EVAR in the treatment of ruptured abdominal aortic aneurysms (rAAA) is an MDEpiNet Coordinating Center -supported clinical trial project nested under the ICVR. UAB has been established as an MDEpiNet collaborator for this and future projects.
The aim of this project is to evaluate the safety and effectiveness of EVAR devices used to treat rAAA (compared to open rAAA repair) by international evaluation in the existing ICVR registries. The project is intended to provide manufacturers of currently approved EVAR devices (Cook, Endologix, Gore, Medtronic) with real-world data allowing them to understand better how their devices perform in the setting of ruptured aneurysm.
As EVAR is now the primary treatment for AAA, there is increasing importance to evaluate these parameters from a surgical quality and outcome perspective. Additionally, these data could be used as support for a regulatory application to modify the labeling of the endovascular grafts evaluated in this study with respect to rAAA.
The central purpose of this project is to evaluate in-hospital mortality after EVAR for rAAA in a multinational registry collaboration using mortality associated with standard open repair to establish performance goals. Given that untreated rAAA carries a mortality approaching 100%, the project will focus specifically on survival to discharge. Further, the long-term safety and effectiveness of these EVAR devices has been extensively studied and established for elective AAA repair. The major endpoint for this project is improving initial survival based on the improvement of outcomes after rAAA repair.
This figure (Beck AW et al. 2019) demonstrates the modality of repair for intact (A) and ruptured (B) aneurysms internationally27. EVAR has become the dominant method of repair for elective aneurysms internationally. In the United States, the proportion of ruptured aneurysms treated with EVAR exceeds 50%, despite a lack of formal evaluation in this clinical setting.