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Afib and Stroke Prevention - Left Atrial Appendage Occlusion with Watchman and Lariat Devices - St Vincent's Birmingham
- 2. • Most common cardiac arrhythmia • Affects more than 3 million individuals in the US • Projected to increase to 16 million by 2050 • 5-fold higher risk of stroke • Over 87% of strokes are thromboembolic • >90% of thrombus originates in the Left Atrial Appendage (LAA) • Stroke is the number one cause of long-term disability and the third leading cause of death in patients with AF Atrial Fibrillation www.theafcenter.com
- 3. 3000838-6 0 2 4 6 8 10 12 14 16 1990 1995 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050 Mayo Clinic data (assuming a continued increase in AF incidence) Mayo Clinic data (assuming further increase in AF incidence) ATRIA study data (50% >80 yo) Patients with atrial fibrillation (millions) Year 2.08 2.26 2.44 2.66 2.94 3.33 3.8 4.34 4.78 5.16 5.42 5.61 5.1 5.6 6.1 6.8 7.5 8.4 9.4 10.3 11.1 11.7 12.1 5.1 5.9 6.7 7.7 8.9 10.2 11.7 13.1 14.3 15.2 15.9 www.theafcenter.com
- 4. 0 5 10 15 20 25 30 35 50-59 60-69 70-79 80-89 3000838-7 % Percent of Total Strokes Attributable to Atrial Fibrillation Stroke 22(18), 1991 • 500,000 strokes/year in U.S. • Up to 20% of ischemic strokes occur in patients with atrial fibrillation www.theafcenter.com
- 5. >90% of strokes in AF patients are secondary to LAA emboli www.theafcenter.com
- 9. 3000838-9 Blackshear: Ann Thoracic Surg 61, 1996 Johnson: Eur J Cardiothoracic Surg 17, 2000 Fagan: Echocardiography 17, 2000 • Insufficient contraction of LA and LAA leads to stagnant blood flow • Most likely culprit: embolization of LAA clot • 90% of thrombus found in LAA • TEE-based risk factors • Enlarged LAA • Reduced inflow and outflow velocities • Spontaneous Echo contrast www.theafcenter.com
- 11. Cardiac failure Hypertension Age >75 Diabetes Stroke – 2 points Limitation CHADS2 of 0 or 1 patients may still have a moderate risk for stroke www.theafcenter.com
- 15. *Hypertension is defined as systolic blood pressure > 160 mmHg. INR = international normalized ratio. Atrial Fibrillation HAS-BLED Bleeding Risk Score www.theafcenter.com
- 16. 3000838-10Cooper: Arch Int Med 166, 2006 Lip: Thromb Res 118, 2006 • Warfarin still cornerstone of therapy • Assuming 51 ischemic strokes/1000 pt-yr • Warfarin prevented 28 strokes at expense of 11 fatal bleeds • Aspirin prevented 16 strokes at expense of 6 fatal bleeds • Warfarin • 60-70% risk reduction vs no treatment • 30-40% risk reduction vs aspirin www.theafcenter.com
- 17. • Warfarin is not always well-tolerated • Narrow therapeutic range (INR between 2.0 – 3.0) • Effectiveness is impacted by interactions with some foods and medications • Requires frequent monitoring and dose adjustments • Less than 50% of patients eligible are being treated with warfarin due to tolerance or non-compliance issues • SPORTIF trials • 60% of patients are within a therapeutic INR range • 29% have INR levels below 2.0 • 15% have levels above 3.0 Atrial Fibrillation Challenges in Treating AF www.theafcenter.com
- 18. 0 10 20 30 40 50 60 70 <55 55-64 65-74 75-84 85 3000838-13 % Ann Int Med 131(12), 1999 • 55% of eligible AF patients are on warfarin • Other studies cite warfarin use in AF patients from 17-50% • Elderly patients with increased absolute risk least likely to be taking warfarin • Contraindications 30-40% www.theafcenter.com
- 19. Contraindications for anticoagulants: ◦ Bleeding ◦ Hemorrhagic Stroke ◦ Frequent Falls ◦ Low Platelet Count ◦ Recent Surgery Patient’s choice www.theafcenter.com
- 20. What can we offer patients that cannot take oral anticoagulants? Or do not want to take OACs ◦ Left Atrial Appendage Closure www.theafcenter.com
- 22. SUTURE DELIVERY DEVICE GUIDE CANNULA User controlled, remote suture delivery for precise placement, confirmatio n and closure of targets as large as 40mm wide Soft-tipped, 4.3mm guide cannula for placement and direction of the LARIAT Suture Delivery Device GUIDE WIRE SYSTEM Magnetically tipped guide wires that connect to each other to precisely deliver catheters with minimal management OCCLUSION BALLOON Fluoro and echo visible, 15mm low profile occlusion balloon compatible with 8.5F access catheters SUTURE TIGHTENER Eliminates operator variability in suture tightening and assures consistency in closure outcomes SUTURE CUTTER Remote suture cutter with easy-load threader designed to terminate remnant suture without risk to the knot TM TM TM TM TM TM www.theafcenter.com
- 33. Device subject takes warfarinPreimplant interval Day 0 Control subject takes warfarin Device subject gets implant Device subject has ceased warfarin Ongoing to 5 years Randomize Day 0 Day 45 postimplantDay 2-14 Ongoing to 5 years DeviceControl 3000838-60 www.theafcenter.com
