Presentation on theme: "Transcatheter LAA Occlusion"— Presentation transcript:
1 Transcatheter LAA Occlusion Ahmed A. KhattabCardiologyBern – 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 -2Simultaneous 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.
13 Three-month clinical overall complications LAA Closure with Amplatzer Cardiac Plug: Bern ExperienceThree-month clinical overall complicationsN = 95• 2 device embolizations, 1 with surgery• 2 pericardial effusions, treated conservatively• 1 stroke- 1st day after procedure- reversible• No myocardial infarction1%1%2%Complete LAA Occlusion65/68 with FU TEE (96%)2%95%* 1 Mobile thrombus3 Nonmobile thrombi8 Questionable thrombi
14 Amplatzer LAA Occlusion in Bern Thromboembolic events: expected and observed6.5Events1.0Event2.3Events1.0EventFU 6.0 ± 1.2 years: patient-years CHADS2 2.2± deaths (nonrelated to device)
15 AMPLATZER® Cardiac Plug CE Mark 2008Implanted since December 2008Several physician initiated studiesPre-registry data – Park et al. ( )Italian Registry – Santoro et al. ( )Dual Center – Park, Meier ( )EU Post-Marketing RegistryFirst patient enrolled August 2009Enrollment completed September 2011US FDA Randomized TrialCompleted 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 CentersHistoryIndicationPlease 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 enrollmentN= 148
17 ACP Registry Implant Success Implant/Technical Success*LAA Closure Rates (TEE/ TTE)140/145 (96.5%)No device embolizations during implant procedureNO 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 Registry1ACP Italian registry2Dual Center experience3ACP Post Marketing RegistryN = 143N = 100N = 131N = 145Enrollment periodDecember November 2009December 2008 –November 2010August 2009-May (interim)Serious Pericardial EffusionN = 5 (3.5%)N = 2 (2.0 %)N = 0N = 3Device EmbolizationN = 2 (1.4%)N = 0 (0%)N= 2Ischemic StrokeN = 3 (2.1%)Total reported safety eventsN = 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.22764G. 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 OACEmbolism under OACDifficult adjustment of INRPatient‘s wish to discontinue OACElderly patients liabe for repeated fallsPatients subject to repeated injuries (e.g. butcher, etc.)