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Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE
Konstantinos A Gatzoulis1, Dimitrios Tsiachris1, Petros Arsenos1
1First Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital, 114 Vasilissis Sofias avenue, Athens, Attica, Greece.
Insights
This study developed a two-step risk stratification for sudden cardiac death (SCD) in post-myocardial infarction (MI) patients with preserved ejection fraction. The approach effectively identifies high-risk individuals for implantable cardioverter-defibrillator (ICD) therapy, preventing major arrhythmic events.
Area of Science:
- Cardiology
- Electrophysiology
- Preventive Medicine
Background:
- Sudden cardiac death (SCD) affects 0.6-1% of post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF) ≥40%.
- Current guidelines lack recommendations for implantable cardioverter-defibrillator (ICD) use in this specific patient group.
- Risk stratification is crucial for identifying individuals who may benefit from ICD implantation.
Purpose of the Study:
- To introduce and evaluate a combined non-invasive/invasive risk stratification strategy.
- To identify a subpopulation of post-MI patients with preserved LVEF at risk for major arrhythmic events (MAEs).
- To assess the effectiveness of implantable cardioverter-defibrillators (ICDs) in this identified high-risk group.
Main Methods:
- A multicentre, prospective, observational cohort study was conducted.
- Patients with post-MI, LVEF ≥40%, and no residual ischemia were assessed.
- A two-step approach involved non-invasive risk factors (NIRFs) followed by programmed ventricular stimulation (PVS) for inducible patients, with ICDs offered to those inducible.
Main Results:
- 575 patients were included; 35.5% had at least one positive NIRF.
- 7.1% of the total sample (41/152) were inducible via PVS and received an ICD.
- During a 32-month follow-up, no SCDs occurred, and 9 ICDs (1.57%) were appropriately activated. Patients without NIRFs or with negative PVS had no MAEs.
Conclusions:
- The PRESERVE EF study's two-step approach effectively detects high-risk post-MI patients with preserved LVEF.
- This strategy allows for targeted ICD implantation, significantly reducing the risk of major arrhythmic events.
- The findings support the use of this risk stratification algorithm for guiding ICD therapy in selected post-MI patients.
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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