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2/12/2019

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Advances in Electrophysiology

Left Atrial Appendage Closure

Matthew P. Latacha, MD, FACC, FHRS

Medical Director

Cardiac Electrophysiology Laboratory

Nebraska Methodist Hospital

Left Atrial Appendage Closure

• Indications for percutaneous left atrial

appendage (LAA) closure

• Watchman LAA closure procedure and

follow up

Atrial Fibrillation is a Prevalent and Growing

Condition and a Leading Cause of Stroke

AF

~5M people with AF in U.S.,

expected to more than double

by 20501

‘15 ‘20 ‘30 ’40 ‘50

5M

12M increased risk of stroke

for AF patients2

1. Go AS. et al, Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e245.

2. Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528–536 3. Hart RG, Halperin JL. Atrial fibrillation and thromboembolism: a decade of progress in stroke prevention. Ann Intern Med. 1999.

4. Wolf PA et al, Duration of Atrial Fibrillation and the Imminence of Stroke: The Framingham Study, Stroke 1983; 14:664-667

5X

1 in 5 strokes occur in

patients with AF3

47% of AF patients experiencing a

stroke will suffer a second stroke

within 6 months4

2014 ACC/AHA/HRS Treatment Guidelines to

Prevent Thromboembolism in Patients with AF

• Assess stroke risk with CHA2DS2-VASc score

• Score 1: Annual stroke risk 1%,

oral anticoagulants or aspirin may be

considered

• Score ≥2: Annual stroke risk 2%-15%,

oral anticoagulants are recommended

• Balance benefit vs. bleeding risk

2014 AHA/ACC/HRS Guideline for the

Management of Patients with AF

January, CT. et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. JACC. 2014; doi: 10.1016/j.jacc.2014.03.022

CHA2DS2 VASc Score Recommendation

0 No anticoagulant

1 Aspirin (81-325 mg daily) or warfarin (INR 2-3)

≥2 Oral anticoagulants are recommended (warfarin (INR 2-3),

dabigatran, rivaroxaban or apixaban

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Oral Anticoagulation is Standard of Care,

but Not Ideal for All

Warfarin

• Bleeding risk

• Daily regimen

• High non-adherence rates

• Regular INR monitoring

• Food and drug interaction issues

• Complicates surgical procedures

Novel Oral Anticoagulants

• Bleeding risk

• Daily regimen

• High non-adherence rates

• Complicates surgical procedures

• Lack of reversal agents

• High cost

1. Hsu, J et al. JAMA Cardiol. Published online March 16, 2016. doi:10.1001/jamacardio.2015.0374

Use of OACs in AF Patients peaks

at ~50%,

use declines with increasing risk

NOAC/DOAC

Despite NOAC Adoption and Ability to Switch NOACs,

Adherence to Anticoagulation Remains a Challenge

Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost. 2015 Dec 22;115(1):31-9. doi: 10.1160/TH15-04-0350.

~30% of NOAC patients stop taking any drug at 2 years

Introducing the

WATCHMAN™ LAAC Device

A first-of-its-kind, proven alternative to

long-term warfarin therapy for stroke risk

reduction in patients with non-valvular AF

Most studied LAAC therapy, only one

proven with long-term data from

randomized trials and multi-center

registries

A safe alternative to long-term warfarin

therapy which offers comparable stroke

risk reduction and enables patients to

stop taking warfarin

1. Reddy, V et al. JAMA 2014; Vol. 312, No. 19.

2. Reddy, V et al. Watchman I: First Report of the 5-Year PROTECT-AF and Extended PREVAIL Results. TCT 2014.

WATCHMAN™ LAAC Device

• WATCHMAN™ LAAC Device:

• Reduces risk of thromboembolism from

the left atrial appendage in patients with

non-valvular atrial fibrillation

• For patients who:

• Are at increased risk for stroke or

systemic embolism based on CHADS2

or CHA2DS2-VASc scores and are

recommended for anticoagulation

therapy

• Are deemed by their physicians to be

suitable for warfarin

• Have an appropriate rationale to seek a

non-pharmacologic alternative to

warfarin, taking into account the safety

and effectiveness of the device

compared to warfarin

WATCHMAN Therapy 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

CHADS2 or CHA2DS2-VASc scores and are recommended for

anticoagulation therapy;

• Are deemed by their physicians to be suitable for warfarin; and

• Have an appropriate rationale to seek a non-pharmacologic

alternative to warfarin, taking into account the safety and

effectiveness of the device compared to warfarin.

