Watchman a Stroke Prevention Technology for Patients with Atrial Fibrillation
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1 Watchman a Stroke Prevention Technology for Patients with Atrial Fibrillation Scripps hospital,la Jolla, CA
2 Atrial fibrillation is a major source of cardiogenic embolic related stroke 500,000 strokes per year (U.S only) AHA estimates that 15 20% of strokes/year are related to AF Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 198
3 Stroke: A Life Threatening and Debilitating Disease Functional impact of AF-related strokes Unknown 2% Transient 11% Moderately Disabling 11% Fatal 31% Non- Disabling 17% Severe Neurological Deficit 28%
4 Atrial fibrillation patients have a much higher incidence of stroke Cardiovascular patients with atrial fibrillation are six times more likely to have stroke than patients without AF Comparison of stroke risk for patients with and without AF Average Stroke risk (% per yr) Relative Study age (yrs) With AF Without AF risk Framingham, U.S.A % 0.74% 5.6x Shibata, Japan Reykjavik, Iceland Whitehall, U.K Average 3.1% 0.53% 5.9x Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 1987
5 . AF Strokes: Occur primarily with sub-therapeutic INR Adequacy of anticoagulation in patients with AF coming to a hospital clinic LOW INR < % Therapeutic INR % HIGH INR > %
6 Warfarin Use in AF Patients by Age 70% 60% 58.1% 60.7% 57.3% 50% 40% 30% 20% 10% 44.3% 35.4% 0% < Only 55% of AF patients with no contraindications to warfarin had evidence of warfarin use in previous 3 months Other studies site warfarin use among AF patients from 17% - 50% Elderly patients with an increased absolute risk of stroke were least likely to be taking warfarin
7 Warfarin Therapy Effective in reducing risk of stroke In controlled settings 50-80% pts were within the desired therapeutic range. Bleeding is a major side effect 2 INR s: increase the risk of ICH 7 10 fold Mortality rate for ICH is 60%
8 Reasons for Warfarin Underutilization Adverse side effect profile Drug & dietary interactions Difficulties in administration Frequent blood tests Narrow therapeutic range Patient quality of life Physician reluctance to prescribe to elderly patients Bleeding complications Risk of injury. Compliance issues
9 Left Atrial Appendage
10 LAA What does it do? May mediate thirst in hypovolemia via stretch receptors Modulates relationship between pressure & volume Improve filling of LV Endocrine organ ANP 40-fold higher in LAA than in the rest of the atrial free wall or ventricle
11 Left Atrial Appendage Remnant of original embryonic LA develops during 3rd week of gestation LAA Orifice diameter mm
12 Left Atrial Appendage Post Mortem LAA Casts LAA body variable size and morphology 0.77 to cm 2 and trabeculated
13 Thrombi Formation in the LAA
14 Left Atrial Appendage Why not make it go away?
15 Left atrial appendage is a major source of thrombi that cause stroke in AF patients 91% of all thrombus in patients with AF is found in the left atrial appendage (LAA) The four largest TEE studies comprising 1,181 patients showed that 98% of thrombi were found in the LAA Location of thrombi in non-rheumatic atrial-fibrillation Total # of thrombi found in Found LAA Found in left atrium Setting LAA and atrium Number % Number % Reference TEE % 1 1.5% Stoddard, JACC 95 TEE Manning, Circulation 94 Autopsy Aberg, Acta. Med. Scan. 69 TEE Tsai, JFMA 90 TEE Klein, Int J. Card. Imag. 93 TEE & operation Manning, Circulation 94 SPAF III 1 & TEE Klein, Circulation 94 TEE Leung, JACC 94 TEE Hart, Stroke 94 Total % %
16 WATCHMAN LAA closure system Procedure consists of percutaneous placement of a filter device just distal to the ostium of the left atrial appendage to keep harmful sized emboli from exiting. For clinical investigational use only
17 WATCHMAN Device 160 µ PET fabric Device available in various sizes: 21, 24, 27, 30 and 33 mm (diameter) Device diameter is measured across face of device Device Length = Device Diameter Barbs Frame: Nitinol (shape memory) Contour shape accommodates most LAA anatomy Barbs engage the LAA tissue Fabric Cap: Polyethyl terephthalate (PET) Fabric Prevents harmful emboli from exiting during the healing process
18 WATCHMAN System Components Transseptal Access Sheath Single or Double Curve styles 14F O.D. (4.7 mm), 12F I.D. 75 cm working length WATCHMAN Delivery System 12F O.D. (compatible with all device sizes) Preloaded device
19 WATCHMAN LAA System Plane of maximum diameter distal to ostium Fixation barbs engage LAA wall
20 WATCHMAN Procedure
21 Basic Procedure Steps Access the left atrium via a transseptal approach Locate the LAA via fluoroscopy, transesophogeal echocardiography (TEE) Determine size, shape of LAA Select appropriate sized device Deliver device in LAA (distal to LAA ostium) Assess device post deployment (confirm: position, size, seal and stability) Release the device
22 WATCHMAN LAA System
23 RAO Long Axis View
24 Positioning the Sheath
25 Sizing / Positioning the Device TEE
26 Deploying the Device TEE
27 Deploying the Device Assessing Stability Releasing the Device
28 WATCHMAN LAA System Internal view of Complete Healing of LA Canine 45 days Autopsy 9 mos
29 WATCHMAN LAA System Status
30 WATCHMAN System Feasibility Study Primary End Point To characterize the rates of ischemic stroke, systemic embolism and major bleeding in patients with non-valvular atrial fibrillation who require treatment for potential thrombus formation and are eligible for warfarin therapy.
31 WATCHMAN System Feasibility Study - Demographics Ṅ=66 Age Gender Baseline CHADs Score Procedure Time Mean = 69.2 years (47 85) Male = 66% Female = 33% Mean = 1.7 (0 5) Mean = 59 min ( min)
32 WATCHMAN Study Status (as of Feb 2006) First human implant (Germany) August 22, 2002 First US implant October 31, implanted patients cumulative implant years 10 patients 3 years post-implant 32 patients 2 years post-implant all patients 1 year post-implant No reported strokes or systemic embolism events
33 WATCHMAN System Feasibility Study Major adverse events: 2 device embolizations early in study Recaptured percutaneously patients doing fine Device has been enhanced, no further issues 1 delivery system issue requiring surgical intervention Delivery system enhanced, no further issues 2 pericardial effusions with tamponade 5 procedural events: 3 pericardial effusions 2 hematomas requiring transfusion
34 WATCHMAN System Feasibility Study No ischemic stroke or systemic embolism One death at 9 months, non-device related ascending aortic dissection, autopsy revealed complete healing of device One death at 20 months, non-study related multi-organ failure following colon surgery 97.1% warfarin cessation at 6 months
35 WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients with Atrial Fibrillation (PROTECT AF)
36 WATCHMAN System PROTECT AF Study Design Multicenter, prospective randomized study, comparing the WATCHMAN device to longterm warfarin therapy, demonstrating the treatment arm is non-inferior to the control arm.
37 WATCHMAN System PROTECT AF Study Primary End Point To characterize the rates of all stroke, systemic embolism, TIA and cardiovascular death in patients with non-valvular atrial fibrillation who require treatment for potential thrombus formation and are eligible for warfarin therapy.
38 PROTECT AF Study Follow up post randomization 45 days, 6, 9 and 12 months Semi- annually thereafter for up to 5 years Up to 30 centers are participating in this study. Over 200 patients have been randomized thus far.
39 PROTECT AF Demographics 422 patients enrolled (237 WATCHMAN, 116 Control) 69 Rollin Gender M (70%) F (30%) Average Age 71.5 (37-89) CHADS Score 2.12 ±1.10 CHF 24% Hypertension 90% Age > 75 39% Diabetes 27% Prior Stroke/TIA 20%
40 Conclusion Percutaneous LAA Closure with the Watchman device is an extremely promising technique. Following successful implantation, the Watchman device appears to be very effective in obliterating flow into the left atrial appendage few weeks post implantation. If these initial promising results are confirmed in the ongoing randomized trial, this technology will undoutebly lead to a paradigm shift in the treatment of patients with atrial fibrillation.
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