The results of this single centre, retrospective case series demonstrate that adding a PEG sealant to the anastomotic closure of aortic Bentall procedures provides a beneficial effect on blood loss and transfusion requirements. Compared with sutures alone, PEG sealant significantly reduced postoperative drainage loss and transfusion requirements, with no additional adverse events. In addition, a trend towards a reduced rethoracotomy rate versus sutures alone was also observed. These benefits may have translated into substantial cost savings for aortic Bentall procedures over the 30-month study period (January 2004 to June 2006).
Several studies have recommended the use of surgical sealants for treating anastomotic suture lines in patients undergoing aortic reconstructions
[2–5, 8], and the positive findings reported here are supported by other retrospective analyses of sealant use in aortic reconstruction
. However, the case series reported here provides a more accurate overview of routine clinical practice than a controlled clinical study environment, and therefore the results are highly relevant to practising cardiac surgeons.
In addition to the benefits on clinical outcomes reported here, there are also important practical aspects that should be considered. Unlike haemostatic gelatins (with or without the use of thrombin), or haemostatic agents that induce platelet aggregation, the PEG sealant used in this study works independent of the clotting cascade, allowing its use in patients with severely inhibited coagulation. In addition, PEG sealant can and should be applied pre-emptively of any bleeding and requires the application of smaller volumes than other sealants, particularly if the spray applicator is utilised. This is advantageous as the use of smaller volumes of sealant can help to reduce the risk of stenosis, which is particularly important under the ostium of the left coronary artery. While the PEG sealant used provides a seal of great strength via covalent tissue bonds, it still retains flexibility. This allows normal physiological dilation without stiffening, thus avoiding any additional wall stress and weakening of the surrounding tissue
. The PEG sealant also begins to set in five seconds and is fully polymerised as a hydrogel in one minute
, providing rapid sealing of the prosthesis. This prevents blood loss at unclamping, reducing the risk of further complications related to the extracorporeal circulation.
Cost calculations reported here are hypothesis generating, do not represent a detailed or formal analysis of cost effectiveness and warrant further confirmation in dedicated economic studies. Nevertheless, based on the estimated €1,943 per patient cost saving associated with use of PEG sealant in this analysis, it seems plausible that substantial reductions observed for some of the surgical requirements may have directly translated into procedural cost savings. The cost savings associated with the lower rate of transfusions conferred by the use of PEG sealant reported here add further to the data supporting the economic benefit of this intervention
[11, 12]. In particular, the suggested reduction in the rethoracotomy rate, which in itself influences the amount of RBC and FFP required as a result of the complication, results in cost savings from the use of PEG sealant far outweighing the cost of the treatment itself. In addition, the significant reductions in ICU stay and hospital stay associated with the use of PEG sealant would be expected to further reduce healthcare costs. We therefore consider the adjunctive use of the PEG sealant in this analysis of considerable economic benefit.
As with all clinical studies, there are limitations that should be considered. This was a retrospective analysis of non-blinded data, recorded at a single study centre. As such it may be open to potential bias. Three of the participating surgeons routinely added a PEG sealant to the anastomotic closure of aortic procedures, whereas the other three did not. Therefore, the results may have been influenced by particular surgeons’ experience and individual techniques. Furthermore, the fact that the data to be recorded for the efficacy and safety outcomes were not pre-defined, but taken out of the existing routine documentation, may also impact the suitability of the measured parameters. With regard to concomitant aspirin use, while it is likely that urgent or emergent cases did not have their aspirin discontinued before surgery and postoperative drainage volumes were increased as a result, the percentages of urgent/emergent cases were similar in the two groups (6/48 [12.5%] versus 8/54 [14.8%], respectively). Postoperative hypertension was not recorded during this study, so comparisons to establish the effectiveness of the PEG sealant in patients with postoperative hypertension were not possible. While the PEG sealant has been demonstrated to withstand supra-physiological pressures of up to 660 ± 150 mmHg
, this is still an important clinical consideration that warrants further investigation in future studies.