Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.
Study Type
OBSERVATIONAL
Enrollment
1,032
Study on Data
Chu Amiens
Amiens, France
Ch D'Auxerre
Auxerre, France
Chu Besancon
Besançon, France
Polyclinique Reims-Bezannes
Bezannes, France
Chu Bordeaux Pessac
Bordeaux, France
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, France
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Time frame: 12 months after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Time frame: Up to 7 years after ICD implantation
Rate of rhythmic storm defined by ACC / AHA / ESC 2006 guidelines (≥3 episodes of VF, sustained VT or appropriate shock in 24 hours).
Time frame: 12 months and up to 7 years after ICD implantation]
Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.
Time frame: : 12 months and up to 7 years after ICD implantation
Rate of all-cause death.
Time frame: 12 months and up to 7 years after ICD implantation
Rate of hospitalization for heart failure worsening.
Time frame: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Time frame: Frame: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Time frame: 12 months and up to 7 years after ICD implantation
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Chu Brest
Brest, France
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Bron, France
CHU de Caen
Caen, France
Chu Clermont-Ferrand
Clermont-Ferrand, France
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