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.