimated at 3,000 annually per patient, with the total burden close to 13.5 billion in the EU alone. 6 In addition to the burden on healthcare systems, AF has further indirect costs due to rehabilitation and lost work, both in terms of sickness absence and early retirement. 7 WHY IS PRIMARY CARE SO IMPORTANT? AF can be diagnosed and managed by a variety of healthcare professionals; however, as undiagnosed (and sometimes asymptomatic) patients often visit primary care settings for common co-morbidities, Primary Care Physicians (PCPs) have a unique opportunity to actively seek patients with AF. Opportunistic screening and directed screening of high-risk patients can ultimately prevent unnecessary cases of stroke and other CV events. 8 In addition to screening for AF, PCPs play an important role in the first stages of AF management. A TYPICAL AF PATIENT PROFILE Symptoms of AF are typically palpitations, chest pain, dizziness, breathlessness, sleep apnoea, and anxiety. As around a third of cases are asymptomatic, 1 it is important for physicians to be aware of typical co-morbidities and risk factors associated with AF (Figure 1). Advancing age Diabetes Valvular heart disease Obesity Atrial Fibrillation High blood pressure Heart failure Sleep apnoea Figure 1: Known co-morbidities and risk factors for AF may help primary care physicians assess risk in individuals 3

6 GOALS OF AF MANAGEMENT The overarching goals of managing AF are to reduce morbidity and mortality and to improve quality of life. These goals must be pursued in parallel, especially in newly detected AF. Prevention of AF-related complications relies on antithrombotic therapy, control of ventricular rate, and adequate therapy of concomitant cardiac diseases Symptom relief (if not alleviated by rate control) may warrant additional rhythm control therapy by cardioversion, antiarrhythmic drug treatment, ablation or surgery AF is a complex condition and requires customized management; assessing individual patient characteristics and comorbidities should guide the optimal treatment selection. 9 It should be noted that differences between various guidelines largely reflect variation in regulatory, medico-legal, practice and guideline environments, rather than differences in the interpretation of evidence. Available guidelines include: ESC ACC/AHA/ESC 200 6,10 ACCF/AHA/HRS Focused Update and Dabigatran update 12 Consolidated ACC/AHA/ESC 2006 Guidelines and ACCF/AHA/HRS 2011 Updates 13 Canadian Cardiovascular Society ACC/AHA/ESC ,10 N.B. The drugs mentioned in this tool are referenced within one or more of the above guidelines. This does not reflect all treatments available for this condition. DIAGNOSIS Both in patients with potential symptoms of AF and those at risk, routine pulse-taking plays an important role in the detection of AF. 15 An irregular pulse should raise the suspicion of AF and necessitates an electrocardiogram (ECG) to diagnose AF. Any arrhythmia that has the ECG characteristics of AF and lasts sufficiently long for a 12-lead ECG to be recorded, or at least 30 seconds on a rhythm strip, should be considered as AF. 1 The ECG (which can be in the form of a 12-lead ECG, bedside telemetry or ambulatory Holter recordings) can also be used to exclude alternative diagnoses and to determine any underlying causes. 6,16 It is recommended that all patients with AF have a thorough assessment upon diagnosis of AF, including a history and physical examination, ECG, and basic laboratory investigations. In most patients it may be useful to perform an echocardiogram. Identifying the underlying cause of AF is an important part of the initial investigation to identify risk factors for AF, which, if treated, could reduce or eliminate the occurrence of further AF and / or improve the overall outcome of the patient. 16 PCPs should test thyroid function and consider underlying heart / CV disease. REFERRAL TO SPECIALIST CARE In cases where the answer is yes to any of the questions below, the patient should be referred for specialist opinion: 1. Is there uncertainty about the need for anticoagulation (e.g. CHA = 0 or CHA 2 -VASc = 1)? 2. Is there uncertainty that the ECG rhythm is AF? 3. Is the AF recent in onset (< 6 months) or paroxysmal (occurring in repeated attacks)? 4. Is the patient young (< 65 years) or symptomatic? 5. Is there a suspicion of underlying cardiovascular disease? EMERGENCY REFERRAL Unstable patients (collapse / syncope or fast heart rate [> 120 bpm]), patients with signs of transient ischemic attack or stroke, and patients with heart failure require an emergency referral. 4

