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Transcatheter LAA Occlusion
Ahmed A. KhattabCardiology
Bern – Switzerland
Patients with AF have a 5-fold higher risk of stroke
>87% of strokes are thromboembolic
>90% of thrombus originates in the Left Atrial Appendage (LAA)
Thrombus in LAA
Background -1
Background -2
• Simultaneous surgical closure during cardiac surgery has been common practice since many years and is recommended in current guidelines.
• Thoracoscopic epicardial occlusion under general anaesthesia is an option.
• Non-surgical transcatheter LAA exclusion was first introduced in 2001.
Bonow RO, et al. JACC, 2006.Blackshear JL, et al. JACC, 2003.Sievert H, et al. Circulation, 2002.
First randomized trial using WATCHMAN Device
Holmes DR, et al. Lancet, 2009.
900 patient-year cohort
LobeHooks
Waist
Disc
• Flexible braided nitinol • Filled with polyester tissue• Double curved 9-13F sheath
Pacifier Principle
LAA
LA
The Amplatzer Cardiac PlugTM
St. Jude - AGA
Currently available devices
Khattab AA and Meier B. EHJ, 2010.
Khattab AA and Meier B. EHJ, 2010.
Amplatzer LAA Cardiac Plugs in Bern: 95 cases
CHADS2 Score (n)mean 2.5±1.3
Results: indications for LAA occlusion• 98% procedural success• ACPs 16-30mm• In 94% first selected device implanted
N = 95
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Combined procedures (75/95 or 79%)N = 95
64%
10%7%
25%
35%
21%
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Schneiter Elisabeth, 29.11.1926, 28.09.2010, Khattab, Windecker
Amplatzer Cardiac Plug24 mm
Medtronic CoreValve26 mm
Amplatzer Septal Occluder14 mm
Termporary Pacemaker Lead
Amplatzer TorqueVue Sheath13 French
Biomatrix Stent3.0 x 18 mm
LAD Stenting + LAA Occlusion + ASD Closure + TAVI(Female, 84 years, LAD stenosis, atrial fibrillation, ASD, aortic stenosis)
September 28, 2010, A. Khattab, MD, S. Windecker, MD
One Stop Shop
Three-month clinical overall complications • 2 device embolizations, 1 with surgery• 2 pericardial effusions, treated conservatively• 1 stroke - 1st day after procedure - reversible• No myocardial infarction
N = 95
* 1 Mobile thrombus3 Nonmobile thrombi8 Questionable thrombi
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Complete LAA Occlusion65/68 with FU TEE (96%)
95%
2%
1%
1%
2%
2.3Even
ts1.0
Event
FU 6.0 ± 1.2 years: 231 patient-years CHADS2 2.2±1.2 5 deaths (nonrelated to device)
Thromboembolic events: expected and observed
Amplatzer LAA Occlusion in Bern
6.5Even
ts
1.0Event
AMPLATZER® Cardiac Plug
• CE Mark 2008– Implanted since December 2008
• Several physician initiated studies– Pre-registry data – Park et al. (2008-2009)– Italian Registry – Santoro et al. (2008-
2010)– Dual Center – Park, Meier (2010-2011)
• EU Post-Marketing Registry– First patient enrolled August 2009– Enrollment completed September 2011
• US FDA Randomized Trial– Completed enrollment in feasibility phase
(45 patients)– Up to 2000 patients to be enrolled in pivotal
phase – expected start: Q1 2012
Paroxysmal28%
Persistent12%
Permanent60%
History of Atrial Fibrillation
N= 148
- Only 3.3% on anticoagulation at enrollment
ACP Post Marketing RegistryBaseline Demographics
13 European Centers
HistoryIndication
ACP RegistryImplant Success
Implant/Technical Success*• 140/145 (96.5%)• No device embolizations
during implant procedure
LAA Closure Rates (TEE/ TTE)
Implant D/C 1 M 6 M0%
20%
40%
60%
80%
100%
Large (> 3 mm)
Small (≤ 3 mm)
No Residual Flow
N=140 N=140 N=129 N=87
*Success: Devices implanted in those attempted
ACP Results Across Series*ACPInitial European Registry1
ACPItalian registry2
Dual Center experience3
ACP Post Marketing Registry
N = 143 N = 100 N = 131 N = 145
Enrollment period December 2008 -November 2009
December 2008 –November 2010
2010 - 2011 August 2009-May 2011 (interim)
Serious Pericardial Effusion
N = 5 (3.5%) N = 2 (2.0 %) N = 0 N = 3
Device Embolization
N = 2 (1.4%) N = 0 (0%) N = 0 N= 2
Ischemic Stroke N = 3 (2.1%) N = 0 (0%) N = 0 N = 0
Total reported safety events
N = 10 (7%) N = 2 (2%) N = 0 (0%) N = 5 (3.4%)
1. Park, J.-W. et al. (2011), Left atrial appendage closure with Amplatzer Cardiac Plug in Atrial Fibrillation: Initial European experience. Catheterization and Cardiovascular Interventions, 77: 700–706. doi: 10.1002/ccd.22764
2. G. Santoro (presented at the Progress In Clinical Pacing Congress in Rome) December 2010.3. Park, J.W., Leithauser, B., Schmid, M., Khattab, A., Gloeckler, S., Sperl, T., Kasch, F. and Meier, B. (2011) Dual Center Experience with Different Strategies of Left Atrial Appendage Closure with
Amplatzer Cardiac Plug for Prevention of Stroke in Atrial Fibrillation. Presented at UHK_Mayo Clinic Asia cardiovascular summit. 26-7 March (Hong Kong).
* Hospital discharge ≤ 24 hrs.
Indications for LAA occlusionPatients with AF and....
• Bleeding under OAC• Embolism under OAC• Difficult adjustment of INR• Patient‘s wish to discontinue OAC• Elderly patients liabe for repeated falls• Patients subject to repeated injuries (e.g.
butcher, etc.)