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Transcatheter LAA Occlusion

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.

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Transcatheter LAA Occlusion

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  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 • Simultaneoussurgicalclosure during cardiac surgery has been common practice since many years and is recommended in current guidelines. • Thoracoscopicepicardialocclusionundergeneralanaesthesiais an option. • Non-surgicaltranscatheterLAA exclusion was first introduced in 2001. BonowRO, et al. JACC, 2006. BlackshearJL, et al. JACC, 2003. Sievert H, et al. Circulation, 2002.

  4. First randomizedtrialusing WATCHMAN Device 900 patient-yearcohort Holmes DR, et al. Lancet, 2009.

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

  6. Currentlyavailabledevices Khattab AA and Meier B. EHJ, 2010.

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

  8. Amplatzer LAA Cardiac Plugs in Bern: 95 cases CHADS2 Score (n) mean 2.5±1.3

  9. 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

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

  11. 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

  12. * 1 Mobile thrombus 3 Nonmobile thrombi 8 Questionable thrombi LAA Closure with Amplatzer Cardiac Plug: Bern Experience Three-month clinical overall complications N = 95 1% • 2 device embolizations, 1 with surgery • 2 pericardial effusions, treated conservatively • 1 stroke - 1st day after procedure - reversible • No myocardial infarction 1% 2% Complete LAA Occlusion 65/68 with FU TEE (96%) 2% 95%

  13. Amplatzer LAA Occlusion in Bern Thromboembolic events: expected and observed FU 6.0 ± 1.2 years: 231 patient-years CHADS2 2.2±1.25 deaths (nonrelated to device) 6.5 Events 1.0 Event 2.3 Events 1.0 Event

  14. 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

  15. ACP Post Marketing RegistryBaseline Demographics 13 European Centers History Indication - Only 3.3% on anticoagulation at enrollment N= 148

  16. ACP RegistryImplant Success Implant/Technical Success* LAA Closure Rates (TEE/ TTE) • 140/145 (96.5%) • No device embolizations during implant procedure N=140 N=140 N=129 N=87 *Success: Devices implanted in those attempted

  17. ACP Results Across Series* * 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).

  18. Indicationsfor LAA occlusionPatientswith AF and.... • Bleedingunder OAC • Embolismunder OAC • Difficultadjustmentof INR • Patient‘swishtodiscontinue OAC • Elderlypatientsliabeforrepeated falls • Patientssubjecttorepeatedinjuries (e.g. butcher, etc.)

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