Transcatheter Left Atrial Appendage

Occlusion in Atrial Fibrillation:

Comparison of Non-Dedicated Versus

Dedicated Amplatzer Devices

Steffen Gloekler, Michael Schmid, Ardan M. Saguner, Ahmed A. Khattab, Andreas Wahl,

Peter Wenaweser, Stephan Windecker, and Bernhard Meier

Cardiology, Swiss Cardiovascular Center Bern, University Hospital, Switzerland

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Speaker’s name: Steffen Gloekler

I do not have any potential conflict of interest

Potential conflicts of interest

Atrial fibrillation & stroke

• 25% of persons >40 years will develop atrial fibrillation (AF)

• Overall risk for stroke in non-anticoagulated patients with AF: ∼5% per year

• Stroke risk ↑ with CHADS2 Score up to 18% per year

• 20% of strokes are lethal

• Long-term warfarine: standard of care

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>90% of thrombi

originate from LAA*

Blackshear et al, Ann Thorac Surg 1996 Alberg et al, Acta Med Scand 1969 Stoddard et al , JACC 1995

* LAA = Left Atrial Appendage

Blackshear et al, Ann Thorac Surg 1996 Alberg et al, Acta Med Scand 1969 Stoddard et al, JACC 1995

* LAA = Left Atrial Appendage

* LAA = Left Atrial Appendage

Rationale for LAA occlusion

• Limitations of standard therapy

• Risk reduction for thrombi of 90%

• Contraindication for OAC

• Obviation of long-term OAC

• Solution for patients unwilling to take OAC

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2002Watchman

2001

PLAATO

Devices for LAA occlusion

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2008Amplatzer

CardiacPlug

Previous Data from LAA occlusion

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Proof of concept !!

Methods

• Oberservational, single center study

• Patients with nonvalvular AF

• Comparison of 32 patients with NDA* vs 32 with ACP **

• Local anesthesia, femoral venous-transseptal access

• No intraprocedural echocardiography

(fluoroscopy-guided only)

• Immediate postprocedural stop of warfarin

• Follow-up: 3-6 months and long-term (NDA group)

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* NDA = non-dedicated Amplatzer devices (septal occluders) ** ACP = Amplatzer Cardiac Plug

Baseline Characteristics

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NDA ACP p

Age 63 ± 7 69 ± 10 0.005

CHADS2 Score 1.0 ± 1.0 2.5 ± 1.3 0.44

Major bleeding 38% 69% 0.01

Falls 3% 9% 0.3

INR 2-3 not achievable 9% 9% 1

Patient desire 50% 13% 0.001

Warfarin 72% 50% 0.07

Acetylsalicylic acid 16% 47% 0.007

Thienopyridine 0% 13% 0.04

Procedural Outcome

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NDA ACP p

Flouroscopy time 28 ± 13min 19 ± 21min 0.03

Amount of contrast 424 ± 182 226 ± 134 0.001

Early device embolization 16% 0% 0.02

Cardiac tamponade 6% 0% 0.2

Air embolism 3% 3% 1

Thromboembolism 3% 0% 0.3

Vascular complications 6% 0% 0.2

Procedural success 84% 100% 0.02

Follow-up Results @ 3-6 months

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NDA ACP p

Stroke (all-cause) 0% 0% 1

Incomplete occlusion of LAA 18% 4% 0.1

Suspicion of thrombi* (any) 12% 21% 0.41

- mobile 6% 0% 0.19

- non-mobile 6% 7% 0.87

- possible 0% 14% 0.1

Acetylsalicylic acid 91% 68% 0.03

Thienopyridine 41% 19% 0.06

Warfarin 3% 6% 0.5

*on device in TEE follow-up

Long-term follow-up Results

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• NDA: mean 6.3± 1.3 years: 197 patient-years

5 died (nonrelated reasons)

• ACP: mean 13 ± 4 months: 34 patient-years, 0 died

• Thromboembolic events: Expected and observed (in %)

Conclusions

• Non dedicated Amplatzer devices

- difficult to select

- high rate of embolization

- stoke prevention: good long-term results

• LAA-adapted ACP

- pivotal technical refinements

- 100% procedural success rate

- long-term results promising, but pending

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Key data from PROTECT AF

• 91% successful implantations

• Device embolization 0.6%

• TEE guidance and general anesthesia

• Aggressive antiplatelet Tx / anticoagulaton (triple Tx for 45d or longer)

• OAC stopped only after 45d in 86% of patients, after 6mo in 92%

• OAC in 34% of patients out of range despite 2-weekly control

• Serious pericardial effusion in 5%

• All stroke (ischemic and hemorrhagic) 2.3% vs 3.2%

• All-cause mortality 3.0% vs 4.8%

Blaauw et al. Heart 2008 Gage et al. JAMA 2001 Lip et al. Lancet Neurology 2007

Warfarin: ~ 60-70% RRR for stroke and systemic embolism 30% RRR in overall mortality

Stroke risk and CHADS2 score