Welcome to the ICD Registries Educational Overview. The content in this presentation was developed by Carolyn Morgan and Christina Koutras. I am Denise Pond and I will narrate this presentation. The objectives for this registry overview are for the learner to be able to define the purpose and background of the ICD Registry, identify the significance of ventricular arrhythmias in sudden cardiac death, and examine the role of federal requirements and registry governance. The Implantable Cardioverter-Defibrillator Registry, or ICD Registry, is a national data collection tool designed to capture the characteristics, treatments, and outcomes of patients receiving ICD generators. The data also provides a means to assess for quality improvement opportunities, optimize patient outcomes and management, as well as a tool to track your compliance with the national coverage determination. Patient-level data is submitted by participating hospitals on a quarterly basis to the American of Cardiology Foundation's National Cardiovascular Data Registry, or NCDR, which then produces an outcomes report of the hospital's data with comparison to both a volume peer group, which is the number of ICD patients submitted annually, and the entire ICD Registry dataset. Participating hospitals may use their data for quality improvement or QI purposes to improve patient care at their respective institutions. The data collected can be used to optimize the outcomes and management of ICD patients through implementation of evidence-based clinical guideline recommendations to facilitate efforts to improve quality and safety of patients at risk for sudden cardiac death, to investigate novel QI methods, and to provide a risk-adjusted assessment of patients for comparison. The procedures captured in the ICD Registry are significant to population health. Greater than 5 million patients in the United States are diagnosed with heart failure. Patients with heart failure suffer sudden cardiac death at a rate of 6 to 9 times greater than the general population. More than 326,000 people of all ages experience emergency medical service assessment out of hospital non-traumatic sudden cardiac death each year, and 9 out of 10 victims die. Clinical trials, such as the Sudden Cardiac Death in Heart Failure Trial, reinforce the need to provide preventative ICD prevention and revise the ICD medical guidelines. As you can see, understanding patient risk, evaluating treatments, and patient outcomes can provide life-saving benefits. The ICD Registry has a long history of value, supporting quality improvement efforts, research, guideline, and other stakeholder needs. On January 27, 2005, the Centers for Medicare and Medicaid Services, or CMS, announced its expanded ICD coverage decision for primary prevention ICD therapy in the form of a national coverage decision, which includes, as part of the criteria, participation in a data collection registry for coverage. The ICD Registry, Version 1, launched in 2006. Facilities were required to submit their Medicare primary prevention patients to the registry. However, the majority of facilities found value in submitting all their generator and leads procedures to have robust quality improvement metrics. After 13 years, on February 15, 2018, CMS ended the requirement for data collection in the ICD Registry. However, the ICD Registry is still strong and focused on data abstraction and quality initiatives for all ICD and CRTD device implants. Even though the data collection requirement was fulfilled, CMS maintains a national coverage determination for ICD implantation, which still requires certain criteria be met. The ICD Registry is here to assist and still maintains its commitment to quality improvement. It serves as a valuable documentation tool for risk mitigation associated with meeting the CMS coverage criteria. The registry includes patients of all ages who are receiving any of the following procedures, an initial implant of an ICD or CRTD generator, whether for primary or secondary prevention, generator changes, generator explants, or ICD or CRTD lead changes and revisions. An ICD or CRTD generator will be implanted for either primary or secondary prevention. In addition, there may be an indication for pacing or resynchronization therapy. Placement for primary prevention means the utilization of an ICD to prevent an initial episode of sudden arrhythmic cardiac death. The patient has not yet suffered a life-threatening event. However, the patient is at risk and includes those patients with risk factors such as heart failure, MI, and low ejection fraction. Placement for secondary prevention means the utilization of an ICD to prevent or treat a recurrent life-threatening arrhythmic event. The patient has already suffered an episode of a life-threatening arrhythmic event or sustained ventricular tachycardia, not due to a reversible cause. Reversible causes which may trigger ventricular tachycardia include but are not limited to electrolyte imbalances, acute ischemia, and possible proarrhythmic effects of antiarrhythmic drugs. As a nationally recognized surveillance tool, the ICD Registry is well positioned within the healthcare industry to support ongoing quality improvement efforts for patients having these procedures. The ICD Registry provides hospitals feedback on their data in comparison to the registry benchmark on a weekly basis through an interactive dashboard and quarterly through published outcome reports. The 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. The ICD Registry has become a tool for outside stakeholders, healthcare systems, states, and payers who use it to assess the incidence and trends of ICD and CRTD procedures and the quality of care provided by providers and centers engaged in these procedures. It supports numerous research initiatives, informs clinical practice and guideline development. Additionally, registered data can be used to support ACC accreditation services, EP accreditation, and select metrics have been developed for public reporting. Hospitals who engage in public reporting will receive credit towards their score for ranking with the U.S. News and World's Report Best Hospitals in Cardiology and Heart Surgery, and their data will appear on the ACC's publicly facing CardioSmart website supporting patient knowledge. The ICD Registry is governed by a 7 to 10 member steering committee with a chair and ex officio members from the ICD Registry Research and Publications Subcommittee and NCDR Management Board. Committee members have expertise in clinical practice, financial management, quality measurement and improvement, and or health systems strategy and innovation. The steering committee provides registry strategic oversight and direction. They offer guidance for program activities, identify quality improvement opportunities, and scientific research insights helping to identify priorities. ICD recommendations are provided to the NCDR Management Board and help inform decisions. Please be sure all website resources are reviewed as part of registry participation. Thank you for being part of the ICD Registry community. This concludes the overview of the ICD Registry. Thank you for your participation. Thank you. Thank you. Thank you.

ICD Registry

Implantable Cardioverter-Defibrillator

national data collection

patient outcomes

compliance with national coverage determination