Anatomical Feasibility of the Off-the-Shelf G-Branch System for Treatment of Thoracoabdominal Aortic Aneurysms

Abstract

Objective:

This study was performed to evaluate the anatomical feasibility of the off-the-shelf G-Branch device (Lifetech Scientific, Shenzhen, China) for the endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs).

Methods:

Digital computed tomography angiograms were analyzed in 171 consecutive patients with TAAAs who enrolled for imaging screening in a national multicentre clinical trial to evaluate the feasibility of the G-Branch system between November 12, 2021 and June 25, 2023. Anatomical feasibility was assessed based on the investigational protocols and the instructions for use (IFUs).

Results:

According to the standard, conservative, and liberal IFU criteria, the overall feasibility of the G-Branch system was 74.9% (128/171), 59.1% (101/171), and 80.7% (138/171), respectively. The top 3 factors limiting feasibility by the standard IFU criteria were a stenosed or occlusive renal artery (19/171), an accessory renal artery with a diameter of ≥3 mm (15/171), and a renal artery landing zone of <15 mm (14/171).

Conclusions:

The G-Branch system demonstrates favorable feasibility for the endovascular treatment of TAAAs, particularly with the aid of other endovascular techniques. The main limitations were stenosed or occlusive renovisceral arteries and accessory renal arteries.

Clinical Impact

The G-Branch system’s high anatomical feasibility, especially with the aid of other endovascular techniques, has the potential to change clinical practice in the treatment of thoracoabdominal aortic aneurysms (TAAAs). For clinicians, it offers a more viable off-the-shelf option that can be applied to a large proportion of TAAA patients, expanding the scope of endovascular treatment and providing a more convenient and efficient alternative to traditional open surgery. The innovation behind this study lies in the comprehensive evaluation of the G-Branch system’s anatomical feasibility based on a large sample size from a national multicentre clinical trial, which provides valuable insights into its clinical application and helps identify the main limitations that need to be addressed in future device development and clinical practice.