DAI BIVENTRICULAIRELa solution à tous les

problèmes ?

Julien LaborderieJulien Laborderie

CHU Haut LévèqueCHU Haut Lévèque

Service Pr ClémentyService Pr Clémenty

Mortalité dans l‘insuffisance cardiaque

all-cause mortality:81.5% CV death

non CV death18.5%

Publications reporting all-cause mortality, CV death, SCD, death by progression of HF (N= 20728 pts, control groups, 16 studies)

Consensus, Solvd T, Solvd P, Save, Aire, Trace, Rales, Ephesus, Cibis, S Carvedilol, Merit HF, Cibis II, Best, Capricorn, Copernicus, Comet

Sudden CardiacDeath 42%

HF Progression36%

Other CV death

Publications reporting all-cause mortality, CV death, SCD, death by progression of HF (N= 20‘728 pts, control groups, 16 studies)

Consensus, Solvd T, Solvd P, Save, Aire, Trace, Rales, Ephesus, Cibis, US Carvedilol, Merit HF, Cibis II, Best, Capricorn, Copernicus, Comet

Mortalité dans l‘insuffisance cardiaque

Décès en fonction de la classe

NYHA

MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). LANCET. 1999;353:2001-07.

NYHA IINYHA II12%12%

64%64%24%24%

CHFOther

Sudden DeathDeaths = 103

NYHA IVNYHA IV

56%56%

11%11%

33%33%CHF Other

Sudden DeathDeaths = 27

NYHA IIINYHA III26%26%

15%15%

59%59%

CHF Other

Sudden DeathDeaths = 232

I.E.C

b-BLOQUANTS

ALDACTONE (EPLERENONE?)

NITRÉS +/- Digoxine si FA

RESYNCHRO+/- DEF

ASSISTANCE CIRCULATOIRE - TRANSPLANTATION

Asymptomatique symptomatique sévère réfractaire

Optimisation du traitement médicamenteux

RÈGLES HYGIÉNO-DIÉTÉTIQUES - ÉDUCATION THÉRAPEUTIQUE

DIURETIQUE DE L’ANSE

L’insuffisance cardiaque

Défibrillateur Bi-ventriculaireConcept

Assurer à l ’aide d ’une seule prothèse implantable les fonctions:

d ’un stimulateur multisited ’un défibrillateur automatique

Avec pour objectifs d ’améliorer la qualité de vie (hémodynamique), et de réduire la mortalité (hémodynamique, événements arythmiques ventriculaires)

Prévalence et valeur pronostique de la Prévalence et valeur pronostique de la désynchronisation ventriculairedésynchronisation ventriculaire

41%Schoeller

53%Aaronson

27%Aaronson

46%Lamp

31%Shamim

0 50 100 150 200

<120 ms>120 ms

Nombre de patients

60%

70%

80%

90%

100%

0 60120180240300360Days in Trial

Cu

mu

lati

ve S

urv

ival

QRS Duration (msec)

<9090-120120-170170-220

>220

Adapted from Gottipaty et al.

60%

70%

80%

90%

100%

0 60 120 180 240 300 360

Days in Trial

Cu

mu

lati

ve S

urv

ival

QRS Duration (msec)<90

90-120

120-170

170-220

>220

Adapted from Gottipaty et al.

200

250

300

350(ms)

PR

50

100

150

0 402010 30

QRS

Xiao: International Journal of Cardiology 1996; 53, 163-70

RV pacing

LV pacing

BBB PROXIMAL OU DISTAL

CONDUCTION ALTEREEANOMALIE DE CONTRACTIONAMELIORATION DE LA CONTRACTION

SINUSAL BIV

CONCEPTCONCEPT

Cazeau SCazeau S (PACE 94;17(Pt. II):1974-79)

RSYNCHRONISATION

Concept de la resynchronisation

CRT dans l’insuffisance cardiaque

0

1000

2000

3000

4000

1999 2000 2001 2002 2003 2004 2005

Results Presented

Cum

ula

tive P

ati

ents

PATH CHF

MUSTIC SR

MUSTIC AF

MIRACLE

CONTAK CD

MIRACLE ICD

PATH CHF II

COMPANION

MIRACLE ICD II

CARE HF

Qualité de vie Diminution de la mortalité

Study (n)Study (n) NYHANYHA QRSQRS SinusSinus ICD?ICD? StatusStatus ResultsResults

MIRACLE (453)MIRACLE (453) III, IVIII, IV 130130 NormalNormal NoNo PublishedPublished ++

MUSTIC SR (58)MUSTIC SR (58) IIIIII 150150 NormalNormal NoNo PublishedPublished ++

