What s New in the AF Guidelines

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1 Impact on New AF Guidelines on Heart Failure Management Gothenburg - May 22 nd 2011 Europace (2010) 12, JACC (2011) 57, What s New in the AF Guidelines ESC 2010 AF Guidelines, ACCF/AHA/HRS Guideline Update 2011, CCS AF Guidelines 2010 John Camm SGUL, London, United Kingdom

2 Impact on New AF Guidelines on Heart Failure Management Gothenburg - May 22 nd 2011 What s New in the AF Guidelines ESC 2010 AF Guidelines, ACCF/AHA/HRS Guideline Update 2011, CCS AF Guidelines 2010 John Camm Conflicts of Interest: Consultant/Advisor/Speaker Advisor / Speaker : Ambit, Servier, Novartis, Sanofi, Astra Zeneca, Cardiome, Prism, Astellas, Menarini, Xention, ARYx, Bristol Myers Squibb, Daiichi, Bayer, Merck, Medtronic, St. Jude, Biotronik, Boehringer Ingleheim, Takeda, GlaxoSmithKline, Boston Scientific, Pfizer,, Actelion, Johnson and Johnson, Solvay Pharma

3 Principles of Antiarrhythmic Drug Therapy to Maintain Sinus Rhythm 1. Treatment is motivated by attempts to reduce AF-related symptoms 2. Efficacy of antiarrhythmic drugs to maintain sinus rhythm is modest 3. Clinically successful antiarrhythmic drug therapy may reduce rather than eliminate recurrence of AF 4. If one antiarrhythmic drug fails a clinically acceptable response may be achieved with another agent 5. Drug-induced proarrhythmia or extra-cardiac side-effects are frequent 6. Safety rather than efficacy considerations should primarily guide the choice of antiarrhythmic agent

4 ESC AF Guidelines Antiarrhythmic Medication for Rhythm Control ESC Recommendation Class Level The following antiarrhythmic drugs are recommended for rhythm control in patients with AF, depending on underlying heart disease: amiodarone dronedarone flecainide propafenone d.l-sotalol I I I I I A A A A A

5 ESC AF Guidelines Recommendations Class a Level b is more effective in maintaining sinus rhythm than sotalol, propafenone, flecainide (by analogy) or dronedarone (LoE A), but because of its toxicity profile should generally be used when other agents have failed or are contraindicated (LoE C). I A C In patients with severe heart failure, NYHA class III and IV or recently unstable (decompensation within the prior month) NYHA class II, amiodarone should be the drug of choice. I B

6 Antiarrhythmic Drugs for AF Underlying Heart Disease? Underlying Heart Disease? Underlying Heart Disease? β-blocker β-blocker / Flecainide / Propafenone / Sotalol Flecainide / Propafenone / Sotalol Flecainide / Propafenone Sotalol β-blocker Efficacy Cost Safety

7 Cascade of Antiarrhythmic Drugs Minimal or No Heart Disease β-blocker / Flecainide / Propafenone / Sotalol

8 Antiarrhythmic Drugs for AF Significant Underlying Heart Disease Treatment of Underlying Condition and Prevention of Remodelling - ACE-I / ARB / Statin Cost and Antiarrhythmic Efficacy HT LVH CAD β-blocker Sotalol Dofetilide / NYHA I/III Dofetilide / CHF NYHA IV or unstable NYHA II-IV Dofetilide /

9 Antiarrhythmic Drugs for AF Significant Underlying Heart Disease Treatment of Underlying Condition and Prevention of Remodelling - ACE-I / ARB / Statin Safety and Outcome Indication HT LVH CAD β-blocker NYHA I/III CHF NYHA IV or unstable NYHA II-IV Sotalol

10 Antiarrhythmic Drugs for AF Management Congestive Heart Failure CHF CHF NYHA I/III NYHA IV or unstable NYHA II-III NYHA I/II NYHA III/IV or unstable NYHA II

