Background

Since the introduction of the E-Vita Open NEO aortic prosthesis in 2020, several incidences of post-anastomotic oozing from the polyester portion of the graft have emerged. The use of BioGlue to prime E-Vita Open NEO to prevent this has been suggested as a way to mitigate this worrying complication. We investigate the extent of graft oozing in E-Vita Open NEO and evaluate the use of BioGlue in preventing oozing, both experimentally and in terms of potential clinical complications.

Materials and Methods

E-Vita Open NEO (in straight and branched configurations) was implanted in a perfused model. The distal stent graft and side branches were clamped, and the graft was pressurized with blood to 120 mmHg. The volume of blood (ml) oozing from the graft within 60 s was measured. Nonpressurized grafts were coated with BioGlue up to a thickness of 1, 2, and 3 mm, and the volume (mm3) of BioGlue required to do so was recorded.

Results

Within 60 s, 250.0 ml of blood oozed from the grafts tested. 43.694, 87.389, and 174.778 mm3 of BioGlue were required to coat the device with 1, 2, and 3 mm of BioGlue.

Conclusion

Graft oozing from E-Vita Open NEO represents an omnipresent and worrying risk. The use of BioGlue herein is likely associated with several adverse consequences, which are an additional risk on top of that posed by graft oozing. These risks call into question the suitability of E-Vita Open NEO, especially when compared to alternative devices not affected by oozing.