2. METHODS AND MATERIALS
In a clinical research laboratory setting, the E-Vita Open NEO hybrid
prosthesis was tested in a perfused thoracic model to assess its
propensity for oozing, and subsequently, the efficacy of BioGlue for
preventing oozing. E-Vita Open NEO was tested in both its straight and
branched configurations. Device dimensions are summarised in Table 1.
Ethical review and approval, or written informed consent for
participation were not required for the study in accordance with local
legislation and institutional requirements.
The E-Vita Open NEO device was fully perfused within an experimental
thoracic model, replicating as close as possible the real-life surgical
scenario. The distal stented segment and all four side branches were
clamped distally. The graft was then pressurised to 120 mmHg with human
blood (from blood packs) from the proximal end until full, at which
point the inflow valve was closed and the volume of blood in (ml)
leaking from the graft wall was measured for 60 seconds. Subsequently,
the volume (mm3) of BioGlue required to cover the
outer surface of E-Vita Open NEO (28mm and 30mm), up to thicknesses of
1.0, 2.0, and 3.0 mm, was measured. This aspect was measured while the
prosthesis was not filled or subject to endoluminal pressure to
replicate the conditions in which Ho et al. recommend priming the graft
with BioGlue (after anastomosis and prior to resumption of blood
flow).8 The priming technique depicted by Ho et al.
was used.