11 ESC Guidelines on ESC Recommendation Class Level should be considered in order to reduce cardiovascular hospitalizations in patients with nonpermanent AF and cardiovascular risk factors IIa B ESC Recommendation Class Level is not recommended for treatment of AF in patients with NYHA class III and IV, or with recently unstable (decompensation within the prior month) NYHA class II heart failure III B

12 ACCF/AHA/HRS Focused Update vs ESC Guidelines Recommendation for Use of 2011 Focused Update Recommendation Comments Class IIa 1. is reasonable to decrease the need for hospitalization for cardiovascular events in patients with paroxysmal AF or after conversion of persistent AF. can be initiated during outpatient therapy. (Level of Evidence: B) Class III Harm 1. should not be administered to patients with class IV heart failure or patients who have had an episode of decompensated heart failure in the past 4 weeks, especially if they have depressed left ventricular function (left ventricular ejection fraction 35%). (Level of Evidence: B) New recommendation New recommendation

13 Antiarrhythmic Drugs for AF Minimal or No Heart Disease Significant Underlying Heart Disease? Prevention of Remodelling ACEI / ARB / Statin. β blockade where appropriate Treatment of Underlying Condition and? Prevention/Reversal of Remodelling - ACEI / ARB / Statin. β blockade where appropriate HT CAD CHF No LVH LVH Stable NYHA I/II NYHA III/IV or unstable NYHA II / Flecainide / Propafenone / Sotalol Sotalol ESC 2010 Guideline

14 Canadian Cardiovascular Society Antiarrhythmic Drugs Normal EF Normal Ventricular Function Abnormal Left Ventricular Function Flecainide* Propafenone* Sotalol EF > 35% EF 35% Sotalol* Class I agents should be AVOIDED in CAD. They should be combined with an AVnodal blocking agents * Sotalol should be used with caution with EF 35-40% Contra-indicated in women >65 years taking diuretics

15 Optimal Rate Control Recommendations Class a Level b It is reasonable to initiate treatment with a lenient rate control protocol aimed at a resting heart rate < 110 bpm. It is reasonable to adopt a stricter rate control strategy when symptoms persist or tachycardiomyopathy occurs, despite lenient rate control: resting heart rate < 80 bpm and heart rate during moderate exercice < 110 bpm. After achieving the strict heart rate target a 24 h Holter monitor is recommended to assess safety. It is reasonable to achieve rate control by administration of dronedarone in non-permanent AF except for patients with NYHA class III - IV or unstable heart failure. IIa IIa IIa B B B

16 AF Ventricular Rate Control Guideline Heart Rate Target 2010 CCS Guidelines We recommend that treatment for rate control of persistent/permanent AF/AFL should aim for a resting heart rate of less than 100 bpm (Strong recommendation, high quality) 2010 ESC Guidelines Lenient rate control protocol aimed at resting HR <110 bpm. Adopt a stricter rate control strategy When symptoms persist or tachy-cardiomyopathy occurs, despite lenient rate control: HR <80 bpm and moderate exercise <110 bpm. (IIa-LoE:B) 2010 ACCF/AHA Guidelines Update Treatment to achieve strict rate control of heart rate (<80 bpm at rest or <110 bpm during a 6- minute walk) is not beneficial compared to achieving a resting heart rate <110 bpm (III-LoE:B)

17 Indication for LA Catheter Ablation

18 Ablation when SHD is Present Relevant underlying heart disease CHF CAD Hypertension with LVH NYHA III/IV or unstable NHYA II Stable NYHA II Sotalol Catheter ablation for AF

19 ACCF/AHA/HRS Focused Update Recommendations for Catheter Ablation 2011 Focused Update Recommendation Class I 1.Catheter ablation performed in experienced centers* is useful in maintaining sinus rhythm in selected patients with significantly symptomatic, paroxysmal AF who have failed treatment with an antiarrhythmic drug and have normal or mildly dilated left atria, normal or mildly reduced LV function, and no severe pulmonary disease. (Level of Evidence: A) Comments Modified recommendation (class changed from IIa to I, wording revised, and LOE changed from C to A)

