In a UK trial (CAVA) reported in The Lancet, Jonathan G. Moss, MBChB, FRCR, of the Institute of Cardiovascular and Medical Sciences, University of Glasgow, and colleagues found that among central venous access devices, totally implanted ports (PORTs) were associated with significantly reduced rates of complications compared with Hickman-type tunneled catheters (Hickman) and peripherally inserted catheters (PICCs) in delivery of systemic anticancer therapy.1
Jonathan G. Moss, MBChB, FRCR
In the open-label multicenter trial, 1,061 patients aged ≥ 18 years receiving systemic anticancer therapy for at least 12 weeks for solid or hematologic malignancies were enrolled between November 2013 and February 2018 and randomly assigned to use of a central access device according to four options: Hickman vs PICC vs PORT (2:2:1), PICC vs Hickman (1:1), PORT vs Hickman (1:1), and PORT vs PICC (1:1). Randomization was stratified for center, body mass index, cancer type, device use history, and treatment mode.
The primary outcome measure was complication rate—a composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other factors—assessed until device removal, withdrawal from the study, or 1-year follow-up. Comparisons of complication rates were analyzed for PICC vs Hickman (noninferiority), PORT vs Hickman (superiority), and PORT vs PICC (superiority).
Among 424 patients in the PICC vs Hickman comparison, PICCs were used in 212 and Hickman, in 212. Among 556 in the PORT vs Hickman comparison, PORTs were used in 253 and Hickman, in 303. Among 346 in the PORT vs PICC comparison, PORTs were used in 147 and PICCs, in 199.
Across comparisons, Hickman catheters were most commonly placed by radiologists (46%–48%), nurses (23%–35%), and anesthetists (13%–20%); PICCs were most commonly placed by nurses (67%–73%); and PORTs were most commonly placed by radiologists (59%–78%), nurses (2%–24%), and anesthetists (10%–11%). Across comparisons, 87% to 97% of patients had solid tumors.
PICC vs Hickman Comparison
In the PICC vs Hickman noninferiority analysis, complications were observed in 110 of 212 patients (52%) with PICCs vs 103 of 212 (49%) with Hickman. Although the observed difference was less than the 10% noninferiority margin, noninferiority of PICCs was not confirmed (odds ratio [OR] = 1.15, 95% confidence interval [CI] = 0.78–1.71), potentially representing inadequate statistical powering. Periprocedural complications occurred in 2% vs 1% of patients. PICCs were associated with higher rates of an inability to aspirate blood (21% vs 16%) and mechanical failure (15% vs 3%). Hickman use was associated with a higher rate of all infections (30% vs 11%). Similar rates of venous thrombosis, pulmonary embolism, and other complications were observed in the two groups. PICCs were in place for a shorter duration (median = 113 vs 158 days), associated with a higher complication rate per catheter week (0.12 vs 0.07, P = .01), and a higher rate of removal due to complications (42% vs 32%).
PORT vs Hickman and PICC Comparisons
In the PORT vs Hickman analysis, PORTs were superior, with complications observed in 73 of 253 patients (29%) with PORTs vs 131 of 303 (43%) with Hickman (OR = 0.54, 95% CI = 0.37–0.77). Periprocedural complications occurred in 1% vs 1% of patients. PORTs were associated with lower rates of laboratory-confirmed bloodstream infection (6% vs 16%) and exit-site infection (4% vs 9%) and a higher rate of suspected catheter-related bloodstream infection (8% vs 5%). Venous thrombosis occurred in 1% vs 2% of patients (P = .56). Rates of other complications were similar in the two groups. PORTs were in place for a longer period (median = 367 vs 165 days), associated with a lower rate of complications per catheter week (0.02 vs 0.06), and a lower rate of removal due to complications (14% vs 32%).
In the PORT vs PICC analysis, PORTs were superior, with complications observed in 47 of 147 patients (32%) with PORTs vs 93 of 199 patients (47%) with PICCs (OR = 0.52, 95% CI = 0.33–0.83). Periprocedural complications occurred in 0% vs 4% of patients. PORTs were associated with lower rates of venous thrombosis (2% vs 11%, P = .0024) and mechanical failure (3% vs 11%). PORTs were associated with a higher rate of infection of any type (12% vs 8%), although the mean number of infections per catheter week was 0.02 in both groups. PORTs were in place for a longer period (median = 393 vs 119 days), associated with a lower rate of complications per catheter week (0.05 vs 0.13), and a lower rate of removal due to complications (24% vs 38%).
Overall, the median durations of devices remaining in place were more than 350 days for PORTs, approximately 160 days for Hickman catheters, and approximately 120 days for PICCs. The longer duration for PORTs reflected lower rates of PORT removal due to complications.
The investigators concluded: “For most patients receiving [systemic anticancer therapy], PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving [systemic anticancer therapy] for solid tumours should receive a PORT within the UK National Health Service.”
DISCLOSURE: The study was funded by the UK National Institute for Health Research Health Technology Assessment Programme. Prof. Moss is paid a personal fee to run PORT training courses for Smith Medical and received PORTs free of charge from four manufacturers.
1. Moss JG, Wu O, Bodenham AR, et al: Central venous access devices for the delivery of systemic anticancer therapy (CAVA): A randomised controlled trial. Lancet 398:403-415, 2021.