NCDR LAAO Registry Enables Comparison of LAAO in Clinical Practice vs. Clinical Trials
Patients undergoing left atrial appendage occlusion (LAAO) in clinical practice had a lower risk of ischemic stroke, similar risk of hemorrhagic stroke, and greater mortality risk over the 425 days following implant when compared with patients enrolled in pivotal LAAO clinical trials, based on an analysis published May 2 in JACC: Cardiovascular Interventions.
Daniel J. Friedman, MD, FACC, et al., used propensity matching to compare data from ACC’s LAAO Registry with data from patients enrolled in the PROTECT-AF and PREVAIL trials. The LAAO Registry is part of ACC’s NCDR suite of clinical data registries. All registry patients included in the analysis were considered “trial-eligible.”
Results found that risk of periprocedural ischemic stroke and 425-day risk of ischemic stroke was higher in LAAO trial patients compared with registry patients (0.9% vs. 0.2% and 2.70% vs. 1.21%, respectively). Additionally, the rate of complications and LAAO implant failure were substantially higher among clinical trial participants compared with those in the registry.
In other findings, researchers observed a similar risk of hemorrhagic stroke among the registry and trial groups; however, hemorrhagic stroke risk was much lower after LAAO in registry patients compared with trial patients on warfarin (1.44% vs. 0.20%). Researchers also noted significantly lower mortality risk among clinical trial patients in contrast to those from the registry (2.92% vs. 6.23%), largely attributable to noncardiovascular deaths.
According to Friedman and colleagues, their findings suggest improved safety and effectiveness of LAAO in clinical practice. However, they suggest more research is needed to determine the efficacy of the Watchman device for higher-risk patients who fail to meet trial criteria. They also highlight the value of having a national registry like the LAAO Registry to evaluate the outcomes of implementing new technologies in clinical practice.
In an accompanying editorial comment, Stephen A. Tang, MD, FACC, and Shephal K. Doshi, MD, FACC, call ACC’s LAAO Registry a critical resource for reviewing patient outcomes. They assert, “While caution should be exercised in performing LAAO in patient populations that have not been studied rigorously, it is only through large databases such as the NCDR that we can rapidly collect such valuable data.”
Keywords: Septal Occluder Device, Atrial Fibrillation, Ischemic Stroke, Registries, Stroke, Hemorrhagic Stroke, Brain Ischemia, Atrial Appendage, Warfarin, LAAO Registry
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