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• One-time implant that does not need to be replaced

• Performed in a cardiac cath lab/EP suite, does not need

hybrid OR

• Performed by a Heart Team • IC/EP or IC&EP, TEE, General Anesthesia, Surgical Back- up, WATCHMAN Clinical

Specialist

• Transfemoral Access: Catheter advanced to the LAA via the

femoral vein

(Does not require open heart surgery)

WATCHMAN™ Left Atrial Appendage

Closure (LAAC) Device Procedure

• General anesthesia*

• 1 hour procedure*

• 1-2 day hospital

stay*

* Typical to patient treatment in U.S. clinical trials

Minimally Invasive, Local Solution • Available sizes: 21, 24, 27, 30, 33 mm diameter

Intra-LAA design • Avoids contact with left atrial wall to help prevent

complications

Nitinol Frame • Conforms to unique anatomy of the LAA to reduce

embolization risk

• 10 active fixation anchors - designed to engage tissue

for stability

Proximal Face • Minimizes surface area facing the left atrium to

reduce post-implant thrombus formation

• 160 micron membrane PET cap designed to block

emboli and promote healing

Warfarin Cessation • 92% after 45 days, >99% after 12 months1

• 95% implant success rate1

Anchors

160 Micron

Membrane

WATCHMAN™ LAAC Closure

Device

1. Holmes, DR et al. JACC 2014; Vol. 64, No. 1

WATCHMAN Implant Procedure Review

1. Procedure Equipment

2. LAA Anatomy/Assessment • Ostium size, LAA type, considerations

3. Transseptal (IAS) Crossing

4. WATCHMAN™ Access Sheath Navigation/Manipulation

5. WATCHMAN™ Device Deployment

6. Device Release Criteria – P.A.S.S.

7. Device Recapture

8. Final Device Release

1. WATCHMAN Procedure Equipment

• WATCHMAN Delivery System (delivery catheter

and pre-loaded LAA closure device)

• Venous Introducer (optional)

• Standard Transseptal Access System

• 0.035” Guidewire (exchange length extra

support)

• 5F or 6F angiographic pigtail catheter

• WATCHMAN® Access System (which includes

the access sheath and dilator)

• TEE

• Heparin – minimum ACT of 200-300sec

throughout procedure

• Add’l equipment necessary for complex

cardiovascular intervention, per hospital

procedure

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Agenda

• WATCHMAN™ Left Atrial Appendage Closure

System Components

• WATCHMAN™ Implant Procedure

• WATCHMAN™ Post-Implant Follow-Up

WATCHMAN™ Pre-Loaded

Delivery System

Preformed access sheath curve shapes

guide position in LAA

WATCHMAN™ Access Sheath 14F outer diameter (4.7mm), 12F inner diameter (4mm)

75 cm working length

WATCHMAN™ Delivery Sheath

WATCHMAN™ Delivery Sheath

Constrained Device

Distal Marker Band Hemostasis

Valve

Core Wire

Deployment Knob

12F outer diameter Compatible with all five device sizes

Agenda


System Components



WATCHMAN Implant Procedure Review

1. Procedure Equipment

2. LAA Anatomy/Assessment • Ostium size, LAA type, considerations





7. Device Recapture


Assess the following through multiple imaging planes (0 - 135 deg sweep): • LAA size /shape, number of lobes in LAA and location of lobes relative to ostium

Record LAA ostium and LAA length measurements (0 - 135 deg sweep):

• Measure the LAA ostium at approximately these angles:

•at 0º

•at 45º

•at 90º measure from top of the MV annulus to a point 2cm from tip of the “limbus”

•at 135º

• Measure the approximate LAA usable length from the ostium line to the apex of the LAA

2. LAA Anatomy / Assessment Ostium size and shape

measure from coronary artery marker to a point 2cm from tip of the “limbus”

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2. LAA Anatomy / Assessment Morphology

Wind Sock:

An anatomy in which one

dominant lobe of sufficient

length is the primary structure

Chicken Wing:

An anatomy whose main feature is a

sharp bend in the dominant lobe of

the LAA at some distance from the

perceived LAA ostium

Broccoli:

