|
|
| Journal of Vascular Access 2002; 3: 147 - 153 |
| Valved central venous catheter connected to subcutaneous port: A multicenter phase IV study based on a cohort of 50 oncology patients |
R. Biffi1, M. Pittiruti2, J.P. Gillet3, D. Fobe3, J.P. Hermanne3, M. Pescio4, A. Gourlia5, K. Collet6, C. Battelli7, S. Cenciarelli1
1Division of General Surgery, European Institute of Oncology, Milano - Italy
2Shock Pathophysiology Research Centre, Catholic University, Rome – Italy
3Departments of Surgery and Oncology, Centre Hospitalier Régional de Namur, Namur - Belgium
4Department of Anesthesiology, Hôpital Régional de Pontoise, Pontoise - France
5Department of Anesthesiology, Clinique Claude Bernard de Metz, Metz - France
6Department of Anesthesiology, Clinique Victor Hugo de Boulogne/Billancourt, Boulogne - France
7Departments of Surgery and Oncology, Catholic University, Rome - Italy
ABSTRACT
Purpose: Since technical aspects and clinical features of central venous valved catheters are far from being completely understood, a multinational group of investigators has decided to assess a new distally-valved catheter connected to a port, in the clinical setting of oncology patients undergoing chemotherapy, in an attempt to verify its safety and viability, while also investigating its practical features. Methods: Our project was structured as a phase IV multicenter study. Hospitalized adults (ages 18-80 years) who had solid tumors and were candidate for intravenous chemotherapy met the criteria to enter the study. One single type of port was used (made of titanium, plastic and silicone) connected to a silicone, distally valved catheter (as manufactured by B. Braun Aesculap). A case report form was provided for each treated case; all relevant data regarding implantation and follow-up were entered into the form, mailed to a coordinating center (G. Chevillon, B. Braun Medical, France) and stored in a software database for statistical analysis. Results: 50 patients (from 6 participating centers) were included in this study. No major complications occurred at insertion. The most frequent clinical problem during follow-up was inability to draw blood samples (9% during the first chemotherapy cycle; 8% after the second cycle); blood obtained from the device was defined “unsuitable for hematology test” in 9% of the cases at first chemotherapy cycle and in 23% of the cases after the second cycle. No catheter obstruction occurred. Conclusion: The distally valved catheter port tested in this study was reliable, safe and practical for long-term treatment of an oncology patients’ population undergoing chemotherapy. As most other reports and clinical trials dealing with other types of distally valved catheters pointed out, inability to draw viable blood samples (so called withdrawal occlusion) is a major concern in their clinical use. Mechanisms underlying this technical problem are still unclear. (The Journal of Vascular Access 2002; 3: 147-53)
Full Text, Printable Format |
|
