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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., Patients and Methods: Under an FDA investigational device exemption, we opened the only HAI program in Kentucky and enrolled patients with uCLM and uIHC 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: A total of 21 patients (n = 17 uCLM, n = 4 uIHC) underwent hCMP implantation before accrual was stopped early owing to FDA approval of the Intera 3000 pump. 20/21 (95%) patients met the primary safety endpoint. Serious adverse events (AEs) included a grade 5 coronavirus disease 2019 (COVID-19) infection (n = 1) and a grade 3 catheter erosion into the bowel (n = 1). Biliary sclerosis developed in two patients (9.5%). Median distance to infusion center was 47.6 miles (2-138 miles), 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)., 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., (© 2023. Society of Surgical Oncology.)

The effects of volume replacement with 4% gelatin containing 1% glycine at pH 5.8 and 6.4 on the changes in mean arterial blood pressure (MABP) and blood levels of glucose, lactate and urea following acute haemorrhage in dogs were studied. Comparison was made with dogs given homologous blood. Dogs bled 30% of blood volume, maintained in shock for 30 min, and infused with gelatin solutions, showed values of MABP, blood glucose, lactate and urea nitrogen insignificantly different from dogs similarly bled and infused with homologous blood. The responses obtained in dogs infused with gelatin at pH 5.8 were better than at pH 6.4.

The effect of addition of metaraminol, insulin and trasylol to fluid replacement with glucose-saline, on the responses to haemorrhage (30% of blood volume) in dogs, was investigated. Addition of metaraminol significantly increased the blood sugar and lactate responses to haemorrhage; the lactate-pyruvate (L/P) ratio, plasma phosphate and free fatty acid (FFA) levels were also significantly increased. A delayed hypotension was observed. Responses to haemorrhage during infusion of glucos-saline + insulin showed reduced blood sugar, blood lactate, pyruvate, and L/P ratios, plasma inorganic phosphate and FFA were diminished while, mean arterial blood pressure (MABP) changes were significantly higher than the glucose-saline group. Infusion of trasylol in glucose-saline did not significantly affect the blood sugar, lactate, and pyruvate resonses and the L/P ratio. Plasma phosphate response was also like the control group. The responses of plasma FFA and of MABP in this group were significantly higher than glucose-saline group. The mechanisms of these effects and the significance of thse results are discussed.