An anatomy whose main feature

is an LAA that has limited overall

length with more complex

internal characteristics

Use Color Doppler and echo contrast as necessary

2. LAA Anatomy / Assessment Absence of Thrombus

Maximum LAA

Ostium (mm)

Device Size (mm)

17-19 21

20-22 24

23-25 27

26-28 30

29-31 33

• Maximum LAA ostium and LAA depth measurements determine device size selection

• Maximum LAA ostium size should be >17mm or <31mm to accommodate available device sizes

• Available/useable LAA length should be equal to or greater than the ostium

2. LAA Anatomy / Assessment Proper device sizing


• Suggested crossing location –

posterior and inferior

• Preferred use of bicaval and short

axis views to confirm position in

TEE

• Inferior on short axis, posterior on

bicaval

• Preferred exchange of guidewire to

WATCHMAN™ Access Sheath in

LUPV or left atrium

• Carefully advance 6F pigtail through

Access Sheath into distal portion of

LAA under fluoro guidance

• Carefully advance Access Sheath

over pigtail catheter in multiple

angio and echo views

Bicaval view: Poster

Short axis: Inferior

Marker bands


• Radiopaque marker bands guide initial sheath placement/depth in the LAA

• Align radiopaque marker band corresponding to device size until at or just distal to LAA ostium

• To better visualize complex LAA anatomy and verify access sheath tip position:

• Obtain multiple views with: • Angiography (min. RAO cranial/caudal)

• TEE (min. 0° - 135° sweep)

Access Sheath

Marker Band Loaded Device Length*

21mm 20.2mm

24mm 22.9mm

27mm 26.5mm

30mm 29.4mm

33mm 31.5mm


• Select device based on

maximum LAA ostium width

recorded; LAA depth must be at

least as long as the LAA ostium

width

• Confirm distal tip of constrained

device aligned with distal

marker band of Delivery System

• Maintain fluid to fluid connection

when inserting Delivery Sheath

into Access Sheath

• Switch manifold/contrast to delivery system

Maximum

LAA Ostium

Device Size

(uncompressed

diameter)

Maximum

(20%)

Compression

Measured

Diameter*

Minimum (8%)

Compression

Measured

Diameter*

17-19 mm 21 mm 16.8 mm 19.3 mm

20-22 mm 24 mm 19.2 mm 22.1 mm

23-25 mm 27 mm 21.6 mm 24.8 mm

26-28 mm 30 mm 24.0 mm 27.6 mm

29-31 mm 33 mm 26.4 mm 30.4 mm

*Measure in-situ device diameter at approximate TEE angles of 0, 45, 90 and 135 degrees to accurately assess device compression

Constrained Device

Distal Marker Band

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=

=


On fluoro, align most distal marker band on

Delivery System with most distal marker

band on Access Sheath

Stabilize WATCHMAN Delivery System, retract Access Sheath

and snap together

Disconnecte

d

Delivery/Acc

ess Sheaths

Connected

WATCHMA

N System


• Observe distal end of device to ensure no forward motion (or repositioning relative to ostium) has occurred

• Tactile feel may be decreased, risk of complications may be increased

• Loosen hemostasis valve on Delivery System, hold deployment knob stationary, retract Access Sheath/Delivery System assembly to deploy device

• Unsheath device using slow stable motion for optimal control (at least 3-5 seconds), ensure distal tip remains in desired position


Caution: Investigational device limited to investigational use only under US federal law. Not for sale.

All criteria must be met prior to device release (PASS)

Position – device is at the ostium of the LAA

Anchor – fixation anchors engaged / device is stable

Size – device is compressed 8-20% of original size

Seal – device spans ostium, all lobes of LAA are covered

WATCHMAN™ Device features one-step deployment

Recapturable and Repositionable

6. Device Release Criteria – Position

Device should be at or just distal to the LAA ostium

Device Position: TOO DISTAL Partial Recapture

• Advance tip of Access/Delivery System assembly up to device (do not unsnap)

• Stabilize deployment knob position with right hand and gently advance Access/Delivery System over shoulders of device

• Resistance will be felt as device shoulders collapse

Too Distal - possible uncovered lobes, incomplete seal or residual flow in LAA

• Continue to advance System up to, but not past, fixation anchors

When resistance is felt a second time (anchor contact), stop, tighten hemostasis valve

• Reposition Access/Delivery System assembly proximally and re-deploy by holding deployment knob and retracting Access Sheath until device is completely deployed

