Welcome to this learning activity titled an LAAO Registry Overview. After participating in this learning activity, the learner will be able to define the purpose of the LAAO Registry and associated federal requirements, state LAAO Registry inclusion population, and outline the follow-up timeframes associated with data collection. The Left Atrial Appendage Occlusion Registry, otherwise known as the LAAO Registry, is designed to capture data to assess the prevalence, demographics, management, and outcomes of patients who are undergoing percutaneous and epicardial-based left atrial appendage occlusion procedures to reduce the risk of stroke. Patient-level data is submitted by participating hospitals on a quarterly basis to the LAAO Registry. The primary aims of the LAAO Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous and epicardial-based left atrial appendage procedures, and to investigate novel quality improvement methods, as well as provide risk-adjusted assessments of patients for comparison with nationwide NCDR data. As new technologies develop, there is a need to understand the selection of patients and longitudinal outcomes for these procedures in contemporary clinical practice. The National Registry supports the collection and analysis of data for patients with non-valvular atrial fibrillation who are undergoing these therapies as new treatment options become available. The Registry serves to assist institutions in assessing the quality of care delivered for quality improvement initiatives. The LAAO Registry is considered an observational registry which can quickly accumulate large amounts of data on real-world practice and effectiveness of new left atrial appendage occlusion procedures. Physicians and hospitals can use these data and benchmark reporting to support quality improvement efforts locally, monitor patterns of care, and assess procedure utilization and variability. Registry data will be used to help develop clinical guidelines leading to improved patient care. Ultimately, the Registry will provide a better understanding of this population and emerging treatment options. What is the impact on population health which drives the need for procedures such as the left atrial appendage closures? It is estimated that over 6 million individuals in the United States are affected by atrial fibrillation and these individuals may account for as many as 1 in 5 strokes in persons aged over 80 years. There is evidence to support the hypothesis that for patients with non-valvular atrial fibrillation, the left atrial appendage is the most common source of thrombus formation resulting in stroke. Stroke is the fifth leading cause of death in the United States and a leading cause of disability in the United States, affecting over a half a million men and women a year. Traditionally, the standard of care for stroke prevention in patients with atrial fibrillation who have had an elevated stroke risk profile is chronic anticoagulation therapy with medication choice dependent upon the patient's risk of bleeding. Some patients with AFib whose stroke risk profiles would indicate anticoagulation therapy have contraindications to anticoagulation. Others are unable or unwilling to adhere to long-term anticoagulation therapy. In order to address the unmet needs of these patients, alternatives to pharmacological therapy to reduce the risk of stroke have been pursued. In this picture of the left atrium and ventricle, the blue circle highlights the left atrial appendage. This is the site where thrombus formation in patients with atrial fibrillation may occur. Sealing off the appendage to prevent blood from pooling in this area and thus reducing the risk of thrombus formation leading to stroke is the basis for the left atrial appendage procedure. With the evolution of percutaneous approaches to the left atrial appendage occlusion, the registry is positioned to assist in the collection of large amounts of data on real-world practice and effectiveness of new left atrial appendage occlusion procedures. Clinics and hospitals can use these data to support quality improvement efforts locally and monitor patterns of care, procedure utilization, and variability. The LAAO Registry launched in December of 2015 to meet these needs. On February 8, 2016, the Centers for Medicare and Medicaid Services issued a Final Decision Memo that supported a national coverage determination for Medicare patients undergoing percutaneous left atrial appendage closure. One component of the CMS decision includes a requirement to participate in a registry in order to receive reimbursement on Medicare patients undergoing this procedure. Visit the CMS.gov website or navigate to the Registry Resource Documents page to locate the details of the coverage decision. CMS has identified the LAAO Registry as an approved registry to meet the requirements of the national coverage determination for Medicare patients undergoing percutaneous left atrial appendage closure. The following patient population is included in the LAAO Registry. For patients undergoing a percutaneous catheter-based approach to LAA occlusion, the device being used for the occlusion is non-investigational and is FDA approved. All data on consecutive patients 18 years or older at the time of the procedure. The Registry captures data on the in-hospital encounter as well as follow-up information at four different time frames post-procedure. First follow-up should occur at 45 days post-procedure, second at six months, third at one year, and the fourth at two years post-procedure. Review the follow-up time frame guide for specific details on the follow-up data collection process. This document is located on the Registry website under Resource Documents. A unique component of the LAAO Registry is the event adjudication of specific neurologic and bleeding events. Many of these neurologic events occur, such as hemorrhagic, ischemic, or undetermined stroke, TA, intracranial hemorrhage, or systemic thromboembolism. Many of these bleeding events occur, such as site bleeding, GI bleeding, hematoma, hemothorax, requiring and not requiring drainage, or systemic hemorrhage, pericardial effusion with and without tamponade, peritoneal bleeding. Vascular complications are peripheral vascular events, like an AV fistula requiring surgical repair, spinal aneurysm requiring endovascular repair, surgical repair, thrombin injection, or lung intervention. In the hospital episode of care or during the follow-up timeframe, additional fields will need to be completed. These events will be adjudicated as an agreement confirmation process based on the additional data provided. A nationally recognized tool. The LAAO Registry is well positioned within the healthcare industry to support ongoing quality improvement as technology evolves over time. The LAAO Registry has become a tool for outside stakeholders who use it to assess the incidence and trends of left atrial appendage occlusion procedures as well as a quality improvement tool. It supports numerous research initiatives, informs clinical practice and guideline development. The LAAO Registry provides hospitals feedback on their data in comparison to the registry benchmark on a weekly basis through an interactive dashboard and quarterly published outcomes reports. This data can support the hospital's internal process and quality improvement efforts and provide timely insights into their adherence to performance measures and guideline care. The large ACC governance structure in place with many layers to provide oversight of the ACC NCDR registries. Mostly connected to the registry is the Steering Committee. The Left Atrial Appendage Occlusion Registry Steering Committee is governed by a 7-10 member Steering Committee with a Chair, a representative from the Society for Cardiovascular Angiography and Interventions, a Physio member from the LAAO Registry Research and Publication Subcommittee and a member of the NCDR Oversight Committee. These members have expertise in clinical practice, financial management, quality measurement and improvement and or health system strategy and innovation. The NCDR Registry monitors the registry's strategic direction, recommends changes to the NCDR Oversight Committee and identifies quality improvement opportunities. The NCDR Registry provides content, expertise and guidance for registry program activities. For those who are participating in this learning activity titled an LAAO Registry Overview, now that you have completed this learning activity, the learner will be able to define the purpose of the LAAO Registry and associated federal requirement, identify the LAAO Registry inclusion population and outline the follow-up timeframes associated with data collection.

LAAO Registry

left atrial appendage occlusion

stroke risk reduction

atrial fibrillation

data collection

patient-level data

clinical guidelines