Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion. Greg Francisco, MD, FACC

Transcription

1 Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion Greg Francisco, MD, FACC

2 DISCLOSURES None to declare

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4 Estimated 33.5million have AF worldwide (6-7million in US)

5 Atrial Fibrillation - 2X increased dementia - 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

6 Atrial Fibrillation - 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

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8 Strokes due to AF are Devastating

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10 Neurology 2011

11 Kaplan Meier curve of 2-year survival, stratified by antithrombotic medication category at ischemic stroke onset. Niamh Hannon et al. Stroke. 2011;42: Copyright American Heart Association, Inc. All rights reserved.

12 CHADS 2 -> CHA 2 DS 2 VASc CHADS2 Risk Score CHA2DS2-VASc Risk Score CHF 1 Hypertension 1 Age > 75 1 Diabetes 1 Stroke or TIA 2 From ESC AF Guidelines CHF or LVEF < 40% 1 Hypertension 1 Age > 75 2 Diabetes 1 Stroke/TIA/ Thromboembolism Vascular Disease 1 Age Female 1 2

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14 Swedish Study Using a Wide stroke definition 140,420 patients CHADS2vasc = %/yr for men %/yr for women Friberg, JACC 2015

15 What about Bleeding Risk?

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18 HAS BLED The higher HAS BLED Score, the higher Stroke Risk, too.

19 Warfarin can be Challenging

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21 Dabigatran 1 Rivaroxaban 2 Apixaban 3 Comparator Warfarin Warfarin Warfarin Total Enrolled Subjects 18,113 14,264 18,201 Trial Design Randomized, controlled, noninferiority (doses of dabigatran were blinded) Randomized, controlled, doubleblind, non-inferiority Randomized, controlled, doubleblind, non-inferiority Median Duration of Follow up 2 years 1.94 years 1.8 years Average CHADS 2 Score 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

22 Relatively High Discontinuation Rates with DOACs Treatment Study Drug Discontinuation Rate Major Bleeding (rate/year) Rivaroxaban 1 24% 3.6% Apixaban 2 25% 2.1% Dabigatran 3 (150 mg) Edoxaban 4 (60 mg / 30 mg) 21% 3.3% 33 % / 34% 2.8% / 1.6% Warfarin % %

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24 Left Atrial Appendage Occlusion: Watchman Lariat Atriclip

25 Watchman

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27 FDA Approves Watchman March 2015 For 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 2016 For 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

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29 PROTECT AF CAP Registry PREVAIL CAP2 Registry Totals Enrollment Enrolled Randomized WATCHMAN: warfarin (2:1) 463 : : : 382 Mean Follow-up (years) N/A Patient-years

30 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%

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33 EWOLUTION: 1 year Real-World Follow-up Boersma et al. Heart Rhythm Journal 2017

34 EWOLUTION: 1 year Real-World Follow-up Boersma et al. Heart Rhythm Journal 2017

35 EWOLUTION: 1 year Real-World Follow-up Boersma et al. Heart Rhythm Journal 2017

36 So who should get a Watchman? 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?

37 Watchman Protocol 1. Watchman performed general anesthesia; 1 hour procedure day hospitalization 3. 6 weeks anticoagulation 4. 6 week TEE if no thrombus on atrial side of device and no leak, then stop anticoagulation /2 months dual antiplatelet therapy (may forego if high bleeding risk) 6. Lifetime baby aspirin if possible 7. TEE at 1 year

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39 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

40 6 week followup TEE

41 Case 2 42 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

42 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

43 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

44 Thank you QUESTIONS?