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LAA Occlusion in Korean Multi-Center Registry

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LAA Occlusion in Korean Multi-Center Registry LAA Occlusion in Korean Multi-Center Registry Jung-Sun Kim, MD, Ph D Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine Severance Cardiovascular Hospital Yonsei University College of Medicine Disclosure Information Jung-Sun Kim, MD, PhD Grants/Research Support: National Research Foundation of Korea, Ministry of Heath & Welfare and Daewoong and CJ Pharmaceutical Co. Support/Consultant: St. Jude Medical, Boston Scientific and Pfizer Speaker’s Bureau: ISU Abxis, Sanofi and AstraZeneca Severance Cardiovascular Hospital Yonsei University College of Medicine LAA Occlusion Korean Multi-Center Registry 5 Hospitals participated in Multi-Center Korean LAA Occlusion Registry . Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul (Jang Y, Pak HN and Kim JS) . Korea University Anam Hospital, Seoul (Lim DS and Yoo CW) . Sejong General Hospital, Seoul (Choi RK and Lee HJ) . Gil Hospital, Gachon University, Incheon (Kang WC) . Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan (Shin ES) Severance Cardiovascular Hospital Yonsei University College of Medicine Purpose of Study Investigate overall incidence of death, stroke, systemic embolization and major bleeding in Korean Population Compare between 2 LAA occlusion devices (ACP and Watchman). Kim JS, Lee HC, et al. Circulation J 2016 Severance Cardiovascular Hospital Yonsei University College of Medicine Available Devices in Korea WATCHMAN® System Amplatzer Cardiac Plug (Boston Scientific) (St Jude Medical) •Nitinol with 160 micron PET •More operator dependent filter) •Unique design – flexibility to •21, 24, 27, 30, 33 mm work in varied anatomy •TEE, Angiography •Small profile - 9F to 13F •12 F delivery sheath •45 days of Coumadin Polyester polyethylene terephthalate (PET) Severance Cardiovascular Hospital Yonsei University College of Medicine Study Flow 99 consecutive patients from 5 centers in Korea Between Oct 2010 and Feb 2015 3 patients not implanted 96 patients was eligible 96 patients - Follow-up for 6 months 93 patients - Follow-up TEE evaluation 3 patients was excluded for FU TEE analysis 1 respiratory arrest, 1 cardiac tamponade and 1 device embolization Severance Cardiovascular Hospital Yonsei University College of Medicine Indication Non-valvular AF (paroxysmal, persistent or permanent) with CHADS2 ≥ 1 or CHADS2VASc score ≥ 2 and high risk of bleeding or contraindication to anti-coagulation. High risk of bleeding or contraindications to warfarin 1) major or recurrent minor bleeding event on anticoagulation 2) high risk of bleeding according to HAS-BLED score ≥3 3) stroke during anti-coagulation Severance Cardiovascular Hospital Yonsei University College of Medicine Recurrent Embolism during Anti-Coagulation 2016.4 2016.3 Renal infarction Embolism at Rt Ulnar A 2015.9 2013.1 2013.2 Cerebellar infarction Embolism at Lt. Pop. A Severance Cardiovascular Hospital Yonsei University College of Medicine LAA Thrombus Heart CT Severance Cardiovascular Hospital Yonsei University College of Medicine Intra-Procedure TEE Lobe and disc was implanted in LAA as gentle as possible. Severance Cardiovascular Hospital Yonsei University College of Medicine LAA occlusion Device separation was performed. Sealing was maintained after separation. Severance Cardiovascular Hospital Yonsei University College of Medicine Coumadin toxicity of 88 Year-old Gentleman Rt. arm pain, PT INR 3.01 11.40 Severance Cardiovascular Hospital Yonsei University College of Medicine Post-Procedure CT The device was well implanted in LAA. Severance Cardiovascular Hospital Yonsei University College of Medicine Baseline Characteristics Gender Type of AF Female Permanent Paroxysmal 58.5 % 26.0 % 22.9 % Male Persistent 51.0 % 61.5 % Device Amplatzer Watchman Cardiac Plug 48.0 % 52.0% Severance Cardiovascular Hospital Yonsei University College of Medicine Stroke Risk Factors 70.8% 75.0% 50.0% 43.8% 40.6% 38.5% 40.6% 34.4% 40.6% 25.0% 15.6% 0.0% Severance Cardiovascular Hospital Yonsei University College of Medicine Stroke Risk Assessment CHA DS -VASc Score 2 2 Mean : 3.9 ± 1.6 20 22 21 20 15 13 10 9 7 5 4 0 0 0 1 2 3 4 5 6 7 8 9 Severance Cardiovascular Hospital Yonsei University College of Medicine Bleeding Risk Assessment