Complications Associated With Totally Implanted Venous Access Devices in the Arm Versus the Chest: A Short-Term Retrospective Study

Purpose: To retrospectively compare complications for totally implanted venous access devices (TIVADs or ports) in the arm vs. the chest. One participating institution implanted all TIVADs in the arm, whereas the other institution implanted them in the chest. Methods: Subjects were consecutive patients > 18 years with a device inserted between July 2017 and January 2019 at either Hospital A, where all devices were implanted in the arm, or at Hospital B, where all devices were implanted in the chest. Complications (rates/1,000 catheter-days and frequencies) were compared between the arm and chest locations. Results: 201 arm devices (71% female, mean age 59.4 years) and 203 chest devices (66% female, mean age 61.5 years) were assessed. Overall complication rates did not differ between the arm and chest [arm: 30 complications per 56,938 catheter-days (0.530/1,000 catheter-days) vs. chest: 47 complications per 63,324 catheter-days (0.742/1,000 catheter-days), p-value 0.173]. Periprocedural complications and mechanical malfunction also did not differ. Although prophylactic antibiotic use was higher in the chest (79.3% vs. 1.50%, p-value < 0.0001), infection rates did not differ. Arm venous thrombosis was significantly higher in the arm cohort (0.205 vs. 0.017/1,000 catheter-days, p-value 0.003) and pulmonary thromboembolism in the chest cohort (0.269 vs 0.056/1,000 catheter-days, p-value 0.002). Conclusions: While arm venous thrombosis was higher in the arm and pulmonary thromboembolism in the chest cohort, other complications were similar. Antibiotic use was more frequent in the chest cohort, while infection rates remained similar in both cohorts.

Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT)

Background: The presence of totally implantable venous access devices (TIVADs), as any permanent or semipermanent medical devices, has an impact on the quality of life (QoL) of patients. Therefore, the purpose of this trial was to evaluate the efficacy of psychological support for patients undergoing this procedure.Methods: This randomized controlled trial (RCT) aimed to compare the efficacy of a psychological intervention vs. standard care on QoL in patients receiving TIVAD for chemotherapy treatment (ClinicalTrials.gov NCT02075580). The trial was conducted at the Veneto Institute of Oncology IOV-IRCCS (Padua, Italy) between October 2013 and September 2018. Participants were neoplastic adults receiving TIVAD for chemotherapy treatment for any cancer, not undergoing visible demolitive interventions, without psychopathological diagnosis and language understanding. The exclusion criteria were patients without a diagnosis of cancer, with psychopathological diagnosis, or with language misunderstanding.Results: The variation of C30-QL2 and BR32-BI was not statistically different between intervention and control arms in men and women. However, the variation of C30-SF was statistically better in the intervention than control arm in men [mean difference (MD) 22.3, 95% CI 3.5 to 41.0] but not in women (MD −2.7, 95% CI −24.0 to 18.7). The variations of the other secondary outcome measures were not statistically different between intervention and control arms.Conclusion: Psychological support did not show any clear advantages on global QoL and body image perception in patients at 15 days after TIVAD insertion for chemotherapy. In contrast, male patients might benefit from even a very short psychological counseling before or during chemotherapy even if they do not seem to ask for it.

ECHOTIP: A structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in adult patients

Central venous access devices are routinely used in clinical practice for administration of fluids and medications, for drawing blood samples and for hemodynamic monitoring. The adoption of ultrasound guided venipuncture has significantly reduced procedure-related complications, as documented by the recommendations of most recent guidelines. Ultrasound has also an important role also in other aspects of central venous catheterization, such as in the pre-procedural evaluation of the venous patrimony and in the detection of early and late non-infective complications. Recently, bedside ultrasound has been regarded as a promising tool also for ensuring an accurate and intraprocedural method of tip navigation and tip location. The aim of this paper is to review all the evidence about the accuracy of ultrasound methods for tip navigation and tip location in adult patients, and to suggest a structured standardized protocol for clinical practice.

