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LAA treatment results in adults
J. Januska, M. Poloczek*, M. Branny
Podlesi Hospital, Trinec,* Faculty Hospital Brno Bohunice Czech Republic
Stroke• 85% Ischemic ( 30-45% cryptogenic)
• 15% Hemorrhagic
• Mortality felt down from 35 to 19% (US 1998-2008)
• 40% patients with TIA will go on to experience a
stroke
Embolic stroke
• Prevalence 1%, over 80 yrs more than 10%
• 4-5x higer risk of ischemic stroke
• Cause of 15% ishemic strokes, over 80 y 30%
• Thrombembolic stroke by AF has higher morbidity and mortality ( 50% per year)
• Risk of embolization the same in all forms of AF
• Warfarin decreased risk of stroke by 64%
• Thrombus in AF pts (>90%) in LAA
Marini C Stroke2005 Stafford and Singer, Arch Int. Med, 1996 Overell Neurology 2000
CHADS2 Score
5
Medical Management: Anticoagulant Effective: 67% stoke risk reduction Narrow therapeutic window for proper dose Contraindicated in 14-47% of patients at risk of stroke Major complication: bleeding
Surgical Excision (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
Currently Available Management Options
LAA closure x anticoagulation• Protect AF
• 463 (Watchman) vs. 244 pts
(warfarin) 3,0 % vs. 4,9%
(stroke,TIA,death risk/year)
• Interventional approach
carried increased risk of
complication (7,4 vs. 4,4%)
• Continued access protocol
(CAS) complication risk 2,2%
• ACP registry
• First 143 - 7%complications
Next 148 – 3,4% Holmes D, Lancet 2009
Devices for occlusionAmplatzer Cardiac Plug
Lariat
Watchman
Watchman studies
Protect AF
Holmes D, Lancet 2009; 374: 534-42
463 (Watchman) ; 244 pts (warfarin)
3,0 % vs. 4,9% annual risk
stroke/systemic embolization/deat; RR
0,62
->99,9% non-inferiority
Risk of complication more frequent with
intervention –
7.4% vs. 4.4% RR 1,69
(major bleeding/pericardial effusion /
embolization of occluder)
Conclusion : non-inferiority of LAA closure vs. Warfarin with higher rate of
adverse events , mainly periprocedural complications
-non-inferiority of all strokes (-29%), superiority of bleeding stroke (-91%),
non-inferiority of all cause mortality (-38%)
Protect AF
Primary Efficacy Results
Primary Safety Results
Prevail
Prevail – Implant Succes
Complications
Prevail Primary Endpoint
ACP Registry
• Prospective , nonrandomised multicentric european
post market study
• 200 pts with AF
• Aim : follow of succesfull clouser and risk of
complications
• 168 pts to june/2011
• Interim analysis of 145 pts
(J-W Park, CSI Frankfurt, 2011)
ACP – complicationsACP InitialEuropean
Registry (1)
ACP Italianregistry (2)
ACP Dual Center
experience (3)
ACP Initial Asia-Pacific
experience (4)
ACP Registry (5)
N = 143 N = 100 N = 131
N=20 (KI
warfarinizace) N=148
Time12/2008-11/2009 12/2008 - 11/2010 2010-2011 6/2009-5/2010 8/2009-5/2011
Pericardialeffusion 5 (3.5%) 2 (2.0 %) 0 0 3 (2.1%)
Embolization ofoccluder 2 (1.4%) 0 0 0 2 (1,4%)Ischemic
stroke/TIA3(2.1%) 0 0 0 0
total 10(7%) 2(2%) 0 0 5 (3,4%)
1.Park, J.-W. et al. : Catheterization and Cardiovascular Interventions, 77: 700–706;2011
2.G. Santoro. Presented at the Progress In Clinical Pacing Congress in Rome, December 2010.
3.Park, J.W. at all(2011). Presented at UHK_MayoClinic Asia cardiovascular summit. March 2011 (Hong Kong).
4. Lam, Y.-Y. et al. : Catheterization and Cardiovascular Interventions, 79: 794-800;2012
5. Park, J.-W. et al. Presented at CSI Frankfurt June 2011 (interim)
Anticoagulation in stroke
event no/100 pat-yaerRivaroxaban Dabigatran
150 mgDabigatran
110 mg
Warfarin (RELY/ROCKET
AF/PROTECT AF)ACP Registry Protect AF/CAP
Serious bleeding 3,6 3,11 2,71 3,4/3,36/4,1 0 3,5/__
Fatal bleeding 0,2 ___/0,5/2,0 0
Intracranial bleeding 0,5 0,3 0,23 0,74/0,7/__ 0
Haemorhagic stroke 0,1 0,12 0,38/___/1,6 0 0,1/
Total mortality 4,5 3,64 3,75 4,13/4,9/4,8 0 3/
Devastating stroke/death 1 0,66 0,94 0
Ischemic stroke
1,7 vs 2,2w
0,92 1,34 1,2/___/1,6 0 2,2/0
Systemic embolisation 0,19 0,19 0,49/___/0 0 0,3/0
Summary• Anticoagulation is gold standard in embolic or
paradoxical embolic stroke patients
• In some situation especially due to risk of bleeding
we can offer well established transcatheteric LAA
closure
• There are data from radomisation studies, registries
and retrospective studies less complication after
transcatheteric closure
Prevail – Implant Succes
Prevail - Warfarin
Pericardial EffusionRequired Intervention