Philip P. Goodney, MD, is unveiling a pivotal monitoring tool during the Vascular Quality Initiative (VQI) Annual Meeting, VQI@VAM, today—the Long-Term EVAR Assessment and Follow-up (LEAF) surveillance protocol, a multi-stakeholder initiative aimed at enhancing long-term monitoring of endovascular aneurysm repair (EVAR) outcomes.
The presentation, being delivered by the section chief at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, highlights the importance of post-market, observational surveillance in improving patient outcomes and device performance over a 10-year period.
To improve the quality, safety, and effectiveness of vascular care after EVAR, the LEAF surveillance protocol uses fully anonymized and de-identified real-world evidence and data from the VQI VISION’s registry-claims linked datasets and Kaiser Permanente datasets, which represents over 52,000 patients from more than 400 centers. The protocol will provide device-specific long-term safety evaluation for endpoints such as reintervention, rupture and mortality.
The LEAF surveillance protocol was created in collaboration with industry device manufacturers Cook Medical, Gore, Endologix, Medtronic and Terumo Aortic and approved by the Food and Drug Administration (FDA). The protocol will ingest real-world data to provide insight into long-term outcomes in a sustainable manner. The multi-year initiative will generate annual device-specific clinical outcomes reports to ultimately provide a 10-year view into EVAR outcomes, with the ultimate goal of improving quality care for patients. All collected data are generated as reports without patient specific details in compliance with the rules and regulations of registry and Medicare beneficiaries.
“Improving outcomes is always a top priority for the SVS VQI and our industry partners,” said Philip Goodney, MD, chair of the SVS VQI LEAF Steering Committee, speaking ahead of his presentation. “This protocol is a testament of our commitment to quality. Real-world data provided by the SVS VQI registry is a vital tool for the analysis of medical products and devices.”
Key clinical endpoints on the LEAF surveillance Protocol include overall mortality, aneurysm-related mortality, rupture, reintervention and conversion to open surgery. Imaging endpoints will track changes in aneurysm size, endoleak classification and device patency. Follow-up will be conducted according to each site’s standard of care, with the next major data report scheduled for release this fall at the 18-month mark. Goodney emphasized the collaborative nature of the initiative, calling it “a critical step forward in ensuring the long-term safety and effectiveness of EVAR technologies in everyday clinical practice.”
