Exclusion de l auricule gauche par voie percutanée

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1 Exclusion de l auricule gauche par voie percutanée Jean-Michel Juliard, Dominique Himbert, Pierre Aubry, Eric Brochet, Alec Vahanian Hôpital Bichat, Paris Pas de conflit d intérêt 2012

2 The Left Atrial Appendage: our Most Lethal Attachment! Hypothesis: Stroke in patients with AF is largely due to the left atrial appendage as a thromboembolic source Johnson WD Eur J Cardiothorac Surg 2000;17:718-22

3 Success of Surgical Left Atrial Appendage Closure Assessment by Transesophageal Echocardiography With current surgical techniques, excision, or exclusion by sutures or stapling, LLA management is unsuccessful in nearly 60% Excision of the LAA is most effective, success rate of 73% However there is a likelihood of leaving a residual stump Kanderian AS et al J Am Coll Cardiol 2008;52:924-9

4 Magnitude of the Problem: AF and Stroke AF : Prevalence of 0.4% of general population (> 80 years: 10%) 2/3 of the AF population is considered at high-risk of stroke AF accounts for approximately 15% of all strokes Anticoagulation (warfarin) therapy is proven effective but sometimes contraindicated and most often underutilized in clinical practice

5 New ESC guidelines Fundamentally: everyone with AF and one risk factor should be on anticoagulation therapy Assessment of bleeding risk should be part of the patient assessment before starting anticoagulation Camm AJ et al, Guidelines for the management of Atrial Fibrillation Eur Heart Journal 2010

6 Stroke Risk Assessment: CHA 2 DS 2 -VASc score Letter Risk factor Points awarded C H A D S V A Sc - Congestive heart failure/lv dysfunction - Hypertension - Age >75 - Diabetes mellitus - Stroke/TIA/thrombo-embolism - Vascular disease - Age Sex-category (i.e. female sex) Maximum score 9 Camm AJ et al, Guidelines for the management of Atrial Fibrillation Eur Heart J 2010;31:

7 Risk Stratification and Antithrombotic Prophylaxis Absolute Reduction in Stroke Ischemic Stroke Rate (%/year) Aspirin Warfarin Number of patients needed-to-treat to prevent 1 stroke/year 1 0 High-risk Intermediate-risk Low-risk J Am Coll Cardiol 1998; 31:1622-6

8 Cumulative risk of stroke Major Bleeding Lancet 2006;367:

9 Lancet 2007;370:

10 Euro Heart Survey on Atrial Fibrillation Stroke Risk and Treatment

11 Role of major hemorrhage on warfarin Stroke prevention among elderly patients with atrial fibrillation remains challenging Aggregate hemorrhage rate 7.2% per person-yrs 13.08% for pts 80 yrs 4.75% pts <80 yrs First 90 days associated with 3-fold increased risk. 26% pts 80 yrs taken off warfarin; 81% due to safety concerns Cumulative incidence of major bleeding (patients aged 80 & <80 years (n=472)) Hylek et al Circulation 2007;115:

12 Risk assessment 1 yr bleeding HAS-BLED score Letter H A S B L E D Clinical characteristic - Hypertension (systolic blood pressure > 160 mmhg) - Abnormal renal & liver function (1 point each) - Stroke - Bleeding - Labile INRs - Elderly (age > 65 yrs) - Drugs or alcohol (1 point each) Maximum Score of 3 indicates high risk Points awarded 1 1 or or 2 9 points Lip et al Chest 2010;137:263-72

13 Striking a fine balance Preventing Stroke, Avoiding Bleeds

14 LAA Percutaneous Closure Technical requirements TEE under general anesthesia Transeptal approach LAA anatomically suitable for device implantation and free of thrombus

15 Results PLAATO device Stroke observed/expected (%) Death (%) Tamponade(%) Pericardial effusion(%) Plaato I 1 (n = 111) 2.2/ Plaato II 2 (n = 150) 1.8/ = Ostermayer. J Am Coll Cardiol 2005;46: = Y. Bayard, ESC Stockolm 2005

16 Holmes DR et al Lancet 2009;374:534-32

17 Primary endpoint: stroke, cardiovascular death and systemic embolism Efficacy Safety Stroke Mortality Holmes DR et al Lancet 2009;374:534-32

18 Safety

19 LAA occluder devices A B Watchman ACP AGA C D Occlutech Coherex

20 New Devices

21 Conclusion Technique innovante à réserver au cas par cas, après une réflexion entre cardiologues et neurologues du rapport risque/bénéfice des anticoagulants Actuellement pas de remboursement Il faut continuer l apprentissage des nouveaux systèmes de fermeture dans des centres experts L apport des nouveaux anticoagulants, anti II et anti Xa, à la fois plus sûrs et plus efficaces que les antivitamines K, doit faire rediscuter la place de cette technique en comparaison au traitement anticoagulant

22 The end

23 Back-up slides

24 Although recent results with the percutaneous closure device are promising, the evidence of efficacy and safety is insufficient to recommend this approach for any patients other than those in whom long-term warfarin is absolutely contraindicated Circulation 2009;120:

25 AF and Stroke Risk (Framingham Study, Wolf, 1991)

26 Stroke rates in relation to age among patients in untreated control groups of radomized trials of antithrombotic therapy Arch Intern Med 1994;154:

27 How to optimize the benefit/risk Ratio? Hylek EM et al, Ann Med Intern 1994;120:

28 Adjusted stroke rate according to CHA 2 DS 2 -VASc score Camm AJ et al, Guidelines for the management of Atrial Fibrillation Eur Heart J 2010;31:

29 Higher Incidence of LAA thrombus in patients with AF

30 30

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