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Watchman Device for LAA Occlusion
Tucker Harrison, DO
Interventional Cardiology
Warren Clinic Cardiology of Tulsa
Patients with atrial fibrillation are at high risk for stroke LAA thrombus
Oral Anticoagulants For Stroke Prevention
• Reduce the risk of stroke by 60-70%, but…
• 30-50% of patients never started on therapy due to real or perceived bleeding risk
• The risk of major bleeding episodes averages about 3% each year, including a small risk of intracranial bleeds
• Bleeding risk may be much higher in some groups of patients , especially those with prior bleeding problems
• up to 1/3 of patients end up stopping these medications– they are then unprotected
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1
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RE-LY ROCKET AF ARISTOTLE
NOAC
Warfarin
Maj
or
Ble
ed
ing
Rat
e (
%/y
ear
)
Annual Frequency of Major BleedingIn the Major NOAC Trials
0
10
20
30
40
50
RE-LY ROCKET AF ARISTOTLE
NOAC
Warfarin
Frequency of Discontinuing Anticoagulation in the Major NOAC Trials
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2011Q1
2011Q2
2011Q3
2011Q4
2012Q1
2012Q2
2012Q3
2012Q4
Total on Oral Anticoagulation
Warfarin
NOACs
Anticoagulant Use in Patients with NVAF and CHADS2 ≥ 2
n=25719 n=29194 n=31582 n=36490 n=67102 n=70667 n=70320 n=71396
Trends in Oral Anticoagulation UsePinnacle Registry Data
If we could just get rid of the atrial
appendage maybe we could
protect patients from stroke without
exposing them to the risk of
bleeding.
Watchman Procedure For LAA Occlusion
WATCHMAN™ LAAC ProcedureImplant Video
Watchman Procedure For LAA Occlusion
• One-time implant performed in cardiac cath lab
• Femoral venous access
• General anesthesia with TEE imaging during procedure
• 1 hour procedure
• DC home next day
Appearance After 6 Months
Is it Safe?
Does it Work?
The Studies
• Protect AF – initial trial randomized 2:1 watchman vs. coumadin , 463 implants
• CAP -1: open label nonrandomized, 566 implants
• PREVAIL: second randomized trial, designed to see if new centers could achieve same safety record – 269 implants
• CAP-2: second open label phase, 579 implants
• EWOLUTION – EU registry, 1024 implants
• USA post approval 2015-2016 – 3822 implants
©2012 MFMER | slide-19
Outcomes in the Post-FDA Approval Watchman Experience
N=3822
Post-FDA Approval
Experience
Complications
Pericardial Tamponade 39 (1.02%)
Treated with Pericardiocentesis 24 (0.63%)
Treated Surgically 12 (0.31%)
Resulted in Death 3 (0.078%)
Pericardial Effusion – No Intervention 11 (0.29%)
Procedure-Related Stroke 3 (0.078%)
Device Embolization 9 (0.24%)
Removed Percutaneously 3
Removed Surgically 6
Death
Procedure-Related Mortality 3 (0.078%)
Additional Mortality within 7 days 1 (0.026%)
©2017 MFMER | 3659271-20
Bleeding Outcomes After LA Appendage Closure Compared with Long-term Warfarin
0.0
0.2
0.4
0.6
0.8
1.0
0 6 12 18 24 30 36 42 48 54 60
Even
t-fr
ee p
rob
ab
ilit
y
Time (months)
Control
Device
Freedom of major bleeding over 3
adjunctive pharmacotherapy intervals
72%>6 months
post-procedure
7 d
ays
6 m
on
ths
Meta-Analysis combining PROTECT AF and PREVAIL
Source: Holmes DR, et al. Holmes, DR et al. JACC 2015; In Press. Combined data set of all PROTECT AF and PREVAIL WATCHMAN patients versus chronic warfarin patients
HR p-value
Efficacy 0.79 0.22
All stroke or SE 1.02 0.94
Ischemic stroke or SE 1.95 0.05
Hemorrhagic stroke 0.22 0.004
Ischemic stroke or SE >7 days 1.56 0.21
CV/unexplained death 0.48 0.006
All-cause death 0.73 0.07
Major bleed, all 1.00 0.98
Major bleeding, non procedure-related 0.51 0.002
0.01 0.1 1 10
Favors WATCHMAN → Favors warfarin
Hazard Ratio (95% CI)
©2016 MFMER | 3597970-22
Event RatesAnnual Risks
1Lee et al: J Med Econ 11:281, 2008; 3Ruff et al: Lancet 383(9921):955, 2014; 9Pooled analysis of PROTECT-AF avg of 5 yrs follow-up & PREVAIL at an avg of 3.2 yrs follow-up. Data on file, Boston Scientific. 10Hart et al: Ann Intern Med 146:857, 2007; 11Freeman
et al: Ann Int Med 154(1):1, 2011; 12Connelly et al: NEJM 361:1139, 2009; 13Granger et al: NEJM 365:981, 2011; 14Pisters et al: Chest 138:1093, 2010
Annual risks†LAAC*
(%)
Warfarin
(%)
NOACs
(%)
Ischemic stroke 1.159
0.8610
0.793
TIA‡
0.459
0.3310,11
0.313
Systemic embolism 0.12 0.1112,13
0.103
Hemorrhagic stroke 0.139
0.7914
0.383
Major bleeding 0.889
1.0914
1.373
MI 0.701
1.473
1.433
*LAAC annual risks are post-procedural event rates†Calculated from relative risk to warfarin (LAAC and NOACs) or no therapy (warfarin) ‡TIA estimate derived from previously published data 11
Not All Strokes Are Equal
©2016 MFMER | 3587094-24
Mortality Reduction (vs warfarin)
0.00
0.50
1.00
1.50
2.00
Dabigatran110
Dabigatran150
Rivaroxaban Apixaban WATCHMAN4 yrs
PROTECT AFRE-LY ROCKET-AF ARISTOTLE
P=0.051P=0.13 (NS) P=0.15 (NS) P=0.047
P=0.0379
Results from different clinical trials:1Connolly, S. NEJM 2009; 361:1139-1151 – 2 yrs f-up2Patel, M. NEJM 2011; 365:883-891 – 1.9 yrs f-up, ITT
3Granger, C NEJM 2011; 365:981-992 – 1.8 yrs f-up4Reddy, V. LBCT HRS 2013 – 4 yrs f-up
Red
ucti
on
in
all
-cau
se
mo
rtali
ty (
%)
Watchman Case
• 69 yo female
• PAF
• CHA2DS2VaSc = 3, annual stroke risk 4.3%
• HASBLED = 2, annual bleeding risk 3.1%
• Recent life threatening GIB, deemed high risk for recurrence
Periprocedural Antithrombotic therapy and FU
• Aspirin/warfarin will be continued for 45 days post implant and then we will check a TEE
• If the 45 day TEE looks good then we will stop warfarin and convert to aspirin/plavix until the 6 month mark
• At 6 months post implant we will stop plavix and continue aspirin indefinitely
Who is a Watchman Candidate?
– Paroxysmal or chronic atrial fibrillation
– CHADS2 score ≥ 2 or a CHA2DS2-VASc score ≥ 3
– Able to take short-term warfarin, but deemed a poor candidate to take long-term oral anticoagulation• Frequent significant falls
• Coumadin problems (compliance/labile INR) and can’t afford DOAC
• Prior major GIB
• History of ICH
• Bladder cancer/hematuria
• Cirrhosis/varices
• Need for long term antiplatelet therapy (stents, severe CAD
• Lifestyle – trauma risk
Amplatzer Occluder (Amulet)
QUESTIONS