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Treatment Options for Stroke Prevention in Nonvalvular Atri Treatment Options for Stroke Prevention in Nonvalvular Atri

Treatment Options for Stroke Prevention in Nonvalvular Atri - PowerPoint Presentation

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Treatment Options for Stroke Prevention in Nonvalvular Atri - PPT Presentation

Percutaneous Left Atrial Appendage LAA Exclusion Aaditya Vora MD Cardiac Electrophysiologist Baptist heart specialists Disclosures None gt 33M people with AF Worldwide 1 Many patients are unprotected ID: 605733

laa case device atrial case laa atrial device warfarin stroke left appendage closure patients june15 risk 230506 watchman fibrillation

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Slide1

Treatment Options for Stroke Prevention in Nonvalvular Atrial Fibrillation: Percutaneous Left Atrial Appendage (LAA) Exclusion

Aaditya Vora, MD

Cardiac Electrophysiologist

Baptist heart specialistsSlide2

Disclosures

NoneSlide3

>

33M

people with

AF Worldwide

1

Many patients are unprotected

AF

is the most common cardiac arrhythmia

AF increases risk of stroke

Blood clots form in the left atrial appendage

5xgreater risk of stroke with AF2

>90%of stroke-causing clots that come from the left atrium in non-valvular AF are formed in the LAA3

<

90%

Thrombus

Originate LAA

10%

Non-LAA

90%

Thrombus

Originate LAA

10%

Non-LAA

15%

15%

70%

Treated with Warfarin

Contraindicated

Intolerant

~45%

of patients eligible for

warfarin

are

untreated

(

tolerance/adherence)

4

1

Chugh

, S et al. Circulation, 2014; 129: 837-847

2

Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528–536.

3 Blackshear

JL. Odell JA

., Annals of Thoracic Surgery.

1996;61:755-759

4 Waldo, AL

. JACC

2005;46:1729-1736. /

Holmes DR et al, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528–536

Atrial Fibrillation & Stroke Risk

SH-230506-AD June15Slide4

Manage

AF

Pacing

Drugs

for Rhythm &

Rate

Control

Manage

AF Related

Stroke Risk

Warfarin

(Coumadin®)

Intervention

Ligation, Clips,

LAA Closure Devices

Ablation

New Drugs

Dabigatran

,

Apixaban

, Rivaroxaban,

Edoxaban

And/Or

AF

Diagnosis

Treatment Goals in Non-Valvular AF

SH-230506-AD June15Slide5

Yes, there is an App for that!Slide6

Left atrial appendageAutopsy studies have shown approximately 90% of all thrombi in patients with nonvalvular AF are located in LAA.

Alberg H. Atrial fibrillation: a study of atrial thrombus and systemic embolism in a necropsy material. Acta Med Scand 1969;185:373-79Slide7

Thrombus in the Left atrial AppendageSlide8

1

Piccini

, et al.. Pharmacotherapy in Medicare beneficiaries with atrial fibrillation. Heart Rhythm. 2012;9:1403-1408

Stroke Treatment Option: warfarin (Coumadin®)

Medicare

claims data, 2006-2007

1

Warfarin

use less than 60

% in high-risk patients

CHADS

2 Score

p <

0.001(n=27,164)

Warfarin use declines with increased stroke risk

AF Patients Using Warfarin

SH-230506-AD June15Slide9

Stroke Treatment Option: Novel Oral Anticoagulants (NOACs)

This chart is not based on a head-to-head trial and is not intended to suggest head-to-head comparisons of the separate trials or the therapies under study.

Treatment

Study Drug

Discontinuation Rate

Major

Bleeding

(rate/year)

Rivaroxaban

1

24%

3.6%

Apixaban

2

25%

2.1%

Dabigatran

3

(150 mg)

21%

3.3%

Edoxaban

4

(60 mg /

30 mg)

33 % / 34%

2.8% / 1.6%

Warfarin

1-4

17 – 28%

3.1 – 3.6%

There is an unmet need of stroke risk reduction for patients with AF who are seeking an alternative to long-term OACs

1Connolly, S. NEJM 2009; 361:1139-1151 – 2

yrs

follow-up (Corrected) 2Patel, M. NEJM 2011; 365:883-891 – 1.9

yrs

follow-up, ITT 3Granger, C NEJM 2011; 365:981-992 – 1.8

yrs

follow-up, 4Giugliano, R. NEJM 2013; 369(22): 2093-2104 – 2.8

yrs

follow-up.

SH-230506-AD June15Slide10

Surgical approaches to thromboembolic prophylaxis have been explored since the 1940s

LAA closure or obliteration has most often been considered as an adjunct to other cardiac procedures such as mitral valvotomy or cardiac bypass surgery

Studies on patients undergoing LAA closure have shown a trend toward reduction in embolic events

A review of the literature on LAA closure prior to

2010 found

closure rates of 10%-

73%

1Excision

Ligation w/ SuturesLigation w/ Staples

1 Dawson AG, et al. Interact Cardiovasc Thorac Surg 2010, 10:306-11 2 Kanderian et al.

JACC 2008, 52:924–9Method of SuccessfulLAA Closure2

Stroke Treatment Option: LAA Ligation

SH-230506-AD June15Slide11

LAA Closure (LAAC) Devices

LAA Clip

EXCLUDE

Trial (completed)

AtriClip

Device was FDA approved in 2010 for LAA closure

No specific indication for Stroke Reduction

ClinicalTrials.gov

identifier: NCT00779857

PLAATO

WATCHMAN™

Device

ACP

Surgical Ligation

“Safety

and Efficacy of Left Atrial Appendage Occlusion

Devices”

Observational Study (retrospective)

To compare LARIAT® vs. WATCHMAN™

LARIAT currently does not

have a specific indication for LAA Closure or Stroke Reduction

ClinicalTrials.gov

identifier: NCT01695564

Stroke Treatment Options: LAA Ligation, LAA Clips and LAA Closure

First LAAC device (2001)

Device no longer available

Only LAAC device with 2 Randomized Controlled Trials

FDA approved with specific indication to

reduce the risk of thromboembolism

ClinicalTrials.gov identifiers: NCT00129545 (PROTECT AF)

NCT01182441 (PREVAIL)

US Trial halted in 2013

AMPLATZER™

 

Cardiac

Plug Clinical

Trial

ClinicalTrials.gov identifier: NCT01118299

SH-230506-AD June15Slide12

Left Atrial Appendage Closure (LAAC) Description

Device alternative to oral anticoagulation therapy in patients with non-valvular AF

Designed

to reduce the risk of

thromboembolism

by closing off the left atrial appendage (LAA), which is

believed to be the

source of a

majority of stroke-causing blood clots in people with non-valvular

AF

Over time, patients may be able to stop taking oral anticoagulants

3 Blackshear JL. Odell JA

., Annals of Thoracic Surgery.

1996;61:755-759

SH-230506-AD June15Slide13

Nitinol

Frame

Radially expands to maintain position in LAA

Available sizes:

21, 24, 27, 30, 33 mm (diameter)

10 Active fixation anchors around device perimeter engage LAA tissue for stability and retention

Features an intra-LAA design to avoid contact with Left Atrial wall

160 Micron Membrane

Polyethylene terephthalate (PET) capDesigned to block emboli from exiting the LAA

Anchors

160 Micron Membrane

Designed specifically for the left atrial appendage

WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device Overview

SH-230506-AD June15Slide14

One-time

implant that does not need to be

replaced

Performed

in a cardiac cath lab/EP suite,

does

not need hybrid

ORPerformed by a Heart Team EP/IC or

EP&IC, TEE, General Anesthesia, Surgical Back-up, WATCHMAN Clinical SpecialistTransfemoral Access: Catheter advanced to the LAA via the femoral

vein (Does not require open heart surgery)General anesthesia (typical)1 hour procedure (typical)1-2 day hospital stay (typical)

WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device Procedure

SH-230506-AD June15Slide15

Indications for Use

The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

Are at increased risk for stroke and systemic embolism based on CHADS

2

or CHA

2

DS

2-VASc scores and are recommended for anticoagulation therapy;

Are deemed by their physicians to be suitable for warfarin; andHave an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

