Key result
Two-step risk stratification identifies high-risk post-MI patients with preserved LVEF facing a ~22% arrhythmic event rate.
Why the study?
Sudden cardiac death incidence is 0.6-1% annually in post-MI patients with LVEF ≥40%, but no recommendations for ICD use exist in this population.
Does a two-step risk stratification algorithm using non-invasive risk factors and programmed ventricular stimulation identify post-MI patients with LVEF ≥40% at high risk for major arrhythmic events?
Cohort (n=575)
Yes
Does a two-step risk stratification algorithm using non-invasive risk factors and programmed ventricular stimulation identify post-MI patients with LVEF ≥40% at high risk for major arrhythmic events?
A two-step non-invasive and invasive risk stratification algorithm successfully identified post-MI patients with LVEF ≥40% at high risk for major arrhythmic events who could be effectively protected by an ICD.
May support targeted ICD evaluation in high-risk post-MI preserved-LVEF patients; leaves open efficacy pending randomized trials.
AIMS: Sudden cardiac death (SCD) annual incidence is 0.6-1% in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)≥40%. No recommendations for implantable cardioverter-defibrillator (ICD) use exist in this population. METHODS AND RESULTS: We introduced a combined non-invasive/invasive risk stratification approach in post-MI ischaemia-free patients, with LVEF ≥ 40%, in a multicentre, prospective, observational cohort study. Patients with at least one positive electrocardiographic non-invasive risk factor (NIRF): premature ventricular complexes, non-sustained ventricular tachycardia, late potentials, prolonged QTc, increased T-wave alternans, reduced heart rate variability, abnormal deceleration capacity with abnormal turbulence, were referred for programmed ventricular stimulation (PVS), with ICDs offered to those inducible. The primary endpoint was the occurrence of a major arrhythmic event (MAE), namely sustained ventricular tachycardia/fibrillation, appropriate ICD activation or SCD. We screened and included 575 consecutive patients (mean age 57 years, LVEF 50.8%). Of them, 204 (35.5%) had at least one positive NIRF. Forty-one of 152 patients undergoing PVS (27-7.1% of total sample) were inducible. Thirty-seven (90.2%) of them received an ICD. Mean follow-up was 32 months and no SCDs were observed, while 9 ICDs (1.57% of total screened population) were appropriately activated. None patient without NIRFs or with NIRFs but negative PVS met the primary endpoint. The algorithm yielded the following: sensitivity 100%, specificity 93.8%, positive predictive value 22%, and negative predictive value 100%. CONCLUSION: The two-step approach of the PRESERVE EF study detects a subpopulation of post-MI patients with preserved LVEF at risk for MAEs that can be effectively addressed with an ICD. CLINICALTRIALS.GOV IDENTIFIER: NCT02124018.
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Gatzoulis et al. (2019) conducted a cohort in Post-myocardial infarction with preserved ejection fraction (LVEF ≥ 40%) (n=575). High arrhythmic risk profile (presence of ≥1 non-invasive risk factor and inducible upon programmed ventricular stimulation) vs. Low/intermediate arrhythmic risk profile (no non-invasive risk factors, or risk factors present but non-inducible upon programmed ventricular stimulation) was evaluated on Major arrhythmic event (MAE): sustained ventricular tachycardia/fibrillation, appropriate ICD activation, or sudden cardiac death (p=<0.001). A two-step approach identified a high-risk subgroup of post-MI patients with preserved LVEF (inducible upon programmed ventricular stimulation) who experienced a 22% rate of major arrhythmic events, compared to 0% in those without risk factors or non-inducible (p<0.001).
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