Left Atrial Appendage Closure: Moving Beyond Blood Thinners to Prevent Stroke in Atrial Fibrillation October 29, 2016
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1 Left Atrial Appendage Closure: Moving Beyond Blood Thinners to Prevent Stroke in Atrial Fibrillation October 29, 2016 Jesse Jorgensen, MD, FACC Director, Cardiac Cath Lab, Greenville Health System
2 Disclosures Speakers Bureau Janssen Pharmaceuticals (Xarelto) Abiomed (Impella) Abbott Vascular (ABSORB Vascular Scaffold)
3 Atrial Fibrillation: Now and The Future Current AF burden in U.S. >3 million Go AS. JAMA. 2001;285(18):
4 Atrial Fibrillation and Strokes AF increases the risk of ischemic stroke ~5-fold Strokes in the setting of AF have a higher mortality rate and higher likelihood of recurrence Lin H et al. Stroke. 1996;27:
5 Atrial Fibrillation 91% of emboli in nonvalvular AF originate in LAA Systemic oral anticoagulation (OAC) reduces the risk of stroke in AF OAC limitations: preexisting contraindication bleeding on therapy medication noncompliance unpredictable drug dose-response. Time in Therapeutic Range (TTR) 50-60%.
6 Left Atrial Appendage Closure Local vs. Systemic stroke prophylaxis Surgical exclusion of the LAA has been performed for years Stand alone procedure for poor Warfarin candidate Combination procedure (CABG, Valve, MAZE, etc) Variable results, high LAA patency Evolution of Percutaneous Technology
7 Watchman Device Metallic (Nitinol) frame, fixation barbs, polyester mesh membrane cover 5 sizes: 21, 24, 27, 30, 33 mm Implant via femoral vein access, transeptal puncture, TEE/fluoro guidance
8 PROTECT-AF Trial Adapted from Reddy, VY. Heart Rhythm Society Late Breaking Clinical Trials 2013
9 PROTECT-AF Trial Patient Characteristics Holmes, DR. Lancet 2009;374:
10 PROTECT-AF Trial Anticoagulation Regimen Implant to 6 weeks: Warfarin (INR 2-3) + ASA 6 weeks to 6 months: Clopidogrel 75 mg + ASA >6 months: ASA monotherapy
11 PROTECT-AF Mid Term Results (1500 pt yrs/mean 2.3 Year Follow Up) Primary Efficacy Endpoint Primary Safety Endpoint Reddy, VY. Circ 2013;127:
12 PROTECT-AF Mid Term Results (1500 pt yrs/mean 2.3 Year Follow Up) Reddy, VY. Circ 2013;127:
13 Components of Safety Outcome Requiring percutaneous/surgical drainage Requiring 2 units RBC or surgery 6 of 7 hemorrhagic strokes fatal Esophageal tear and procedure related arrhythmia Peridevice leak: 32.1% (1 yr) Device thrombus formation: 4.2% (20 pts; only 3 suffered stroke) Holmes, DR. Lancet 2009;374:
14 PROTECT-AF Long Term Results: Primary Efficacy Endpoint at 45mo Adapted from Reddy, VY. Heart Rhythm Society Late Breaking Clinical Trials 2013
15 PROTECT-AF Long Term Results : Safety Endpoint Rate Ratio Watchman/Warfarin, 1.17 (95% CI, ) Adapted from Reddy, VY. Heart Rhythm Society Late Breaking Clinical Trials 2013
16 PROTECT-AF Long Term Results: All Cause Mortality All Cause Mortality 3.2 vs 4.9 per 100 patient-years Hazard Ratio with Watchman, 0.66 (95% CI, ) P = Adapted from Reddy, VY. Heart Rhythm Society Late Breaking Clinical Trials 2013
17 PROTECT-AF Long Term Results: Efficacy Driven by Reduced Hemorrhagic CVA
18 CAP Registry (Continued Access Protocol) Designed to address safety concerns in PROTECT- AF Subset of PROTECT-AF investigators Nonrandomized study of 460 patients with similar protocol to PROTECT-AF
19 CAP Registry CAP Safety Endpoint 3.7 vs. 7.7% in PROTECT-AF (p =.007) Reddy VY. Circulation. 2011;123:
20 PREVAIL Trial Designed to confirm safety and efficacy of PROTECT-AF and CAP Registry Prospective, randomized trial similar to PROTECT- AF enrolling 407 patients
21 PREVAIL: Procedure Implant Success Adapted from Holmes DR. ACC 2013
22 Vascular Complications: 7 Day Serious Procedure/Device Related Adapted from Holmes DR. ACC 2013
23 ASAP Study
24 ASAP Study Reddy, VY. JACC 2013;61:
25 Percutaneous Suture Ligation: The Lariat Device Suture-based lasso placed over the LAA via pericardial access Requires dry pericardial tap and Femoral vein access with transeptal puncture Lariat is advanced over LAA once magnet wires are connected in LAA Bartus, K. JACC 2013;62:
26 Lariat Procedure Sequence Bartus, K. JACC 2013;62:
27 Lariat Procedure Sequence Bartus, K. JACC 2013;62:
28 Percutaneous Suture Ligation: The Lariat Device The Lariat is FDA approved For soft tissue ligation, not specifically for LAA closure No randomized trials Data limited to a single center feasibility registry and additional single center experiences
29 Lariat PLACE II Registry Single Center Study in Poland, mean CHADS2=1.9 Poor anticoagulation candidate
30 Amplatzer Cardiac Plug Initial experience in 52 patient in 7 Canadian hospitals Urena M. JACC. 2013;62(2):96-102
31 Amplatzer Cardiac Plug Urena M. JACC. 2013;62(2):96-102
32 What Have We Learned?
33 LAA Anatomy is Complex Distribution of number of lobes (1 to 4) of left atrial appendage Veinot J P et al. Circulation. 1997;96:
34 LAA Anatomy is Complex Lariat Planning: 3D CT Reconstruction Bartus, K. JACC 2013;62:
35 Left Atrial Appendage and The Heart Team Approach Jorgensen, JP. Echocardiography 2007; 24:
36
37 Conclusions Left Atrial Appendage closure may represent a treatment option for stroke prophylaxis in patients with Atrial Fibrillation at high risk of stroke AND high risk for bleeding Multiple device designs will allow for individualized treatment for each patient
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