Transcatheter LAA Occlusion
Ahmed A. Khattab
Cardiology
Bern – Switzerland
Background -1
Thrombus in LAA
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)
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
900 patient-year cohort
Holmes DR, et al. Lancet, 2009.
The Amplatzer Cardiac PlugTM
St. Jude - AGA
Hooks
Waist
Lobe
Pacifier Principle
Disc
• Flexible braided nitinol
• Filled with polyester tissue
• Double curved 9-13F sheath
LA
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
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
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%
35%
25%
21%
7%
10%
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
Amplatzer Cardiac Plug
24 mm
Biomatrix Stent
3.0 x 18 mm
Schneiter Elisabeth, 29.11.1926, 28.09.2010, Khattab, Windecker
Amplatzer Septal Occluder
14 mm
Amplatzer TorqueVue Sheath
13 French
Medtronic CoreValve
26 mm
Termporary Pacemaker Lead
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
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%
1%
2%
Complete LAA Occlusion
65/68 with FU TEE (96%)
2%
95%
*
1 Mobile thrombus
3 Nonmobile thrombi
8 Questionable thrombi
Amplatzer LAA Occlusion in Bern
Thromboembolic events: expected and observed
6.5
Events
1.0
Event
2.3
Events
1.0
Event
FU 6.0 ± 1.2 years:
231 patient-years CHADS2 2.2±1.2
5 deaths (nonrelated to device)
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
ACP Post Marketing Registry
Baseline Demographics
13 European Centers
Indication for LAA Closure
History of Atrial Fibrillation
Paroxysmal
28%
Contraindications
Intolerance
45%
Permanent
60%
History
Prior
Bleeding
46%
Indication
Persistent
12%
Prior
Stroke
on warfarin
9%
- Only 3.3% on anticoagulation at enrollment
N= 148
ACP Registry
Implant Success
Implant/Technical Success*
• 140/145 (96.5%)
• No device embolizations
during implant procedure
LAA Closure Rates (TEE/ TTE)
100%
80%
60%
Large (> 3 mm)
40%
Small (≤ 3 mm)
No Residual Flow
20%
0%
N=140
Implant
*Success: Devices implanted in those attempted
N=140
N=129
N=87
D/C
1M
6M
ACP Results Across Series*
ACP
Initial European
Registry1
ACP
Italian 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 2009May 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%)
* Hospital discharge ≤ 24 hrs.
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).
Indications for LAA occlusion
Patients with AF and....
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•
•
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•
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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.)