Utilization and procedural adverse outcomes associated with Watchman device implantation

Area of Science:

• Cardiology
• Medical Devices
• Interventional Procedures

Background:

• The Food and Drug Administration (FDA) approved the Watchman device for percutaneous left atrial appendage occlusion (LAAO).
• Widespread adoption of LAAO procedures has occurred across numerous US centers.
• Estimating nationwide utilization and adverse outcomes of Watchman device implantation is crucial.

Purpose of the Study:

• To evaluate peri-procedural complications associated with Watchman device implantation.
• To compare complication rates with previous studies, including randomized controlled trials (RCTs) and the European Watchman registry (EWOLUTION cohort).
• To assess nationwide utilization and adverse outcomes of Watchman device implantation.

Main Methods:

• Utilized the National Inpatient Sample (NIS) database for hospitalizations in 2016 with atrial fibrillation/flutter and percutaneous LAAO.
• Assessed peri-procedural complications: mortality, stroke, major bleeding, and pericardial effusion.
• Compared complication rates against published RCTs and the EWOLUTION cohort.

Main Results:

• An estimated 5175 LAAO procedures were performed in 2016.
• The overall complication rate was 1.9%, with in-hospital mortality at 0.29%.
• Pericardial effusion (0.68%) was the most frequent complication; stroke and systemic embolism rates were low (0% and 0.29%).

Conclusions:

• Percutaneous LAAO with the Watchman device in the USA is linked to low in-hospital complications.
• The safety profile is comparable to the EWOLUTION cohort and favorable when compared to major RCTs.
• Findings support the favorable safety and efficacy of Watchman device implantation for LAAO.