Benchtop testing with procedural feasibility and safety evaluation of an ultrahigh-resolution optical coherence tomography catheter for assessment of the biliary tree

Tuesday, March 7, 2023

3:00 PM – 3:09 PM

Location: Phoenix Convention Center, 222AB

Presenting Author(s)

Tushar Garg, MD (he/him/his)

Postdoctoral Research Fellow
Johns Hopkins University School of Medicine

Disclosure information not submitted.

Author/Co-author(s)

HP

Hyeoncheol Park, PhD

Research Associate
Johns Hopkins University
AS

Alex Solomon, MD

Resident Physician
Johns Hopkins University School of Medicine
CL

Cheng-Yu Lee, PhD

Postdoctoral Research Fellow
Johns Hopkins University
CW

Clifford R. Weiss, MD

Professor
Department of Radiology, Radiological Science and Biomedical Engineering, Johns Hopkins University School of Medicine
XL

Xingde Li, PhD

Professor of Biomedical Engineering, Electrical and Computer Engineering and Oncology
Johns Hopkins University
Harjit Singh, MD, FSIR

Professor of Radiology and Radiological Science
Johns Hopkins Hospital

Disclosure(s):

Clifford R. Weiss, MD: Boston Scientific: Consultant (Ongoing), Intellectual Property Rights (Ongoing), Research Grant Recipient (Ongoing); Guerbet: Research Grant Recipient (Ongoing); Medtronic: Consultant (Ongoing), Research Grant Recipient (Ongoing); Siemens Healthineers: Consultant (Ongoing), Research Grant Recipient (Ongoing)

Harjit Singh, MD, FSIR: No financial relationships to disclose

Purpose: To evaluate the feasibility of a novel, ultrahigh-resolution optical coherence tomography (UHR-OCT) catheter by ex vivo testing on a 3-D printed benchtop model followed by its procedural feasibility and safety by in vivo assessment of the biliary tree via a pre-existing percutaneous biliary access.

Materials and Methods: An in-house developed flexible 3.8 French (1.27 mm) fiber-optic UHR-OCT catheter, encased in a 5.3 French (1.78mm) medical-grade transparent catheter, with resolution of 2.4 um x 6.2 μm axial and lateral resolution, respectively, and a penetration depth of 1 mm, was evaluated ex and in vivo. The UHR-OCT device was introduced into the 3D printed benchtop model to evaluate the image quality and coverage based on the type of imaging used, sector vs luminal. For in vivo testing, the UHR-OCT device was introduced into the biliary tree of six patients via a directional or non-directional catheter through the pre-existing biliary drainage catheter access site and an ultrahigh-resolution, two- and three-dimensional survey of the biliary duct was performed. 2D cross-sectional images are displayed on the monitor in real-time while 3D intraluminal images, acquired at 10-20 frames/second, became available after off-line processing and reconstruction.

Results: On benchtop testing, the image quality of UHR-OCT catheter was able to image the wall of the 3D printed model at the appropriate resolutions and depth. Sectoral imaging was found to be more feasible to image the complete biliary wall as a directional catheter can be used for each section of the bile duct wall by opposing the catheter to it. On in vivo testing, in 100% (6/6) of the procedures the catheter was successfully introduced into the biliary tree, however, in 83.3% (5/6) of the procedures high-resolution real-time 2D and 3D images could be captured allowing the interventional radiologist to identify microanatomical details of the biliary tree, and liver parenchyma. There were no (0/6) adverse advents and the procedure time was marginally increased.

Conclusion: UHR-OCT is a promising technology in the evaluation of biliary pathology. This study demonstrates the first use of UHR-OCT via a percutaneous approach to successfully and safely evaluate the biliary tree using a novel device with significantly improved resolution and 3D image reconstruction capabilities compared to commercially available OCT products. Future studies will evaluate UHR-OCT image characteristics of benign and malignant biliary pathology.