Off-Label Use of Device to Prevent Stroke in A-Fib Patients is Prevalent and Potentially Dangerous
Perelman School of Medicine at the University of PennsylvaniaThe Lariat device is associated with a significant incidence of death and urgent cardiac surgery during its frequent off-label use to prevent stroke in patients with the irregular heartbeat known as atrial fibrillation. Following a systematic review of case reports and an FDA safety database, researchers are calling for formal controlled investigations into the safety and efficacy of off-label use of the Lariat device, which has never been approved for treatment of this condition.