Presentation on theme: "Protecting Against Stroke"— Presentation transcript:
1Protecting Against Stroke LAA Closure Devices:Protecting Against StrokeTitle Slide LayoutModeratorTed E. Feldman, MDDirectorCardiac Catheterization Laboratory Evanston HospitalEvanston, Illinois
2Saibal Kar, MD Mark Reisman, MD Vivek Y. Reddy, MD Panelists Director Interventional Cardiac ResearchCardiology DivisionDepartment of MedicineCedars-Sinai Medical CenterLos Angeles, CaliforniaMark Reisman, MDChief Scientific OfficerDirectorCardiovascular Research and EducationSwedish Medical CenterSeattle, WashingtonVivek Y. Reddy, MDProfessor of MedicineDepartment of CardiologyIcahn School of Medicine at Mount SinaiDirectorElectrophysiology LaboratoriesMount Sinai HospitalNew York, New YorkTitle Slide Layout
3Placing LLA Closure Device Insert videoContent Slide Layout: TEXT
4Atrial FibrillationStroke is a leading cause of serious, long-term disability and is the third leading cause of death in the United States.aAF increases stroke risk 5-fold and accounts for approximately 15% of all strokes.bAF affects 12% of adults ≥ 75 years and prevalence is expected to double by 2050.bIschemic stroke may be the first manifestation of AF.Standard of care for higher risk patients: Anticoagulation with warfarin, dabigatran, rivaroxaban, apixabana. Rosamund W, et al. Circulation. 2008;117:e25-e146.b. Lloyd-Jones DM, et al. Circulation. 2004;110: 
5Oral AnticoagulationWarfarin reduces annual risk of ischemic stroke by approximately two-thirds, from 4.5% to 1.4%.aRisk factors for bleeding similar to risk factors for strokeElderly population has increased risk for fallsInteractions between warfarin and other medications, foodMany patients with AF not treated or discontinue treatment prematurelyNovel 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 warfarina. Go AS, et al. JAMA. 2001;285: 
6LAA: source of 90% of AF-related thrombia Left Atrial AppendageLeft atriumLAA: source of 90% of AF-related thrombiaa. Blackshear JL, et al. Ann Thorac Surg. 1996;61: Patrick J. Lynch, medical illustrator; C. Carl Jaffe, MD, cardiologist.
7Control subject takes warfarin Device subject gets implant PROTECT AF DesignWarfarin to 45 days, then clopidogrel + aspirin to 6 months and aspirin indefinitelyPre-implant intervalDay 0Control subject takes warfarinDevice subject gets implantWarfarin ceasedOngoing to 5 yearsRandomizeDay 45post-implantDay 2-14DeviceControlFountain RB, et al. Am Heart J. 2006;151: 
8Permeab Polyester fabric WATCHMAN™ DeviceNitinol framePermeab Polyester fabricFixation barbsThe 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.
9PROTECT AF 2.3-Year Follow-up Efficacy Results Device No. of Events/100 Patient-year(95% Crl)ControlNo. of Events/ 100 Patient-yearRate Ratio(Intervention/ Control)Noninferiority Posterior ProbabilitiesSuperiority Posterior ProbabilitiesPrimary Efficacy3.0( )4.3( )0.71( )> 0.990.88Ischemic Stroke1.9( )1.4( )1.30( )0.760.18CV/ Unexplained Death1.0( )2.8( )0.38( )0.99SE0.3( )__Study limitations: Small number of patients, 1/3 of patients randomized to continued warfarin, primary composite endpoint included ischemic + hemorrhagic strokeReddy VY, et al. Circulation. 2013;127: 
10PROTECT AF 2.3-Year Follow-up Safety Results Procedure-related eventseg, pericardial effusion that required intervention or hospitalization, procedure-related stroke, or device embolizationMajor bleedingeg, intracranial bleeding/GI bleeding that required transfusionSafety Events %/Year(95% CI)RR (95% CI)WATCHMAN Group5.5 ( )Control3.6 ( )1.53 ( )Conclusions:LAA closure is noninferior to OACLAA implicated in the pathogenesis of stroke in AFReddy VY, et al. Circulation. 2013;127: 
11PROTECT AF and CAP PROTECT AF CAP Patients, % Implant SuccessPatients, %Reddy VY, et al. Circulation. 2011; 123: 
12PREVAIL Study Goals Multicenter, prospective, randomized 2:1 trial 407 patients, 41 US centersConfirm the results of PROTECT AF and demonstrate improved safety profileNew centers and operators to document that enhancements to the training program are effectiveRoll-in phase allowed new centers to implant 2 patients prior to randomization phase
13PREVAIL Primary Endpoints First Primary EndpointAcute (7-day) Procedural Safety : Pre-specified criterion met (95% Upper confidence bound < 2.67%); 95% CI = 2.618%Second Primary EndpointComparison of composite of stroke, SE, and CV/unexplained death: Similar 18-month event rates in both control and device groupsData courtesy of David R. Holmes, MD.
14Comparison of Cardiac Perforations and Pericardial Effusions Requiring Intervention Data courtesy of David R. Holmes, MD.
15PREVAIL Complications New vs Experienced OperatorPatients, %Data courtesy of David R. Holmes, MD.
16Using LAA Devices Expertise with TEE imaging of LAA Close working relationship with EPsDevelopment of program/system for use of devicesTraining programsBarriers to using devices vs medical therapyFear of procedure complicationsMany 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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