A two-step risk stratification approach using non-invasive risk factors and programmed ventricular stimulation predicted major arrhythmic events with 100% sensitivity and 100% negative predictive value.
Cohort (n=575)
Yes
Does a two-step non-invasive and invasive risk stratification approach identify post-myocardial infarction patients with LVEF ≥ 40% at risk for major arrhythmic events who may benefit from an ICD?
A two-step risk stratification strategy using non-invasive testing followed by programmed ventricular stimulation effectively identifies post-MI patients with LVEF ≥40% at high risk for arrhythmic events who may benefit from an ICD.
Absolute Event Rate: 21.95% vs 0%
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.
Gatzoulis et al. (Thu,) conducted a cohort in Post-myocardial infarction with preserved ejection fraction (n=575). Two-step non-invasive and invasive risk stratification algorithm vs. Patients without non-invasive risk factors or with negative programmed ventricular stimulation was evaluated on Occurrence of a major arrhythmic event (MAE), namely sustained ventricular tachycardia/fibrillation, appropriate ICD activation or sudden cardiac death. A two-step risk stratification approach using non-invasive risk factors and programmed ventricular stimulation predicted major arrhythmic events with 100% sensitivity and 100% negative predictive value.