The long-term endovascular aneurysm repair (EVAR) assessment and follow-up (LEAF) surveillance program: A framework for national long-term safety evaluation after cardiovascular interventions

On November 3, 2021, the Circulatory System Devices Panel of the Medical Device Advisory Committee met to discuss the role of real-world evidence in measuring the safety and long-term effectiveness of endovascular stent grafts used to treat abdominal aortic aneurysms. The panel concluded that long-term surveillance after endovascular aortic aneurysm repair (EVAR) was necessary, and 10-year outcomes in real-world practice should be collected and reported to stakeholders. In collaboration with endograft manufacturers, a multidisciplinary group created the Long-term EVAR Assessment and Follow-up (LEAF) surveillance program. This program leverages registry-based data sources and data from a national health care system, Medicare claims-based linkages, enhanced registry data entry, and targeted clinical and imaging follow-up to better surveil long-term device performance after EVAR. In this practice management guideline, we discuss the role of the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network and Kaiser Permanente in this process, the methodology of linking registry-level and Medicare claims data for long-term device surveillance, the development of LEAF, and key points for the future and additional possible applications to cardiovascular procedures. This guideline can inform the processes behind developing long-term device monitoring protocols, which can serve as a benchmark report for the iterative expansion for future surveillance programs.