Background: Central venous access is extensively used in oncology, though practical information from randomized trials on the most convenient insertion modality and site is unavailable. Methods: Four hundred and three patients eligible for receiving i.v. chemotherapy for solid tumors were randomly assigned to implantation of a single type of port (Bard Port™, Bard Inc., Salt Lake City, UT), through a percutaneous landmark access to the internal jugular, a ultrasound (US)-guided access to the subclavian or a surgical cut-down access through the cephalic vein at the deltoid–pectoralis groove. Early and late complications were prospectively recorded until removal of the device, patient's death or ending of the study. Results: Four hundred and one patients (99.9%) were assessable: 132 with the internal jugular, 136 with the subclavian and 133 with the cephalic vein access. The median follow-up was 356.5 days (range 0–1087). No differences were found for early complication rate in the three groups {internal jugular: 0% [95% confidence interval (CI) 0.0% to 2.7%], subclavian: 0% (95% CI 0.0% to 2.7%), cephalic: 1.5% (95% CI 0.1% to 5.3%)}. US-guided subclavian insertion site had significantly lower failures (e.g. failed attempts to place the catheter in agreement with the original arm of randomization, P = 0.001). Infections occurred in one, three and one patients (internal jugular, subclavian and cephalic access, respectively, P = 0.464), whereas venous thrombosis was observed in 15, 8 and 11 patients (P = 0.272). Conclusions: Central venous insertion modality and sites had no impact on either early or late complication rates, but US-guided subclavian insertion showed the lowest proportion of failures.

BACKGROUND Implanted central venous access is practiced extensively in oncology; however, information on the relevance of using the device with a valved catheter (Groshong), compared with an open‐ended catheter, is scarce. The authors investigated the two types of catheters in a randomized trial using the same type of subcutaneous port and evaluated efficacy as well as early and late complications. METHODS Three hundred four patients with malignant disease (solid tumors) who were eligible to receive intravenous chemotherapy were accrued during a 15‐month period. After providing informed consent, the patients were assigned randomly to implantation of a titanium and silicone, rubber port (Dome Port™; Bard Inc., Salt Lake City, UT) attached either to an 8.0‐F silastic Groshong™ catheter tube (experimental group) or to a 9.6‐F silastic open‐ended catheter tube (control group). Both catheters were manufactured by Bard Inc. Implantation, care, and follow‐up followed the same protocol guidelines until removal of the device, death, or ending of the study. Power and color Doppler ultrasound examinations of internal jugular and subclavian veins were performed at 1 month and at 4 months or at anytime when a venous thrombosis was suspected. RESULTS Three hundred two patients (99.3%) were evaluable, 150 patients in the control group and 152 in the experimental group. The median follow‐up was 237 days. There was a trend toward more early complications in the experimental group (5.9%; 95% confidence interval [95% CI], 2.7–10.9%) than in the control group (2.7%; 95% CI, 0.7–6.7%), although the difference was not statistically significant (P = 0.26). There was also a trend toward more late complications in the experimental group (17.1%; 95% CI, 11.5–24.1%) compared with the control group (10.7%; 95% CI, 6.2–16.7%; P = 0.13), although the difference, again, was not statistically significant. The most frequent late complication was the inability to draw blood samples (12.5% in the experimental group and 2% in the control group; P < 0.001). Sepsis was observed in 1 patient and in 3 patients and venous thrombosis was observed in 6 patients and in 11 patients in the experimental and control treatment groups, respectively (P value not significant). CONCLUSIONS In the tested clinical setting, the use of a Groshong catheter was not superior to a traditional, open‐ended device in terms of early and late complications of the implant and its use. The theoretical justification for its superiority for more efficient use of the implantable device could not be substantiated. Cancer 2001;92:1204–12. © 2001 American Cancer Society.

Background: The complication rate of central venous totally implantable access ports (TIAP), used for high-dose chemotherapy with autologous stem cell transplantation support, has not been fully investigated to date, due to the almost exclusive use of externalised, tunnelled devices in this clinical setting. Patients and methods: During a 66-month period (from 1 January 1997 to 30 June 2002), 376 patients suffering from breast cancer, ovarian cancer, lymphoma or multiple myeloma were treated with high-dose chemotherapy and autologous stem cell transplantation at the European Institute of Oncology (Milan, Italy). A single type of port was used, constructed from titanium and silicone rubber, connected to a 7.8 F polyurethane catheter (Port-A-Cath™; SIMS Deltec, Inc., St Paul, MN, USA) inserted into the subclavian vein. They were followed prospectively for device-related complications until the device was removed, the patient died or the study was closed (30 June 2002). Results: No TIAP-related deaths were observed in this series. Seven pneumothoraxes (1.8%) occurred as a complication of TIAP placement, one patient only (0.2%) requiring a tube thoracostomy. Port pocket infection occurred twice in this series (0.53%, 0.01 episodes/1000 days of use), whereas three patients suffered from port-related bacteraemia (0.8%, 0.016/1000 days of use). Infections were successfully treated with antibiotics; all three cases had the ports removed at programme completion. Four cases of deep vein thrombosis were detected (1.06%, 0.022/1000 days of use); low molecular weight heparin was given, followed by oral anticoagulants. Finally, one case of extravasation occurred (0.26%, 0.005/1000 days of use), requiring port removal and local medical therapy. Conclusions: The use of TIAPs has resulted in a safe and effective option for high-dose chemotherapy deliverance and stem cell transplantation, in spite of inducing severe neutropenia and increasing the risk of sepsis in this category of oncology patient.

Background: Subcutaneously anchored securement devices (or subcutaneous engineered securement devices) have been introduced recently into the clinical practice, but the number of published studies is still scarce. The Italian Group of Long-Term Central Venous Access Devices (GAVeCeLT)—in collaboration with WoCoVA (World Congress on Vascular Access)—has developed a Consensus about the effectiveness, safety, and cost-effectiveness of such devices. Methods: After the definition of a panel of experts, a systematic collection and review of the literature on subcutaneously anchored securement devices was performed. The panel has been divided in two working groups, one focusing on adult patients and the other on children and neonates. Results: Although the quality of evidence is generally poor, since it is based mainly on non-controlled prospective studies, the panel has concluded that subcutaneously anchored securement devices are overall effective in reducing the risk of dislodgment and they appear to be safe in all categories of patients, being associated only with rare and negligible local adverse effects; cost-effectiveness is demonstrated—or highly likely—in specific populations of patients with long-term venous access and/or at high risk of dislodgment. Conclusion: Subcutaneously anchored securement is a very promising strategy for avoiding dislodgment. Further studies are warranted, in particular for the purpose of defining (a) the best management of the anchoring device so to avoid local problems, (b) the patient populations in which it may be considered highly cost-effective and even mandatory, (c) the possible benefit in terms of reduction of other catheter-related complications such as venous thrombosis and/or infection, and—last but not least—(d) their impact on the workload and stress level of nurses taking care of the devices.