1. ICD in prevenzione
primaria
Dott. Brunacci Michele
Dott. Bianco Daniele

2. The Problem: Sudden Cardiac Death
► In the United States, accounts for 325,000
deaths per year.
► Often the first presentation of heart
disease.
► More often than not, occur in people with
structural heart or coronary disease.
► Out of hospital cardiac arrests are unlikely
to survive (rates from 1.4 - 20%). Those
who do survive are often not neurologically
intact.

3. Epidemiologia della Morte Improvvisa
• In Italia i dati disponibili provengono dallo studio MONICA,
condotto in Brianza, in cui è stata riportata un’incidenza di
MCI di 0.95/1000 abitanti/anno, pari a 40-50 000 nuovi
eventi ogni anno .
• Evidenze più recenti sono offerte da uno studio basato su
dati ISTAT del 2001, secondo cui la MCI rappresenterebbe
il 10% della mortalità totale2, mentre elaborazioni CUSAS
su dati ISTAT 2006 e Ministero della Salute portano questa
percentuale al 10.84% 3 .

4. Dr. Mirowski (1924 – 1990)

5. Road to ICDs

6. Linee Guida

7. Implantable Cardioverter-
Defibrillators
I IIa IIb III ICD therapy is not indicated for patients who do not
have a reasonable expectation of survival with an
acceptable functional status for at least 1 year, even if
they meet ICD implantation criteria specified in the Class
I IIa IIb III I, IIa, and IIb recommendations above.
ICD therapy is not indicated for patients with incessant
VT or VF.
I IIa IIb III
ICD therapy is not indicated in patients with significant
psychiatric illnesses that may be aggravated by device
implantation or that may preclude systematic follow-up.
I IIa IIb III ICD therapy is not indicated for NYHA Class IV patients
with drug-refractory congestive heart failure who are not
candidates for cardiac transplantation or cardiac
resynchronization therapy defibrillators (CRT-D).
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.

8. Implantable Cardioverter-
Defibrillators
I IIa IIb III ICD therapy is not indicated for syncope of undetermined
cause in a patient without inducible ventricular
tachyarrhythmias and without structural heart disease.
ICD therapy is not indicated when VF or VT is amenable
I IIa IIb III
to surgical or catheter ablation (e.g., atrial arrhythmias
associated with the Wolff-Parkinson-White syndrome, RV
or LV outflow tract VT, idiopathic VT, or fascicular VT in
the absence of structural heart disease).
I IIa IIb III ICD therapy is not indicated for patients with ventricular
tachyarrhythmias due to a completely reversible disorder
in the absence of structural heart disease (e.g.,
electrolyte imbalance, drugs, or trauma).
All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of
survival with good functional capacity for more than 1 year.

9. ICD as primary prevention:
Ischemic Cardiomyopathy

10. I TRIALS : Multicenter Automatic Defibrillator Implantation Trial
196 pz Risultati sulla sopravvivenza
CAD
FE ≤ 35%
1.0
Probabilità di sopravvivenza
TVNS asin
TV SEF Defibrillatore
0.8
0.6
0.4 Terapia
convenzionale
0.2
Valore P = 0,009
0.0
0 1 2 3 4 5
N. pazienti Anno
Defibrillatore
95 80 53 31 17 3
Terapia
convenzionale 101 67 48 29 17 0
Moss AJ. N Engl J Med. 1996;335:1933-40.

11. I TRIALS : Multicenter Automatic Defibrillator Implantation Trial II
1232 pz
1.0
Risultati sulla sopravvivenza
CAD >1
mese
FE≤ 30% 0.9
sopravvivenza
Probabilità di
Defibrillatore
0.8
0.7 Terapia
convenzionale
P = 0,007
0.6
0.0
0 1 2 3 4
N. a rischio Anno
Defibrillatore 742 503 (0,91) 274 (0,94) 110 (0,78) 9
Terapia
convenzionale 490 329 (0.90) 170 (0,8) 65 (0,69) 3
Moss AJ. N Engl J Med. 2002;346:877-83.

12. I TRIALS : Multicenter UnSustained Tachycardia Trial
• 351 pazienti ischemici con TVNS asintomatiche e FE 40%
• randomizzati a terapia antiaritmica SEF-guidata od ICD
0.5
I 3 gruppi di pazienti sono inducibili al SEF:
Terapia AA SEF guidata efficace (NO ICD)
Frequenza di eventi
0.4 No Terapia AA, NO ICD
Terapia AA SEF guidata inefficace ICD
0.3 p < 0.001
0.2
0.1
0
0 1 2 3 4 5
Tempo successivo all’arruolamento (Anni)

13. I TRIALS : Sudden Cardiac Death in Heart Failure Trial
2521 pz
FE ≤35%
Enpoint Primario : Mortalità per tutte le cause
NYHA II/ III
Mortality by Intention-to-treat
52 % CAD
48% idiop
23% Riduzione
della Mortalità per
tutte le cause per
la Terapia con ICD
(p-value 0.007)
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart
failure. N Engl. J Med. 2005; 352:225-237. © 2005 Massachusetts Medical Society. All rights reserved.

14. ICD as primary prevention:
Non ischemic
Cardiomyopathy

15. IDCM - Incidence and
Prognosis
• Prevalence is 36 per 100,000 population
• Third most common cause of heart failure
• Most frequent cause of heart
transplantation
• DCM accounts for approximately 10,000
deaths and 46,000 hospitalizations per year
in the US
• Complete recovery is rare

16. Cardiomiopatia dilatativa
idiopatica
Anni
“ The NATURAL history of of idiopathic dilated cardiomyopathy ”
Am J Cardiol 1981; 47:525

17. I TRIALS : Defibrillators In Non-Ischemic Cardiomyopathy
Treatment Evalutation
458 pz
FE ≤ 30%
TVNS-PVC
Solo non CAD
Alan Kadish, Alan Dyer, James P. Daubert et al