Totally implantable venous access port systems and risk factors for complications: A one-year prospective study in a cancer centre

https://doi.org/10.1016/j.ejso.2011.06.016Get rights and content

Abstract

Background

Totally Implantable Venous Access Port Systems (TIVAPS) are widely used in oncology, but complications are frequent, sometimes necessitating device removal and consequently delays in chemotherapy. The aim of this study was to investigate possible risk factors for morbidity.

Methods

A total of 815 consecutive cancer patients (median age: 56.2 years [0.8–85.2]; 522 female) were enrolled in this observational, single-centre study between May 2nd 2006 and April 30th 2007. TIVAPS implantation involved principally cephalic or external jugular vein access. Patients were followed up for one year unless the device was removed earlier.

Results

The overall morbidity rate was 16.1% (131/815). Complications necessitated device removal in 55 patients a mean of 3.7 months [0.2–12.0] after implantation. These comprised TIVAPS-related infection (19), port expulsion (14), catheter migration (6), venous thrombosis (5), mechanical problems (3), skin disorders (2), pain (2), drug extravasation (2) infection unrelated to TIVAPS (1) and inflammation (1). No patient died during the study. The factor most strongly predictive of complications was the interval between insertion and first use of the TIVAPS, ranging from 0 to 135 days (median: 8.0 days). The morbidity rate was 24.4% when this interval was 0–3 days, 17.1% when it was 4–7 days and 12.1% when it exceeded 7 days (p < 0.01; Chi2 test). The median interval was 6 days (0–53) and 8 days (0–135), respectively, in patients with and without complications (p < 0.001).

Conclusion

To reduce complications, an interval of at least 8 days between placement of the TIVAPS and its first use may be advisable.

Introduction

First introduced in the early 1980’s, totally implantable venous access port systems (TIVAPS) are now routinely used in oncology, facilitating long-term chemotherapy and other precedures.1, 2

Although TIVAPS are generally associated with a lower long-term risk of infection compared to Hickman-type central venous catheters,3, 4 complications during their placement and long-term use are still a matter of concern. These complications, including infection, catheter fracture, thrombosis and extravasation,5, 6, 7 may necessitate device replacement, resulting in additional patient stress and treatment delays. Cancer patients have an intrinsically high risk of venous thrombosis, related to both the disease process itself and certain cancer treatments,8 this risk being further increased by placement of a catheter or TIVAPS.1

Several studies in cancer patients have investigated potential risk factors for TIVAPS-related complications, including the vein accessed5, 9, 10 and patient age and gender,11, 12 with somewhat conflicting results. Yildizeli et al. found no significant difference in the rates of early or late complications according to the vein catheterised (internal jugular, subclavian or cephalic), but failed attempts at catheter placement were significantly fewer with subclavian vein access.5 Biffi et al. similarly detected no difference in complication rate between cephalic and subclavian vein access.6 Vardy et al. reported successful catheter placement via the subclavian vein in practically all patients, with low complication rates.9 However, Araújo et al. showed lower rates of immediate complications, catheter malpositioning, long-term morbidity (including venous thrombosis) and catheter malfunction with internal jugular vein rather than subclavian vein access.10 A retrospective analysis of factors associated with TIVAPS failure by Hsieh et al. did not indicate a significant impact of insertion site, but identified increasing age, male gender and open-ended catheters as statistically significant risk factors.11 In contrast, Hung et al., in a retrospective analysis of paediatric patients, showed a higher risk of infection after TIVAPS implantation in younger patients.12

In view of the importance of minimising complications associated with TIVAPS and the few data available on potential risk factors, we initiated a large-scale prospective, observational study to explore this issue in the context of routine clinical practice in our cancer treatment centre.

Section snippets

Study design

This was a prospective, observational, descriptive study of the insertion and use of TIVAPS in a specialised cancer treatment center. The primary objective was to determine the complications associated with TIVAPS during the year following their insertion and to analyse the risk factors for these. The complications assessed were specified prior to the study in the protocol and case report form (CRF). The secondary objective was to evaluate patient satisfaction with TIVAPS placement

Patient population

A total of 815 consecutive cancer patients (552 female) undergoing TIVAPS placement and meeting the specified selection criteria were enrolled between May 2nd 2006 and April 30th 2007. Mean age (±SD) at inclusion was 55.7 ± 13.0 years and median age 56.2 years (range: 0.8–85.2). Mean (±SD) body mass index (BMI) was 25.0 ± 5.5 kg/m2 and median BMI 24.2 kg/m2 (range: 12.6–58.4).

The patients presented various cancers, predominantly breast (314), gastrointestinal (125), lung (79), upper airways

Incidence of complications

The overall incidence of complications in our study (16.1%) was similar to those reported after TIVAPS implantation in cancer patients by Wolosker et al.13 (17.7%), Leinung et al.14 (15.4%) and Araújo et al.10 (15.8% in the case of subclavian vein access). Lower rates were reported by Hoareau-Gruchet et al.15 (7.4%), Hsieh et al.11 (7.5%), Vardy et al.9 (8.2%) and Araújo et al.10 in the case of internal jugular vein access (7.6%), Hartkamp et al.7 reporting a higher rate (25.2%). As in other

Conclusions

The results of our study suggest that respect of an approximately one week interval between the implantation and first use of TIVAPS for administration of chemotherapy may reduce the likelihood of complications and the need for premature device removal. If confirmed by further investigations, this finding may be worth taking into account in routine clinical practice. Placement of the TIVAPS in the cephalic vein rather than the external jugular vein appears to be preferable in terms of the risk

Conflict of interest statement

The authors declare that they have no financial or personal relationships with other people or organisations that could have inappropriately influenced or biased their work.

Role of the funding source

The study was partially funded by Perouse Medical, a company manufacturing implantable venous access port systems. This funding was used to remunerate the clinical research personnel involved in the project.

Acknowledgements

The authors thank all the medical, nursing and auxiliary staff of the Oscar Lambret Regional Anticancer Centre for their dedicated teamwork during this study, Muriel Chapoutier for monitoring the study, Brice Dubois, Samia Swyndauw and Jean-Pierre Meurant for their valuable assistance with data management, and the Clinical Research Unit (in particular, Stéphanie Clisant).

Cited by (91)

  • Complications from port-a-cath system implantation in adults with malignant tumors: A 10-year single-center retrospective study

    2022, Journal of Interventional Medicine
    Citation Excerpt :

    There were 52 cases (3.0%) of catheter dislocation, including 21 (1.2%) of tip displacement and 31 (1.8%) of fracture, which included 14 (14/31, 45%) cases of pinch-off syndrome and 17 (17/31, 55%) of detachment of the port from the proximal end of the catheter. Several studies have shown that the incidence of catheter dislocation is only 0–4.1%,30,39–44 however, it can lead to death and severe complications.45–48 Therefore, once this occurs, immediate intervention should be carried out.

  • Capacity Prioritization Initiative Reduced the Wait Time for Port Placement and Facilitated Increased Volume of Port Placements at a Large County Health System

    2021, Current Problems in Diagnostic Radiology
    Citation Excerpt :

    Such delays exacerbate health disparities seen, as a recent study of Medicaid patients showed that if chemotherapy began more than 60 days after diagnosis, overall survival decreased by 66%.10 In addition to the impact of delays in therapy, patients who must begin therapy prior to port placement face increased risk of port infection, subsequent removal, and loss of access.11,12 Finally, patients undergoing chemotherapy prior to port placement are at risk of same-day procedure cancellation due to neutropenia, further delaying definitive long-term access.13

View all citing articles on Scopus
View full text