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All patients 40 days post mi should receive icd
1. ALL PATIENTS 40 DAYS
POST MI SHOULD RECEIVE
ICD
DR. AASIT S. SHAH MD, DM
JASLOK HOSPITAL AND RESEARCH CENTRE
2. INTRODUCTION
• Indications for ICD implant have evolved in last few
years
• Not meant only for drug refractory ventricular
arrhythmias
• Focus has changed from identifying patient who
needs ICD to identifying patients who can avoid
ICD.
3. ICD TRIALS
• Multiple RCT’s have shown that ICD is better than
antiarrhythmic drugs
• Applicable to patients for secondary prevention and
for primary prevention
4. ICD TRIALS- SECONDARY PREVENTION
• AVID
• CASH
• CIDS
• 73-83% PTS. HAD CAD
• EF 32-45%
5. Secondary Prevention Trials:
Reduction in Mortality with ICD Therapy
Overall Death
Arrhythmic Death
•Non-significant results.
1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583.
2 Kuck Kh, et al. Circulation. 2000;102:748-754.
3 Connolly SJ, et al. Circulation. 2000;101:1297-1302.
80
60
40
20
0
AVID CASH CIDS
1 2 3
31%
56%
23%*
58%
20%*
33%
% Mortality Reduction w/ ICD Rx
6. ICD TRIALS- PRIMARY PREVENTION
• MADIT
• MUSTT
• MADIT 2
• SCD-HeFT
• Two recent meta-analyses have shown 20-30% net
risk reduction for total mortality
7. Overall Death
Arrhythmic Death
75%
55%
73%
31%
61%
1 2 3, 4
1 Moss AJ. N Engl J Med. 1996;335:1933-40.
2 Buxton AE. N Engl J Med. 1999;341:1882-90.
3 Moss AF. N Engl J Med. 2002;346:877-83.
4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March
19, 2002.
80
60
40
20
0
54%
MADIT MUSTT MADIT-II
27 Months 39 Months 20 Months
% Mortality Reduction w/ ICD Rx
PRIMARY PREVENTION
8. PRIMARY VS. SECONDARY PREVENTION
ICD mortality
reductions in
primary
prevention trials
are equal to or
greater
than those in
secondary
prevention trials.
80
60
40
20
0
Overall Death
Arrhythmic Death
MADIT MUSTT MADIT-II
80
60
40
20
0
2 3, 4
Overall Death
Arrhythmic Death
1
AVID CASH CIDS
5 6 7
54%
75%
55%
76%
31%
61%
27 months 39 months 20 months
31%
56%
28%
59%
20%
33%
% Mortality Reduction w/ ICD Rx % Mortality Reduction w/ ICD Rx
3 Years 3 Years 3 Years
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;346:877-83
4 Moss AJ. Presented before ACC 51st
Annual Scientific Sessions, Late Breaking
Clinical Trials, March 19, 2002.
5 The AVID Investigators. N Engl J Med.
1997;337:1576-83.
6 Kuck K. Circ. 2000;102:748-54.
7 Connolly S. Circ. 2000:101:1297-1302.
9. ICD TRIALS
Hence it is clear that ICD therapy for SCD provides
greater reduction in SCD mortality than
antiarrhythmic drug therapy in high risk patients post
MI
The most important risk stratification factor is the
ejection fraction
10. SCD INCIDENCE POST MI
• Incidence of SCD is highest in the early phase post MI- first 30
days.
VALIANT TRIAL
14703 pts.
HIGHEST SCD IN 1 MTH POST MI-19%
83% OF ALL SCD OCCURRED IN 1 MTH
EF<30% HAD HIGHEST RISK OF SCD-
Hence it is logical that if we provide antiarrhythmic therapy early to our
post MI high risk patients, incidence of SCD should reduce.
11. VALIANT TRIAL
EF <30%
<31-40%
>40%
Rates of sudden death or cardiac arrest
15. ICD TRIALS EARLY POST MI
• These trials did not show improvement in overall
mortality when ICD was implanted 6-40 days post MI.
• There was a reduction in SCd in the ICD group;
however non SCD deaths in ICD group also increased.
• This paradox has not been satisfactorily explained
16. ICD TRIALS EARLY POST MI
• Risk stratification factors
• Deleterious effect of ICD therapy –including
appropriate programming
• Other causes of sudden death
• Role of EP study
JACC 2009; 54(22) 2001-2005
17. ACC 2012 RECOMMANDATION
CLASS I A : ICD therapy is indicated in patients with LVEF less than or
equal to 35% due to prior MI who are at least 40 days post-MI and
are in NYHA functional Class II or III
CLASS I A : ICD therapy is indicated in patients with LV dysfunction
due to prior MI who are at least 40 days post-MI, have an LVEF less
than or equal to 30%, and are in NYHA functional Class I
CLASS I B : ICD therapy is indicated in patients with nonsustained VT
due to prior MI, LVEF less than or equal to 40%, and inducible VF or
sustained VT at electrophysiological study.
20. PRIMARY PREVENTION
ICD Therapy
3 4
11
9
20
26
28
37
50
45
40
35
30
25
20
15
10
5
0
simvastatin
captopril
Metoprolol
succinate
MUSTT MADIT MADIT II AVID SAVE Merit-HF 4S Amiodarone
Meta-analysis
(5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr)
NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)
amiodarone
Drug Therapy
Number Needed to Treat
to Save a Life
21. CONCLUSIONS
• All patients who match current guidelines should be
offered ICD implant
• Better risk stratification criteria and more
appropriate device programming
• Need more trials and data to identify patients at
high risk for SCD early after MI
When reviewing the MADIT II results vs. the other primary prevention ICD studies, again, the MADIT II overall mortality reduction is lower than the other studies.
_______________________
Overall death results:
The blue bars show the relative overall mortality reductions for the three studies. We note that the overall mortality results for MADIT and MUSTT are similar and greater than those for MADIT II. It is important to note that these comparisons are done at different time points due to the different average follow-up periods, as noted under the respective study name above. The MADIT II study had the shortest average follow-up and the survival curves in MADIT II continued to widen throughout the course of the study. It is probable that the survival curves would have continued to widen with a longer follow-up period given the recently reported finding that ICD therapy arm patients who had been followed for 4 years had a 40% probability of appropriate ICD therapy (ATP or shock).
Arrhythmic death results:
MADIT: Was calculated to be 75% using the percentage of arrhythmic deaths for the conventional therapy (12.9%) and the percent of arrhythmic deaths for ICD therapy (3.15%)
MUSTT: Was calculated to be 73% using the percentage of arrhythmic deaths with defibrillator therapy and the percent of arrhythmic deaths with no anti-arrhythmic therapy.
MADIT-II: Was calculated to be 62% using the percentage of arrhythmic deaths for conventional therapy (9.39%) and the percentage of arrhythmic deaths for ICD therapy (3.63%). These arrhythmic death numbers were presented at by Dr. Moss before the ACC 51st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002, but have not been published.
This slide compares the mortality benefits in the primary prevention trials with those in the secondary prevention trials. Intuitively, one would think that patients who have had a cardiac arrest or spontaneous, sustained ventricular arrhythmias would have more impressive mortality benefits than those who have not had a sustained ventricular arrhythmia event or SCA event. However, this has not been the case as shown in the slide above. MADIT II and AVID had similar mortality benefits. So… if ICD therapy is considered standard of care in AVID patients…why not MADIT II???!