7 AN OVERVIEW OF AF MANAGEMENT Does the patient require emergency care? Suggestive symptoms Suggestive co-morbidities Irregular pulse ECG Atrial Fibrillation Does the patient require emergency care? Refer Anticoagulate if CHA 1 or CHA 2 -VASc is 2 Rate control Does the patient require specialist care or opinion? Refer Follow-up Figure 2: An overview of AF management 5

8 ANTICOAGULATION THERAPY Anticoagulation therapy has been shown to reduce AF-related mortality. 1 Despite this, a proportion of AF patients (up to ~50 per cent) receive sub-optimal treatment. 7,17 Even patients treated with rhythm control strategy are still at risk of stroke anticoagulation cannot be discontinued indiscriminately. Additionally, the risk of stroke is independent of the pattern of AF (i.e. paroxysmal, persistent, or permanent), but is dependent upon stroke risk factors (quantified by stroke risk scores). The CHA 2 -VASc * risk score (Figure 3), 1,18 is a refinement of the widely used CHA risk score, by the inclusion of additional common stroke risk factors. Use of the revised version is in line with recognition that stroke risk is a continuum and that traditional artificial categorization into low, moderate, and high risk strata may be of limited predictive value. 1 Based on the CHA 2 -VASc score, patients with a score of 2 should receive an oral anticoagulant (OAC); patients with a score of 1 should receive antithrombotic therapy with an OAC or aspirin mg/d (but an OAC is preferred); and patients with a score of 0 should receive either aspirin or no anticoagulant (but no antithrombotic therapy is preferred). Risk factor-based approach expressed as a point based scoring system, with the acronym CHA 2 -VASc Risk Factor Score Congestive heart failure / left ventricular dysfunction 1 Hypertension 1 Age 75 2 Diabetes mellitus 1 Stroke / transient ischemic attack / thrombo-embolism 2 Vascular disease 1 Age Sex category (i.e. female sex) 1 Maximum score 9 Figure 3: The CHA 2 -VASc score 1 ; based on 18 Note maximum score is 9 since age may contribute 0, 1, or 2 points Although different guidelines use different risk scores, the overall recommendations are broadly similar: 1,6 Anticoagulation should be based upon the absolute risks of stroke and bleeding and the risk benefit ratio for the patient Anticoagulation should be considered for patients with AF with at least one stroke risk factor provided there are no contraindications In such patients, anticoagulation with an OAC such as a vitamin K antagonist (VKA, e.g. warfarin) or dabigatran etexilate is recommended - The dose of VKA should be adjusted to achieve the target intensity international normalized ratio (INR) of 2 3, unless contraindicated, and monitored at least weekly during initiation of therapy and monthly when anticoagulation is stable (for patients with AF who have mechanical heart valves, the target intensity of anticoagulation should be an INR of at least 2.5, or at least 2.0 for those with an aortic valve.** For these patients, only VKA is recommended, as dabigatran etexilate is not approved in patients with artificial heart valves). - The dose of dabigatran should usually be 150 mg b.i.d., but in patients at potential risk of bleeding (i.e. HAS- BLED score 3), dabigatran 110 mg b.i.d should be considered.** - The ESC guidelines acknowledge that patients with just one (non-major) risk factor, aspirin mg/d is acceptable, but an OAC is preferred. 1 The ACC/AHA/ESC recommend aspirin mg daily as an alternative to a VKA in low-risk patients (i.e. lone AF) or in those with contraindications to oral anticoagulation. 6 The ESC guidelines prefer no antithrombotic therapy (over aspirin) in patients with truly lone AF, essentially a CHA 2 -VASc score = 0 1 For patients with poor anticoagulant control or with serious difficulties in achieving INR control, new therapies may be suitable. * CHA 2 -VASc refers to congestive heart failure, hypertension, age 75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 74, and sex category (female) ** Please refer to the full guidelines for more information. 6

9 Alternatives to VKAs The oral direct thrombin inhibitor dabigatran etexilate is now available in some countries, for example, the US, EU, Canada, Japan, etc., for stroke prevention in AF and is recognized by the latest guidelines as an alternative to a VKA in patients without contraindications 1,12 A number of other agents are in development for the same indication. These agents may offer benefits to patients in terms of convenience. In addition, clopidogrel plus aspirin may be considered for those in whom VKAs are unsuitable. 1,11 As always, the decision to commence anticoagulation should be based on absolute risks of stroke and bleeding and the relative risk and benefit for a given patient. A simple, novel bleeding risk score such as HAS-BLED provides a practical tool to assess the individual bleeding risk and can aid clinical decision making regarding antithrombotic therapy in patients with AF. 19 A score of 3 indicates high risk and warrants caution with the use of antithrombotic agents; regular review, management of correctable risk factors for bleeding and patient education are recommended. Letter Clinical characteristic Points awarded H Hypertension 1 A Abnormal renal and liver function (1 point each) 1 or 2 S Stroke 1 B Bleeding history or predisposition 1 L Labile INRs (if the patient is taking a VKA) 1 E Elderly (e.g. age > 65 years) 1 D Drugs (aspirin or NSAIDs) concomitantly or alcohol abuse or excess (1 point each) 1 or 2 Maximum 9 points Figure 4: The HAS-BLED bleeding risk score 1,19 RATE AND RHYTHM CONTROL The goals of rate and rhythm control are to improve symptoms and clinical outcomes, such as CV events; however, these goals do not necessarily imply the elimination of all AF. 20 For patients with symptomatic AF lasting many weeks, initial therapy may be anticoagulation and temporary rate control, while the long-term goal is to restore sinus rhythm. 6 Preferred initial options are not mutually exclusive, and the decision is very much symptom directed and patient centred. A rate control strategy is generally more suitable for older patients (i.e. age > 65 years), those with coronary artery disease, or those with contraindications to antiarrhythmic drugs. A rhythm control strategy may be more suitable for symptomatic patients, younger patients, those who are presenting for the first time with lone AF, and those with AF secondary to a treated / corrected precipitant. Patients with recent-onset AF (< 6 months) and symptoms should be referred for specialist advice on the most appropriate strategy for rhythm control versus rate control, which will be guided by their symptoms, the duration of the arrhythmia, and the presence of underlying disease as a cause or consequence of AF. Specialist referral for guidance on rhythm and rate control should not delay the decision to start anticoagulation therapy. If a strategy of rate or rhythm control is not successful, crossover to the alternate strategy may be required. 20 Often, medications that exert both antiarrhythmic and rate-controlling effects are required. 6 The ESC Guidelines suggest that rate control should be attempted first, as studies have failed to show a survival benefit for rhythm-control over rate-control therapy. 1,21,22 In those who remain symptomatic after adequate trials of antiarrhythmic drug therapy and in whom a rhythm control strategy remains desired, referral to a specialist for an expert opinion on management alternatives, such as cardioversion, may be considered. 16 The guidelines also acknowledge that some patients should be considered for early rhythm control. Rate control - Beta-blockers or rate-limiting calcium antagonists should be the preferred initial monotherapy in all patients. 5,20 If needed, digoxin (also known as digitalis) can be added as a second-line agent, although in elderly or sedentary patients digoxin monotherapy may suffice. The ACCF/AHA/HRS focused update states that lenient rate control (< 100 bpm) may be adopted as a reasonable strategy in patients with permanent AF, as strict rate control is not beneficial and is less convenient. 11 The ESC guidelines agree, but add that a stricter form of rate control may be needed if the patient remains symptomatic. 1 7

