Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2

Study Overview
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Brief Summary
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Implantable cardioverter-defibrillators (ICD) are currently recommended (ESC guidelines 2015) for the primary prevention of sudden cardiac death (SCD) in patients with a remote myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF). Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. As a consequence, the current implantation strategy of prophylactic ICDs, based on LVEF, needs to be improved in post-MI patients. Stratification of the rhythmic risk after IDM is therefore still a major public health issue. Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI) is a strong risk-stratifier of VT/VF risk in post- MI patients. In a recent multicenter retrospective study, the investigators showed that the presence of a critical surface of intramural scar (which is consequently neither epicardial nor endocardial) at the infarct border (measured by LGE-MRI) has a major association with the occurrence of VT/VF in post-MI patients with a LVEF≤35%. The aim of the TVScreen 2 study is therefore to validate the relevance of the MRI criterion in a new independent cohort of patients.

Official Title
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Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2

Conditions
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Myocardial Infarction, Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person who has received full information on the organization of the research and who has not objected to the use of this data; Person having had an ICD implantation for primary prevention before 12/31/2017 after myocardial infarction; Person with LVEF ≤35% at the time of ICD implantation. Exclusion Criteria: Patient with a history of persistent atrial fibrillation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br> | Device: MRI<br>* Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the presence of the MRI criterion intramural scar ≥ 1.47cm² measured by MRI and the occurrence of VT / VF after implantation of the ICD from the patient's medical record. | The area of the intramural scar will be determined from the MRI images. VT / VF events during the follow-up period will be reported from cardiac events recorded by the ICD and present in the patient's medical record. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the MRI criterion intramural scar ≥ 1.47cm² measured by MRI and all-cause mortality from the patient's medical record. | The area of the intramural scar will be determined from the MRI images. All-cause mortality during the follow-up period will be collected from the patient's medical record. | 5 years | 
| Association between the MRI criterion intramural scar ≥ 1.47cm² measured by MRI and the combined criterion of all-cause mortality or occurrence of VT / VF from the patient's medical record. | The area of the intramural scar will be determined from the MRI images. VT / VF events and all-cause mortality during the follow-up period will be collected as described previously. | 5 years |