Too Proximal - Device protrudes into LA, low compression

or unstable device

Device Position: TOO PROXIMAL Full Recapture

• Advance tip of Access/Delivery System up to face of device (do not unsnap)

• Stabilize deployment knob position with right hand and gently advance System until device is completely collapsed

• Resistance will be felt as device shoulders collapse

• Withdraw device until distal anchors are proximal to marker band then tighten hemostasis valve

• Unsnap and remove Delivery System from Access Sheath while maintaining position within LAA

• Insert pigtail catheter to reposition Access Sheath in LAA

• Repeat implant steps with new Delivery System

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6. Device Release Criteria – Anchor

1. To test stability, gently retract

deployment knob and let go, observe

device returns to original position

2. If the device moves to where position is

no longer acceptable or the

compression is no longer sufficient, the

device should be recaptured

3. Test stability more than once if device

stability is questionable

Hemostasis Valve

Core Wire

Deployment Knob

Tug Test – Pass or Fail

Maximum

LAA Ostium

Device Size

(uncompressed

diameter)

Maximum

(20%)

Compression

Measured

Diameter*

Minimum (8%)

Compression

Measured

Diameter*

17-19 mm 21 mm 16.8 mm 19.3 mm

20-22 mm 24 mm 19.2 mm 22.1 mm

23-25 mm 27 mm 21.6 mm 24.8 mm

26-28 mm 30 mm 24.0 mm 27.6 mm

29-31 mm 33 mm 26.4 mm 30.4 mm

6. Device Release Criteria - Size

Caution: Investigational device limited to investigational use only under US federal law. Not for sale.

*Measure in-situ device diameter at approximate TEE angles of 0,

45, 90 and 135 degrees to accurately assess device compression

20.8

Device Compression Table

6. Device Release Criteria – Seal

Residual flow around the device of ≤ 3mm acceptable

• If residual jet around device noted - re-assess position, size or device

orientation

– If device not yet released, partial recapture and reposition or full recapture and replacement are possible

• If all four P.A.S.S. release criteria are

met, device can be released

• Advance WATCHMAN System to face

of device, rotate deployment knob

counter clockwise 3-5 full turns

• Perform final check of the following post device release: – Device position in all angles

– Device compression and LAA sealing


• Perform check for pericardial effusion

• Consider performing repeat TTE prior to discharging the patient

WATCHMAN™ Device Endothelialization

Canine Model – 30 Day

Canine Model – 45 Day Human Pathology - 9 Months Post-implant

(Non-device related death)

Images on file at Boston Scientific Corporation. Results in animal models may not necessarily be indicative of clinical outcomes.

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Agenda


System Components



Post Procedure Information

• Post-procedure warfarin therapy is

required in ALL patients receiving a

Device

• 81-100mg of aspirin and warfarin for 45

days min. post implant (INR 2.0-3.0)

• At 45 days post-implant, perform device

assessment with TEE to assess the

presence of LAA blood flow through

and/or around the WATCHMAN device

• Cessation of warfarin is at physician

discretion provided that any peri-device

flow demonstrated by TEE is <5mm

Post Procedure Information

• If adequate seal is not demonstrated,

subsequent warfarin cessation decisions are

contingent on demonstrating flow <5mm

• Patients ceasing warfarin should begin

clopidogrel 75mg daily and increase aspirin

dosage to 300-325mg daily for six months post-

implant

• If LAA closure satisfactory, patient should

remain on 300-325mg aspirin daily indefinitely

• If a patient remains on warfarin and aspirin 81-

100mg for at least six months post-implant, and

then ceases warfarin, clopidogrel is not

required, but aspirin should be increased to 300-

325mg daily, taken indefinitely

ABBREVIATED STATEMENT

WATCHMANTM Left Atrial Appendage Closure Device

with Delivery System and WATCHMAN Access System

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 CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;

• Are deemed by their physicians to be suitable for warfarin; and

• Have 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.

CONTRAINDICATIONS

Do not use the WATCHMAN Device if:

• Intracardiac thrombus is visualized by echocardiographic imaging.

• An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.

• The LAA anatomy will not accommodate a device. See Table 46 in the DFU.

• Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.

• There are contraindications to the use of warfarin, aspirin, or clopidogrel.

• The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN Device is contraindicated.

WARNINGS

• Device selection should be based on accurate LAA measurements obtained using fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0º, 45º, 90º, 135º).

• Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria.

• If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE.

• The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period.

• Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion.

• For single use only. Do not reuse, reprocess, or resterilize.

PRECAUTIONS

• The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.

• The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the device.

• Use caution when introducing the WATCHMAN Access System to prevent damage to cardiac structures.

• Use caution when introducing the Delivery System to prevent damage to cardiac structures.

• To prevent damage to the Delivery Catheter or device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.

• If using a power injector, the maximum pressure should not exceed 100 psi.

• In view of the concerns that were raised by the RE-ALIGN1 study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN

Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation.

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:

Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect , AV fistula , Bruising,

hematoma or seroma, Cardiac perforation , Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device

thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection / pneumonia, Interatrial septum thrombus,

Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device / improper seal of the appendage / movement of device from appendage wall, Myocardia erosion, Nausea, Oral bleeding, Pericardial effusion / tamponade, Pleural effusion,

Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency / failure, Surgical removal of the device, Stroke – Ischemic , Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding,

esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions

There may be other potential adverse events that are unforeseen at this time.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and

Operator’s Instructions.

© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.

1Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.

Procedural Success

Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm * The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.

1 Boersma, L. V. A., B. Schmidt, et al. EHJ 2016; 37(31): 2465. 2. Reddy, V. Y., D. N. Gibson, et al. JACC 2016; 69(3): 253-261

~50% new operators ~70% new operators

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Favorable Procedural Safety Profile:

All Device and/or Procedure-related Serious Adverse

Events within 7 Days

9.9%

4.8% 4.1% 4.1% 3.8%

2.8%

0%

2%

4%

6%

8%

10%

12%

PROTECT AF1st Half

PROTECT AF2nd Half

CAP PREVAIL CAP2 EWOLUTION*

Patients With

Safety Event

(%)

N=232 N=231 N=566 N=269 N=579 N=10191

~50% New

Operators in

PREVAIL

* The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.

1 Boersma, L. V. A., B. Schmidt, et al. EHJ 2016; 37(31): 2465. 2. Reddy, V. Y., D. N. Gibson, et al. JACC 2016; 69(3): 253-261


Major Procedural Complications Across

WATCHMAN Studies

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

PROTECT AF (n=463)CAP (n=566)PREVAIL (n=269)CAP2 (n=579) EWOLUTION (n=1021)US Cohort (n=3822)

Co

mp

lic

ati

on

Ra

tes

Pericardial Tamponade

Procedure-Related Stroke

Device Embolization

Procedure-Related Death

Clinical Trial Experience Post Approval Experience


Source: Reddy VY, Holmes DR, et al. JACC 2016; 69(3): 253-261.

PROTECT-

AF PREVAIL CAP CAP2 EWOLUTION

Post-FDA

Approval

Aggregate

Data

Pericardial Tamponade 20 (4.3%) 5 (1.9%) 8 (1.4%) 11 (1.9%) 3 (0.29%) 39 (1.02%) 86 (1.28%)

Treated with

pericardiocentesis 13 (2.8%) 4 (1.5%) 7 (1.2%) n/a 2 (0.20%) 24 (0.63%)

Treated surgically 7 (1.5%) 1 (0.4%) 1 (0.2%) n/a 1 (0.10%) 12 (0.31%)

Resulted in death 0 0 0 0 0 3 (0.78%)

Pericardial effusion – no

intervention 4 (0.9%) 0 5 (0.9%) 3 (0.5%) 4 (0.39%) 11 (0.29%) 27 (0.40%)

Procedure-related

stroke 5 (1.15%) 1 (0.37%) 0 2 (0.35%) 1 (0.10%) 3 (0.078%) 12 (0.18%)

Device embolization 3 (0.6%) 2 (0.7%) 1 (0.2%) 0 2 (0.20%) 9 (0.24%) 17 (0.25%)

Removed

percutaneously 1 0 0 0 1 3

Removed surgically 2 2 1 0 1 6

Death

Procedure-related

mortality 0 0 0 0 1 (0.1%) 3 (0.078%) 4 (0.06%)

Additional mortality

within 7 days 0 0 0 1 (0.17%) 3 (0.29%) 1 (0.026%) 5 (0.07%)


Major Procedural Complications Across WATCHMAN

Studies


Source: Reddy VY, Holmes DR, et al. JACC 2016; 69(3): 253-261.

