CRT-P or CRT-Dquels arguments pour notre choix?

C. LeclercqDepartment of Cardiology

Centre Cardio-Pneumologique Rennes

Why an ICD in patients with reduced LVEF?

Mechanisms of sudden death in HF

Ventricular fibrillation

Asystole

Electrical-mechanical dissociation

Sudden cardiac death in heart failure population

Controlled studies / Control groups

Study year n grade 1-year mortality SCDV-HEFT (1) 1986 642 II-III 12% 45%V-HEFT (2) 1991 804 II-III 15% 50%CHF-STAT 1995 674 II-III 15% 49%RALES 1999 822 III-IV 23% 35%CIBIS II 1999 1320 III-IV 14% 36%MERIT-HF 1999 2001 II-IV 11% 35%Copernicus 2001 2289 IIIb-IV 18% 36%Ephesus 2003 3319 I-IV 16% 36%Emphasis 2010 1364 II 10% 35%

Modes of Death in HF

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 II12%

64%24%

CHFOther Sudden Death

Deaths = 103

NYHA IV

56%

11%

33%CHF OtherSudden Death

Deaths = 27

NYHA III26%

15%

59%

CHF Other Sudden Death

Deaths = 232

Influence of Medical Treatment on the Incidence of Sudden Death in Heart Failure

vs placebo 1-year mortality sudden death

Amiodarone* - 23 % (NS) - 19 % (NS)

ACE-inhibitors* - 13 % (p = 0.003) NS

Spironolactone (RALES) - 33 % (p < 0.001) - 30 % (p = 0.02)

Beta-blockers* - 33 % (p < 0.001) - 35 % (p<0.001)

Eplerenone - 15% (p = 0.008) - 21% (p = 0.03)

* meta-analysis

Adapted from Eucomed Source population data: OECD

Units by Eucomed based on reports from major manufacturers

CRTD implant rate 2005-2010 evolution: growing constantly everywhere, but wide variability by Country

Europe 2010 average

~42.000 CRTD in 2010(over 420 mil. inhab.)

Adapted from Eucomed Source population data: OECD

Units by Eucomed based on reports from major manufacturers

Europe 2010 average

CRTP implant rate 2005-2010 evolution: towards a rediscovery

~13.000 CRTP in 2010(over 420 mil. inhab.)

CRT in France

2009 2010 2011 20120

1000

2000

3000

4000

5000

6000

7000

8000

9000CRTDCRTP

2009 2010 2011 20120

20

40

60

80

100

120

140

160

IHMT Data

Centers (n)Implants (n)

65 %

35 %

CRT-P ou CRT-Dy a-t-il des différences?

• Techniques d’implantation: – Sondes de défibrillation moins maniables: +/-– Position de la sonde de défibrillation apex versus

septum (études SEPTAL et SEPTAL CRT): non– Nécessité de réaliser un DFT (de moins en moins)– Nécessité d’une AG (11% dans le registre

européen; 12% à Rennes)

CRT et « safety » : no differences between CRT-P/CRT-D

McAlister . JAMA 2007; 297:2502-14

CRT (54 trials) CRT-ICD (36 trials) (6123 pts) (5199pts)

Peri-implantationImplant success 93% 94%Implant death 0,3% 0,5%

Mechanical malfunction 4,0% 4,6%Post-Implantation

Device malfunction 5,4% 5,0%Lead malfunction 6,6% 7.2%Infections 1,8% 1,1%Arrhythmias 12,5% 6,4%

Short FU time 6 to 12 months

Event-free lead function: comparison early models versus recent models

Event-free lead function: all leads

Circulation 2007; 115: 2474-2480

Estimated lead survival rate: 85% at 5 years; 60% at 10 years Consensus report on pacemaker lead performance: target lead survival > 95% at 10 years

CRT et « safety » : Infections

Romeyer-Bouchard C. Eur Heart J 2010;31:203-10

• Bénéfice clinique?– Sondes PM et DAI en termes de

resynchronisation cardiaque?

– Protection contre la mort subite?

CRT-P ou CRT-DY a-t-il des différences?

