The effects of a pressure-enabled drug delivery microcatheter on radiotracer distribution compared to a standard microcatheter in radioembolization, an interim analysis

Monday, March 6, 2023

3:00 PM – 3:09 PM

Location: Phoenix Convention Center, 227ABC

Presenting Author(s)

PS

Patrick Sutphin, MD, PhD

Assistant Professor
Massachusetts General Hospital, Boston, MA 02114

Disclosure(s): No relevant disclosure to display

Author/Co-author(s)

EW

Eric Wehrenberg-Klee, MD

Faculty
Massachusetts General Hospital
Sanjeeva Kalva, MD, FSIR, FCIRSE, FACR (he/him/his)

Professor
Massachusetts General Hospital
Raul N. Uppot, MD

Associate Professor
Massachusetts General Hospital
VW

Vincent Wu, MD

Faculty
Massachusetts General Hospital

Disclosure(s):

Patrick Sutphin, MD, PhD: No relevant disclosure to display

Sanjeeva Kalva, MD, FSIR, FCIRSE, FACR: BD Bard: Consultant (Ongoing); Biogen Inc, Clover Health Investments Corp, Inovio Pharmaceuticals, Moderna Inc, Pfizer Inc, Novavax Inc, Orphazyme, Cassava Sciences Inc, Vivos Therapeutics Inc, Ardelyx Inc, Althea Health, Sarepta Therapeutics, Clover Health Investments Corp, CureV: Ownership Interest (Ongoing), Stocks (Ongoing); Boston Scientific Corp: Consultant (Ongoing); Canon Medical: Consultant (Ongoing), Speaking and Teaching (Ongoing); Covidien/Medtronic: Consultant (Ongoing); Instylla, Inc.: Consultant (Ongoing); Okami Medical: Consultant (Ongoing); Penumbra Inc.: Consultant (Terminated), Speaking and Teaching (Terminated); Sirtex Medical: Consultant (Ongoing); Varian: Consultant (Ongoing)

Raul N. Uppot, MD: No relevant disclosure to display

Purpose: To quantify differences in the delivery of 99m-technetium-labeled macroaggregated albumin(^99mTc-MAA) to tumor and normal liver between a 2.4 Fr standard microcatheter (SMC) compared to a 2.4 Fr Pressure-Enabled Drug Delivery (PEDD) microcatheter (TriNav^® Infusion System; TriSalus Life Sciences Inc., Westminster, CO) in pre-radioembolization mapping procedures.

Materials and Methods: Five patients with either hepatocellular carcinoma (HCC) (n = 1) or colorectal liver metastases (CLM) (n=4) undergoing radioembolization completed this ongoing IRB-approved investigator-initiated prospective randomized-controlled study. Each patient underwent two mapping procedures, one with a 2.4 Fr SMC and the other with a 2.4 Fr PEDD microcatheter. Microcatheter tip position was consistent between the two mapping procedures. The sequence of device used for ^99mTc-MAA delivery was randomized. Procedures were evaluated for technical success of positioning of the delivery catheter and associated catheter-related complications. A SPECT/CT was performed after each mapping procedure and Tumor to Normal (T:N) ratio was calculated for each mapping procedure using MIMpacs SurePlan LiverY90 version 7.0.4 (MIM Software, Inc. Beachwood, OH) of all tumors within the target region.

Results: Both the SMC and PEDD microcatheter were successfully navigated and positioned to the appropriate position for radiotracer delivery with no associated catheter-related complications. The T:N ratio for HCC in a single patient was 27% lower with the PEDD microcatheter compared to the SMC. Three of the four CLM patients experienced an increase in the T:N ratio with the PEDD microcatheter. The T:N ratio over the four CLM patients increased by an average of 64% ranging from -26% to 195% with the PEDD microcatheter compared to the SMC.

Conclusion: Interim analysis demonstrates 100% technical success in the positioning of both the SMC and PEDD catheter for delivery of radiotracer without associated catheter-related complications. Evaluation of T:N ratio demonstrates a trend toward improved T:N ratio with the PEDD microcatheter in CLM patients, though patient sample size remains small.