MUSTIC AF (43)MUSTIC AF (43) IIIIII 200200** AFAF NoNo PublishedPublished ++

PATH CHF (41)PATH CHF (41) III, IVIII, IV 120120 NormalNormal NoNo PublishedPublished ++

MIRACLE ICD (369)MIRACLE ICD (369) III-IVIII-IV 130130 NormalNormal YesYes PublishedPublished ++

CONTAK CD (227)CONTAK CD (227) II-IVII-IV 120120 NormalNormal YesYes PublishedPublished ++

MIRACLE ICD II (186)MIRACLE ICD II (186) IIII 130130 NormalNormal YesYes PublishedPublished ++

PATH CHF II (89)PATH CHF II (89) III, IVIII, IV 120120 NormalNormal Y/NoY/No PublishedPublished ++

COMPANION (1520)COMPANION (1520) III, IVIII, IV 120120 NormalNormal NoNo PublishedPublished ++

CARE HF (813)CARE HF (813) III, IVIII, IV 120120†† NormalNormal NoNo PublishedPublished ++

* RV paced QRS † Echo-based criteria for QRS < 150 msecLVEF 35% for all trials

3800 patients included !!!

CRT Improves:

NYHA Class, Quality of life score (MLWHF),Exercise Capacity: 6 MW, Peak VO2

LV function: EF, MRReverse remodeling: LVEDVHospitalization,Mortality

30%

of n

on re

spon

der p

atie

nts!!

La resynchronisation cardiaque

Cardiac Resynchronisation in Heart FailureCARE-HF

BaselineEvaluation

Randomization(1:1)

OMT

CRT(CRT+OMT)

Minimum 18 Months Follow-up

813 patients, 82 centers,12 countries, FU: 29.4 MNYHA class III/IV, EF 35%QRS 150 ms or Echo if QRS 120-149 ms

CRT

MedicalTherapy

0 16000.00

0.25

0.50

0.75

1.00

Su

rviv

al

Time (days)400 800 1200

CRT = 38 HF deaths (9.3%)Medical Therapy = 64 HF deaths (15.8%)

Hazard Ratio 0.55 (95% CI 0.37 to 0.82; P=0.003)

Cardiac Resynchronisation in Heart FailureCARE-HF

Diminution de la mortalité globale

CRT

MedicalTherapy

0 16000.00

0.25

0.50

0.75

1.00

Su

rviv

al

Time (days)400 800 1200

CRT = 32 sudden deaths (7.8%)Medical Therapy = 54 sudden deaths (13.4%)

Hazard Ratio 0.54 (95% CI 0.35 to 0.84; P=0.006)

Cardiac Resynchronisation in Heart FailureCARE-HF

DAI: prévention secondaire

VT/VF Patients

ICD Therapy vs. AA Drugs

AVIDCIDSCASH

* Non-significant results.1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583.

2 Kuck K. Circulation. 2000;102:748-754.3 Connolly S. Circulation. 2000;101:1297-1302.

DAI: prévention secondaire

0

20

40

60

80

AVID CASH CIDS

Overall Death

Arrhythmic Death

1 2 3

31%

56%

23%

58%

20%*

33%

% M

ort

ality

Red

ucti

on

w/

ICD

Rx

3 Years 4.75 Years

3 Years

Prévention primaire Post-infarctus tardif

MADITMulticenter Automatic Defibrillator Implantation

TrialMoss AJ. N Engl J Med 1996:335:1933-40.

MUSTTMulticenter Unsustained Tachycardia Trial

Buxton AE. N Engl J Med. 1999;341:1882-90.

MADIT-IIMulticenter Automatic Defibrillator Implantation

Trial-IIMoss AJ. N Engl J Med. 2002;346:877-83.

1232 pts: 742 ICD Rx 490 Conv.Rx

31% reduction in mortality with ICD Rx

(20 months mean follow-up)

55-60% reduction in mortality with ICD Rx(39 months mean follow-

up)

54% reduction in mortality with ICD Rx

(27 months mean follow-up)

704 randomized pts: 353 no EP guided 352 EP guided: 190 AA drugs 161 ICDs

196 pts: 101 Conv. Rx 95 ICD Rx

MI, EF < 30%CAD, EF < 40% , NSVT, inducible VT at EPS

(95% MI Hx)

MI, EF < 35% , NSVT, inducible VT at EPS, nonsuppressible with AA drug

MADIT-II3MUSTT2 MADIT1

1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AJ. N Engl J Med. 2002; 346:877

Moss AJ. N Engl J Med. 2002;346:877-83.

DefibrillatorDefibrillator

ConventionalConventional

P = 0.007P = 0.007

1.01.0

0.90.9

0.80.8

0.70.7

0.60.6

0.00.0

Pro

bab

ilit

y o

f S

urv

ival

Pro

bab

ilit

y o

f S

urv

ival

00 11 22 33 44

YearYearNo. At RiskNo. At Risk

DefibrillatorDefibrillator742742 502 (0.91)502 (0.91) 274 (0.94)274 (0.94) 110 (0.78)110 (0.78) 99

ConventionalConventional 490490 329 (0.90)329 (0.90) 170 (0.78)170 (0.78) 65 (0.69) 65 (0.69) 33

MADIT-IIICM + LVEF < 30%

Prévention primaire Post-infarctus tardif

Prévention primaire Myocardiopathie primitive

N Engl J Med 2004;350:2151-2158

A Death from Any Cause

Pro

bab

ilit

y o

f S

urv

ival

Survival (yr)

1.0

6543210

0.9

0.8

0.7

0.0

ICD

P=0.08 Standard therapy

Prophylactic ICD in Non-ischemic DCM (LVEF<36%),n=454, 79% NYHA I-II

DEFINITE Trial

SCD-HeFT:The Sudden Cardiac Death

in Heart Failure Trial

Bardy, N Engl J Med. 2005;342:225-37

Prévention primaire Myocardiopathie primitive + ischémique

N = 440

N = 880 N = 880

Primary end point:

all cause hospitalisation

or all cause mortality

COMPANIONComparison of Medical Therapy, Pacing and Defibrillation in

Heart Failure Trial

Prévention primaire DAI ± CRT

CRT and ICD thérapies Contak CD study 2002

0

10

20

30

40

50

60

ATP SHOCK ATP orSHOCK

CRT(n=245)

No-CRT(n=245)

2727

MADIT II

March 2002

Previous ACC/AHA Guidelines for ICDs September 2002

COMPANION May 2004

SCD-HeFT January 2005

The Road to the New Guidelines

ESC updated guidelines May 2005

ACC/AHA updated guidelines August 2005

CARE-HF April 2005

Updated guidelines as result of

evidence-based medicine

Recommandations SFC february 2006

Classe I: recommandations françaises

Classe II: recommandations françaisesClasse II: recommandations françaises

New ESC guidelines 2005 for HF

CRT CRT ”in patients with EF ”in patients with EF << 35% and QRS 35% and QRS >>120 msec) and who 120 msec) and who remain symptomatic (NYHA III-IV) despite OMT to improve remain symptomatic (NYHA III-IV) despite OMT to improve symptoms symptoms and reduce hospitalizations (class I, level of and reduce hospitalizations (class I, level of evidence A) and evidence A) and mortality mortality (class I, level of (class I, level of evidence B)”evidence B)”

ICD ICD is reasonable “in selected symptomatic patients with LVEF is reasonable “in selected symptomatic patients with LVEF << 30-35%, not within 40 days of MI,on OMT..” 30-35%, not within 40 days of MI,on OMT..” (Class 1 recommendation, level of evidence A)(Class 1 recommendation, level of evidence A)

CRT-D CRT-D “in patients who remain symptomatic with HF NYHA Class “in patients who remain symptomatic with HF NYHA Class III-IV, LVEF III-IV, LVEF << 35%, and QRS 35%, and QRS >> 120 ms… 120 ms…to improve morbidity and mortality…”to improve morbidity and mortality…” (Class 2a recommendation, level of evidence B) (Class 2a recommendation, level of evidence B)

CRT should be considered as part of routine therapy for pts with moderate to severe HF due to LVSD

with evidence of cardiac dyssynchrony

Limites et PerspectivesCRT

-Diminution des non répondeurs:-Diminution des non répondeurs:- meilleure sélection des patients- meilleure sélection des patients- optimisation de la position des - optimisation de la position des

sondessondes- optimisation de la programmation - optimisation de la programmation

(PEA, délai VV)(PEA, délai VV)

-Extension des indications:-Extension des indications: - QRS fins- QRS fins - classe II (REVERSE,MADIT CRT)- classe II (REVERSE,MADIT CRT) - FE > 35% - FE > 35%

Limites et PerspectivesDAI

-Age des patients, -Age des patients, stade IV NYHA, chocs stade IV NYHA, chocs inappropriés, rupture de inappropriés, rupture de sonde……. sonde…….

-Doit on implanter -Doit on implanter systématiquement un systématiquement un DAI? (CMD primitive en DAI? (CMD primitive en prévention primaire)prévention primaire)

DAI triple chambre16500 €

PM triple chambre 4600 €

Coût

ConclusionConclusion

Progrès indéniable OUI!

Solution à tous les problèmes NON!