INTRODUCTION:
Atrial fibrillation (AF) is the most commonly encountered sustained
cardiac arrhythmia in clinical practice and responsible for more than
20% of all embolic strokes (1,2). AF-associated strokes tend to have
worse morbidity and mortality when compared to strokes not related to AF
(3,4). The left atrial appendage (LAA) is the location for thrombus
formation in more than 90% of patients with non-valvular AF (5).
Coumadin and direct oral anti-coagulants (DOACs) are the gold-standard
therapy for reducing stroke risk in AF patients with risk factors for
stroke. However, their utilization is often limited by lack of patient
compliance and adverse effects (6,7,8). Left atrial appendage occlusion
(LAAO) using an endocardial Watchman device has shown promising results
in mitigating stroke risk when utilized in selected AF patients (9). The
landmark PROTECT (Percutaneous closure of the left atrial appendage
versus warfarin therapy for prevention of stroke in patients with atrial
fibrillation) trial showed the Watchman device to be non-inferior to
coumadin in terms of the primary efficacy end-point of stroke, systemic
embolism and cardiovascular/unexplained death (10). Subsequently, the
PREVAIL (Prospective randomized evaluation of the Watchman left atrial
appendage closure device in patients with atrial fibrillation versus
long-term warfarin therapy) trial confirmed these results and also
showed a reduced rate of short-term complications (11). The results of
these two trials eventually led to Food and Drug Administration (FDA)
approval of the Watchman device in March of 2015. Since FDA approval of
the Watchman device, there has been limited real-world data on trends in
utilization, complications and in-hospital mortality from the procedure
in contemporary practice. The aim of the present study is to assess
these parameters from a comprehensive, national United States (US)
population database.