Anticoagulation for TAVR Patients E Murat Tuzcu MD

Disclosure: No conflict of interest E Murat Tuzcu, MD Cleveland Clinic

Anticoagulation for TAVR Patients • Procedural anticoagulation • Post-TAVR antithrombotic therapy • Treatment of

$Procedural Anticoagulation • Unfractionated heparin • ACT 250 -300 or >300 • Reversal by$

Pros and Cons of UFH during TAVR Cleveland Clinic Sergie et al. J Thrombolysis

et al. Major bleeding (48 hrs. ) Cleveland Clinic Death, MI, stroke and major

Post-TAVR Antithrombotic Rx Cleveland Clinic

WRITTEN – Global TAVR Survey Antithrombotic Rx – No AC Indication Survey completed by

138 pts w/o prior hx of AF had TAVR w/ balloon expendable valve Episodes

CHA 2 DS 2 VASc : For Typical TAVR patient Points TAVR pt C

WRITTEN – Global TAVR Survey Antithrombotic Rx – Other AC Indication Survey completed by

Anticoagulation for AF in TAVR Patients Warfarin vs. VKA+ 1 Antiplatelet CV Death, MI,

• 51 patients with leaflet thickening - 29 Rx with VKA - 21

Effect of Anticoagulation Regimen on Leaflet Restriction Score Leaflet restriction (score) 9 AC-group 8

Relapse of Leaflet Thickness after Discontinuation of Anticoagulation Thrombus Extend (Score) Maximum Thickness (mm)

HAS-BLED: For Typical TAVR patient HAS-BLED Score Condition Bleeding Risk Points TAVR 1 85

TAVR and LAA Occlusion Cleveland Clinic Bogunovic et al, Euro. Intervention 2012; 7: 1361

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Anticoagulation for TAVR Patients E Murat Tuzcu, MD Chief Academic Officer Chief, Department of CV Medicine Cleveland Clinic Abu Dhabi Cleveland Clinic

Disclosure: No conflict of interest E Murat Tuzcu, MD Cleveland Clinic

Anticoagulation for TAVR Patients • Procedural anticoagulation • Post-TAVR antithrombotic therapy • Treatment of AF after TAVR • Prevention of valve thrombosis Cleveland Clinic

$Procedural Anticoagulation • Unfractionated heparin • ACT 250 -300 or >300 • Reversal by$

Procedural Anticoagulation • Unfractionated heparin • ACT 250 -300 or >300 • Reversal by Protamine Cleveland Clinic

Pros and Cons of UFH during TAVR Cleveland Clinic Sergie et al. J Thrombolysis 2013; 35: 483 -493

et al. Major bleeding (48 hrs. ) Cleveland Clinic Death, MI, stroke and major bleeding (30 days) Dangas et al. J Am Coll Cardiol 2015; 66: 2860 -2868

Post-TAVR Antithrombotic Rx Cleveland Clinic

WRITTEN – Global TAVR Survey Antithrombotic Rx – No AC Indication Survey completed by 250 centers in 38 countries Cumulative experience of ≈ 70, 000 TAVR procedures 6. 7 Aspirin alone, lifelong 14. 2 DAPT, 1 month 41. 0 DAPT, 3 months DAPT, 6 months 32. 6 DAPT, 12 months 5. 0 DAPT, lifelong 1. 3 0 Cleveland Clinic 10 20 30 40 50 % Cerratot et al. Int J Cardiol; 2017; 228: 640 -647

138 pts w/o prior hx of AF had TAVR w/ balloon expendable valve Episodes of AF >30 sec. while patients are in hospital New onset AF in 44 (32%) pts. 48 hrs. (median) after TAVR Cleveland Clinic

