| Paper | |
|---|---|
| (PROTECT AF) Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation _____ A multicenter RCT comparing LAA closure to warfarin in patients with A fib and a CHADS2 score >0, finding LAA closure to be non-inferior & superior to warfarin for stroke/systemic embolism/cardiovascular death, with lower mortality in the closure group, but an increased rate of early/periprocedural safety events. | LINK |
| (PREVAIL) Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy _____ A RCT comparing LAA closure to warfarin in patients with A fib and at least two additional stroke risk factors. Here, LAA closure was not found to be non-inferior to warfarin for stroke/systemic embolism/cardiovascular death, but was non-inferior for stroke/systemic embolism prevention >7 days post-randomization, with far fewer periprocedural safety events than in the PROTECT AF study. | LINK |
| 5-Year Outcomes After Left Atrial Appendage Closure: From the Prevail and PROTECT AF Trials _____ A meta-analysis of 5-year patient data from the PREVAIL and PROTECT-AF trials, finding similar rates of stroke/systemic embolism/cardiovascular death in closure and warfarin groups. The closure group had a non-significantly higher number of ischemic stroke/systemic embolism events, and lower rates of hemorrhagic stroke, major bleeding and mortality. | LINK |
| The NCDR Left Atrial Appendage Occlusion Registry _____ A study describing the characteristics of patients, hospitals, and physicians after over 38,000 Watchman procedures had been performed. In terms of adverse events, major in-hospital events occurred in 2.16% of patients, most commonly pericardial effusions or major bleeding, a lower rate than seen in the PROTECT AF and PREVAIL trials. | LINK |
| (PINNACLE FLX) Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device _____ A prospective non-randomized FDA study evaluating safety and effectiveness after placement of the Watchman FLX device, finding a low 0.5% incidence of safety end-point events, and 100% effectiveness (peri-device flow <6 mm). | LINK |