1. CRT-P or CRT-D
quels arguments pour notre choix?
C. Leclercq
Department of Cardiology
Centre Cardio-Pneumologique
Rennes

2. Why an ICD in patients with reduced LVEF?

3. Mechanisms of sudden death in HF
Ventricular fibrillation
Asystole
Electrical-mechanical dissociation

4. Sudden cardiac death in heart failure population
Controlled studies / Control groups
Study year n grade 1-year mortality SCD
V-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%

5. 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 II
12%
64%
24%
CHF
Other
Sudden Death
Deaths = 103
NYHA IV
56%
11%
33%
CHF
Other
Sudden Death
Deaths = 27
NYHA III
26%
15%
59%
CHF
Other
Sudden Death
Deaths = 232

6. 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

7. 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.)

8. 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.)

9. CRT in France
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
2009 2010 2011 2012
CRTD
CRTP
0
20
40
60
80
100
120
140
160
2009 2010 2011 2012
IHMT Data
Centers (n)Implants (n)
65 %
35 %

10. CRT-P ou CRT-D
y 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)

11. 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-implantation
Implant 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

12. 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

13. CRT et « safety » :
Infections
Romeyer-Bouchard C. Eur Heart J 2010;31:203-10

14. • Bénéfice clinique?
– Sondes PM et DAI en termes de
resynchronisation cardiaque?
– Protection contre la mort subite?
CRT-P ou CRT-D
Y a-t-il des différences?

15. Heart failure hospitalizations
McAlister . JAMA 2007; 297:2502-14

16. Mortality
McAlister . JAMA 2007; 297:2502-14

17. 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

18. COMPANION, CARE-HF, CARE-HF extension :
modes de décès
23%
44%
32%
47%
36%
42%
37%
40%
35%
40%
32%
38%
16%
50%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Mort subite Défaillance
cardiaque
Mort subite Défaillance
cardiaque
Mort subite Défaillance
cardiaque
Mortalité
OPT CRT-P CRT-D
COMPANION (14m) CARE-HF ext (36,4m)CARE-HF (29.4m)

19. 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 0.87
Non-ischemic (N=552) 0.57 0.02
NYHA Class III (N= 1048) 0.76 0.08
NYHA Class IV (N=164) 0.99 0.98
SBP<112 mmHg 0.98 0.92
SBP>112 mmHg 0.69 0.08
M Bristow Circulation 2005, 112: II-673 (AHA 2005)

20. Sudden death
in patients with ICD
Mitchell. JACC, 2002; 39:1323-8
n = 320 deaths

21. 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

23. 27%
43%
19%
53%
17%
32%
12%
Diabetes Stroke/TIA Renal
Dysfunction
Atrial/
Arrhythmias
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

24. 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.

25. Score 0
Score>1
Score 1
Score 2
Score>3
Goldenberg. J Am Coll Cardiol 2008; 51: 288-96,

26. Le “coût-efficacité”
Yao. Eur Heart J 2007;28: 42-51

27. ICD* CABG+ Statins‡
Economic impact of
over- prescribing
antibiotics^
Lost dollars from
health care fraud,
abuse and waste^^
2 8 9
30
100
294
9
0.0
50.0
100.0
150.0
200.0
250.0
300.0
350.0
AnnualCostinBillions
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!!

28. 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

29. What do the guidelines recommend?

30. Sudden death
Lindelfeld. Circulation. 2007;115: 204-12
Death
NYHA class IV

31. Comorbidities
Renal failure
Van Bommel. J Am Coll Cardiol 2011;57:549–55

32. • 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