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