Clinical Outcomes of Zone 0 Landing Thoracic Endovascular Aortic Repair (TEVAR): A Comparative Study of In-Situ Fenestration and Fenestrated Najuta Stent-Grafts" for clarity and specificity

Hybrid Thoracic Endovascular Aortic Repair (TEVAR), which combines TEVAR with surgical intervention for aortic arch pathologies, has been increasingly utilized in high-risk patients unsuitable for open repair. This study aims to evaluate the clinical outcomes of zone 0 landing TEVAR and compare the efficacy and safety between in-situ fenestration and fenestrated Najuta stent-grafts.

Materials and Methods:

This single-center, retrospective observational cohort study reviewed 798 consecutive patients who underwent TEVAR for thoracic aortic aneurysm between July 2007 and April 2024. Sixty-seven patients treated with zone 0 TEVAR were included, divided into two groups: in-situ fenestration (n=39) and fenestrated Najuta stent-graft (n=28). The median age was 81.4 years. Outcomes assessed included technical success, 30-day mortality, perioperative complications, endoleak incidence, branch patency, aneurysm enlargement, and re-intervention rates during the follow-up period.

Results:

Technical success was achieved in 100% of cases, with a 30-day mortality rate of 0.0%. The overall perioperative complication rate was 17.9% (in-situ fenestration 23.1% vs. fenestrated Najuta 10.7%; p=0.333). The perioperative stroke rate was 4.5% (in-situ fenestration 5.1% vs. fenestrated Najuta 3.6%; p=1.000). The 30-day endoleak rate was 16.4% (in-situ fenestration 15.4% vs. fenestrated Najuta 28.6%; p=0.231). During follow-up, endoleaks increased in the in-situ fenestration group but gradually decreased in the fenestrated Najuta group. No branch occlusions were observed. The 3-year survival rate was 59.6% (in-situ fenestration 53.6% vs. fenestrated Najuta 71.6%; p=0.052). The aneurysm enlargement-free rate at 3 years was 84.6% (in-situ fenestration 87.9% vs. fenestrated Najuta 77.8%; p=0.666), and the re-intervention-free rate was 91.8% (in-situ fenestration 88.8% vs. fenestrated Najuta 96.4%; p=0.348). The median follow-up period was 705.2 days (in-situ fenestration 855.7 days vs. fenestrated Najuta 495.6 days; p=0.057).

Conclusion:

Zone 0 landing TEVAR using in-situ fenestration and fenestrated Najuta stent-grafts is feasible and safe for high-risk patients unsuitable for open repair, demonstrating high technical success and relatively low rates of complications, aneurysm enlargement, and re-interventions. Notably, endoleak incidence decreased over time in the fenestrated Najuta group, suggesting potential long-term stability.