Introduction
Atrial fibrillation (AF) affects an estimated 33.5 million patients
worldwide, including 5 million patients in the United States
alone1. AF is associated with increased stroke risk,
particularly among the elderly2. In cases of stroke in
which a thrombus can be identified, the left atrial appendage (LAA) is
implicated in more than 90% of cases3. Left atrial
appendage closure (LAAC) devices have emerged as a novel alternative
option to minimize embolic stroke burden among patients with
non-valvular AF as an alternative to indefinite oral anticoagulation.
The WATCHMAN (Boston Scientific, Natick, MA) device is the first FDA
approved percutaneous approach for LAAC 4. Approval
was granted on the basis of results from two randomized controlled
trials, PROTECT-AF5 and PREVAIL6.
However, initially, high rates of serious procedural and device-related
events were noted, including pericardial effusion, cardiac tamponade,
device-related thrombus, device-related embolism, and
stroke5–7. Recent data suggests that these event
rates have steadily declined since FDA approval8.
Other percutaneous LAAC devices include the AMPLATZER cardiac plug, the
AMPLATZER Amulet device (St. Jude Medical; Saint Paul, MN) and the
WaveCrest device (Coherex Medical; Salt Lake City, UT) which are
available in Europe. The LARIAT Suture Delivery Device (SentreHEART,
Inc; Redwood City, CA) offers an epicardial approach with a success rate
of 95%, but concerns remain about device safety9,10.
With the advent of new diagnostic tools, such as mobile
telemetry11, detection of AF and the volume of LAAC
procedures will likely increase.
Since Watchman’s FDA approval in March 2015 its use has gained
popularity nationwide, however, data regarding readmission rates after
device insertion in the post-market era are largely unknown. The Centers
of Medicare and Medicaid Services (CMS) increasingly utilizes 30-day
readmission rates as a metric of hospital performance. Therefore, we
sought to determine the incidence, predictors, and causes of
readmissions following LAAC device insertion.
Additionally, we also set out to develop and validate a scoring system
to predict 30-day readmission after LAAC device insertion.