Transcript Diapositive 1 - High Tech Cardio
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
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
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
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
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
Stroke Risk Assessment: CHA
2
DS
2
-VASc score
Letter
C H A D S V A Sc
Risk factor -
Congestive heart failure/LV dysfunction Hypertension Age >75 Diabetes mellitus Stroke/TIA/thrombo-embolism Vascular disease Age 65 –74 Sex-category (i.e. female sex)
Points awarded
1 1 2 1 2 1 1 1 Maximum score
Camm AJ et al, Guidelines for the management of Atrial Fibrillation Eur Heart J 2010;31:2369-2429
9
Risk Stratification and Antithrombotic Prophylaxis Absolute Reduction in Stroke
5 4 1 0 3 2 8 7 6
42 83 250
Aspirin Warfarin High-risk Intermediate-risk Low-risk
J Am Coll Cardiol 1998; 31:1622-6
Number of patients needed-to-treat
to prevent 1 stroke/year
Cumulative risk of stroke Major Bleeding Lancet 2006;367:1903-12
Lancet 2007;370:493-503
Euro Heart Survey on Atrial Fibrillation Stroke Risk and Treatment
100% 80% 60% 40% 20% 0%
Low (n=520) Intermediate (n=314) High (n=4438)
None Other Aspirin Vitamin K antagonist
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;115:2689-96 .
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 2 1 1 1 1 1 or 2 9 points
Lip et al Chest 2010;137:263-72
Striking a fine balance Preventing Stroke, Avoiding Bleeds
LAA Percutaneous Closure Technical requirements
TEE under general anesthesia
Transeptal approach
LAA anatomically suitable for device implantation and free of thrombus
Results PLAATO device
Stroke observed/expected (%)
Death (%) Tamponade(%) Pericardial effusion(%) Plaato I 1 (n = 111) 2.2/6.3
5.4
2.7
1.8
1 =
Ostermayer. J Am Coll Cardiol 2005;46:9-14
2
= Y. Bayard, ESC Stockolm 2005
Plaato II 2 (n = 150) 1.8/8.2
1.2
5.3
3
Holmes DR et al Lancet 2009;374:534-32
Primary endpoint: stroke, cardiovascular death and systemic embolism
Efficacy Safety Stroke Mortality
Holmes DR et al Lancet 2009;374:534-32
Safety
A
LAA occluder devices
B
Watchman
C
ACP AGA
D
Occlutech Coherex
New Devices
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
The end
Back-up slides
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;120:1927-32
% 20 15 10 5 0 40 35 30 25 6,5 50-59
AF and Stroke Risk
35 22 8 60-69 Age 70-79
(Framingham Study, Wolf, 1991)
80-89
Stroke rates in relation to age among patients in untreated control groups of radomized trials of antithrombotic therapy
Arch Intern Med 1994;154:1469-57
How to optimize the benefit/risk Ratio ?
Hylek EM et al, Ann Med Intern 1994;120:897-902
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;31:2369-2429
Higher Incidence of LAA thrombus in patients with AF
Options for Stroke Prevention
Pharmacological Management: Anticoagulants
Effective: 67% stroke risk reduction
Management of narrow therapeutic window Major complication: bleeding
Surgical Excision of LAA (Appendectomy)
Residual shunt: 10% Inconsistent outcomes due to incomplete exclusion Can create pouch with stagnant blood flow High invasiveness
Transcatheter Device Closure
Minimally invasive nature
Designed for percutaneous closure of the LAA in prevention of clot embolization that may form in the LAA
Intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation
30