LifeVest Safety and Efficacy in Real Life Settings in France

Appropriate Shock Events Per Patient

Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all appropriate shock events were considered.

Time frame: start to end of WCD use (3 months typical prescription)

Risk of Not Receiving Appropriate Shocks When Necessary

While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.

Time frame: from start to end of WCD use (3 months typical prescription)

Inappropriate Shock Events Per Patient

Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.

Time frame: from start to end of WCD use (3 months typical prescription)