Inner Branch Off the Shelf Technology for Chronic Post-dissection Thoraco-Abdominal Aneurysm with Narrow True Lumen: Results of a European Multicentre Study.

OBJECTIVE

This study aimed to evaluate the early and midterm outcomes of endovascular repair of aortic dissection (AD) using a new pre-cannulated, inner branch based, off the shelf stent graft (E-nside; JOTEC, CryoLife, Inc.).

METHODS

Data from an international multicentre registry on patients treated with the E-nside endograft for AD were analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early and follow up outcomes were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were overall death, aortic related death, aortic related re-intervention rate, endoleak rate, and target vessel instability (TVI) at 30 days and during follow up.

RESULTS

Thirty four patients treated in 14 high volume European institutions between January 2020 and May 2024 were included. The mean patient age ± standard deviation was 66 ± 9.8 years, and 30 (88%) were male. The mean true lumen aortic diameter at the visceral aorta was 24.5 ± 7.7 mm. The median procedure time was 300 minutes (interquartile range 215, 373). The technical success rate was 97%, due to one case of placement of the coeliac trunk covered stent into the branch of the superior mesenteric artery and vice versa. The 30 day mortality and re-intervention rates were 6% (n = 2) and 9% (n = 3), respectively. At a mean follow up of 15.1 ± 7.5 months, there were no aortic related deaths. Freedom from aortic related death and all cause death at 12 months was 97% and 94%, respectively. The TVI rate during the follow up was 13% (four of 32). The total re-intervention rate was 16% (five of 32).

CONCLUSION

Endovascular treatment of AD with an off the shelf, inner branched endograft is feasible, with acceptable short and midterm outcomes. The results showed good technical implantation safety and efficacy. Long term follow up results are needed to better define the clinical role of this novel endograft.