The PROTECT AF trial demonstrated in pts with non-valvular AF and CHADS2 ≥ 1, a LAA closure device is non-inferior to long-term warfarin for stroke prevention. Given this equivalency, quality of Life (QOL) indicators are an important metric for evaluating these strategies.

QOL using the SF-12-V2 measurement tool was obtained at baseline and 12 mos. in a subset of 527 pts in the PROTECT Trial (349 device and 178 control pts). Both general physical and mental paired health data was available. The change within each limb and the magnitude of change between the two were compared. Statistical analysis compared the randomized groups change in QOL adjusted for baseline.

With the device, total physical score improved in 36.1% and unchanged in 30.9% vs control in whom 25.8% were improved and 33.1% were unchanged (p = 0.02). Mental health improvement occurred in 34.3% of the device group vs 24.2% in the control group (p = 0.37). There was a significant improvement in total physical score, physical function and a decrease in physical limitation (Table 1).

Pts with non valvular AF at risk for stroke treated with LAA occlusion have improved QOL at 12 mos. vs pts treated with warfarin.