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  • Title: Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT.
    Author: Wu O, McCartney E, Heggie R, Germeni E, Paul J, Soulis E, Dillon S, Ryan C, Sim M, Dixon-Hughes J, Agarwal R, Bodenham A, Menne T, Jones B, Moss J.
    Journal: Health Technol Assess; 2021 Jul; 25(47):1-126. PubMed ID: 34318743.
    Abstract:
    BACKGROUND: Venous access devices are used for patients receiving long-term chemotherapy. These include centrally inserted tunnelled catheters or Hickman-type devices (Hickman), peripherally inserted central catheters (PICCs) and centrally inserted totally implantable venous access devices (PORTs). OBJECTIVES: To evaluate the clinical effectiveness, safety, cost-effectiveness and acceptability of these devices for the central delivery of chemotherapy. DESIGN: An open, multicentre, randomised controlled trial to inform three comparisons: (1) peripherally inserted central catheters versus Hickman, (2) PORTs versus Hickman and (3) PORTs versus peripherally inserted central catheters. Pre-trial and post-trial qualitative research and economic evaluation were also conducted. SETTING: This took place in 18 UK oncology centres. PARTICIPANTS: Adult patients (aged ≥ 18 years) receiving chemotherapy (≥ 12 weeks) for either a solid or a haematological malignancy were randomised via minimisation. INTERVENTIONS: Hickman, peripherally inserted central catheters and PORTs. PRIMARY OUTCOME: A composite of infection (laboratory confirmed, suspected catheter related and exit site infection), mechanical failure, venous thrombosis, pulmonary embolism, inability to aspirate blood and other complications in the intention-to-treat population. RESULTS: Overall, 1061 participants were recruited to inform three comparisons. First, for the comparison of peripherally inserted central catheters (n = 212) with Hickman (n = 212), it could not be concluded that peripherally inserted central catheters were significantly non-inferior to Hickman in terms of complication rate (odds ratio 1.15, 95% confidence interval 0.78 to 1.71). The use of peripherally inserted central catheters compared with Hickman was associated with a substantially lower cost (-£1553) and a small decrement in quality-adjusted life-years gained (-0.009). Second, for the comparison of PORTs (n = 253) with Hickman (n = 303), PORTs were found to be statistically significantly superior to Hickman in terms of complication rate (odds ratio 0.54, 95% confidence interval 0.37 to 0.77). PORTs were found to dominate Hickman with lower costs (-£45) and greater quality-adjusted life-years gained (0.004). This was alongside a lower complications rate (difference of 14%); the incremental cost per complication averted was £1.36. Third, for the comparison of PORTs (n = 147) with peripherally inserted central catheters (n = 199), PORTs were found to be statistically significantly superior to peripherally inserted central catheters in terms of complication rate (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). PORTs were associated with an incremental cost of £2706 when compared with peripherally inserted central catheters and a decrement in quality-adjusted life-years gained (-0.018) PORTs are dominated by peripherally inserted central catheters: alongside a lower complications rate (difference of 15%), the incremental cost per complication averted was £104. The qualitative work showed that attitudes towards all three devices were positive, with patients viewing their central venous access device as part of their treatment and recovery. PORTs were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships. The main limitation was the lack of adequate power (54%) in the non-inferiority comparison between peripherally inserted central catheters and Hickman. CONCLUSIONS: In the delivery of long-term chemotherapy, peripherally inserted central catheters should be considered a cost-effective option when compared with Hickman. There were significant clinical benefits when comparing PORTs with Hickman and with peripherally inserted central catheters. The health economic benefits were less clear from the perspective of incremental cost per quality-adjusted life-years gained. However, dependent on the willingness to pay, PORTs may be considered to be cost-effective from the perspective of complications averted. FUTURE WORK: The deliverability of a PORTs service merits further study to understand the barriers to and methods of improving the service. TRIAL REGISTRATION: This trial is registered as ISRCTN44504648. FUNDING: This project was funded by the National Institute for Health Research (NHIR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 47. See the NIHR Journals Library website for further project information. For patients who need long-term chemotherapy delivered through a vein, there are currently three options: (1) a Hickman-type device, which is a flexible tube (central line) inserted underneath the skin on the chest into a large vein; (2) a peripherally inserted central catheter, which is a long line tube inserted into a vein in the arm and passed through a large vein in the chest; and (3) a totally implantable device, which is a small chamber (accessed externally by a needle) that sits underneath the skin, usually in the chest, and goes into a large vein. The Cancer And Venous Access (CAVA) trial compared these devices in > 1000 patients and looked at complications, quality of life, acceptability and value for money. We found that totally implantable devices halved the risk of complications compared with the other two options (which had similar complication rates to each other). We found that patients’ quality of life was similar for all three devices, although a quality-of-life measure specific to these devices showed some emotional and psychological benefits in favour of totally implantable devices. All three devices work, although the totally implantable devices are associated with fewer complications and are less intrusive for patients. In the CAVA trial, we found that totally implantable devices are the most costly device to use, followed by the Hickman-type device, with the peripherally inserted central device being the cheapest. This is partly because of the tendency for totally implantable devices to remain in patients for a longer period of time than the other two options. The costs could potentially be reduced by training nurse-led teams to insert totally implantable devices, as already happens with the other two devices. Totally implantable devices can be considered value for money depending on how people value avoiding complications and the quality-of-life benefits for patients.
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