Heart failure hospitalizations

McAlister . JAMA 2007; 297:2502-14

Mortality

McAlister . JAMA 2007; 297:2502-14

Rivero-Ayerza M et al. Effects of CRT alone on overal mortality and mode of death. Eur Heart J 2006; 27: 2682-88

Mode of death in patients treated with CRT alone vs control

COMPANION, CARE-HF, CARE-HF extension : modes de décès

Mort subite Défaillance cardiaque

Mort subite Défaillance cardiaque

Mort subite Défaillance cardiaque

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

23%

44%

32%

47%

36%

42%

37%40%

35%

40%

32%

38%

16%

50%

OPT CRT-P CRT-D

Mor

talit

é

COMPANION (14m) CARE-HF ext (36,4m)CARE-HF (29.4m)

Additional value of ICD to CRT Post-hoc comparison of CRT-D vs CRT in COMPANION:

All-cause Mortality

HR (CRT-D vs CRT) P

All patients (N=1212) 0.92 0.33

Ischemic etiology (N=660) 1.02 0.87Non-ischemic (N=552) 0.57 0.02

NYHA Class III (N= 1048) 0.76 0.08NYHA Class IV (N=164) 0.99 0.98

SBP<112 mmHg 0.98 0.92SBP>112 mmHg 0.69 0.08

M Bristow Circulation 2005, 112: II-673 (AHA 2005)

Sudden death in patients with ICD

Mitchell. JACC, 2002; 39:1323-8

n = 320 deaths

Poole et al, N Engl J Med 2008; 359:1009-17

ICD Shock and the Risk of Death

Prognostic Importance of Defibrillator Shocks in Patients with Heart Failure

27%

43%

19%

53%

17%

32%

12%

Diabetes Stroke/TIA

RenalDysfuncti

on

Atrial/Arrhythmi

as

Hypertension

Respiratory

Disease

Dementia

La population IC est différente de celle des essais cliniques

notamment en termes de comorbidités

Cleland Eur Heart J 2003;24:442-63

Goldenberg. J Am Coll Cardiol 2008; 51: 288-96,

U-Shaped Curve for ICD Efficacy

Risk stratification for primary prevention

NYHA class II, age > 70 years, BUN > 26 mg/dl, QRS > 0.12 s,

and atrial fibrillation.

Score 0

Score>1

Score 1

Score 2

Score>3

Goldenberg. J Am Coll Cardiol 2008; 51: 288-96,

Le “coût-efficacité”

Yao. Eur Heart J 2007;28: 42-51

ICD* CABG+ Statins‡

Economic impact of over- prescribing

antibiotics^

Lost dollars from health care fraud,

abuse and waste^^

2 8 930

100

294

90.0

50.0

100.0

150.0

200.0

250.0

300.0

350.0An

nual

Cos

t in

Billi

ons

PTCA†

*Medtronic estimations (total number of implants x $30,000).†Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data.+AHA 2002 / Cowper, et al; American Heart Journal. 143;(1):130–9.‡ Pharmacy Times, “Top 200 drugs of 2000”; 2001.^ National Institute of Health, Antimicrobial Resistance, NIAID Fact Sheet.^^ U.S. General Accounting Office 2001.1 Woolhandler S, et al. Costs of Healthcare Administration in the United States and Canada. N Engl J Med 344, 2003; 349: 768-75.

$11.6 B—estimated amount due to miscoding,

insufficient documentation, etc. in Medicare

(HCFA 2000 Financial Report)

Healthcare

Administration1

Le “coût-efficacité”Relativisons un peu tout de même!!

What do the guidelines recommend?

In the absence of proven superiority by trials and the small survival benefit, this Task Force is of the opinion that no strict recommendations can be made, and prefers to merely offer guidance regarding the selection of patients for CRT-D or CRT-P, based on overall clinical condition, device-related complications and cost

What do the guidelines recommend?

Sudden death

Lindelfeld. Circulation. 2007;115: 204-12

Death

NYHA class IV

Comorbidities Renal failure

Van Bommel. J Am Coll Cardiol 2011;57:549–55

• Les recommandations sont une aide à la décision

• Le bon sens clinique!!!• Patient avec projet de transplantation

cardiaque ou assistance VG: CRT-D• Patient > 80 ans: CRT-P (médiane de survie 13

mois..)• Entre les deux, Le bon sens clinique!!!– âge physiologique, comorbidités, classe NYHA….

Conclusion