The efficacy of primary prevention with ICD in
patients with ischemic heart disease in Korea
Sungkyunkwan University School of Medicine, Samsung Medical Center,
Seung-Jung Park
KHRS 06/22, 2019
ICM, NICMw/o Hx of SCD/VTA
PrimaryPrevention
Particularly in Korean patients with ICM
“Korean patients are generally resistant to VT/SCA because they have a relatively
smaller heart size”
Myth or Truth ?
ICD for Primary Prevention
MADIT II Prior MI, LVEF ≤ 30%NSVT or EPS: not requiredn=1232
ICD
Medical
DEFINITENICM, LVEF ≤ 35%VPC’s (≥ 10 /hr) or NSVTn=458
Ove
rall
Death
ICD
Medical
ICD
Medical
Arrhyt
hm
ic S
CD
Overall death HR = 0.69, P=0.016 Overall death, HR = 0.65, P=0.08Arrhythmic death HR = 0.20, P=0.006
N Engl J Med 2002;346:877-83 N Engl J Med 2004;350:2151-8
ICD/CRTD per million per year
John Camm, and Seah Nisam, Europace 2011;13:448
USA
EUICM
NICM
Current Status of ICD therapy in Korea ?
Cardiac device implantation in KorHF registry
Park et al. Am Heart J. 2013;165(1):57-64.
No 1st AVB
nQRS
1st AVB
nQRSno 1st AVB
wQRS
1st AVB
wQRS
June 2004 ~ April 2009
Current Status of Cardiac Device Implantation in Asia-Pacific Regions
The APHRS White Book 2013
(www.aphrs.asia)
Philipnes
Singapore
Thailand
KoreaTaiwan
IndiaChina
Japan
0
10000
20000
30000
40000
50000
60000
2010 2011 2012 2010 2011 2012 2010 2011 2012
Annual ICD implantation in Korea
0
200
400
600
800
1000
1200
2010 2011 2012 2013 2014 2015 2016
Total ICDs Primary Prevention Secondary Prevention
Annual ICD/CRT-D implantation in Korea
0
200
400
600
800
1000
1200
1400
1600
2010 2011 2012 2013 2014 2015 2016
ICD CRT-D ICD + CRT-D
Primary Prevention in Korea
0
10
20
30
40
50
60
70
2010 2011 2012 2013 2014 2015 2016
Primary / Total ICD Primary+CRT-D / ICD+CRT-D
(%)
Efficacy of ICD therapy in Korea ?
Korean Circ J 2012;42:173-183
January 2003 to December 2006
Overall Survival and SCD
Overall Survival SCD
40 months follow-up
Korea vs. Western in ICM
Overall Survival SCD
Overall Survival SCD
Korea vs. Western in NICM
ICMP, independent predictor of all-cause mortality {HR 2.91 (1.52-5.59), p=0.001}.
• Group 1: HF + ICD (primary, n=118)
• Group 2: HF + ICD (secondary, n=93)
• Group 3: non-HF + ICD (primary &
secondary, n=194)
ICD therapy
non-HF+ICD(1’+2’)HF+ICD(1’) HF+ICD(2’)
non-HF+ICD(1’+2’)
HF+ICD(1’)
HF+ICD(2’)
Overall Survival
non-HF+ICD(1’+2’)
HF+ICD(1’)
HF+ICD(2’)
Appropriate ICD therapy
Korean Circ J 2017;47(1):72-81
LV EF<30% or
LV EF 30-35% with sustained VT and/or VF on EPS
Overall Survival
Rate of appropriate ICD therapy
Primary outcome: Composite of cardiac death, appropriate shock, or antitachycardia pacing
CIED Retrospective Cohort 구축
1) 연구 대상자
2012년 1월부터 2016년 12월까지
① ICD를 삽입한 심부전 환자
② CRT-D 혹은 CRT-P를 삽입한 심부전 환자
2) Event
① 전체 사망 – ICD/CRT 삽입 환자 전체
② 재입원 및 재입원 원인 – ICD/CRT 삽입 환자 전체
③ ICD 의 적절한 shock 이 들어간 경우 – ICD 혹은 CRT-D 삽입 환자
④ Echocardiography 및 biomarker– CRT 삽입 환자
CIED Retrospective Cohort
• 15개 기관
CIED Cohort
• 15개 기관 / Total N= 828
• CRT = 350
• ICD = 478
– follow up duration : 939.47 (572.68)
CIED final outcome
ICD(N=478)
CRT(N=350)
CRT-D(N=323) CRT-P(N=18)
Death 62(13%) 57(17.1%) 3(16.6%)
Cardiovascular Death 36(7.5%) 31(9.3%) 1(5.5%)
Hospitalization 198(41.4%) 148(44.5%) 6(3.3%)
Appropriate shock 88(8.4%) 23(6.9%) 0(0%)
Inappropriate shock 22(4.6%) 8(2.4%) 0(0%)
Efficacy of ICD+CRT-D for Primary prevention in Korea
Primary Endpoint: All-cause death: ICD+CRT-D (33, 15.2%) / non ICD (102, 47.2%)
ICD + CRT-D cohort (n= 216) Non ICD cohort (n=216)
Propensity Score Matching/IPTW
NECA ICD + CRT-D cohort(n=568)
KorAHF cohort
(n=1406)
KorAHF cohort – inclusion1. LVEF <=35 % at admission and discharge2. FU echocardiography 상 <=35% 3. FU ICD/CRT 시행하지 않은 환자
NECA ICD – inclusion1. LVEF <=35 % at procedure
ICM 50%
Survivals of ICD+CRT-D versus KorAHF wo CIED
ICD+CRT-D
KorAHF
KorAHF wo CIED (n=216)CIED with ICD+CRT-D (n=216)
p<0.001
Efficacy of ICD only for primary prevention in Korea
Primary Endpoint: All-cause death: ICD (28, 15.1%) / non ICD (91, 49.2%)
ICD cohort (n= 185) Non ICD cohort (n=185)
Propensity Score Matching/IPTW
NECA ICD cohort(n=258)
KorAHF cohort
(n=1406)
KorAHF cohort – inclusion1. LVEF <=35 % at admission and discharge2. FU echocardiography 상 <=35% 3. FU ICD/CRT 시행하지 않은 환자
NECA ICD – inclusion1. LVEF <=35 % at procedure
ICM 50%
Survivals of ICD versus KorAHF
KorAHF wo ICD (n=185)CIED with ICD (n=185)
KorAHF wo ICD
CIED with ICD
p<0.001
Korean noninvasive Risk Evaluation study for sudden cardiac DEathFrom INfarction or heart failurE.