Patient Level Meta-Analysis

PROTECT AF, PREVAIL 5 Years

HR p-value

Efficacy 0.82 0.3

All stroke or SE 0.96 0.9

Ischemic stroke or SE 1.7 0.08

Hemorrhagic stroke 0.2 0.0022

Ischemic stroke or SE >7 days 1.4 0.3

Disabling/Fatal Stroke (MRS change of ≥2) 0.45 0.03

Non-Disabling Stroke 1.38 0.35

CV/unexplained death 0.59 0.03

All-cause death 0.73 0.04

Major bleed, all 0.91 0.6

Major bleeding, non procedure-related 0.48 0.0003

0.01 0.1 1 10Favors WATCHMAN Favors warfarin

Hazard Ratio (95% CI)

Sourc

e: . R

eddy V

Y, D

oshi S

K, K

ar

S, et al. 5

-Year O

utc

om

es A

fter Left

Atr

ial A

ppendage C

losure

: F

rom

the

PR

EV

AIL

and P

RO

TE

CT

AF

Trials

. JA

CC

2017;

70(2

4):

2964

-2975.

Ischemic

Stroke Risk

(events per

100 pt-yrs)

PREVAIL

PROTECT AF

Untreated AF Treated with Warfarin WATCHMAN Arm

CAP2

CAP

Baseline CHA2DS2-VASc Score

EWOLUTION

WASP

WATCHMAN Comparable to Warfarin

for Ischemic Stroke

1.3

1.2

1.7

2.3

1.1

1.5

0

2

4

6

8

10

1 2 3 4 5

Reddy VY, Doshi SK, Kar S, et al. JACC 2017; 70(24): 2964-2975.

WATCHMAN Significant Reduction in Disabling

Strokes

(Patient-Level Meta-Analysis)

0.00%

0.50%

1.00%

1.50%

2.00%

WATCHMAN warfarin

Disabling/Fatal Strokes Non-Disabling Strokes

Disabling Stroke defined as MRS ≥2 Two strokes in PREVAIL are excluded because the baseline MRS score was unavailable

HR 0.45 (0.21 – 0.94)

P=0.03

55% Lower

Sourc

e: . R

eddy V

Y, D

oshi S

K, K

ar

S, et al. 5

-Year O

utc

om

es A

fter Left

Atr

ial A

ppendage C

losure

: F

rom

th

e P

RE

VA

IL a

nd P

RO

TE

CT

AF

Trials

. JA

CC

2017;

70(2

4):

2964-2

975.

2/12/2019

10

Observed Rates of Major Bleeding Over

Time According to Treatment Group

LAAC

(n=732)

Long-term warfarin

(n=382) Rate

Ratio

P

value Bleeding Rate (n events / N at risk)

Event Rate per

100 pt-yrs (n events / N at risk)

Bleeding Rate (n events/N at risk)

Event Rate per

100 pt-yrs (n events / N at risk)

Overall 10.8

(79/732)

3.5

(79/2268)

11.3

(43/382)

3.6

(43/1187) 0.96 0.84

Post

Procedure

5.9

(40/682)

1.8

(40/2255)

11.3

(43/381)

3.6

(43/1180) 0.49 0.001

Destination 3.2

(19/601)

1.0

(19/1958

9.7

(35/360)

3.5

(35/1004) 0.28 <0.001

Warfarin +

ASA

(81mg)

daily

Clopidogrel (75mg) +

ASA (325 mg) daily ASA (325mg) daily

Implant 45 days* 6 months

Post Procedure Therapy Destination Therapy

*if leak >5mm, patients remained on warfarin + ASA until seal documented, skipping the clopidogrel + ASA pharmacotherapy

Price, M. J., V. Y. Reddy, et al. JACC: CV Interv 2015; 8(15): 1925-1932

Overall period defined as after randomization to the end of follow-up; post-procedural period as >7 days after randomization to the end of follow-up;

destination therapy period as beyond 180 days post-randomization, when patients assigned to LAA closure were eligible to receive aspirin alone.

