Prospective Multicenter Trial of Modular Inner Branched Stent-Graft for Aortic Arch Repair
Overview
This prospective multicenter study evaluated a non-customized modular inner branched stent-graft for aortic arch repair in 88 patients. The device demonstrated 100% technical success, a 3% 30-day mortality, and a 9% 30-day stroke rate, with overall survival rates of 91%, 86%, and 81% at 12, 24, and 36 months respectively.
Background
Aortic arch pathologies are challenging to treat due to the complexity of the anatomy and risks associated with open surgery, which has a reported early mortality rate of over 10%. Hybrid and total endovascular approaches, including branched stent-grafts, have emerged as alternatives, especially for high-risk patients. However, most branched stent-grafts are custom-made, limiting their availability. This study investigates the safety and efficacy of a standardized modular inner branched stent-graft system as an off-the-shelf solution.
Data Highlights
Outcome
Result
Number of patients enrolled
88
Technical success rate
100%
Mean follow-up duration
28.6 ± 11.7 months
30-day mortality rate
3%
30-day stroke rate
9%
Overall survival at 12 months
91% ± 3%
Overall survival at 24 months
86% ± 4%
Overall survival at 36 months
81% ± 4%
Number of patients with endoleaks
10 (none required reintervention)
Key Findings
The modular inner branched stent-graft achieved a 100% technical success rate in treating aortic arch pathologies.
The 30-day mortality rate was low at 3%, and the 30-day stroke rate was 9%, comparable to other endovascular and hybrid approaches.
Long-term survival rates remained favorable, with 81% survival at 36 months post-procedure.
Endoleaks occurred in 10 patients but did not necessitate reintervention, indicating device durability and safety.
The device offers an off-the-shelf alternative to custom-made branched stent-grafts, potentially expanding treatment options for high-risk patients.
Clinical Implications
The modular inner branched stent-graft provides a feasible and safe endovascular option for aortic arch repair, especially for patients unsuitable for open surgery. Its off-the-shelf availability may reduce procedural delays associated with custom devices. Continued long-term follow-up and comparative studies are needed to confirm its superiority or equivalence to existing treatments.
Conclusion
This study demonstrates that modular branched stent-graft repair of the aortic arch is a viable and safe alternative to custom-made devices and open or hybrid surgical approaches. Further research is warranted to establish long-term comparative effectiveness.
References
Chinese PLA General Hospital et al. 2024 -- Results of a Prospective Multicenter Trial on Endovascular Repair of the Aortic Arch Using a Standard Modular Inner Branched Stent-Graft: An IDEAL 2a Study
