Welcome to the LAO Registries Educational Overview. The content in this presentation was developed and narrated by Christina Koutras. The objectives for this registry overview are for the learner to be able to define the purpose of the LAO Registry and associated federal requirement, state two specific requirements and one associated health risk for AFib patients included in the registry, and to outline the follow-up timeframes associated with data collection. The ACC has the following mission and vision statements, which serve as the heart of what drives the ACC in daily operations. The ACC mission statement is to transform cardiovascular care and improve heart health. The vision, a world where innovation and knowledge optimize cardiovascular care and outcomes. The left atrial appendage occlusion registry is designed to capture data to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous and epicardial baselift atrial appendage occlusion procedures to reduce the risk of stroke. Patient level data will be submitted by participating hospitals on a quarterly basis to the LAO Registry. The primary aims of the LAO Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations and clinical practice. To facilitate efforts for improving the quality and safety for patients undergoing percutaneous and epicardial baselift atrial appendage procedures. To investigate novel quality improvement methods and provide risk-adjusted assessment 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. A national registry will support the collection and analysis of data for patients with non-fabular atrial fibrillation undergoing these therapies as new treatment options become available. The registry can serve to assist institutions in assessing the quality of care delivered for quality improvement initiatives. The LAO 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. Institutions 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 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 over the age of 80. There is evidence to support the hypothesis that, for patients with non-fabular AF, 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 U.S., affecting over half a million men and women a year. Traditionally, the standard of care for stroke prevention in patients with AF who have an elevated stroke risk profile is chronic anticoagulation therapy with medication choice dependent upon the patient's risk of bleeding. Some patients with AF 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 procedures. 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. Physicians and hospitals can use these data to support quality improvement efforts locally and monitor patterns of care, procedure utilization, and variability. The LAO Registry launched in December of 2015 to meet these needs. On February 8th of 2016, the Centers for Medicare and Medicaid Services issued a final decision memo that supports 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. Please 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 LAO Registry as an improved registry to meet the requirements of the national coverage determination for Medicare patients undergoing percutaneous left atrial appendage closure. The following patient population will be included in the LAO Registry. All patients who undergo a percutaneous catheter-based approach to left atrial appendage occlusion where 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 should be entered. Please be sure to review the Submission Population Inclusion Criteria document located on the Registry website under Resource Documents. The Registry captures data on the in-hospital encounter as well as follow-up information at four different time frames post-procedure. The first follow-up should occur at 45 days post-procedure, the second at six months, the third at one year, and the fourth at two years post-procedure. Please 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 LAO Registry is the event adjudication of specific neurologic and bleeding events. If any of these neurologic events occur, hemorrhagic, ischemic, or undetermined stroke, TIA, intracranial hemorrhage, or systemic thromboembolism, or any of these bleeding events occur, access site bleeding, hematoma, vascular complications, GI bleeding, retroperitoneal bleeding, or other hemorrhage occurred during the in-hospital episode of care or during the follow-up time frame, additional fields will need to be completed. These events will be adjudicated as an agreement confirmation process based on the additional data provided by the facility. As a nationally recognized tool, the Left Atrial Appendage Occlusion Registry is well positioned within the healthcare industry to support ongoing quality improvement initiatives as technology evolves over time. The LAO Registry has become a tool for outside stakeholders who use it to assess the incidents 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 LAO Registry provides hospitals feedback on their data in comparison to the registry benchmark on a weekly basis through an interactive dashboard and through quarterly reporting via published outcome reports. These data can support the hospital's internal process and quality improvement efforts and provides timely insight into their adherence to performance measures and guideline care. There is a large ACC governance structure in place with many layers to provide oversight of the ACC NCDR registries. Most closely 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 Member Society, and ex officio members from the LAO Registry Research and Publication Subcommittee and NCDR Management Board. Committee members have expertise in clinical practice, financial management, quality measurement and improvement, and or a health system strategy and innovation. The committee monitors the registry's strategic direction, recommends changes to the management board, identifies quality improvement opportunities, and provides content expertise and guidance for registry program activities. As you navigate to the registry website, please be sure all resources are reviewed as you begin registry participation. Thank you for being a part of the LAO Registry community. This concludes the overview of the LAO Registry. Thank you for your participation.

LAO Registries

Left Atrial Appendage Occlusion

stroke risk reduction

data collection

clinical guidelines