Bleeding Outcomes after Left Atrial Appendage

Closure Compared with Long-term Warfarin

p < 0.001

Price, M. J., V. Y. Reddy, et al. JACC: CV Interv 2015; 8(15): 1925-1932

72% >6 months

post-procedure

Freedom of Major Bleeding Over 3 Adjunctive

Pharmacotherapy Intervals

WATCHMAN™ Clinical Leadership

• WATCHMAN is a safe alternative to long-term warfarin therapy which offers

comparable stroke risk reduction and enables patients to stop

taking warfarin1,2,3

• 95% implant success rate1,2,3

• 1.5% procedural complication rate4

• >92% warfarin cessation after 45 days, >99% after 1 year1

• WATCHMAN therapy demonstrated comparable stroke risk reduction and

statistically significant reductions in disabling/fatal strokes, major non-

procedure related bleeding and mortality compared to warfarin5,6:

• 55% reduction in disabling/fatal stroke, largely driven by5

• 80% reduction in hemorrhagic stroke5

• 72% reduction in major non-procedure related bleeding6

• 27% reduction in all-cause mortality, largely driven by5

• 41% reduction in CV/unexplained mortality5

1. Holmes, DR et al. JACC 2014; 64(1). 2. Reddy VY, Holmes DR, et al. JACC 2016; 69(3): 253-261. 3. Boersma LVA, et al. Heart Rhythm 2017; 14(9): 1302-1308. 4. Varosy P et al. JACC 2018; 71(11): A320. 5. Reddy VY et al. JACC. 2017; 70(24): 2964-2975. 6. Price, M. J., V. Y. Reddy, et al. JACC: CV Interv

2015; 8(15).

WATCHMAN is the Most Studied LAAC Device

with Long-term Clinical Data

Results

Safety WATCHMAN procedure

is safe

95% implant success;

~1.5% complication rates1

Primary

Efficacy

WATCHMAN comparable

to warfarin 18% reduction in events (p=0.27)2

Stroke WATCHMAN comparable

to warfarin

55% reduction in disabling/fatal stroke (p=0.03)*,

largely driven by

80% reduction in hemorrhagic stroke (p=0.003)2

Mortality WATCHMAN statistically

significant to warfarin

27% reduction in all-cause mortality (p=0.04)2

41% reduction in CV/unexplained mortality

(p=0.03)2

Major

Bleeding

WATCHMAN statistically

significant to warfarin

post-procedure

72% reduction after 6-months (p=0.001)3

Warfarin

Cessation

WATCHMAN allows the

majority of patients to

discontinue warfarin

92% of patients discontinue after 45-days;

99% of patients discontinue after 1 year4

1. Varosy P et al. JACC 2018; 71(11): A320. 2. Reddy VY et al. JACC. 2017; 70(24): 2964-2975; 3. Price, M. J., V. Y. Reddy, et al. JACC: CV Interv 2015; 8(15): 1925-1932; 4. Holmes, DR et al. JACC 2014; 64(1): 1-12; 6.

Potential WATCHMAN Patient

Populations

Contraindicated

(5%)2

Intolerant

(35%)3

Tolerant

(60%)

Total AFIB Population – 100% ~ 5,000,000

Non-Valvular AFIB Population – 95%1 ~ 4,750,000

High Risk for Stroke (CHADS2 ≥ 2, CHA2DS2-

VASC ≥ 3) – 75%2

Cannot take

any OAT

Meaningful reason

to not be on OAT

No issues with

OAT therapy

200,000 2,100,000 1,300,00

0 1. the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study JAMA. 2001;285(18):2370-2375. doi:10.1001/jama.285.18.2370 2. Oral Anticoagulant Therapy Prescription in Patients With Atrial

Fibrillation Across the Spectrum of Stroke Risk JAMA Cardiol. Published online March 16,2016.doi:10.1001/jamacardio.2015.0374 3. PINNACLE Q4 2015 national summary report, Data on File

Implant Analytics

• 1st Successful Implant 4-9-18

*Average Procedure Case Time 47 m

• 38 attempted implants

• 34 successful implants

* Total Patients Off OAC: 34

2/12/2019

11

Methodist Hospital Watchman Team WWW.WATCHMAN.COM PHYSICIAN

FINDER

WATCHMAN FLX™ : Designed to Broaden

Treatment Matrix and Improve Ease of Use

• Designed for greatly enhanced stability and ease-of-use • Designed for greater apposition to appendage wall

− New anchor design, additional anchors and reduced main body taper

• Anticipate starting EU and U.S. clinical trials mid-year 2018

Caution: WATCHMAN FLX is an Investigational Device. Limited by Federal (or US) law to investigational use only.

Not available for sale.

Questions?

http://www.watchman.com/

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