Utilization and procedural adverse outcomes associated with Watchman device implantation

Aims The Food and Drug Administration (FDA) approval of the Watchman device [percutaneous left atrial appendage occlusion (LAAO)] has resulted in the widespread use of this procedure in many centres across the USA. We sought to estimate the nationwide utilization and frequency of adverse outcomes associated with Watchman device implantation. The objective of this study was to evaluate the Watchman device implantation peri-procedural complications and comparison of the results with the previous studies. Methods and results The National Inpatient Sample (NIS) was queried for all hospitalizations with a primary diagnosis of atrial fibrillation or atrial flutter during the year 2016 with percutaneous LAAO during the same admission (ICD-10 code02L73DK). The frequency of peri-procedural complications, including mortality, procedure-related stroke, major bleeding requiring blood transfusion, and pericardial effusion, was assessed. We compared the complication rates with the published randomized controlled trials and the European Watchman registry. An estimated 5175 LAAO procedures were performed in 2016. The majority of procedures was performed in males (59.1%), age >= 75 years (58.7%), and White (83.1%). The overall complication rate was 1.9%. The in-hospital mortality was 0.29%. Pericardial effusion requiring pericardiocentesis was the most frequent complication (0.68%). Bleeding requiring transfusion was noted in 0.1% of device implants. The rates of post-procedure stroke and systemic embolism were 0% and 0.29%, respectively. Conclusion Percutaneous LAAO with the Watchman device in the USA is associated with low in-hospital complications and a similar safety profile to a recently published EWOLUTION cohort. The complication rates were lower than those reported in the major randomized clinical trials (RCTs). We report the frequency of peri-procedural complications of the LAAO using the Watchman device from the NIS database. We also compare the frequency of periprocedural complications with the previously published RCTs and EWOLUTION cohort. Our findings are in concordance with findings from EWOLUTION cohort and compare favourably with RCTs.

Automated summary

The FDA approval of the Watchman device has led to its widespread use in the USA. A study was conducted to evaluate the nationwide utilization and adverse outcomes associated with Watchman device implantation in 2016, with findings showing a low overall complication rate of 1.9% and in-hospital mortality rate of 0.29%. The complication rates were lower than those reported in major randomized clinical trials (RCTs) and were similar to the European Watchman registry findings.