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Clinical and Haemodynamic Evaluation of a Novel Physician Modified Inner Branch Iliac Branch Device for East Asians
Mingwei Wu1, Li Zhang2, Shichao Liang3
1Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, China.
Insights
The physician modified inner branch iliac branch device (PM-IIBD) shows 100% technical success for internal iliac artery preservation. This device offers a feasible solution for East Asian patients with short common iliac arteries, demonstrating hemodynamic stability.
Area of Science:
- Vascular Surgery
- Medical Device Engineering
- Biomedical Engineering
Background:
- Iliac branch devices have limited anatomic suitability, especially in East Asians with short common iliac arteries.
- Internal iliac artery (IIA) preservation is crucial during endovascular aneurysm repair.
Purpose of the Study:
- To evaluate the safety and hemodynamic effects of the physician modified inner branch iliac branch device (PM-IIBD).
- To assess the feasibility of PM-IIBD for IIA preservation in patients with challenging anatomy.
Main Methods:
- Observational case series of ten patients treated with PM-IIBD.
- Computational fluid dynamics (CFD) analysis before and 12 months after surgery.
- CFD parameters included velocity, pressure, wall shear stress, and energy loss.
Main Results:
- 100% technical success with no adverse events.
- Minimal changes in pressure and velocity; significant decrease in oscillatory shear index areas.
- Increased time-averaged wall shear stress in the PM-IIBD region; significant decrease in energy loss.
Conclusions:
- PM-IIBD demonstrates safety and hemodynamic stability for IIA preservation.
- The device expands anatomic suitability, particularly for East Asian patients with short common iliac arteries.
Introduction:
The anatomic suitability of the iliac branch device remains limited, particularly in East Asians, in whom the common iliac arteries (CIAs) are notably short. This study aimed to evaluate the safety and haemodynamic effects of the physician modified inner branch iliac branch device (PM-IIBD) via clinical outcomes and computational fluid dynamics (CFD) analysis.
Method:
In this observational case series study, clinical safety was evaluated in ten patients treated with the PM-IIBD for internal iliac artery preservation. CFD analyses were performed before surgery and at 12 month follow up to compare haemodynamic changes in four CIA regions. CFD parameters included velocity, pressure, time averaged wall shear stress (TAWSS), relative residence time, oscillatory shear index (OSI), energy loss, and flow distribution ratios.
Results:
Technical success was 100%, with no peri-operative or follow up adverse events. CFD revealed minimal changes in pressure and velocity after PM-IIBD implantation, with only a slight post-operative decrease in external iliac artery average velocity (0.51 ± 0.12 m/s vs. 0.45 ± 0.16 m/s, p = .039). High oscillatory shear index areas in the CIA region significantly decreased after surgery (0.22 ± 0.14 vs. 0.11 ± 0.07, p = .036). In the PM-IIBD region, both the average TAWSS (0.40 ± 0.45 vs. 0.72 ± 0.22, p = .015) and maximum TAWSS increased statistically significantly (4.47 ± 4.16 vs. 8.44 ± 6.52, p < .001). The PM-IIBD inner branch region showed an increase in high TAWSS areas (0.11 ± 0.39 vs. 0.20 ± 1.44, p = .002). Energy loss decreased significantly after surgery (3.82 ± 2.13 vs. 3.11 ± 1.76, p = .013), with no significant changes in the relative residence time and flow distribution ratio.
Conclusion:
Preliminary clinical and CFD analyses have demonstrated the efficacy and haemodynamic stability of the PM-IIBD. By reducing spatial demands on the CIA, the PM-IIBD expands anatomic suitability, offering a feasible solution for internal iliac artery preservation in East Asians.
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