LAAO Registry Study Finds Infrequent Rate of Thromboembolic Events After Transcatheter LAAO
The rate of thromboembolic events after transcatheter left atrial appendage occlusion (LAAO) may be infrequent over the first year post procedure when considering the high-risk profile of the population, according to "real-world" data from ACC's LAAO Registry published April 4 in JACC: Cardiovascular Interventions (JINT).
Transcatheter LAAO with the Watchman device was approved by the U.S. Food and Drug Administration in 2015 as an alternative to pharmacologic therapy for stroke prevention in select patients with atrial fibrillation. ACC's LAAO Registry was initiated to meet a condition of Medicare coverage and to allow the assessment of LAAO clinical outcomes.
Matthew J. Price, MD, FACC, looked at one-year clinical outcomes from ACC's LAAO Registry which included data from 36,681 patients entered for a Watchman procedure between Jan. 1, 2016, and Dec. 31, 2018. The mean age was 76 years, the mean CHA2DS2-VASc score was 4.8 and the mean HAS-BLED score was 3.0. A quarter (25.5%) had a prior stroke, 69.5% had clinically relevant bleeding and 11.9% had intracranial bleeding.
Results showed that for the primary endpoint of ischemic stroke, the Kaplan-Meier estimated one-year rate was 1.53%. The rates for key secondary endpoints were 2.19% for ischemic stroke or systemic embolism and 8.52% for mortality. The one-year estimated rate of major bleeding was 6.93%. Most bleeding events occurred between discharge and 45 days following the procedure.
The authors conclude the rate of all-cause and noncardiovascular mortality in this high-risk group underscores the need for an individualized approach to maximize the clinical utility in this population. "Clinicians and patients can integrate these data in shared decision-making when considering this therapy," they add.
In an accompanying JINT editorial comment, Apostolos Tzikas, MD, PhD, notes that the data is useful but dated because the Watchman device has been replaced by next-generation devices. "The one-year results of the NCDR LAAO Registry are extremely valuable. Hopefully … results from the next-generation LAAO devices will be available soon," he writes.
In a perspective on ACC.org, Geoffrey D. Barnes, MD, MSc, FACC, adds that moving forward, "Future studies are needed to assess the risk of thromboembolism and bleeding in the absence of anticoagulation or multiple antithrombotic agents. Furthermore, the newer-generation Watchman FLX device was not included in this study population, but may impact thromboembolic risk. Nonetheless, this 'real-world' analysis of the Watchman LAAO provides reassuring evidence of efficacy and safety, re-affirming LAAO as a viable therapy for stroke prevention in atrial fibrillation for patients who are not good candidates for anticoagulation therapy."
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: LAAO Registry, National Cardiovascular Data Registries, Fibrinolytic Agents, Atrial Appendage, Atrial Fibrillation, Brain Ischemia, Patient Discharge, United States Food and Drug Administration, Medicare, Stroke, Anticoagulants, Thromboembolism, Registries, Hemorrhage, Ischemic Stroke, Embolism, Echocardiography, Transesophageal
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