Key result
The novel electromagnetically guided endovascular instrumentation successfully achieved in situ fenestration in all 22 in vitro trials, demonstrating the feasibility of the antegrade approach.
Why the study?
Current in situ endograft fenestration faces technical limitations, including difficulty targeting the fenestration site under fluoroscopic guidance and inadequate mechanical support during endograft perforation.
Novel electromagnetically trackable instruments demonstrate in vitro feasibility for in situ endograft fenestration, potentially expanding indications for standard endovascular aneurysm repair.
In vitro feasibility supports device iteration; leaves open clinical translation and safety of antegrade in situ fenestration.
Objective: This work aims at providing novel endovascular instrumentation to overcome current technical limitations of in situ endograft fenestration including challenges in targeting the fenestration site under fluoroscopic control and supplying mechanical support during endograft perforation. Technology: Novel electromagnetically trackable instruments were developed to facilitate the navigation of the fenestration device and its stabilization at the target site. In vitro trials were performed to preliminary evaluate the proposed instrumentation for the antegrade in situ fenestration of an aortic endograft, using a laser guidewire designed ad hoc and the sharp end of a commercial endovascular guidewire. Results: In situ fenestration was successfully performed in 22 trials. A total of two laser tools were employed since an over bending of laser guidewire tip, due to its manufacturing, caused the damage of the sensor in the first device used. Conclusions: Preliminary in vitro trials demonstrate the feasibility of the proposed instrumentation which could widespread the procedure for in situ fenestration. The results obtained should be validated performing animal studies. Clinical Impact: The proposed instrumentation has the potential to expand indications for standard endovascular aneurysm repair to cases of acute syndromes.
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Condino et al. (2020) studied Abdominal aortic aneurysms (in vitro models) (n=22). Electromagnetically guided endovascular instrumentation was evaluated on Successful in situ fenestration. The novel electromagnetically guided endovascular instrumentation successfully achieved in situ fenestration in all 22 in vitro trials, demonstrating the feasibility of the antegrade approach.
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