1. BACKGROUND
Surgical glue has been a familiar component of the surgeon’s
armamentarium since the 1990s, and is used as an adhesive or adjunct
across nearly all surgical specialties.1 Of the
several commercially available options, BioGlue (CryoLife Inc.,
Kennesaw, GA, USA) has enjoyed particularly widespread use among
cardiothoracic and vascular surgeons, after it gained FDA approval for
use as a haemostatic adjunct in cardiovascular surgery in
2001.1 Its indications were then extended to entail
aortic aneurysm surgery, and in particular aortic arch surgery.
Observation studies have delineated its adjunctive use to vascular
anastomosis, which yielded reduced intraoperative and postoperative
bleeding, and overall length of stay in cases of aortic
dissection.2,3
However, the use of BioGlue has also been associated with toxicity,
embolic risk, impaired aortic growth, myocardial and nerve damage,
pseudoaneurysm formation, cardiac tamponade, inflammation, and
necrosis.1,4-6 Enthusiasm for the use of surgical
adhesives for AD has reportedly diminished over concerns of these
additional risks.6 Notably, CryoLife also warn against
exposure of intracardiac structures, circulating blood, and nerves to
BioGlue, as well as against its application in
excess.7
In a recently published report, Ho et al. outline a potential new
application of BioGlue in total arch replacement.8 Out
of concern for excessive oozing from the polyester graft segment of the
E-Vita Open NEO hybrid prosthesis (CryoLife Inc., Kennesaw, GA, USA),
BioGlue was used to prime the graft fabric between completion of
anastomoses and resumption of blood flow. Satisfactory haemostasis was
reported achieved following the use of two vials of BioGlue (for
priming) and thromboelastography (TEG)-guided blood product
transfusion.8
The suggested use of BioGlue as a pre-emptive safeguard against graft
oozing is particularly intriguing and seeks to prevent catastrophic
bleeding that may occur during E-Vita Open NEO implantation in the
absence of any technical error.8,9 Indeed, the
propensity for the polyester segment of E-Vita Open NEO to ooze
excessively once blood flow is resumed is an extremely concerning flaw;
with multiple cases reported in literature following its introduction in
2020.9 It is thought that the lack of gelatine and
collagen impregnation greatly increases the porosity of the E-Vita Open
NEO graft, and that patient-specific haemodynamic factors may further
augment the risk of oozing.8,10
Ho and colleagues’ report advocating the use of BioGlue priming to
prevent E-Vita Open NEO graft oozing highlights several unanswered
questions and areas for further research.8 Namely, in
addition to the sequelae associated with graft oozing, what further
risks does priming the outer surface of the arch prosthesis with BioGlue
introduce? Are both additional risks justified by improved performance
associated with E-Vita Open NEO, in comparison to existing market
alternatives (in which oozing has hitherto not been reported)?
With these issues in mind, our investigation seeks to elucidate the
extent of graft wall porosity in E-Vita Open Neo and the amount of
BioGlue needed to prevent oozing, with a view of evaluating the safety
and efficacy of BioGlue priming as a preventative strategy.