Update in Left Atrial Appendage Closure Devices. Faisal Al-Samadi MBBS, FRCPC, FACP, FACC, FSCAI, FHRS

Transcription

1 Update in Left Atrial Appendage Closure Devices Faisal Al-Samadi MBBS, FRCPC, FACP, FACC, FSCAI, FHRS

2 Atrial Fibrillation - Overview Higher stroke risk for older patients and those with prior stroke or TIA AF = most common cardiac arrhythmia, and growing AF increases risk of stroke 15-20% of all strokes are AF-related AF results in greater disability compared to non-af-related stroke 5M 12M < High mortality and stroke recurrence rate ~5 M people with AF in U.S., expected to more than double by x greater risk of stroke with AF 2 1. Go AS. et al, Heart Disease and Stroke Statistics 2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:

3 Atrial Fibrillation Methods of Treatment Endovascular LAA

4 Atrial Fibrillation Drug Treatment Assess stroke risk with CHA 2 DS 2 -VASc score Score 1: Annual stroke risk 1%, oral anticoagulants or aspirin may be considered Score 2: Annual stroke risk 2%-15%, oral anticoagulants are recommended 2014 AHA/ACC/HRS Guideline for the Management of Patients with AF Balance benefit vs. bleeding risk January, CT. et al AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. JACC. 2014; doi: /j.jacc

5 Atrial Fibrillation Drug Treatment Use of OACs in AF Patients peaks at ~50%, use declines with increasing risk Warfarin Bleeding Risk Daily Systematic Regimen High non-adherence rate Complicates surgical procedure Food and drug interaction Regular INR monitoring Noval OAC Bleeding Risk Daily Systematic Regimen High non-adherence rate Complicates surgical procedure Lack of reversal agents High Cost 1. Hsu, J et al. JAMA Cardiol. Published online March 16, doi: /jamacardio

6 Atrial Fibrillation Drug Treatment ~30% of NOAC patients stop taking any drug at 2 years Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost Dec 22;115(1):31-9. doi: /TH

7 Atrial Fibrillation Drug Treatment Bleeding Risk Continues Study RE-LY 1 Treatment Dabigatran (110 mg) Dabigatran (150 mg) Major Bleeding Hemorrhagic Stroke 2.71% 0.12% 3.11% 0.10% Warfarin 3.36% 0.38% ROCKET-AF 2 Rivaroxaban 3.6% 0.5% Warfarin 3.4% 0.7% ARISTOTLE 3 Apixaban 2.13% 0.24% Warfarin 3.09% 0.47%

8 Atrial Fibrillation Treatment Drugs (warfarin) Drugs (dabigatran, rivaroxaban)

9 History of LAA Occlusion The first case worldwide was in Germany on Aug 21, PLAATO DEVICE In Saudi Arabia the first case was in October 2010 Watchman

10 LAA Closure Devices - Epicardial AtriClip : From AtriCure Epitek : From Epitek, Out of Business Lariat : From SentreHEART Risk of epicardial approach Risk of incomplete Occlusion

11 LAA Closure Devices - Endovascular Lambre Device : From Life Tech Watchman : From Boston Scientific Ultrasep : From Cardia Inc. ACP : From St. Jude, ABBOTT WaveCrest : From JnJ

12 Atrial Fibrillation Epicardial Vs Endocardial Left Atrial Appendage Closure Devices Understanding The Transforming U.S. Market By Kamran Zamanian, Ph.D, and Sean Collins, idata Research Inc

13 Endocardial LAA Closure ESC 2016 Indication

14 Most Studied Devices Watchman Device Most Studies Device LAA Closure Device Five studies, >2400 patients, nearly 6000 patient-years of follow-up FDA Approved in 2015 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[2] 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 safety and effectiveness of the device compared to warfarin.

15 LAA Devices - FDA Indication The WATCHMAN device is a First of its Kind proven Alternative to Long-Term Warfarin Therapy, establishing a new category of stroke risk reduction for patients with non valvular Atrial Fibrillation.

16 LAA Devices New Large Post Market Registry WATCHMAN EWOLUTION Registry Registry on WATCHMAN Outcomes in Real-Life Utilization Real world clinical outcomes of Watchman device. Patients : 1025 patients F/U Duration : 21 months Follow up Results : One Year follow up to be presented in ACC or HRS 2017 WATCHMAN WASP Registry WATCHMAN Outcomes in Real-Life Utilization Patients : 200 patients F/U Duration : 24 months Follow up Closing date : Jan., 2018

17 LAA Devices New Randomized Trail WATCHMAN ASAP TOO Assessment of the WATCHMANTM Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) Patients : 888 Randomized patients Control : Single antiplatelet therapy or no therapy Watchman : DAPT 3 months F/U Duration : 5 Years Follow up

18 Case Selection Who to Consider Oral anticoagulation contraindicated Intolerant to OAC Multiple anticoagulants/antiplatelets Elderly patients with risk of bleeding/risk of fall Risk of bleeding Intracranial hemorrhage/gastrointestinal bleeding Other major bleeds (retroperitoneal etc.) Difficulty with INR monitoring Geographical barriers Non-compliance Patients preference Pharmacokinetic interference Drug interaction Dietary interference

19 LAA Closure Saudi Chapter Watchman cases in Saudi Arabia Centers Centers Medical Technology Est. Case Reports FY s:

20 LAA Closure Saudi Chapter Total Cases Y10 Y11 Y12 Y13 Y14 Y15 Y16 Y17 Cases Cases in Province Y 10 - Y11 Y12 Y13-Y16 Y17 Central- Riyadh Eastern Central- Qassim Western- Jeddah Medical Technology Est. Case Reports FY s:

21 Complications Saudi Chapter LAA closure procedures : 313 Success Rate : 98.2% Patients stopped OAC : 304 Patients are waiting days follow-up : 5 Complications Rate : 1.29% - 1 LAA perforation - 1 RA perforation - 1 LUPV dissection - 1 Device Embolism

22 Procedure Overview

23 Thank You