WATCHTAVR Trial Status and Update Samir Kapadia MD

WATCH-TAVR Trial: Status and Update Samir Kapadia, MD Professor of Medicine Director, Cardiac Catheterization Laboratory Section head, Interventional Cardiology Cleveland Clinic

Watch-TAVR + WATCHMAN (n = 156) Aortic Stenosis & Atrial Fibrillation TAVR + Medical Rx (n = 156) National PIs: Samir Kapadia & Martin Leon Grant support: Boston Scientific 1 o Outcome: • Death, stroke, bleeding 2 o Outcome: • Individual primaries • Any thromboembolism • Cardiovascular death • Re-hospitalization • Qo. L (KCCQ-12) • Procedural costs

Stroke Risk Persists Beyond TAVR Trial 30 day (%) 1 year (%) 30 days – 1 year (%) PARTNER 1 A 5. 5 8. 3 2. 8 Core. Valve 6. 2 12. 6 6. 2 PARTNER 2 A 5. 5 8. 0 2. 5 PARTNER 2 B 4. 8 7. 8 3. 0 PARTNER S 3 i 2. 7 4. 6 1. 9

Chronic Afib is Common in TAVR Patients 40. 8 33. 9 30. 0 29. 0 16. 4 32. 9 32. 1 26. 6 29. 3 30. 0 32. 8 25. 3

CHA 2 DS 2 VASc is High for the Typical TAVR patient Condition/Risk Factor Points 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% 1. Lip GY et al, Chest. 2010; 137(2): 263 -72 TAVR pts

CHA 2 DS 2 VASc > 3 in PARTNER (96%) CHA 2 DS 2 VAsc – score 1 2 3 4 5 6 7 8 9 ALL 5 (0. 19) 15 (0. 57) 73 (2. 8) 314 (12) 830 (32) 838 (32) 348 (13) 154 (5. 9) 44 (1. 7) 1 -year probability of stroke 20 0 3. 1 4. 8 4. 5 5. 6 4. 2 8. 6 4. 6 Kapadia et al, Circ Intervention, 2016

% Patients New-Onset AF After TAVR is Common

Thrombus Location in Aortic Stenosis Pts is the LAA Blackshear et al, Ann Thorac Surg 1996; 61: 755 -9 Parashar et al, JACC 2016; 68: 770 -1

Major Bleeding – 5 -6% Trial P 1 A Core. Valve P 2 A P 2 B 30 day Major Bleeding 9. 3 13. 6 10. 4 18. 3 1 year Major Bleeding 14. 7 16. 6 15. 2 23. 2

Kapadia, Krishnaswamy, & Tuzcu; JACC INT 2017

Watch-TAVR + WATCHMAN (n = 156) Aortic Stenosis & Atrial Fibrillation TAVR + Medical Rx (n = 156) National PIs: Samir Kapadia & Martin Leon Grant support: Boston Scientific 1 o Outcome: • Death, stroke, bleeding 2 o Outcome: • Individual primaries • Any thromboembolism • Cardiovascular death • Re-hospitalization • Qo. L (KCCQ-12) • Procedural costs

Combined TAVR and LAAO is Safe • 52 patients w TAVR and LAAO (Amplatzer) Attinger-Toller et al, JACC INT 2016; 9: 1487

Case • • • 82 year old patient High risk TAVR, redo, surgery, CRF AF on Coumadin High bleeding and storke risk Randomized to device in WATCH TAVR study

Procedural Steps • • • Conscious sedation Access (RFA – valve and pigtail, RFV - pacemaker) Sentinel TAVR After TAVR don’t remove large access sheath Take PPM out and upsize vein to 16 F TEE probe insertion Transseptal Watchman Remove vein and artery sheaths (Preclose)

Procedural Steps – Access, Sentinel 5 F Vein sheath placed but no need for temp pacing since patient had PPM

TAVR

TEE and Watchman RAO Caudal RAO Cranial

33 mm Watchman

Sheath Removal and Transfer to Floor • • ASA and Coumadin for 6 weeks TEE at 6 weeks Stop Coumadin ASA and Plavix for 6 months (physician discretion)

WATCH TAVR Status • • 312 patients to be randomized 156 patients to be randomized to each arm: TAVR + Medical Therapy vs. TAVR + WATCHMAN Combined To accumulate 191 Primary Events Enrollment started November 2017 Competitive enrollment with approximately 25 sites activated 263 Subjects enrolled

Top Enrolling Sites

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