- 34. • Reasons for remaining on warfarin therapy after 45-days: • Observation of flow in the LAA (n = 30) • Physician Order (n = 13) • Other (n = 9) Visit Watchman N/Total (%) 45 day 349/401 (87.0) 6 month 347/375 (92.5) 12 month 261/280 (93.2) 24 month 95/101 (94.1) 87% of implanted subjects were able to cease warfarin at 45 days and the rate further increased at later time points www.theafcenter.com
- 35. • Primary Efficacy Endpoint • All stroke: ischemic or hemorrhagic • deficit with symptoms persisting more than 24 hours or • symptoms less than 24 hours confirmed by CT or MRI • Cardiovascular and unexplained death: includes sudden death, MI, CVA, cardiac arrhythmia and heart failure • Systemic embolization • Primary Safety Endpoint • Device embolization requiring retrieval • Pericardial effusion requiring intervention • Cranial bleeds and gastrointestinal bleeds • Any bleed that requires ≥ 2uPRBC • NB: Primary effectiveness endpoint contains safety events www.theafcenter.com
- 36. • Key Inclusion Criteria • Age 18 years or older • Documented non-valvular AF • Eligible for long-term warfarin therapy, and no other conditions that would require long-term warfarin therapy • Calculated CHADS2 score > 1 • Key Exclusion Criteria • NYHA Class IV Congestive Heart Failure • ASD and/or atrial septal repair or closure device • Planned ablation procedure within 30 days of potential WATCHMAN Device implant • Symptomatic carotid disease • LVEF < 30% • TEE Criteria: Suspected or known intracardiac thrombus (dense spontaneous echo contract) www.theafcenter.com
- 37. Baseline Demographics Characteristic WATCHMAN N= 463 Control N= 244 P-value Age (years) 71.7 8.8 463 (46.0, 95.0) 72.7 9.2 244 (41.0, 95.0) 0.1800 Height (inches) 68.2 ± 4.2 462 (54.0, 82.0) 68.4 ± 4.2 244 (59.0, 78.0) 0.6067 Weight (lbs) 195.3 ± 44.4 463 (85.0, 376.0) 194.6 ± 43.1 244 (105.0, 312.0) 0.8339 Gender Female Male 137/463 (29.6) 326/463 (70.4) 73/244 (29.9) 171/244 (70.1) 0.9276 www.theafcenter.com
- 38. Baseline Risk Factors WATCHMAN N= 463 Control N= 244 P-value CHADS2 Score 1 2 3 4 5 6 158/463 (34.1) 157/463 (33.9) 88/463 (19.0) 37/463 (8.0) 19/463 (4.1) 4/463 (0.9) 66/244 (27.0) 88/244 (36.1) 51/244 (20.9) 24/244 (9.8) 10/244 (4.1) 5/244 (2.0) 0.3662 AF Pattern Paroxysmal Persistent Permanent Unknown 200/463 (43.2) 97/463 (21.0) 160/463 (34.6) 6/463 (1.3) 99/244 (40.6) 50/244 (20.5) 93/244 (38.1) 2/244 (0.8) 0.7623 LVEF % 57.3 ± 9.7 460 (30.0, 82.0) 56.7 ± 10.1 239 (30.0, 86.0) 0.4246 www.theafcenter.com
- 39. 0.8 0.9 1.0 0 365 730 1,095 Event-free probability Days Events Total Rate Events Total Rate Rel. Risk Non- Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) inferiority Superiority 900 pt-yr 20 582.3 3.4 16 318.0 5.0 0.68 0.998 0.837 (2.1, 5.2) (2.8, 7.6) (0.37, 1.41) Device Control Posterior Probabilities Randomization allocation (2 device : 1 control) ITT Cohort: Non-inferiority criteria met 244 147 52 12 463 270 92 22 WATCHMAN Control www.theafcenter.com
- 40. 0.7 0.8 0.9 1.0 0 365 730 1095 Intent-to-Treat All Stroke ITT cohort: Non-inferiority criteria met Event-freeprobability Days244 147 52 12 463 270 92 22 WATCHMAN Control 3000838-101 900 patient-year analysis Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) inferiority 600 14 409.3 3.4 8 223.6 3.6 0.96 0.927 0.488 pt-yr (1.9, 5.5) (1.5, 6.3) (0.43, 2.57) 900 15 582.9 2.6 11 318.1 3.5 0.74 0.998 0.731 pt-yr (1.5, 4.1) (1.7, 5.7) (0.36, 1.76) Device Control Posterior probabilities Randomization allocation (2 device:1 control) www.theafcenter.com
- 41. 0.7 0.8 0.9 1.0 0 365 730 1095 Intent-to-Treat Hemorrhagic Stroke ITT cohort: Superiority criteria met Event-freeprobability Days244 147 53 12 463 275 95 23 WATCHMAN Control 900 patient-year analysis Events Total Rate Events Total Rate RR Non- Superiority Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) inferiority 600 1 416.7 0.2 4 224.7 1.8 0.13 0.998 0.986 pt-yr (0.0, 0.9) (0.5, 3.9) (0.00, 0.80) 900 1 593.6 0.2 6 319.4 1.9 0.09 >0.999 0.998 pt-yr (0.0, 0.6) (0.7, 3.7) (0.00, 0.45) Device Control Posterior probabilities Randomization allocation (2 device:1 control) www.theafcenter.com
- 42. Oral Anticoagulation is still considered first line therapy Currently available technologies are reserved for patients with Contraindications to oral anticoagulants ◦ Lariat Device Watchman device ◦ Great results in patients that were eligible to take warfarin www.theafcenter.com
- 43. • Long-term treatment with OAC is effective, but presents difficulties and risk • Left Atrial Appendage • In PROTECT AF, hemorrhagic stroke risk is significantly lower with the device. • In PROTECT AF, all cause stroke and all cause mortality risk are non-inferior to warfarin 3000838-123 www.theafcenter.com
- 44. Many LAA closure devices are being tested and should be approved soon In the near future, it may be considered first line therapy Present: ◦ Good alternative for patients at higher risk for stroke who cant tolerate OAC www.theafcenter.com