New research using data from ACC's LAAO Registry to assess long-term stroke and mortality rates in patients following left atrial appendage occlusion (LAAO) with the Watchman device was part of late-breaking science presented at ESC Congress 2023.

The study, presented by James V. Freeman, MD, MPH, MS, FACC, from Yale School of Medicine, assessed data from 34,975 patients (mean age 77.5 years; 41.8% female) in the LAAO Registry from Jan. 1, 2016 through Dec. 31, 2019. Researchers linked data to Medicare claims data. The primary endpoints were any stroke, ischemic stroke, and death. Stroke and mortality cumulative incidence rates were calculated per 100 person-years (PY). The cumulative incidence function was used to evaluate rates of stroke accounting for the competing risk of death and the Kaplan-Meier (K-M) method was used to evaluate rates of survival over four years of follow-up.

Overall findings found long-term stroke rates among Medicare patients were low despite the high thromboembolic risk of the patient population. The cumulative incidence rate per 100 PY for stroke was 1.89 for any stroke, 1.55 for ischemic stroke, and 9.51 for death. The cumulative incidence function rate for stroke was very consistent at 1.84 and the K-M estimate for death was 8.63. Rates of stroke and death remained overall consistent over the four-year follow-up period.

"These results demonstrate the effectiveness of LAAO for stroke prevention in this high-risk real-world population, but the relatively high risk for death highlights the importance of informed patient selection and shared decision-making," said Freeman. "The study further evaluated risk factors associated with increased risk of mortality that may be helpful in this shared decision-making process, including being underweight, high fall risk and heart failure."

According to Freeman, a final important finding of the study, is that the rates of stroke and death found using Medicare data were very consistent with those previously published using the prospectively collected site-reported data in the LAAO Registry alone. "This demonstrates a very good data capture in the registry," he said.

Clinical Topics: Arrhythmias and Clinical EP

Keywords: ESC Congress, ESC23, ACC International, National Cardiovascular Data Registries, LAAO Registry, Atrial Function, Left

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