Outcome | Definition |
---|---|
Mortality | |
Cardiovascular | Any of the following criteria: • Death due to proximate cardiac cause (eg, 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 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 • Sudden or unwitnessed death • Arrhythmia or cardiac arrest • Death of unknown cause |
Non-cardiovascular | Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide) |
Myocardial infarction | |
Periprocedural | ≤48 h after the index procedure: absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus ≥1 of the following criteria: • New significant Q waves or equivalent • Flow-limiting angiographic complications • New “substantial” loss of myocardium on imaging |
Spontaneous | > 48 h after the index procedure: detection of rise and/or fall in cardiac biomarkers with ≥1 value above the 99th percentile upper reference limit, together with the evidence of myocardial ischaemia with ≥1 of the following present: • Symptoms of ischaemia • Electrocardiographic changes indicative of new ischaemia (new ST-T changes or new left bundle branch block • New pathological Q-waves in ≥2 contiguous leads • Imaging evidence of a new loss of viable myocardium or new wall motion abnormality • Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischaemia, and accompanied by presumably new ST elevation, or new left bundle branch block, and/or evidence of fresh thrombus by coronary angiography and/or at autopsy, but death occurring before blood samples could be obtained, or at a time before the appearance of cardiac biomarkers in the blood • Pathological findings of an acute myocardial infarction |
Revascularisation | Endovascular or surgical procedure performed on the DuraGraft-treated venous or arterial graft(s) because of loss of graft patency |
Stroke | Neurological deficit documented by physical examination or some form of imaging |