20 ACCF/AHA/HRS Focused Update Recommendations for Catheter Ablation 2011 Focused Update Recommendation Class IIa 1.Catheter ablation is reasonable to treat symptomatic persistent AF. (Level of Evidence: A) Class IIb 1.Catheter ablation may be reasonable to treat symptomatic paroxysmal AF in patients with significant left atrial dilatation or with significant LV dysfunction. (Level of Evidence: A) Comments New recommendation New recommendation

21 Risk Factor-based Scoring System - CHA 2 DS 2 -VASc Risk factor Score Congestive heart failure /LV dysfunction 1 Hypertension 1 Age 75 years 2 Diabetes mellitus 1 Stroke / TIA / thrombo-embolism 2 Vascular disease* 1 Age Sex category [i.e. femal sex] 1 Maximum score 9 *Prior myocardial infarction, peripheral artery disease, aortic plaque. Actual rates of stroke in contemporary cohorts may vary from these estimates. ESC guidelines for the management of AF. European Heart Journal, September 2010

22 TE by risk category, % % in risk category Validation of CHA 2 DS 2 VASc in Euro Heart Survey Low Intermediate High AFI SPAF ACC/AHA/ESC ACCP Framingham CHADS2 CHA2DS2 VASc c-statistic AFI SPAF ACC/AHA/ESC ACCP Framingham CHADS2 CHA2DS2 VASc Lip GYH, et al. Chest 2009

23 CHADS 2 v CHA 2 DS 2 VASc All patients with atrial fibrillation not treated with VKAs in Denmark fulfilled the study inclusion criteria Olesen JB et al, BMJ 2011;342:d124

24 AF - CCS Recommendations We recommend that all patients with AF or AFl (paroxysmal, persistent or permanent), should be stratified using a predictive index for stroke (e.g. CHADS 2 ) and for the risk of bleeding (e.g. HAS-BLED), and that most patients should receive antithrombotic therapy. (Strong recommendation, High Quality Evidence)

25 ACCF/AHA/HRS Focused Update vs ESC Guidelines Recommendation for Antithrombotic Therapy 2011 Focused Update Recommendation* Comments Class IIb 1.The addition of clopidogrel to aspirin (ASA) to reduce the risk of major vascular events, including stroke, might be considered in patients with AF in whom oral anticoagulation with warfarin is considered unsuitable due to patient preference or the physician s assessment of the patient s ability to safely sustain anticoagulation. (Level of Evidence: B) New recommendation ESC Recommendation Class Level Combination therapy with aspirin mg plus clopidogrel 75 mg daily, should be considered for stroke prevention in patients for whom there is patient refusal to take OAC therapy or a clear contraindication to OAC therapy (e.g. inability to cope or continue with anticoagulation monitoring), where there is a low risk of bleeding Based on: Connolly SJ, et al. N Engl J Med 2009 ;360: IIa B

26 ACCF/AHA/HRS Focused Update Recommendations for Dabigatran 2011 Focused Update Recommendation Comments Class I Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance 15 ml/min) or advanced liver disease (impaired baseline clotting function). (Level of Evidence: B) New recommendation

27 AF - CCS Recommendations Antithrombotic therapy We suggest, that when OAC therapy is indicated, most patients should receive dabigatran in preference to warfarin. In general, the dose of dabigatran 150 mg po bid is preferable to a dose of 110 mg po bid (exceptions discussed in text). (Conditional recommendation. High Quality Evidence).

28 Possible Indications for Dabigatran.should both doses of dabigatran etexilate receive regulatory approval..in AF, the recommendations for thromboprophylaxis..: Where oral anticoagulation is appropriate therapy, dabigatran may be considered, as an alternative to adjusted dose VKA therapy: (i) Dabigatran 150 mg b.i.d.: If a patient is at low risk of bleeding (e.g. HAS-BLED score of 0 2) (ii) Dabigatran 110 mg b.i.d.: (a) If a patient has a measurable risk of bleeding (e.g. HAS-BLED score of 3) (b) In patients with one clinically relevant non-major stroke risk factor (i.e., CHA 2 DS 2 VASc = 1)

29 You can please all the people some of the time, and some of the people all the time, but you cannot please all the people all the time."

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