WATCHMAN™ Device Patient SelectionSlide16

Specific factors may include one or more of the following:

history of major bleeding while taking anticoagulation therapy

patient’s prior experience with OAC (if applicable):

inability to maintain stable INR

inability to comply with regular INR monitoring and unavailability of an approved alternative OAC

medical condition, occupation, or lifestyle placing patient at high risk of major bleeding secondary to trauma

presence of indication(s) for long-term warfarin use, other than non-valvular atrial fibrillation (e.g. mechanical heart valve,

hypercoagulable states, recurrent deep venous thrombosis)

WATCHMAN™ Device Patient SelectionSlide17

WATCHMAN™ Device Clinical Program

Significantly improved safety results

2

Pilot

Early feasibility with >6 years of follow-up

Enrolled

up to 1500 patients at ~ 60 sites

CAP Registry

CAP2

WATCHMAN primary efficacy, CV death, and all-cause mortality superior to warfarin at 4 years

1

Expected rate of stroke reduced by 77% in

patients contraindicated to warfarin

3

Improved implant

success;

procedure safety confirmed with new and experienced operators

4

PROTECT-AF

ASAP

PREVAIL

1 Reddy, VY et al. HRS 2013.. 2 Reddy, VY et al. Circulation. 2011;123:417-424; 3

Reddy

, et al. JACC. 2013; In

Press

.

4

Holmes, DR Jr et al., CIT 2013

SH-230506-AD June15Slide18

PREVAIL SAFETY ENDPOINTSSlide19

Implant Success & Warfarin Cessation

p =

0.04

Study

45-day

12-month

PROTECT AF

87%>93%CAP

96%>96%

PREVAIL92%

>99%Implant success defined as deployment and release of the device into the left atrial appendage

Warfarin CessationPREVAIL Implant SuccessNo difference between new and experienced operators

Experienced Operators

n=2696%

New Operators

n=24

93%

p =

0.28PROTECT AF and

CAP: Reddy, VY et al. Circulation. 2011;123:417-424.PREVAIL: Holmes, DR et al.

JACC 2014; 64(1):1-12.

SH-230506-AD June15Slide20

Device Embolization 3/542 in Protect AF

0/460 in CAPSlide21

Clinical Trial Device Arm Drug Protocol

Holmes, DR et al.

JACC

2014; 64(1):1-12. WATCHMAN DFU.

*Cessation

of warfarin is at physician discretion provided that any

peri-device flow demonstrated by TEE is ≤ 5mm. Before 6 months, when seal is adequate, patients can cease warfarin and should begin

clopidogrel 75 mg daily and increase aspirin dosage to 300-325 mg daily. This regimen should continue until a total of 6 months have elapsed after implantation*

*

SH-230506-AD June15Slide22

Healing processSlide23

Case 167 y/o man with paroxysmal Afib 1. Hypertension 2. CADCHA2DS2-Vasc score 3

Previously on

Xarelto

but stopped due to

intracerebral

hemorrhage. We discussed the risks and benefits of restarting anticoagulation long-term versus Watchman implantation. Slide24

Case 1Slide25

Case 1Slide26

Case 1Slide27

Case 1Slide28

Case 1Slide29

Case 1Slide30

Case 1Slide31

Device Release CriteriaSlide32

Case 1Slide33

Case 1Slide34

Case 1Slide35

Case 1Slide36

Case 1Total procedure time: 36 minutesDischarged home the following day. Now two weeks post implant without issues thus far.

On Warfarin, last INR 2.7. Slide37

Case 283 y/o man with persistent Afib 1. Hypertension 2. DM 3. CADCHA2DS2-Vasc score 5

Recurrent

hemothorax

on Warfarin and

Eliquis

. We discussed the risks and benefits of restarting anticoagulation long-term versus Watchman implantation. Slide38

Case 2Slide39

Case 2Slide40

Case 2Slide41

Case 2Slide42

Case 2Slide43

Case 2Slide44

Case 2Slide45

Case 2Slide46

Case 2Slide47

Case 2Slide48

Case 2Slide49

Case 2Slide50

Case 2Total procedure time: 80 minutesDischarged home the following day. Now one week post implant without issues thus far.

On Warfarin, last INR 2.2. Slide51

Conclusions:LAA Occlusion is feasible.Outcomes appear favorable.Noninferior to

Warfarin

WATCHMAN is the only FDA-approved device for this purpose. Slide52

Thank you!Questions?

Aaditya Vora, MD

Cardiac electrophysiologist

Baptist heart specialists

Cell: 352-665-0038