(K-REDEFINE study)
충북대학교 병원
인제대학교 부산백병원
성균관대학교 삼성서울병원연세대학교 강남세브란스병원
원광대학교 병원
중앙대학교 병원충남대학교 병원
고려대학교 안산병원
부천 세종병원울산대학교 서울아산병원한림대학교 강남성심병원
인천성모병원가천대학교 길병원
계명대학교 동산병원
전남대학교 병원
인제대학교 일산백병원
영남대학교 병원
강원대학교 병원연세대학교 원주세브란스기독병원연세대학교 세브란스병원
대구가톨릭대학교 병원
조선대학교 병원
고신대학교 복음병원
고려대학교 안암병원
제주대학교 병원
아주대학교 병원
인하대학교 병원
27 Participating Tertiary Center
Patient Subgroups
K-REDEFINE
Registry
Heart FailureMyocardial
Infarction
N=1000 N=1000Target numberof enrollment
Interim analysis of the 'DEvice-Detected CArdiac
Tachyarrhythmic Events and Sleep-disordered
Breathing (DEDiCATES)' study
Hye Bin GwagDivision of Cardiology, Department of Internal Medicine
Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
KHRS 2019June 21 Oral 3 (CIED) session
Prospective, multicenter, observational study; 16 centers
300 patients with low-voltage pacing devices,
300 with high-voltage defibrillating devices
CIED-detected SDB
– Specialized diagnostic function of CIEDs; (ex) AP scan (Boston Scientific Inc., Marlborough, MA, USA)
– Continuous monitoring of severity and burden of SDB
– Known variation of SDB severity on repeated PSG
– Good correlation between PSG-detected events
A. shalaby, et al.Pacing Clin. Electrophysiol. 29 (2006) 1036–1043J.S. Healey, et al. J Cardiovasc Electrophysiol. 15 (2004) 1034–1040.HB Gwag, SJ Park, et al. Int J Cardiol. 2019 Apr 1;280:69-73
HB Gwag, SJ Park, et al. Int J Cardiol. 2019 Apr 1;280:69-73
Manual counting of the Respiratory Disturbance Index (RDI)
Clinical follow-up
HB Gwag, SJ Park, et al. Int J Cardiol. 2019 Apr 1;280:69-73
We are thankful to all the participating investigators for the time and great effort.
Single chamber ICD lead with atrial sensing ring
A prospective, multicenter, RCT
comparing atrial sensing ON-ICD to
atrial sensing OFF-ICD
in detecting sub-clinical AF and
reducing inappropriate shock
(Smart-Control study)
SMART-CONTROL: Study design
(N=280)
(N=140)
(N=140)
M/60, ICMP
• 1984 AMI
• 2010 Echo: ICMP with severe LV systolic
dysfunction(LVEF = 19%)
• 2014. 07 CRT-ICD implantation
Wide QRS & CRT-D
ICMP
M/51, ICMP
• 2006: AMI
PCI: m-LAD total occlusion, m&d-RCA 90% stenosis
• 2008: apical aneurysm
ICD was recommended (primary prevention)
• 2013: Amiodarone d/t AF
• 2014. 08 Syncope without prodromal symptoms
• 2014. 12 adm for w/u
Extensive Q waves
Frequent VPCs
ICMP
Cardiomegaly LVEF= 33%Aneurysmal change at LV apex Thinning of IVS (mid to apex)
ICD implantation
Appropriate ICD Shock
Summary
• Risk of SCD/VTA of Korean: Similar to Western countries
• Rate of SCD/VTA after ICD implantation for Primary is not significantly different from Western countries.
• ICD/CRTD improved survival in Korean patients with ICM
• Prospective data still needed
Thank you for your attention!
