Presentation on theme: "LAA Closure Devices: Protecting Against Stroke Moderator Ted E. Feldman, MD Director Cardiac Catheterization Laboratory Evanston Hospital Evanston, Illinois."— Presentation transcript:
LAA Closure Devices: Protecting Against Stroke Moderator Ted E. Feldman, MD Director Cardiac Catheterization Laboratory Evanston Hospital Evanston, Illinois
Panelists Saibal Kar, MD Director Interventional Cardiac Research Cardiology Division Department of Medicine Cedars-Sinai Medical Center Los Angeles, California Vivek Y. Reddy, MD Professor of Medicine Department of Cardiology Icahn School of Medicine at Mount Sinai Director Electrophysiology Laboratories Mount Sinai Hospital New York, New York Mark Reisman, MD Chief Scientific Officer Director Cardiovascular Research and Education Swedish Medical Center Seattle, Washington
Placing LLA Closure Device Insert video
Atrial Fibrillation Stroke is a leading cause of serious, long-term disability and is the third leading cause of death in the United States. a AF increases stroke risk 5-fold and accounts for approximately 15% of all strokes. b AF affects 12% of adults ≥ 75 years and prevalence is expected to double by b Ischemic stroke may be the first manifestation of AF. Standard of care for higher risk patients: Anticoagulation with warfarin, dabigatran, rivaroxaban, apixaban a. Rosamund W, et al. Circulation. 2008;117:e25-e146.  b. Lloyd-Jones DM, et al. Circulation. 2004;110: 
Oral Anticoagulation Warfarin reduces annual risk of ischemic stroke by approximately two-thirds, from 4.5% to 1.4%. a Risk factors for bleeding similar to risk factors for stroke Elderly population has increased risk for falls Interactions between warfarin and other medications, food Many patients with AF not treated or discontinue treatment prematurely Novel oral anticoagulants do not require monitoring and have few drug-drug and drug-food interactions, but also have risk for bleeding and discontinuation rate similar to warfarin a. Go AS, et al. JAMA. 2001;285: 
Left Atrial Appendage Left atrium a. Blackshear JL, et al. Ann Thorac Surg. 1996;61:  Patrick J. Lynch, medical illustrator; C. Carl Jaffe, MD, cardiologist. LAA: source of 90% of AF-related thrombi a
PROTECT AF Design Warfarin to 45 days, then clopidogrel + aspirin to 6 months and aspirin indefinitely Pre-implant interval Day 0 Control subject takes warfarin Device subject gets implant Warfarin ceased Ongoing to 5 years Randomize Day 0 Day 45 post-implant Day 2-14Ongoing to 5 years Device Control Fountain RB, et al. Am Heart J. 2006;151: 
The WATCHMAN LAA closure technology has CE Mark approval and is currently available for investigational use only in the United States. Image courtesy of Boston Scientific Corp. WATCHMAN™ Device Nitinol frame Permeab Polyester fabric Fixation barbs
PROTECT AF 2.3-Year Follow-up Efficacy Results Device No. of Events/100 Patient- year (95% Crl) Control No. of Events/ 100 Patient- year (95% Crl) Rate Ratio (Intervention/ Control) (95% Crl) Noninferiority Posterior Probabilities Superiority Posterior Probabilities Primary Efficacy 3.0 ( ) 4.3 ( ) 0.71 ( ) > Ischemic Stroke 1.9 ( ) 1.4 ( ) 1.30 ( ) CV/ Unexplained Death 1.0 ( ) 2.8 ( ) 0.38 ( ) > SE 0.3 ( ) 0__ Reddy VY, et al. Circulation. 2013;127:  Study limitations: Small number of patients, 1/3 of patients randomized to continued warfarin, primary composite endpoint included ischemic + hemorrhagic stroke
PROTECT AF 2.3-Year Follow-up Safety Results Safety Events %/Year (95% CI)RR (95% CI) WATCHMAN Group 5.5 ( ) Control3.6 ( )1.53 ( ) Reddy VY, et al. Circulation. 2013;127:  Procedure-related events –eg, pericardial effusion that required intervention or hospitalization, procedure-related stroke, or device embolization Major bleeding –eg, intracranial bleeding/GI bleeding that required transfusion Conclusions: LAA closure is noninferior to OAC LAA implicated in the pathogenesis of stroke in AF
PROTECT AF and CAP Reddy VY, et al. Circulation. 2011; 123:  Implant Success Patients, % PROTECT AF CAP
PREVAIL Study Goals Multicenter, prospective, randomized 2:1 trial 407 patients, 41 US centers Confirm the results of PROTECT AF and demonstrate improved safety profile New centers and operators to document that enhancements to the training program are effective Roll-in phase allowed new centers to implant 2 patients prior to randomization phase
PREVAIL Primary Endpoints First Primary Endpoint –Acute (7-day) Procedural Safety : Pre-specified criterion met (95% Upper confidence bound < 2.67%); 95% CI = 2.618% Second Primary Endpoint –Comparison of composite of stroke, SE, and CV/unexplained death: Similar 18-month event rates in both control and device groups Data courtesy of David R. Holmes, MD.
Comparison of Cardiac Perforations and Pericardial Effusions Requiring Intervention n = 7 n = 1 n = 11 n = 7 n = 4 Data courtesy of David R. Holmes, MD.
PREVAIL Complications New vs Experienced Operator Patients, % Data courtesy of David R. Holmes, MD.
Using LAA Devices Expertise with TEE imaging of LAA –Close working relationship with EPs Development of program/system for use of devices –Training programs Barriers to using devices vs medical therapy –Fear of procedure complications Many new devices under investigation: Amplatzer ™ Vascular Plug (St. Jude Medical), Lariat ® Suture Delivery Device (SentreHEART, Inc.), WaveCrest ® LAA Occlusion System (Coherex)
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