SHA24/026002

ESC Guidelines on the management of Atrial Fibrillation

Panos Vardas Prof. of Cardiology, Heraklion University Hospital, Crete

Declaration of Conflict of Interest Modest consultancy fees from

Bayer, Boehringer Ingelheim Bristol Myers Squibb, Medtronic Menarini, Servier

• AF is an arrhythmia responsible for one-third of all hospitalizations for cardiac rhythm disturbances1 • Estimated prevalence rates for AF: – Europe: 4.5 million1 – USA: 5.1 million2

• Approximately 2.5% of the US population are affected

by AF2 • Nearly one in four people at age 55 years will go on to develop AF (24% of men and 22% of women)3 1. ACC/AHA/ESC guidelines: Fuster V et al. Circulation 2006;114:e257–354 & Eur Heart J 2006;27:1979–2030; 2. Miyasaka Y et al. Circulation 2006;114:119–25; 3. Heeringa J et al. Eur Heart J 2006;27:949–53

People with AF in the US (millions)

16 14 12 10 8 Projected incidence of AF assuming a continued increase in age-adjusted incidence as evident in 1980–2000

6 4

Projected incidence of AF assuming no further increase in age-adjusted incidence

2 0 2000

2010

2020

2030 Year

Miyasaka Y et al. Circulation 2006;114:119–25

2040

2050

Anticoagulation risk stratification Use of novel oral anticoagulants (NOACs) Left atrial appendage occlusion/excision Pharmacological cardioversion (vernakalant) Oral antiarrhythmic therapy (dronedarone, and short term therapy) • Left atrial catheter ablation • • • • •

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

European Society of Cardiology Guidelines for the Management of Atrial Fibrillation. Europace 2010;12:1360-420

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

All patients with atrial fibrillation not treated with VKAs in Denmark 1997- 2006

Kaplan-Meier estimate of probability of remaining free of thromboembolism with CHADS2 score 0 and 1. Only patients with CHADS2 scores 0 and 1 were included, and patients were censored at death for causes other than thromboembolism

73 538 fulfilled the study inclusion criteria

Kaplan-Meier estimate of probability of remaining free of thromboembolism with CHA2DS2-VASc score 0 and 1. Only patients with CHA2DS2-VASc scores 0 and 1 were included, and patients were censored at death for causes other than thromboembolism

Olesen JB et al, BMJ 2011;342:d124

Congestive heart failure/ LV dysfunction Hypertension Age > 75 Diabetes mellitus Stroke/TIA/TE Vascular disease (CAD, AoD, PAD) Age 65-74 Sex category (female) Score 0

1 1 2 1 2 1 1 1 –9

Validated in 1084 NVAF patients not on OAC with known TE status at 1 year in Euro Heart Survey OR for stroke if: Female: 2.53 (1.08 – 5.92), p=0.029; Vascular disease: 2.27 (0.94 – 5.46), p=0.063

Lip GYH, et al.

Chest 2009

Olesen JB et al.

BMJ 2011;342:124

HAS-BLED bleeding risk score

Camm et al. ESC AF guidelines 2010 Eur Heart J 2010

Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

New Anticoagulants Superior to Warfarin ‌

Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

New Anticoagulants Superior to Warfarin ‌

Connolly S et al NEJM 2009; Patel M et al NEJM 2011; Granger C et al NEJM 2011

d = pending EMA/FDA approval – prescribing information is awaited European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

ESC Update on the Management of AF: European Heart Journal/EP- Europace 2012

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

ESC Update on the Management of AF: European Heart Journal/EP- Europace 2012

* Includes rheumatic valvular AF, hypertrophic cardiomyopathy, etc. ** Antiplatelet therapy with aspirin plus clopidogrel, or – less effectively – aspirin only, may be considered in patients who refuse any OAC

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

• Patients unwilling to take warfarin • New Patients naive to oral anticoagulation • Those with unstable INR, or warfarin

Holmes DR, et al. Lancet 2009;374:534-42

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

** P≤0.0001 ** P≤0.0001

CRAFT: Dosing was 2+3 mg/kg; data represents % converted at 60 min post last dose; AF duration 3-72 hours ACT I, III & IV: AF <7 days ACT II: Post CABG and valvular AF study; AF duration 3-72 hours

AVRO trial

Time to Treatment-Induced Conversion â&#x20AC;˘

Conversion from AF to SR within the first 90 min post-dose was significantly faster in vernakalant pts (11.0 min)

â&#x20AC;˘

A significantly greater proportion of vernakalant pts (54.4%) converted to SR within the first 4 h post-dose compared with amiodarone pts (22.6%) (p < 0.0001)

Camm, A. J. et al. J Am Coll Cardiol 2011

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

Hohnloser SH et al. N Engl J Med. 2009;360:668-78

Connolly S et al. N Engl J Med. 2011;365:2268-76

September 2009 MULTAQ is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate (see section 5.1).

September 2011 MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile (see sections 4.3 and 4.4), Multaq should only be prescribed after alternative treatment options have been considered.

MULTAQ should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

Multaq (Dronedarone) SmPC Europe, September 2011

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

Sinus rhythm was present in 46.6% of patients after the initial procedure during a median follow-up period of 4.8 years.

After 1.5 procedures stable sinus rhythm was achieved in 79.5% of patients and an additional 13.0% of patients experienced clinical improvement.

Kuck KH et al, Circulation 2010

Arrhythmia-free survival rates after a single catheter ablation procedure were 40%, 37%, and 29% at 1, 2, and 5 years Arrhythmia-free survival following the multiple procedures was 87%, 81%, and 63% at 1, 2, and 5 years HaissaguerreM HaissaguerreM et al, JACC 2011

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs253