LAA Closure Devices Protecting Against Stroke Moderator Ted

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LAA Closure Devices: Protecting Against Stroke Moderator Ted E. Feldman, MD Director Cardiac Catheterization

LAA Closure Devices: Protecting Against Stroke Moderator Ted E. Feldman, MD Director Cardiac Catheterization Laboratory Evanston Hospital Evanston, Illinois

Panelists Saibal Kar, MD Mark Reisman, MD Director Interventional Cardiac Research Cardiology Division Department

Panelists Saibal Kar, MD Mark Reisman, MD Director Interventional Cardiac Research Cardiology Division Department of Medicine Cedars-Sinai Medical Center Los Angeles, California Chief Scientific Officer Director Cardiovascular Research and Education Swedish Medical Center Seattle, Washington 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

Placing LLA Closure Device Insert video

Placing LLA Closure Device Insert video

Atrial Fibrillation • Stroke is a leading cause of serious, long-term disability and is

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 2050. 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: e 25 -e 146. [1] b. Lloyd-Jones DM, et al. Circulation. 2004; 110: 1042 -1046. [2]

Oral Anticoagulation • Warfarin reduces annual risk of ischemic stroke by approximately two-thirds, from

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: 2370 -2375. [3]

Left Atrial Appendage Left atrium LAA: source of 90% of AF-related thrombia a. Blackshear

Left Atrial Appendage Left atrium LAA: source of 90% of AF-related thrombia a. Blackshear JL, et al. Ann Thorac Surg. 1996; 61: 755 -759. [5] Patrick J. Lynch, medical illustrator; C. Carl Jaffe, MD, cardiologist. http: //creativecommons. org/licenses/by/2. 5/

PROTECT AF Design Day 45 Day 2 -14 post-implant Device Day 0 Pre-implant interval

PROTECT AF Design Day 45 Day 2 -14 post-implant Device Day 0 Pre-implant interval Warfarin to 45 days, then clopidogrel + aspirin to 6 months and aspirin indefinitely Ongoing to 5 years Warfarin ceased Control Device subject gets implant Randomize Control subject takes warfarin Day 0 Fountain RB, et al. Am Heart J. 2006; 151: 956 -961. [6] Ongoing to 5 years

WATCHMAN™ Device Permeab Polyester fabric Nitinol frame Fixation barbs The WATCHMAN LAA closure technology

WATCHMAN™ Device Permeab Polyester fabric Nitinol frame Fixation barbs 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.

PROTECT AF 2. 3 -Year Follow-up Efficacy Results Device No. of Events/100 Patientyear (95%

PROTECT AF 2. 3 -Year Follow-up Efficacy Results Device No. of Events/100 Patientyear (95% Crl) Control No. of Events/ 100 Rate Ratio Patient(Intervention/ year Control) (95% Crl) Noninferiority Posterior Probabilities Superiority Posterior Probabilities Primary Efficacy 3. 0 (2. 1 -4. 3) 4. 3 (2. 6 -5. 9) 0. 71 (0. 44 -1. 30) > 0. 99 0. 88 Ischemic Stroke 1. 9 (1. 1 -2. 9) 1. 4 (0. 6 -2. 4) 1. 30 (0. 66 -3. 66) 0. 76 0. 18 CV/ Unexplained Death 1. 0 (0. 5 -1. 8) 2. 8 (1. 5 -4. 2) 0. 38 (0. 18 -0. 85) > 0. 99 SE 0. 3 (0. 1 -0. 7) 0 __ __ __ Study limitations: Small number of patients, 1/3 of patients randomized to continued warfarin, primary composite endpoint included ischemic + hemorrhagic stroke Reddy VY, et al. Circulation. 2013; 127: 720 -729. [7]

PROTECT AF 2. 3 -Year Follow-up Safety Results • Procedure-related events – eg, pericardial

PROTECT AF 2. 3 -Year Follow-up Safety Results • 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 Safety Events %/Year (95% CI) WATCHMAN Group 5. 5 (4. 2 -7. 1) Control 3. 6 (2. 2 -5. 3) Conclusions: RR (95% CI) 1. 53 (0. 95 -2. 70) • LAA closure is noninferior to OAC • LAA implicated in the pathogenesis of stroke in AF Reddy VY, et al. Circulation. 2013; 127: 720 -729. [7]

PROTECT AF and CAP 95 100 90 89. 5 PROTECT AF 9 8 CAP

PROTECT AF and CAP 95 100 90 89. 5 PROTECT AF 9 8 CAP 7. 7 80 Patients, % 7 70 6 60 5 5 50 4 40 3. 7 3 30 2. 2 2 20 10 1 0 0 Implant Success 0. 9 0 Procedure/Device-Related ADE < 7 days Reddy VY, et al. Circulation. 2011; 123: 417 -424. [8] Serious Pericardial Effusion Procedure/Device-Related Stroke

PREVAIL Study Goals • Multicenter, prospective, randomized 2: 1 trial • 407 patients, 41

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 :

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 PROTECT AF 3. 0 PREVAIL

Comparison of Cardiac Perforations and Pericardial Effusions Requiring Intervention PROTECT AF 3. 0 PREVAIL 2. 4 2. 5 Patients, % CAP 2. 0 1. 6 1. 5 1. 4 1. 5 1. 2 1. 0 0. 5 0. 0 0. 2 n=7 n=1 Cardiac perforation requiring surgical repair Data courtesy of David R. Holmes, MD. n = 11 n=7 n=4 Pericardial effusion with cardiac tamponade requiring pericardiocentesis or window

PREVAIL Complications New vs Experienced Operator 2. 0 8. 0 Experienced New 1. 5

PREVAIL Complications New vs Experienced Operator 2. 0 8. 0 Experienced New 1. 5 Patients, % 7. 0 1. 2 1. 0 0. 5 4. 0 2. 0 0 1. 0 0. 0 Device Embolization 3. 0 0. 8 2. 5 0. 6 0. 4 0. 2 0. 0 2. 9 3. 0 1. 0 0. 6 5. 4 5. 0 Patients, % 0. 0 6. 0 n=1 2. 0 Cardiac Perforation Data courtesy of David R. Holmes, MD. 1. 8% 1. 5 1. 0% 1. 0 0. 5 0 7 -Day Procedure-/Device-Related Vascular Complications 0. 0 n=3 PE with Tamponade

Using LAA Devices • Expertise with TEE imaging of LAA – Close working relationship

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 (Sentre. HEART, Inc. ), Wave. Crest ® LAA Occlusion System (Coherex)

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