Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial.

Abstract

Objective: Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR.

Methods: A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR.

Results: A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups.

Conclusion: Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease.

Clinical impact: Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.