National Yearly Trend of Utilization and Procedural Complication of the Watchman Device in the United States.

Abstract

BackgroundComplication from the Watchman device (Boston Scientific Corp, Marlborough, Massachusetts) is operator-dependent, with the latest EWOLUTION trial showing low complication rates (1.8%) thought to be due to maturing physician experience.ObjectivesThe objective of this study is to understand the yearly trend of utilization and complication rates of the Watchman device in hospitalized patients.MethodsThe national inpatient sample (NIS) was queried for all hospitalization with primary atrial fibrillation or flutter from 2016 to 2019 with percutaneous left atrial appendage occlusion (LAAO). The frequency of peri-procedural complications, including death, stroke, major bleeding requiring blood transfusion, pericardial effusion, post-op hypotension, cardiac arrest, postprocedural CHF, implant displacement/leak, systemic embolism, and requiring repeat procedures, were assessed.ResultsFrom 2016 to 2019, an estimated 60,350 LAAO procedures were performed. The majority of the procedure was done in white (84.88%), males (58.40%), with a mean age of 76, at teaching hospitals (88.27%). Complication rates were around 5.72%, with no change from 2016 to 2019 (annual percentage change, APC: 6.23; p-value: 0.170) despite rapid increase in yearly utilization of Watchman from 1.12% in 2016 to 5.45% in 2019 (APC: 62.30; p-value of 0.013). Pericardial effusion (3.41%) was the most common complication, followed by bleeding requiring transfusion (1.40%) that had no significant change over time.ConclusionOur study demonstrates that trend of complications with the Watchman device implantation in the real-world practice didn’t improve over time, possibly due to characteristics inherent to the device and patient population. Hence, we expect a further drop in nationwide complication rates with the improved design of Watchman-FLX and increased placement experience.