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LAA Closure Devices:LAA Closure Devices:Protecting Against Stroke
ModeratorTed E. Feldman, MDDirectorCardiac Catheterization Laboratory Evanston HospitalEvanston, Illinois
Panelists Saibal Kar, MDDirectorInterventional Cardiac Research Cardiology Division Department of MedicineCedars-Sinai Medical CenterLos Angeles, California
Vivek Y. Reddy, MDProfessor of MedicineDepartment of CardiologyIcahn School of Medicine at Mount SinaiDirectorElectrophysiology LaboratoriesMount Sinai Hospital New York, New York
Mark Reisman, MDChief Scientific OfficerDirectorCardiovascular Research and Education Swedish Medical CenterSeattle, Washington
Placing LLA Closure DevicePlacing LLA Closure Device
Insert video
Atrial FibrillationAtrial 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:e25-e146.[1]
b. Lloyd-Jones DM, et al. Circulation. 2004;110:1042-1046.[2]
Oral AnticoagulationOral 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 AppendageLeft Atrial Appendage
Left atrium
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/
LAA: source of 90% of AF-related
thrombia
PROTECT AF DesignPROTECT 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 0Day 45
post-implantDay 2-14 Ongoing to 5 years
Dev
ice
Co
ntr
ol
Fountain RB, et al. Am Heart J. 2006;151:956-961.[6]
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™ DeviceWATCHMAN™ 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(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 0.99
SE0.3
(0.1-0.7)0 __ __ __
Reddy VY, et al. Circulation. 2013;127:720-729.[7]
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 ResultsPROTECT AF 2.3-Year Follow-up Safety Results
Safety Events %/Year(95% CI) RR (95% CI)
WATCHMAN Group
5.5 (4.2-7.1)
Control 3.6 (2.2-5.3) 1.53 (0.95-2.70)
Reddy VY, et al. Circulation. 2013;127:720-729.[7]
• 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 CAPPROTECT AF and CAP
Reddy VY, et al. Circulation. 2011; 123:417-424.[8]
Procedure/Device-Re-lated ADE < 7 days
Serious Pericardial Ef-fusion
Procedure/Device-Re-lated Stroke
0
1
2
3
4
5
6
7
8
9
7.7
5
0.9
3.7
2.2
00
10
20
30
40
50
60
70
80
90
100
89.595
Implant Success
Pat
ien
ts, %
PROTECT AF
CAP
PREVAILStudy GoalsPREVAILStudy 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
PREVAILPrimary EndpointsPREVAILPrimary 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
Comparison of Cardiac Perforations and Pericardial Effusions Requiring Intervention
0.00.51.01.52.02.53.0
1.6
2.4
0.2
1.21.4 1.5
PROTECT AF CAP PREVAIL
Patie
nts,
%
n = 7 n = 1n = 1 n = 11 n = 7 n = 4
Data courtesy of David R. Holmes, MD.
Device Embolization0.0
0.5
1.0
1.5
2.0
1.2
0
Pa
tie
nts
, %
7-Day Procedure-/Device-Related Vas...0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
5.4
2.9
Experienced New
Cardiac Perforation0.0
0.2
0.4
0.6
0.8
1.0
0.6
0
Pa
tie
nts
, %
n = 1
PE with Tamponade0.0
0.5
1.0
1.5
2.0
2.5
3.0
1.8%
1.0%
Pa
tie
nts
, %
n = 3
PREVAIL Complications New vs Experienced Operator
Pat
ien
ts,
%
Data courtesy of David R. Holmes, MD.
Using LAA DevicesUsing 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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