Randomized Clinical Trial Evaluating Complications and Complication-Related Removal of Arm-Situated Power-Injectable and Non-Power-Injectable Totally Implanted Venous Access Devices among Cancer Patients.

ABSTRACT

PURPOSE: To evaluate the hypothesis that power-injectable (PI) totally implanted venous access devices (TIVADs) situated in the arm are associated with more frequent complications and complication-related removal than non-power-injectable (NPI) arm TIVADs among adult cancer patients. MATERIALS AND METHODS: In this single-center trial, 211 adult chemotherapy patients were randomized to receive either a PI or a NPI arm TIVAD. Follow-up involved a standardized telephone interview 1 week after insertion, followed by a chest X-ray, arm X-ray, and Doppler ultrasound at 3 months and 12 months. Online complication reporting was also provided by patients and care providers for a minimum of 1 year. The primary end point was removal for port-related complications; the secondary end point was the occurrence of any port-related complication. RESULTS: Forty-two complications occurred (19.9% of patients), precipitating the removal of 6 PI ports and 7 standard ports. Time-to-removal did not differ between TIVAD types (hazard ratio 0.75, 95% confidence interval [CI] 0.25-2.24; P = .61). Complications were related to thrombosis, infection, or mechanical issues, with no statistical difference between groups for overall occurrence (23.1% vs 17.0%, odds ratio 1.47, 95% CI 0.74-2.92; P = .27); however, by type of complication, thrombosis occurred more frequently among PI TIVAD patients (15.2% vs 6.1%, odds ratio 2.79, 95% CI 1.04-7.44; P = .03). CONCLUSIONS: There was no difference in port-related complication occurrence or complication-related removal when using the arm PI port compared with the NPI port among cancer patients.