Midline catheters for extracorporeal photopheresis in hematological patients

Introduction: Peripheral venous access for extracorporeal photopheresis (ECP) may be difficult in graft versus host disease (GVHD) patients, because of previous intravenous therapies and multiple peripheral cannulations; in this population of patients, ultrasound guided midline catheters may be an alternative option to central venous access. Methods: In this single-center, prospective preliminary study, we enrolled all consecutive patients with a diagnosis of GVHD and candidate to ECP, over a period of 10 months. We used inserted power injectable, non-valved, polyurethane, 20–25 cm single lumen midline catheters (MC). Results: Sixty-nine ECP procedures were carried out in six patients, using single-lumen MCs for outflow (5Fr in 74% and 4Fr in 26% of cases). For inflow, we used 5Fr or 4Fr MCs, or central venous access devices previously placed for other clinical reasons. There were no catheter-related complications during the entire period of ECP treatment. Mean outflow was significantly higher for 5Fr than for 4Fr MCs (35.8 ± 7.3 vs 29.2 ± 7.8 ml/min; p = 0.0008) and the procedure time was significantly shorter (92.9 ± 9.2 vs 108 ± 13.2 min; p < 0.0001). Conclusion: In GVHD patients, ECP can be performed efficiently and safely using single lumen polyurethane power injectable MCs. The best results are obtained with 5Fr rather than with 4Fr catheters. This strategy of venous access should be implemented in DIVA patients requiring ECP treatments, and probably also in other types of apheresis.

Needle Insertion Difficulty Algorithm (NIDA): A novel pilot study to predict Huber needle insertion difficulty in totally implanted devices

Safeguarding of venous assets in cancer patients provides for positioning vascular devices. In totally implanted central venous access devices, hereinafter referred as TIVADs, it’s necessary introducing Huber needle, into subcutaneous port, to use it. This procedure is not easy for all implanted devices. The procedural difficulty is to be attributed both to the type of the implanted port and to the skill of the clinician. The degree of patient satisfaction is variable and related with the clinician performing the maneuver. It follows a professional dissatisfaction of the clinician and a hesitation of the patient. Moreover, the incorrect positioning of the Huber needle into the port, could lead to the infusion of antiblastic drugs into the subcutaneous tissue with the consequent tissue damage due to extravasation of the drugs. Evaluation of different characteristics of TIVADs, allowed grouping them, in different types, setting up the S.P.I.A. method (Subcutaneous Port Investigator Assessment). Collected data from medical records concerning: primary pathology, port’s permanence and using, Huber needle insertion failed events, if a vascular access expert/specialist clinician has been called, weight gain or loss were recruited. These data made it possible to determine the types of implanted ports that were most difficult to insert the Huber needle, creating the N.I.D.A. (Needle Inserting Difficulty Algorithm) as a prognostic index of Huber needle inserting into the port. In particular, the type of implanted port, that is, if it was a brachial or thoracic implant ( p < 0.001), the SPIA type, if type 1, 2, or 3 ( p < 0.001) and the experience of the clinician ( p < 0.001) were considered as predictors of a successful first attempt and then can perform the NIDA. The relevant aspects in the success of the procedure are therefore the type of port (thoracic or brachial), the SPIA type, and the experience of the clinician in the successful insertion of the Huber needle into the port at the first attempt.

A totally implantable venous access device (TIVAD) abandoned for 5 years is re-accessed normally: A case report and literature review

Regular flushing and locking of totally implantable venous access devices (TIVADs) is recommended to maintain their patency when not in use. In this case report, a 73-year-old male patient received radical resection for rectal carcinoma in January 2010. A TIVAD was implanted in 2014 and a total of 12 rounds of chemotherapy of FOLFIRI was completed in 2015. During the period from 2015 to 2020, the patient never used or conducted the monthly infusion port flushing because of the inconvenience, the COVID-19 pandemic, and so on. On 18th April 2020, the patient was admitted to the radiotherapy department of Yiwu Central Hospital. The nurse evaluated the TIVAD upon admission, finding that the skin around the reservoir was normal without any sign of infection as erythema or induration of the skin overlying the implantable port but there was intraluminal occlusion of the devices. In order to re-access the catheter, discussion of a MDT was performed and several days of unremitting efforts were tried. Gratifyingly, the patient’s port was re-accessed successfully without any adverse reactions. This is a rare infusion port that has not been used and maintained for 5 years. For the port that has not been used and maintained for a long time up to 5 years, the medical staff should not give up easily. During the COVID-19 pandemic, prolonging the flushing interval of TIVADs can be an optimal clinical strategy without negative outcomes.

ECHOTIP-Ped: A structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in pediatric patients

Central venous access devices are routinely used in pediatric care for administration of fluids and medications and for drawing blood samples. The adoption of ultrasound guided venipuncture, the availability of bedside ultrasound devices and the use of intraprocedural methods for tip location have been shown to reduce procedure-related complications, as documented by the recommendations of most recent guidelines. In pediatric patients, bedside ultrasound is a promising tool not only for optimizing the choice of the vein and guiding the venipuncture, but also for ensuring an accurate and intraprocedural method of tip navigation and tip location. The aim of this paper is to review all the evidence about the accuracy of ultrasound methods for tip navigation and tip location in pediatric patients, and to suggest a structured protocol for clinical practice.

Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT

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.