The efficacy of primary prevention with ICD in patients with...

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!