Welcome to this learning activity titled an EP device implant registry overview. After participating in this learning activity, the learner will be able to define the purpose and background of the EP device implant registry, identify the significance of ventricular arrhythmias and sudden cardiac death, and review inclusion criteria for the EP device implant registry. The EP device implant registry is a national data collection tool designed to capture the characteristics, treatments, and outcomes of patients receiving ICDs and novel permanent pacemakers. The purpose of this registry is to assess the characteristics, treatments, and outcomes of patients receiving ICD generators and novel permanent pacemakers. Participating hospitals may use their data for QI or quality improvement purposes to improve patient care at their respective institutions. The data collected can be used to optimize the outcomes and management of ICD and novel permanent pacemaker patients through implementation of evidence-based clinical guideline recommendations. To facilitate efforts to improve the quality and safety of patients at risk for sudden cardiac death and to investigate novel QI methods and provide a risk-adjusted assessment of patients for comparison. The registry tracks compliance with the National Coverage Determination. Additionally, patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry or NCDR. The data is then provided in a benchmark outcomes report with comparison to both the volume peer group, which is the number of ICD patients and novel permanent pacemakers submitted annually, and the entire EP device implant registry data set. The procedures captured in the EP device implant registry are significant to population health. About 6.2 million adults in the United States have heart failure and is projected to grow to greater than 8 million in 2030. In 2018, heart failure was mentioned on 379,800 death certificates, which is 13.4%. Heart failure cost the nation an estimated $30.7 billion in 2012. This total includes the cost of health care services, medicines to treat heart failure, and the missed days of work. In 2018, any mentioned sudden cardiac arrest mortality in the U.S. was 393,872. According to 2019 data, most of the out-of-hospital cardiac arrest, OHCA, occur at home or a resident 70% of them, public settings at 18.8%, and nursing homes at 11.2% were the second and third most common locations of OHCA. According to 2019 data, OHCA was witnessed by a layperson in 38.3% of cases and by an EMS provider in 12.7% of cases. Additional trial findings, such as the Sudden Cardiac Death and Heart Failure Trial, the SCUDHEF trial, reinforce the need to provide preventative IC protection and revise the ICD medical guidelines. This bundle and left-bundle pacing has emerged as a novel approach to cardiac resynchronization and RV pacing, and the EPDI registry is now tracking these approaches. As you can see, understanding patient risk, evaluating treatments, and patient outcomes can provide life-saving benefits. The EP Device Implant Registry, which was formerly known as the ICD Registry, has a long history of value supporting quality improvement efforts, research, guidelines, and other stakeholder needs. On January 27, 2005, CMS, which is the Centers for Medicare and Medicaid Services, announced an expanded ICD coverage decision for primary prevention ICD therapy in the form of a national coverage decision, which was included at the time as part of the criteria for participation in a data collection registry for coverage. This was initiated in response to expanded coverage for ICDs implanted based on findings primarily from two trials, the Sudden Death and Heart Failure Trial, the SCUDHEF, and the Multi-Center Automatic Defibrillator Implantation Trial II, otherwise known as MAT-IT II. The QNET, or the Quality Network Exchange, was a temporary data collection tool consisting of 10 questions that was operated by the Iowa Foundation for Medical Care. It was replaced by the ICD Registry on April 1, 2006, when version 1 was launched. It became, and remained, the sole data repository for the collection of primary prevention for ICD or CRTD implants. However, the majority of facilities found value in submitting all of their generator and lead procedures to have robust quality improvement metrics. On April 1, 2010, version 2.1 was launched. The scope expanded to include the addition of pediatric ICD implants, needs data, and needs-only procedures. On April 1, 2016, version 2.2 was launched to create a more parsimonious data collection tool which reduced data abstraction burden without compromising the quality of the registry's metrics and also added data elements to address the appropriate use criteria. CMS ended its requirement for data collection in the EP Device Implant Registry on February 15, 2018, 13 years after the requirement was initiated. The EP Device Implant Registry still continues to bring value, not only in relation to data abstraction and quality initiatives for all ICD and CRT device implants and novel permanent pacemakers, but also supports the CMS national coverage determination, incorporating the patient voice with shared decision-making through the launch of version 2.3 on April 1, 2021. The registry inclusion criteria is comprised of patients of all ages who are having any of the following procedures, an initial implant of an ICD, CRTD, leadless PPM, left-bundled PPM or CRTP generators, whether for primary or secondary prevention, generator changes, generator explants, or ICD, CRTD, or novel permanent pacemaker lead changes and revisions. Referring to primary versus secondary prevention, an ICD or CRTD generator may be placed for various reasons and the ICD implant indication is either for primary or secondary prevention. Implant for primary prevention is the utilization of an ICD to prevent an initial episode of sudden arrhythmic cardiac death as the patient has not yet suffered a life-threatening event or the patient is at risk for SCA due to risk factors such as heart failure, MI, and low EF. Implant for secondary prevention means the utilization of an ICD to prevent or treat recurrent life-threatening arrhythmic events. The patient has already suffered an episode of a life-threatening arrhythmic event or sustained VT not due to reversible causes. Reversible causes which may trigger ventricular tachycardia include but are not limited to causes such as electrolyte imbalances, ischemia, and possible pro-arrhythmic effects of anti-arrhythmic drugs. A nationally recognized surveillance tool, the VT device implant registry is well-positioned within the healthcare industry to support ongoing quality improvement efforts for patients having these procedures. The VT device implant 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 outcomes reports. Data can support the hospital's internal process and quality improvement efforts as well as provide timely insights into their adherence to performance measures and guideline care. The VT device implant registry has become a tool for outside stakeholders, healthcare systems, states, and payers who use it to assess the incidence and trends of ICD-CRTD procedures and the quality of care provided by the professionals and centers engaged in these procedures. The registry supports numerous research initiatives and informs clinical practices and guideline development. Additionally, registry data can be used to support ACC accreditation services, EP accreditation, and public reporting. Hospitals who engage in public reporting will receive credit toward their score for ranking with the U.S. News and World Report's Best Hospitals in Cardiology and Heart Surgery, and their data will appear on the ACC's publicly facing CardioSmart website supporting patient knowledge. The VT device implant registry is governed by a 10-member steering committee led by a chair and includes an ex-officio member of the NCDR Oversight Committee. Committee members have expertise in clinical practice, financial management, quality measurement and improvement, and or a health system strategy and innovation. The steering committee provides strategic oversight and direction by providing guidance for program activities and research insights while helping to identify priorities. Thank you for participating in this learning activity titled An EP Device Implant Registry Overview. After participating in this learning activity, the learner should now be able to define the purpose and background of the EP device implant registry, identify the significance of ventricular arrhythmias and sudden cardiac death, and review inclusion criteria for the EP device implant registry.

EP Device Implant Registry

national data collection tool

ICDs

novel permanent pacemakers

quality improvement purposes

patient care

evidence-based clinical guidelines