CHA 2 DS 2 VASc : For Typical TAVR patient Points TAVR pt C Congestive heart failure 1 100 % H Hypertension 1 85 -90% A Age ≥ 75 years 2 80 -90% D Diabetes mellitus 1 30 -40% S 2 Previous stroke or TIA 2 10 -15% V Vascular disease 1 30 -50% A Age 65 -74 years 1 95 -100% Sc Sex (female gender) 1 50 -60% Annual Risk of Stroke Condition/Risk Factor CHA 2 DS 2 -VASc Score Treatment 0 No treatment 1 Aspirin or warfarin or dabigatran ≥ 2 Warfarin or dabigatran European Society of Cardiology Guidelines 2 Cleveland Clinic CHA 2 DS 2 VASc Score 1. Lip GY et al, Chest. 2010; 137(2): 263 -72 2. Camm AJ et al, Eur Heart J. 2010; 31: 2369– 2429

WRITTEN – Global TAVR Survey Antithrombotic Rx – Other AC Indication Survey completed by 250 centers in 38 countries Cumulative experience of ≈ 70, 000 TAVR procedures 28. 4 VKA alone 37. 3 VKA + Aspirin 26. 3 VKA + Clopidogrel VKA + Aspirin + Clopidogrel 4. 2 Other 3. 8 0 Cleveland Clinic 5 10 15 20 25 30 35 40 % Cerratot et al. Int J Cardiol; 2017; 228: 640 -647

Anticoagulation for AF in TAVR Patients Warfarin vs. VKA+ 1 Antiplatelet CV Death, MI, stroke Cleveland Clinic Major or life threatening bleeding (VARC-2) Altisent et al. J Am Coll Cardiol 2016; 9: 1706 -17

Cleveland Clinic

• 51 patients with leaflet thickening - 29 Rx with VKA - 21 Rx with DAP 1. CTA post TAVI 1. FU-CTA with AC 2. FU-CTA after AC • F/U CT 22 & 16 pts. • 11/16 DAP progressed • 22/22 VKA regressed Cleveland Clinic Ruile et al. Clin Res Cardiol 2017; 106: 85 -95

Effect of Anticoagulation Regimen on Leaflet Restriction Score Leaflet restriction (score) 9 AC-group 8 P=0. 002 7 9 DAPT-group P=0. 013 8 P=0. 013 7 6 6 5 5 4 4 3 3 2 2 1 1 0 0 1 CTA 1 2 CTA 2 AC-group vs. DAPT-group P<0. 001 Cleveland Clinic Ruile et al. Clin Res Cardiol 2017; 106: 85 -95

Relapse of Leaflet Thickness after Discontinuation of Anticoagulation Thrombus Extend (Score) Maximum Thickness (mm) Leaflet Restriction (Score) 9 9 9 8 8 8 7 7 7 6 6 6 5 5 5 4 4 4 3 3 3 2 2 2 1 1 1 0 0 0 1 CTA 3 2 CTA 2 Cleveland Clinic 3 1 CTA 1 2 CTA 2 3 CTA 3 1 CTA 3 2 CTA 2 3

HAS-BLED: For Typical TAVR patient HAS-BLED Score Condition Bleeding Risk Points TAVR 1 85 -90% 1 or 2 10% H Hypertension A Abnormal liver and renal function S Stroke 1 10 -20% B Bleeding 1 30% L Labile INR 1 ? E Elderly (age >65) 1 >95% D Drugs or alcohol 1 or 2 ? ? Score Bleeds Per 100 Patient Years 0 1. 13 1 1. 02 2 1. 88 3 3. 74 4 8. 7 Hypertension, stroke and age are also variables in the CHADS scores Camm et al, European Heart Journal doi: 10. 1093/eurheartj/ehq 278 Pisters R, et al Chest 2010; 138: 1093 -100 Cleveland Clinic

Anticoagulation for TAVR Patients • ARTE (ASA vs. ASA+Clopidogrel) • AVATAR (ASA vs. ASA+Clopidogrel) • POPular-TAVI (ASA or OAC w/ or w/o vs. Clopid. ) • AUREA (ASA+Clopidrogel vs. VKA) • ENVISAGE TAVI (Edoxaban vs. standard Rx. ) • GALILEO (Rivaroxaban vs. ASA+Clopidogrel) • ATLANTIS (Apixoban vs. SAPT/DAPT or VKA) Cleveland Clinic

TAVR and LAA Occlusion Cleveland Clinic Bogunovic et al, Euro. Intervention 2012; 7: 1361 -1363