The document discusses left atrial appendage (LAA) closure as an alternative to anticoagulation for stroke prevention in atrial fibrillation patients. It summarizes several studies on the Watchman device that found LAA closure to be non-inferior to warfarin for stroke risk reduction, with higher risks of complications. The ACP registry showed periprocedural complication rates with LAA closure decreased over time from 7% to 3.4% as operators gained more experience with the procedure. Overall, LAA closure is a viable alternative to anticoagulation for stroke prevention when anticoagulation is contraindicated or poses high bleeding risks, though periprocedural complications remain higher than medical management

1. LAA treatment results in adults
J. Januska, M. Poloczek*, M. Branny
Podlesi Hospital, Trinec,* Faculty Hospital Brno
Bohunice Czech Republic

2. 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

3. 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

4. CHADS2 Score

5. Currently Available Management Options
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

6. 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

7. Devices for occlusion
Amplatzer Cardiac Plug
Lariat
Watchman

8. Watchman studies

9. 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%)

10. Protect AF
Primary Efficacy Results
Primary Safety Results

11. Prevail

12. Prevail – Implant Succes

13. Complications

14. Prevail Primary Endpoint

15. 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)

16. ACP – complications
ACP Initial
European
Registry (1)
ACP Italian
registry (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
Time
12/2008-
11/2009 12/2008 - 11/2010 2010-2011 6/2009-5/2010 8/2009-5/2011
Pericardial
effusion 5 (3.5%) 2 (2.0 %) 0 0 3 (2.1%)
Embolization of
occluder 2 (1.4%) 0 0 0 2 (1,4%)
Ischemic
stroke/TIA
3(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)

17. Anticoagulation in stroke
event no/100 pat-yaer
Rivaroxaban Dabigatran
150 mg
Dabigatran
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

18. 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

21. Prevail – Implant Succes

22. Prevail -Warfarin

23. Pericardial Effusion
Required Intervention