Comparison of Physician Modified Endovascular Grafts With a ZFEN Platform to Non-ZFEN Physician Modified Endovascular Grafts and Non-ZFEN Commercially Manufactured Devices for Repair of Complex Aortic Aneurysms.
Michael Spinosa, Daniel Torrent, Rachael Ellis, Joshua Adams
Carilion Clinic Health System, Roanoke, VA
INTRODUCTION: Fenestrated endovascular aortic aneurysm repair (FEVAR) has been shown to alleviate the limitations of complex aortic aneurysm (CAA) repair. Manufacturers have produced custom-modified commercially manufactured fenestrated devices (CMD) in order to better treat CAA. However, not all physicians have access to CMDs and in emergency situations there is not sufficient time to create a CMD. Physician modified endovascular grafts (PMEG) allow physicians to make back-table modifications of current fenestrated devices. PMEG previously used Zenith-Flex and Zenith TX2 platforms. Using a ZFEN platform PMEG improves treatment options for CAA. To increase treatment options for patients with CAAs, we compared ZFEN platform PMEG repair outcomes with non-ZFEN PMEG and CMD repair published outcomes.
METHODS: A prospectively maintained database following a cohort of patients receiving ZFEN PMEG repairs to treat CAA at Carilion Clinic was evaluated from 2017-2020. Published results of non-ZFEN CMD and PMEG to repair aortic aneurysms was also evaluated. Our primary outcomes are to compare ZFEN PMEG with non-ZFEN PMEGs and CMDs using aneurysm related mortality, all mortality, major adverse events, reinterventions, and target artery patency at 30-day and 1-year follow up. Our secondary outcome is to compare ZFEN PMEG change in aneurysm size at the same time points.
RESULTS: Aneurysm related mortality was non-significant between ZFEN PMEG (n=106) repair and non-ZFEN PMEG (n=145) repair groups at 30-day and 1-year post-op (p=0.422, p=0.125). All mortality was non-significant between groups at 30-day post-op (p=0.568) and significantly lower in the ZFEN PMEG group at 1-year follow up (p=0.003). Major adverse events were significantly less in the ZFEN PMEG group at 30-day post-op (p<0.001). Aneurysm related mortality and all mortality was non-significant between ZFEN PMEG repair and CMD (n=171) repair groups at 30-day post-op (p=0.383, p= 0.055) and 1-year post-op (p=0.146, p=0.792. Major adverse events were significantly less in the ZFEN PMEG group at 30-days (p=0.02). Aneurysm size was significantly decreased in the ZFEN PMEG group at 1-year post-op by 3.3mm (p<0.001).
CONCLUSIONS: This study supports ZFEN PMEG repair as an alternative to non-ZFEN PMEG and CMD repair. We plan to report 3-year follow up data and endoleak status. We hope these results support a future application for an IDE to further study the use of ZFEN PMEG repair.
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