Primary Care Atrial Fibrillation Update:Anticoagulation and Left Atrial Appendage OcclusionGreg Francisco, MD, FACC

DISCLOSURES

• None to declare

Estimated

33.5million have

AF worldwide

(6-7million in US)

Atrial Fibrillation

- Most common arrhythmia (incidence 1% of

all US adults)

- 2% of Medicare beneficiaries <65 have AF

- 12% in 75-85year olds

- 5X increased risk of stroke

- 3X increased risk of Heart Failure

- 2X increased dementia

- 1/3 of all ischemic strokes are due to AF

- Embolic strokes are devastating – up to 50%

mortality, and of survivors, up to 50% disability

- Highest risk in those with prior stroke and >75

years old

Atrial Fibrillation

Strokes due to

AF are

Devastating

Neurology

2011

Kaplan–Meier curve of 2-year survival, stratified by antithrombotic medication category at ischemic stroke onset.

Niamh Hannon et al. Stroke. 2011;42:2503-2508

Copyright © American Heart Association, Inc. All rights reserved.

CHADS2 -> CHA2DS2VASc

CHA2DS2-VASc Risk Score

CHF or LVEF < 40% 1

Hypertension 1

Age > 75 2

Diabetes 1

Stroke/TIA/

Thromboembolism

2

Vascular Disease 1

Age 65 - 74 1

Female 1

CHADS2 Risk Score

CHF 1

Hypertension 1

Age > 75 1

Diabetes 1

Stroke or TIA 2

From ESC AF Guidelines

http://www.escardio.org/guidelines-surveys/esc-

guidelines/GuidelinesDocuments/guidelines-afib-FT.pdf

Swedish Study Using

a Wide stroke

definition

140,420 patients

CHADS2vasc = 1

0.5-0.7%/yr for men

0.1-0.2%/yr for

women

Friberg, JACC 2015

What about Bleeding Risk?

HAS

BLED

The higher HAS BLED Score, the higher

Stroke Risk, too.

Warfarin can be Challenging

Dabigatran1 Rivaroxaban2 Apixaban3

Comparator Warfarin Warfarin Warfarin

Total Enrolled Subjects 18,113 14,264 18,201

Trial Design

Randomized,

controlled, non-

inferiority

(doses of

dabigatran were

blinded)

Randomized,

controlled, double-

blind, non-inferiority

Randomized,

controlled, double-

blind, non-inferiority

Median Duration of Follow

up2 years 1.94 years 1.8 years

Average CHADS2 Score 2.1 3.5 2.1

Results (primary outcome

= stroke or systemic

embolism)

Reduction in

primary outcome

compared to

warfarin

Reduction in primary

outcome compared to

warfarin

Reduction in

primary outcome

compared to

warfarin

Treatment

Study Drug

Discontinuation Rate

Major Bleeding

(rate/year)

Rivaroxaban1 24% 3.6%

Apixaban2 25% 2.1%

Dabigatran3

(150 mg)21% 3.3%

Edoxaban4

(60 mg / 30 mg)33 % / 34% 2.8% / 1.6%

Warfarin1-4 17 – 28% 3.1 – 3.6%

Relatively High Discontinuation Rates

with DOACs

Left Atrial Appendage Occlusion:

Watchman Lariat

Atriclip

Watchman

FDA Approves Watchman March 2015For patients who are:

• At risk for stroke

• Deemed by be suitable for warfarin

• Have appropriate rationale to seek a nonpharmacological alternative

to warfarin

CMS Covers Watchman 8 February 2016For Patients with:

• CHADS2vasc >/= 3

• Formal shared decision with independent non-interventional

physician (internist, cardiologist, neurologist) – must be documented

in record

• Suitable for short term warfarin but deemed unable to take long term

OAC

• Experienced Interventional, EP, or CT surgery perfom

• Must be enrolled in prospective, national, audited registry

PROTECT

AF

CAP

Registry

PREVAIL CAP2

Registry Totals

Enrollment 2005-2008 2008-2010 2010-2012 2012-2014

Enrolled 800 566 461 579 2406

Randomized 707 --- 407 --- 1114

WATCHMAN:

warfarin (2:1)463 : 244 566 269 :138 579

1877:

382

Mean Follow-up

(years)4.0 3.7 2.2 0.58 N/A

Patient-years 2717 2022 860 332 5931

Warfarin Cessation

Study 45-day 12-month

PROTECT AF 87% >93%

CAP 96% >96%

PREVAIL 92% >99%

PREVAIL Implant

Success

No difference between new

and experienced operators

Experienced Operators

• n=26

• 96%

New Operators

• n=24

• 93%

Boersma et al. Heart Rhythm Journal 2017

EWOLUTION: 1 year Real-World Follow-up

EWOLUTION: 1 year Real-World Follow-up

Boersma et al. Heart Rhythm Journal 2017

EWOLUTION: 1 year Real-World Follow-up

Boersma et al. Heart Rhythm Journal 2017

Cannot take

antiocoagulation

Should not take

anticoagulation

Will not take

anticoagulation

Recurrent GI Bleeders Dialysis patients Patients living in remote

locale

History of Intracranial

Bleeding

Stents requiring longterm

DAPT

Active lifestyle?

Frequent falls? High HASBLED score? Patient choice?

So who should get a Watchman?

Watchman Protocol

1. Watchman performed – general anesthesia; 1 hour procedure

2. 1-2 day hospitalization

3. 6 weeks anticoagulation

4. 6 week TEE – if no thrombus on atrial side of device and no

leak, then stop anticoagulation

5. 4 1/2 months dual antiplatelet therapy (may forego if high

bleeding risk)

6. Lifetime baby aspirin if possible

7. TEE at 1 year

CASE STUDY:-EV is an 88 year old woman who suffered a

stroke and was found to have paroxysmal AF

-apixiban was started

-Subdural hematoma after a fall 6 months

later.

Apixiban stopped

-Neurosurgeon states that anticoagulation is

safe for the short-term, but not preferable for

longterm therapy

-Watchman was recommended

6 week followup TEE

Case 242 year old Active Duty Navy sailor presented

with 24 hours of palpitations. Atrial fibrillation

identified

CHADS2VASC = 0

He underwent chemical cardioversion with

flecainide.

No anticoagulation given

10 days later he presented with a cold left hand

Angiogram showing radial and ulnar artery occlusion

Patient started on Xarelto

Thorough hypercoagulable workup negative

2 years later, on anticoagulation, he awoke with severe flank pain –

he was found to have infarcted his right kidney

Watchman recommended for breakthrough embolism on

therapy and questions of compliance

Thank you

QUESTIONS?