Myocardial Infarction, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
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.
Interventions
DEVICEMRI
Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between the MRI criterion intramural scar ≥ 1.47cm² measured by MRI and all-cause mortality from the patient's medical record. | 5 years | 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. |
| 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. | 5 years | 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. |
Countries
France
Contacts
Primary ContactChristian de CHILLOU, MD, PhD
Backup ContactGuillaume DROUOT, PhD
Outcome results
None listed