1. Transcatheter LAA Occlusion
Ahmed A. Khattab
Cardiology
Bern – Switzerland

2. 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)

3. 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.

5. First randomized trial using WATCHMAN Device
900 patient-year cohort
Holmes DR, et al. Lancet, 2009.

6. The Amplatzer Cardiac PlugTM
St. Jude - AGA
Hooks
Lobe
Waist
Pacifier Principle
LAA
Disc
• Flexible braided nitinol
• Filled with polyester tissue
• Double curved 9-13F sheath LA

7. Currently available devices
Khattab AA and Meier B. EHJ, 2010.

8. Khattab AA and Meier B. EHJ, 2010.

9. Amplatzer LAA Cardiac Plugs in Bern: 95 cases
CHADS2 Score (n)
mean 2.5±1.3
Stand Steffen Gloekler

10. Results: indications for LAA occlusion
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Results: indications for LAA occlusion
N = 95
98% procedural success
ACPs 16-30mm
In 94% first selected device implanted
Mehrfachnennungen möglich, z.B. Bleeding UND Patient Decision
2 patients with unsuccessful implantation

11. Combined procedures (75/95 or 79%)
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Combined procedures (75/95 or 79%)
N = 95
64%
35%
25%
21%
10% 7%

12. 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, , , Khattab, Windecker
Amplatzer Septal Occluder
14 mm
Medtronic CoreValve
26 mm
Amplatzer TorqueVue Sheath
13 French
Termporary Pacemaker Lead

13. Three-month clinical overall complications
LAA Closure with Amplatzer Cardiac Plug: Bern Experience
Three-month clinical overall complications
N = 95
• 2 device embolizations, 1 with surgery
• 2 pericardial effusions, treated conservatively
• 1 stroke
- 1st day after procedure
- reversible
• No myocardial infarction 1% 1% 2%
Complete LAA Occlusion
65/68 with FU TEE (96%) 2%
95%
* 1 Mobile thrombus
3 Nonmobile thrombi
8 Questionable thrombi

14. 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: patient-years CHADS2 2.2± deaths (nonrelated to device)

15. AMPLATZER® Cardiac Plug
CE Mark 2008
Implanted since December 2008
Several physician initiated studies
Pre-registry data – Park et al. ( )
Italian Registry – Santoro et al. ( )
Dual Center – Park, Meier ( )
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

16. ACP Post Marketing Registry Baseline Demographics
13 European Centers
History
Indication
Please note percentages for Afib change update Permanent to 60, Paroxysmal 28 and persistent is 12, please update the HX of AF wheel
- Only 3.3% on anticoagulation at enrollment
N= 148

17. ACP Registry Implant Success
Implant/Technical Success*
LAA Closure Rates (TEE/ TTE)
140/145 (96.5%)
No device embolizations during implant procedure
NO devices embolized during the procedure, the devices all embolized after the patients left the cath lab.
Number of subjects per visit type: Implant = 140 – no residudal flow 85%, small 14%, large 1%; 1 month = no residual flow 86%, small 13%, large 1%; 6 month = 87 –no residual flow 82%, small 15%, large 3%
N=140 N=140 N=129 N=87
*Success: Devices implanted in those attempted

18. 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 November 2009
December 2008 –
November 2010
August 2009-
May (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= 2
Ischemic Stroke
N = 3 (2.1%)
Total reported safety events
N = 10 (7%)
N = 2 (2%)
N = 5 (3.4%)
The data for SAEs within 7 days:
3 serious PEs, 3 embolisations and no strokes
* Hospital discharge ≤ 24 hrs.
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: /ccd.22764
G. Santoro (presented at the Progress In Clinical Pacing Congress in Rome) December 2010.
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 March (Hong Kong).

19. Indications for LAA occlusion Patients 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.)