In-hospital adverse events occurred at lower rates after left atrial appendage occlusion in a registry than were shown in two previous randomized trials, according to late-breaking study results presented Sunday at the American College of Cardiology Scientific Sessions 2020 virtual conference.
James Freeman, MD, of Yale University, presented the analysis from the National
Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, which was also published simultaneously online in the Journal of the American College of Cardiology.
Two major randomized trials, PROTECT-AF and PREVAIL, showed that percutaneous LAAO is effective in preventing stroke in patients with atrial fibrillation. However, post-approval clinical data are limited.
In this large study from the LAAO Registry, Freeman and colleagues studied patient, hospital and physician characteristics and in-hospital adverse-event rates for the first 3 years (January 2016 through December 2018) after procedures with the Watchman (Boston Scientific) occlusion device.
A total of 38,158 procedures were performed in 495 hospitals by 1,318 physicians in the U.S. The patients’ mean age was 76±8.1 years, their mean CHA2DS2-VASC score was 4.6±1.5, and their mean HAS-BLED score was 3.0±1.1. The median annual number of LAAO procedures performed per hospital was 30 and per physician was 12. The procedure was aborted or canceled in 7% of the cases and was successful in 92% of the patients. The rate of major in-hospital adverse events was 2%,with the most common adverse event being pericardial effusion requiring intervention (1.4%) and major bleeding (1.2%). In-hospital stroke (0.17%) and death (0.19%) were rare.
Freeman concluded that in a real-world setting, older patients with more comorbidities underwent percutaneous LAAO with the Watchman device for stroke prevention, and the rate of major in-hospital adverse events was lower than that reported in previous randomized controlled trials.
This study was funded by the American College of Cardiology (ACC) National
Cardiovascular Data Registry (NCDR) and the National Heart, Lung and Blood Institute of the National Institutes of Health.