M. D. Balceniuk1, P. Zhao1, L. Cybulski1, M. C. Stoner1 1University Of Rochester,Division Of Vascular Surgery,Rochester, NY, USA
Introduction:
Aneurysmal sac shrinkage is associated with successful aneurysm exclusion following endovascular aortic repair (EVR). There are a variety of approved aortic endografts, with recent data demonstrating device-specific sac shrinkage. The Bolton Treo endograft is a modular two-docking limb EVR device which has completed Phase II trial in the United States and is freely available in other markets. The objective of this study is to evaluate sac shrinkage of the Bolton Medical endograft.
Methods:
This is a retrospective analysis of EVRs at a single institution over a one-year period in which the Bolton graft was used. The change in sac size and rate of sac shrinkage (mm/month) was evaluated between Bolton and non-Bolton grafts. All Bolton grafts were included in the analysis. Non-Bolton grafts were matched a priori for Bolton IFU anatomic specifications. Only elective, intact aneurysm cases were selected. The primary outcome was sac shrinkage and secondary outcomes were composite complication profile within 30 days of operation.
Results:
Six Bolton grafts and 19 non-Bolton grafts were included for analysis (Table). The groups were similar in age, gender and race. The groups were also similar in aortic anatomy prior to EVR. The aneurysm sac shrinkage rate (mm/month) is significantly greater in the Bolton group compared to the non-Bolton group (0.504 ±0.109 vs 0.033 ±0.100, p=0.016). The total average size of sac shrinkage was also greater for the Bolton group (-0.571 ±2.422 vs 12.33 ±2.71, p<0.001). The composite complication profile of stroke, myocardial infarction, death and respiratory complications was not different between groups.
Conclusion:
The Bolton Treo is a pre-market modular endograft with several unique engineering properties. These data demonstrate a potential advantage the Bolton graft has with increased sac shrinkage while maintaining minimal complication rates, compared to other grafts. This study adds to the growing body of literature supporting Bolton graft use for EVR.