HAS-BLED Score Mean : 2.7 ± 1.3 32 30 25 25 20 15 14 15 10 5 3 5 2 0 0 1 2 3 4 5 6 Severance Cardiovascular Hospital Yonsei University College of Medicine Device Size ACP Watchman 50% 40% 34.1% 38.0% 23.9% 25% 22.0% 18.2% 20% 15.9% 14.0% 12.0% 10.0% 6.5% 2.0% 0% 0% 18 22 24 26 28 30 21 24 27 30 33 Mean device size: 26.8±3.2 Mean device size: 27.4±3.5 Severance Cardiovascular Hospital Yonsei University College of Medicine Overall incidence of peridevice leakage ACP Watchman p (%) Post-implantation 0 % 15.2 % 0.004 30.0 Follow-up within 6 months 14.9 % 37.0 % 0.015 ACP Watchman 26.1 25.0 But, no significant leakage (≥ 5 mm) 20.0 was not detected in both device 15.0 12.8 10.0 6.5 5.2 5.0 4.3 4.3 2.1 0.0 0.0 0.0 0.0 0.0 0.0 Minor Moderate Major Minor Moderate Major Immediate post-procedure Follow-up within 6 months Severance Cardiovascular Hospital Yonsei University College of Medicine Procedure-Related Complications Pseudoaneurysm Bleeding Device embolization Cardiac tamponade Pericardial effusion 0 1 2 3 4 5 6 7 PERICARDIAL CARDIAC DEVICE BLEEDING EFFUSION TAMPONADE EMBOLIZATION PSEUDOANEURYSM ACP 3 1 1 1 0 WATCHMAN 4 1 0 0 0 Severance Cardiovascular Hospital Yonsei University College of Medicine Entrapping in Mitral Valve PA Severance Cardiovascular Hospital Yonsei University College of Medicine Capture of Device (distal screw) with Snare PA LAO 90 Severance Cardiovascular Hospital Yonsei University College of Medicine Capture of Distal Screw PA LAO 90 Severance Cardiovascular Hospital Yonsei University College of Medicine Check Sealing RAO 30 CRA 20 RAO 30 CAU 20 Severance Cardiovascular Hospital Yonsei University College of Medicine A B C Angiography D CT (Coronal Plane) E CT (3D Reconstruction) F G H I J K Kim JS, et al. Eur Heart J 2016 Severance Cardiovascular Hospital Yonsei University College of Medicine Device Thrombosis 3/93 cases (3.2 %) 1 ACP and 2 Watchman Hypoechogenic mass on Device Severance Cardiovascular Hospital Yonsei University College of Medicine Major Events 175.1 patient-year follow-up Cardiac death Overall death Major bleeding Stroke/TIA 0 1 2 3 4 5 STROKE/TIA MAJOR BLEEDING OVERALL DEATH CARDIAC DEATH ACP 2 1 2 1 WATCHMAN 2 0 3 0 Severance Cardiovascular Hospital Yonsei University College of Medicine Stroke and Bleeding Reduction (%) 175.1 patient-year follow-up 8.0 Expected Observed 6.0 4.9 53% 4.2 4.0 Reduction 86% Reduction 2.3 2.0 0.8 0.0 Stroke Major bleeding Severance Cardiovascular Hospital Yonsei University College of Medicine Major adverse cardiac events All Cause Death (MACE) 1.0 1.0 0.8 0.8 0.6 0.6 ACP ACP Free Survival Free Free Survival Free - Watchman - 0.4 0.4 Watchman Event Death 0.2 0.2 Log rank: p=0.463 Log rank: p=0.564 12 24 36 12 24 36 Months Months ACP 50 48 45 24 12 7 4 ACP 50 49 44 22 10 5 2 Watchman 46 46 45 37 27 18 10 Watchman 46 44 41 25 26 17 10 MACE was defined as cardiovascular death, ischemic stroke, systemic embolization, and major bleeding. Severance Cardiovascular Hospital Yonsei University College of Medicine Summary of Korean Multi-Center Registry Multicenter 96 patients cohort, LAAO with ACP or Watchman: . An acceptable immediate implant success rate of 96.9 % . Acceptable rate (4.1 %) of periprocedural major adverse events During 175.1 patient-year follow-up . 4 ischemic stroke . 1 cardiac death and 4 non-cardiac death . Anticoagulation cessation rate was 93.6 % Severance Cardiovascular Hospital Yonsei University College of Medicine Conclusion LAA occlusion was feasible in patients with high risk of stroke and bleeding with non-valvular AF in Korean population. LAA occlusion might be an option to reduce the thrombus burden in the left atrium because all patients experienced stroke were fully recovered without any sequelae in current study. This benefit may be offset by complications related to the implantation of the device . Severance Cardiovascular Hospital Yonsei University College of Medicine Thanks for Your Attention . Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul (Jang Y, Pak HN and Kim JS) . Korea University Anam Hospital, Seoul (Lim DS and Yoo CW) . Sejong General Hospital, Seoul (Choi RK and Lee HJ) . Gil Hospital, Gachon University, Incheon (Kang WC) . Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan (Shin ES) Severance Cardiovascular Hospital Yonsei University College of Medicine .
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