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Endoex: Verification And Validation Of A Novel EVAR Explantation Tool
Rishik S. Puppala, BBA1, Brandon A. Look Fong, BSBME1, Maham Rahimi, MD, PhD2, Nicholas Sears, PhD1, Solyman Hatami, BEBME1.
1Texas A&M University, Houston, TX, USA, 2Houston Methodist Hospital, Houston, TX, USA.

Objectives: Endovascular abdominal aortic aneurysm repair (EVAR) and its recent advances has improved the outcomes of the abdominal aortic aneurysm (AAA) repair with lower morbidity and mortality in the short term. However, endovascular stent grafts are associated with two major complications including graft infection (10%) and endoleaks (68%) with sac expansion which both require multiple interventions. Graft explantation is necessary because of infection or failure of endosalvage of endoleak which are both associated with high morbidity and mortality. Consequently, various institutions have explored device solutions to aid in endograft removal safely, with some repurposing surgical syringes or proctoscopes. Currently, there are no available instruments to safely remove endografts, and the need to minimize damage to the aortic wall during EVAR explantation.
Methods: This project utilized an initial prototype developed by our team. This study focused on the development of a benchtop model for prototype testing and iteration. This benchtop model simulates the surgical environment and incorporates methods for evaluating arterial dissection and device effectiveness. Based on feedback from vascular surgeons and analysis done with benchtop testing, features were identified to improve device efficiency and effectiveness.
Result: The current model works using a cylindrical device which hinges to allow the device to wrap around the endograft. At one end of the device an offset shape is used to compress the endograft. On this same side, design features to reduce arterial dissection due to the friction between the device and aortic wall were implemented. Surgeons performed explanations of endografts in a silicon-based analog of an abdominal aorta using the newly designed device. We performed benchtop experiments which validated the feasibility and safety of the device. Based on feedback from testing, the device was modified during user test trials to improve upon past models. Our results indicate the feasibility and improvement of our latest prototype.
Conclusion: Our study has shown that the current standard of care for explantation procedures needs to be improved to reduce morbidity and mortality. This device efficiently addresses the problems associated with endograft explantation. Limitations identified from the initial prototype were resolved and initial testing of the new design is very promising. Future research will be performed in animal models to test the device’s effectiveness.
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