A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation

• Implantable cardioverter defibrillator (Device), also known as ICD: Implantation of an ICD for secondary prevention

Primary outcomes

• All-cause mortality [5 years]: The clinical event committee will aim to attribute the cause of death to the underlying disease process rather than the immediate mechanism. Mortality will be classified as cardiovascular and non-cardiovascular.

Secondary outcomes

• All cause mortality [1 year]
• Sudden cardiovascular death [1 year]: Cardiovascular death fulfilling the following criteria: * In witnessed cases a change in cardiovascular status with time until death being <1 hour. * In unwitnessed cases <24 hours since last seen alive and functioning normal.
• Cardiovascular death [1 year]: Mortality is considered as cardiovascular unless it is clearly attributable to another cause and thus includes: * Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure). * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease. * All procedure-related deaths, including those related to a complication of the ICD-procedure or treatment for a complication of the procedure. * All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events. * Death of unknown or cardiac cause.

Other outcomes

• Device revision or replacement due to infection or malfunction [1 year]: Explorative outcome
• Appropriate shock from an ICD (successfully treated VT/VF) [1 year]: Explorative outcome
• Inappropriate shock from an ICD (shock on non-VT/VF) [1 year]: Explorative outcome
• Register-based all cause mortality [10 years]
• Register-based sudden cardiovascular death [5 years]
• Register-based sudden cardiovascular death [10 years]
• Register-based cardiovascular death [5 years]
• Register-based cardiovascular death [10 years]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with CAD and cardiac arrest due to VF/VT, where angiogram is performed with complete revascularization (PCI, CABG or hybrid coronary revascularization) before ICD implantation. Unfavorable artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization.
* Age ≥18 years
* LVEF >35% at the time of discharge. The most recent LVEF assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline LVEF.

Exclusion Criteria:

* Non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy)
* Previous CABG within the last 3 months before index hospitalization
* Life expectancy less than 1 year or severe neurologic outcome
* Unable or unwilling to give informed consent
* Pregnancy

• Reza Jabbari, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet