Objectives: We devised a novel physician-modified endograft (PMEG) with hydrogel-reinforced fenestrations to provide a more secure connection with the bridging graft than fenestrations alone. We applied this novel PMEG in a clinical setting and evaluated the clinical and technical results.
Methods: In this study, patients with complex thoraco-abdominal aortic pathologies involving the renal, superior mesenteric or coeliac artery were included. However, patients with pararenal abdominal aneurysm were excluded. Regardless of anatomical suitability, all patients referred to our hospital were enrolled. All patients were treated via compassionate use of PMEG. All PMEGs were used following the same procedure using hydrogel-reinforced fenestrations. A retrospective analysis was conducted on consecutive patients who were treated between October 2018 and April 2021.
Results: Out of 40 patients, 29 and 11 were men and women, respectively. The median patient age was 73.6 (range: 49-87) years. Among the patients, 36 (90%) had true aneurysms, whereas the others had false lumen aneurysms and penetrating atherosclerotic ulcer. Despite anatomical challenges, all branches were successfully reconstructed. The mean operative time was 333 (standard deviation 98) min. Postoperative computed tomography angiography did not reveal type I and IIIc endoleaks from the hydrogel-reinforced fenestrations. The 30-day survival rate was 97.5%. One patient died due to brain haemorrhage on postoperative day 5. During follow-up, computed tomography revealed no migration of any bridging graft.
Conclusions: We confirmed the effectiveness of the hydrogel as a sealing material and the secure connection between hydrogel-reinforced fenestrations and side branches in vivo.
Clinical trial registration number: 5287.
Keywords: Branched endografts; Fenestrated endografts; Hydrogel-reinforced fenestrations; Thoracic endovascular aortic repair; Type III endoleak.
© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.