LAA Closure Devices: Protecting Against Stroke - PowerPoint Presentation

Slide1

LAA Closure Devices:

Protecting Against Stroke

Moderator

Ted E. Feldman, MD

Director

Cardiac Catheterization

Laboratory

Evanston Hospital

Evanston, Illinois

Slide2

Panelists

Saibal Kar, MDDirectorInterventional Cardiac Research Cardiology Division

Department of Medicine

Cedars-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, MD

Chief Scientific

Officer

Director

Cardiovascular

Research and Education

Swedish

Medical Center

Seattle, Washington Slide3

Placing LLA Closure DeviceInsert videoSlide4

Atrial FibrillationStroke 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.bIschemic

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]Slide5

Oral AnticoagulationWarfarin 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 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 warfarin

a. Go

AS,

et

al. JAMA

. 2001;285:

2370-2375.

[3]Slide6

Left 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

thrombi

aSlide7

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

p

ost-implant

Day 2-14

Ongoing to 5 years

Device

Control

Fountain RB,

et al.

Am

Heart J

. 2006;151:956

-961.

[6]Slide8

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 barbsSlide9

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

SE

0.3

(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 strokeSlide10

PROTECT 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 AFSlide11

PROTECT AF and CAPReddy

VY, et

al.

Circulation. 2011; 123:417-424.[8]

Implant Success

Patients, %

PROTECT AF

CAPSlide12

PREVAILStudy 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 phaseSlide13

PREVAILPrimary 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 EndpointComparison

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.Slide14

Comparison of Cardiac Perforations and Pericardial Effusions Requiring Intervention

n =

7

n =

1n = 1

n =

11

n =

7

n

= 4

Data courtesy of David R. Holmes, MD.Slide15

PREVAIL

Complications

New

vs Experienced Operator

Patients, %

Data

courtesy

of David R. Holmes,

MD.Slide16

Using LAA Devices

Expertise with TEE imaging of LAAClose working relationship with EPs

Development of program/system for use of

devices

Training programsBarriers to using devices vs medical therapy Fear of procedure complicationsMany new devices under investigation:Amplatzer™ Vascular Plug (St. Jude Medical), Lariat

®

S

uture Delivery Device

(

SentreHEART, Inc.), WaveCrest ® LAA Occlusion System

(

Coherex

)Slide17

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