Baseline, Perioperative, and Follow-up Evaluations
failure or malfunction
COMPLICATIONS
Baseline evaluation included a collection of demographic characteristics,
laboratory data, comorbid conditions, rhythm on electrocardiogram (ECG),
previous interventions, and echocardiogram evaluation with assessment of NYHA
functional status.Perioperative evaluation included a data collection of additional required
procedures or interventions, device failure or malfunction, mortality (related
or not to the valve), and complications (related or not to the valve).Patients were scheduled for follow-up at hospital discharge (up to 30 days),
three to six months, and one year later. These data included an assessment of
NYHA classification, ECG, and linearized rates of AEs.