Frederik Meijer Heart & Vascular Institute

Transcription

1 Frederik Meijer Heart & Vascular Institute David Langholz, M.D. Medical Director, CV Imaging Spectrum Health No conflicts of interest to report PPT Demonstration_CA_

2 Left atrial appendage closure- the concept AF is a growing health care problem within the aging population of the United States. AF is associated with an ongoing risk of thromboembolic stroke and systemic embolism, primarily due to stasis and thrombus formation within the LAA. Anticoagulation is contraindicated in as many as 10% of patients due to major bleeding Major Bleeding Rates in the Randomized Trials of the Novel Anticoagulants Trial Drug Rate (%/y) RE-LY Dabigatran (150 mg BID) 3.11 ROCKET-AF Rivaroxaban 3.6 ARISTOTLE Apixaban 2.13 ENGAGE-AF Edoxaban 2.75 As many as 50% of patient discontinue anticoagulation therapy 3 years after initiation of therapy PPT Demonstration_CA_

3 Proportion of persistent users Patients discharged with drugs and still alive at the end of each time interval. LAA Closure- the background CHADS2, CHA2DS2-VASc, and HAS-BLED scores for ischemic stroke and bleeding risk stratification PPT Demonstration_CA_

4 LAA Closure- the anatomy PPT Demonstration_CA_

5 Other Transcatheter LAA Occlusion Technology AMPLATZER Cardiac Plug (ACP) Lariet Suture Device Left Atrial Appendage Closure with ACP PPT Demonstration_CA_

6 LAA Suture Ligation LARIAT Device Watchman PPT Demonstration_CA_

7 Watchman LAA Occlusive Device The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; Are deemed by their physicians to be suitable for warfarin; and Have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the 13 safety and effectiveness of the device compared to warfarin. 14 PPT Demonstration_CA_

8 Procedural Safety, 7-Day Safety Events 15 Protect AF 4-Year Results 16 PPT Demonstration_CA_

9 Watchman at the Meijer Heart Center ~ 1 hour procedure; home next day First successful implant was in June, /33 successful implantations to date All patients have been able to stop warfarin at 6 week TEE thus far 1 complication: LAA perforation (1 st case, difficult morphology). Patient admitted for 5 days (pericardial drain). Ultimately was able to stop warfarin at 6 weeks. 17 Watchman at the Meijer Heart Center Outpatient evaluation: 2 clinic visits, one with implanting MD and another with a non-interventional MD (per new Medicare rules) Outpatient TEE to assess LAA anatomy: Exclude thrombus LAA os diameter, depth, and morphology (Verify the surgeons haven t beaten us to the punch) Now 2 implant dates per month (6-8 procedures per month) 18 PPT Demonstration_CA_

10 TEE Role in Watchman Guide transseptal puncture Measure LAA to assist in device size selection Monitor for thrombus formation during procedure Guide pigtail/sheath and device positioning in LAA Confirm stable deployment and position Measure compression (device should be compressed 8-20%) Assess for residual flow adjacent to the device ( 5 mm diameter jet is acceptable) 19 Watchman Sizes 8-20% device compression to anchor device LAA depth diameter 20 PPT Demonstration_CA_

11 Left Atrial Appendage Morphology 21 Initial Sizing in 0, 45, 90, PPT Demonstration_CA_

12 Diameter and Length (in all 4 views) 23 Sheath Positioning Posterior I Anterior After transseptal puncture, delivery sheath is positioned in the deepest part of the appendage for successful device deployment (anterior lobe, in this case). 24 PPT Demonstration_CA_

13 Sheath Markers to Determine Adequate Depth 27 mm marker Delivery sheath is advanced over the pigtail catheter positioned in the 25 appendage Biplane View of Deployed Device 26 PPT Demonstration_CA_

14 Color Doppler to verify no leak/flow 27 Deployed Device in 2D 28 PPT Demonstration_CA_

15 Color Doppler (no residual flow) 29 Compression Measurements in All 4 Views mm device is compressed to 23 mm, which is ~ 15% PPT Demonstration_CA_

16 PASS Criteria Prior to device release, PASS criteria must be met: Position device at/near ostium of LAA Anchor fixation anchors engaged, device is stable Size device is compressed 8-20% of original size Seal device spans ostium, all lobes of LAA are covered (jet size 5 mm is acceptable) 31 Fluoroscopy Assessment Visual appearance Satisfactory expansion Correct depth Contrast injection (all lobes covered) Tug test (device anchored and stable) 32 PPT Demonstration_CA_

17 Post implant follow up- 3D View (en face view) 33 3D with Color Doppler 34 PPT Demonstration_CA_

18 Conclusion Atrial fibrillation is a major cause of stroke and systemic embolization LAA appears to be the primary source of thrombus in AF OAC reduce thromboembolic risk, but with ongoing bleeding risk and cost Clinical trial support that closure of the LAA with percutaneous devices is a reasonable alternative to OAC Echocardiography plays a pivotal role in patient selection, device deployment and follow up. 35 Thank You! PPT Demonstration_CA_