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 Lobe Waist Pacifier Principle LAA 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 Stand 2.1.2011 Steffen Gloekler

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

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%

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 Medtronic CoreValve 26 mm Amplatzer TorqueVue Sheath 13 French Termporary Pacemaker Lead

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

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 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

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 = 129 - 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

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 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= 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: 10.1002/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. 26-7 March (Hong Kong).

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.)