Clinical and Haemodynamic Evaluation of a Novel Physician Modified Inner Branch Iliac Branch Device for East Asians

TL;DR

A modified iliac branch device was tested in East Asians, showing safety and improved blood flow, addressing anatomical limitations in this population.

Contribution

The study introduces a physician-modified iliac branch device tailored for East Asians with short common iliac arteries.

Findings

Technical success was 100% with no adverse events in ten patients.

CFD analysis showed improved haemodynamic parameters like TAWSS and reduced energy loss after PM-IIBD implantation.

PM-IIBD significantly reduced high oscillatory shear index areas in the CIA region.

Abstract

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.

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.

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.

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.

•Anatomic suitability of the Iliac Branch Device (IBD) is limited in East Asians.•Physician Modified Inner Branch IBD (PM-IIBD) minimizes CIA spatial demands.•Clinical and computational fluid dynamics validate PM-IIBD safety and efficacy.•PM-IIBD expands IBD anatomic suitability given the anatomic constraints in East Asians.

Anatomic suitability of the Iliac Branch Device (IBD) is limited in East Asians.

Physician Modified Inner Branch IBD (PM-IIBD) minimizes CIA spatial demands.

Clinical and computational fluid dynamics validate PM-IIBD safety and efficacy.

PM-IIBD expands IBD anatomic suitability given the anatomic constraints in East Asians.

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