10 Therapies for rate control Beta-blockers Non-dihydropyridine calcium channel antagonists Digitalis glycosides Others Atenolol, Bisoprolol, Metoprolol Diltiazem, Verapamil Digoxin, Digitoxin Amiodarone Figure 5: Therapies for rate control The choice of drugs depends on life-style and underlying disease 1,6,20 Rhythm control - Antiarrhythmic drugs can be used to maintain sinus rhythm, but should not generally be used in asymptomatic patients (or those who become asymptomatic with adequate rate control therapy); they should usually be first prescribed by a specialist. As antiarrhythmic drugs come with various contraindications and cautions, safety rather than efficacy considerations should primarily guide the choice of antiarrhythmic agent. 1 Antiarrhythmic drugs include: amiodarone, disopyramide, dofetilide (US only), dronedarone, flecainide (/XL), propafenone (/SR), and [d,l-] sotalol. 1,6,20 Therapies for rhythm control Multi-channel blockers Potassium channel blockers Sodium channel blockers Amiodarone, Dronedarone Dofetilide (US only) Disopyramide, Flecainide, Propafenone (/SR), [d,l-]sotalol Figure 6: Therapies for rhythm control The choice of drugs depends on the underlying disease 1,6,20 In addition to pharmacological therapies, specialist referral may provide patients with additional options for the management of their condition, e.g. catheter ablation, surgery, and left atrial appendage closure / occlusion. EMPOWERING PATIENTS A survey on patient perceptions of AF revealed that 61% felt that AF was not serious and 47% were unaware that AF predisposed them to stroke 25 It is well-known that empowering patients by involving them in the decision-making and goal-setting processes can improve outcomes. 23 Despite this, many patients have a poor understanding of AF and its management, and of the associated risks. 24,25 An international survey of patients and cardiologists perceptions of AF revealed that physicians believe the quality of information provided to patients with AF compared poorly with that provided on other common conditions. There is a clear need to support patients through better education, and to close the current gap between patient and physician understanding. 24 8

11 REFERENCES 1 The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC), Guidelines for the management of atrial fibrillation, European Heart Journal 2010;31; Naccarelli GV et al. Increasing prevalence of atrial fibrillation and flutter in the United States. American Journal of Cardiology 2009;104: Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22; Available at: Last accessed: July Thrall G, Lane D, Carroll D, Lip GYH. Quality of Life in Patients with Atrial Fibrillation: A Systematic Review. The American Journal of Medicine 2006;119: 448.e1 448.e19. 5 National Collaborating Centre for Chronic Conditions, Atrial Fibrillation, National clinical guideline for management in primary and secondary care, Royal College of Physicians ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Circulation 2006;114:e Barham, L. Atrial Fibrillation in Europe: How AWARE are you? November Available at: federation.org/ fileadmin/user_upload/documents/af-aware/afawarereport23nov2010.pdf. Last accessed July Atrial Fibrillation Association. Seeking Patients in Atrial Fibrillation. Available at: Medical_Only/AFA%20Seeking%20Patients%20in%20AF%20(HP)%20-%202pps.pdf. Last accessed July Eagle KA, Cannom DS, Garcia DA. Management of Atrial Fibrillation: Translating Clinical Trial Data into Clinical Practice. The American Journal of Medicine 2011;124; ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation executive summary. European Heart Journal 2006;27: ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline). Heart Rhythm 2011;8: ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran). Heart Rhythm 2011;8:e ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011;123:e Canadian Cardiovascular Society Atrial Fibrillation Guidelines Canadian Journal of Cardiology 2011;27: Hobbs FDR, et al. A randomised controlled trial and cost-effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in people aged 65 and over. The SAFE study. Health Technology Assessment 2005;9(40). 16 Healey JS, et al. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Etiology and Initial Investigations. Canadian Journal of Cardiology 2011;27: DeWilde S, et al. Trends in the prevalence of diagnosed atrial fibrillation, its treatment with anticoagulation and predictors of such treatment in UK primary care. Heart 2006;92: Lip GY, et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factorbased approach: the Euro Heart Survey on atrial fibrillation. Chest 2010;137: Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010;138: Gillis AM, et al. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Rate and Rhythm Management. Canadian Journal of Cardiology 2011;27: The AFFIRM Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. New England Journal of Medicine 2002;347: Van Gelder, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. New England Journal of Medicine 2002;347: Trummer UF, Mueller UO, Nowak P et al. Does physician-patient communication that aims at empowering patients improve clinical outcome? A case study. Patient Education and Counselling 2006;61: Aliot E, Breithardt G, Brugada J, et al. An international survey on physician and patient understanding, perception, and attitudes to atrial fibrillation and its contribution to cariovascular disease morbidity and mortality. Europace 2010;12:626: Lip GY, et al. Ethnic differences in patient perceptions of atrial fibrillation and anticoagulation therapy: the West Birmingham Atrial Fibrillation Project. Stroke 2002;33:

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