Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

ABSTRACT:

Aims

Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis.

Methods and results

An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Wa

SUBMITTER: Lakkireddy D 

PROVIDER: S-EPMC10427960 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature