Key result
Indian patients with prior myocardial infarction and LVEF ≤30% who did not receive an ICD had an 18.1% all-cause mortality rate over 20.8 months, comparable to the conventionally treated arm of the MADIT II trial.
Why the study?
It was unclear and unstudied whether MADIT II criteria for ICD implantation are appropriate for Indian patients with prior myocardial infarction and reduced left ventricular ejection fraction.
What is the mortality rate of Indian patients meeting MADIT II criteria without prophylactic ICD implantation?
Observational (n=144)
No
What is the mortality rate of Indian patients meeting MADIT II criteria without prophylactic ICD implantation?
Indian patients meeting MADIT II criteria have a similar mortality rate to the western population without prophylactic ICDs, suggesting they would derive similar benefits from ICD implantation.
MADIT II ICD criteria applicability in Indians remains uncertain; leaves open population-specific validation before routine adoption.
BACKGROUND: The MADIT II investigators had concluded that prophylactic use of an ICD improved survival in patients with prior myocardial infarction reduced left ventricular ejection fraction. Whether MADIT II criteria for ICD implantation are appropriate for Indian patients also is unclear and not studied. METHODS: A total of 144 patients, Mean age 56.23 ± 10.9 years who met MADIT II criteria were prospectively followed for 20.78 + 5.9 months. RESULTS: During the follow-up period, 26 (18.1%) patients died. 18 were sudden cardiac deaths and 8 were non SCD deaths. Total mortality did not correlate with Age, NYHA class, NSVT on Holter, PVC >10/hours, QRS width, or use of statins. Multivariate logistic regression model identified the following variables associated with increase all-cause mortality: No use of beta blocker (odd ratio:13.068, p = 0.021), No past revascularization (odd ratio:11.613,p = 0.007) and Increase serum creatinine level (odd ratio: 4.066, p = 0.035). The mortality rate in the present series was comparable with that in the MADIT II conventional therapy group though patient in present study are younger, less diabetic, hypertensive, smokers and better treated with beta-blockers, ACE/ARB and statin. CONCLUSION: Indian patients with prior MI (more than one month back) and left ventricular ejection fraction of 30% or less had a cardiac mortality similar to western population who are not treated with prophylactic ICD. Patients of Indian origin should derive a similar benefit with prophylactic implantation of ICD as per MADIT II criteria as would a western population.
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Yadav et al. (2020) conducted an observational in Post myocardial infarction with LVEF ≤30% (MADIT II criteria) (n=144). Conventional medical therapy without ICD vs. None (historical comparison to MADIT II conventional therapy group) was evaluated on All-cause mortality. Indian patients with prior myocardial infarction and LVEF ≤30% who did not receive an ICD had an 18.1% all-cause mortality rate over 20.8 months, comparable to the conventionally treated arm of the MADIT II trial.
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