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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RE-LY ROCKET AF ARISTOTLE

NOAC

Warfarin

Maj

or

Ble

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Rat

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%/y

ear

)

Annual Frequency of Major BleedingIn the Major NOAC Trials

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RE-LY ROCKET AF ARISTOTLE

NOAC

Warfarin

Frequency of Discontinuing Anticoagulation in the Major NOAC Trials

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30%

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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

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0 6 12 18 24 30 36 42 48 54 60

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ee p

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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)

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0.50

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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

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-cau

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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