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Transcript of Left Atrial Appendage Closure - Learning Stream › files › DA1537B2-387C-452A-890E-A2… · The...
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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
• WATCHMAN™ Left Atrial Appendage Closure
System Components
• WATCHMAN™ Implant Procedure
• WATCHMAN™ Post-Implant Follow-Up
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
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
3. Transseptal (IAS) Crossing
• 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
4. WATCHMAN™ Access Sheath Navigation/Manipulation
• 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
5. WATCHMAN™ Device Deployment
• 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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=
=
5. WATCHMAN™ Device Deployment
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
5. WATCHMAN™ Device Deployment
• 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
6. Device Release Criteria – P.A.S.S.
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
8. Final Device Release
• 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
• WATCHMAN™ Left Atrial Appendage Closure
System Components
• WATCHMAN™ Implant Procedure
• WATCHMAN™ Post-Implant Follow-Up
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
Favorable Procedural Safety Profile:
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
* The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.
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%)
Favorable Procedural Safety Profile:
Major Procedural Complications Across WATCHMAN
Studies
* The EWOLUTION Registry is a European prospective registry which reflects CE Mark indications for use which differ from the FDA indications for use.
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?