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