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
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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