Abstract
BACKGROUND—Discontinuation of the Codman 3000 pump in 2018 left no Food and Drug Administration (FDA)-approved hepatic artery infusion (HAI) device for unresectable colorectal liver metastases (uCLM) and intrahepatic cholangiocarcinoma (uIHC). Historically HAI has been performed at academic medical centers in large metropolitan areas, which are often inaccessible to rural patients. Consequently, feasibility of dissemination of HAI to rural populations is unknown. METHODS: Under an FDA investigational device exemption, we opened the only HAI program in Kentucky and enrolled uCLM and uIHC patients in a phase I clinical trial. The trial examined the safety of the hybrid Codman catheter/Medtronic Synchromed II pump (hCMP) combination, defined as successful completion of one cycle of HAI chemotherapy. Rural feasibility was assessed by number of missed pump fills appointments. RESULTS: Twenty-one patients (n=17 uCLM, n=4 uIHC) underwent hCMP implantation before accrual was stopped early due to FDA approval of the Intera 3000 pump. 20/21 (95%) patients met the primary safety endpoint. Serious AEs included grade 5 COVID-19 infection (n=1), and grade 3 catheter erosion into bowel (n=1). Biliary sclerosis developed in two patients (9.5%). Median distance to infusion center was 47.6 miles (2-138mi), and 62% were from Appalachia, yet there were no missed pump fill appointments. The 2-year overall survival was 82.4% (uCLM) and 50% (uIHC). Correspondence: Michael J. Cavnar, MD, FACS, FSSO, Department of Surgery, College of Medicine, University of Kentucky, 800 Rose Street, Lexington, KY 40508, michael.cavnar@uky.edu, Fax: 859-257-4488. Disclosures: None Meeting Presentation: Poster presentation at Society of Surgical Oncology International Conference on Surgical Cancer Care 2022 Author manuscript Ann Surg Oncol. Author manuscript; available in PMC 2024 October 10. Published in final edited form as: Ann Surg Oncol. 2024 February ; 31(2): 1252–1263. doi:10.1245/s10434-023-14519-8. CONCLUSIONS: The hCMP device had an acceptable safety profile. Despite the complexity of starting a new HAI program, early results showed feasibility for HAI delivery in a rural catchment area and comparable outcomes to larger urban-based HAI centers.
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