Abstract Two non-metallic vascular access port systems, the Multipurpose Access Port (MPAP) and Miniport, developed by CORDIS S.A., France, have been evaluated clinically in 78 cancer patients. During the investigational period covering a total experience of 369 treatment cycles and 1,370 infusion days, no cases of infection or septicemia were observed. Serious complications such as drug extravasation and catheter occlusion occurred, although the incidence was relatively low (+/- 1%) when compared with the number of treatment courses (cycles), but in relation to the number of patients included in this study, the procedure-related complication rate was 17.5% for the MPAP and 15.8% for the Miniport. Procedure-related complications can be avoided by proper handling and use of suitable drug combinations to minimize crystallization reactions within the port-catheter systems. The final complication rate (total minus procedure-related) in terms of termination of treatment, i.e. explantation of the port-catheter system was 12.1% for the MPAP and 12.5% for the MINIPORT, which generally confirms the results of other groups. More than 87% of both port-catheter systems were still functional at the end of evaluation.
Clinical evaluation of the CORDIS vascular access port systems: a multicenter study.
BERTOGLIO, SERGIO;
1993-01-01
Abstract
Abstract Two non-metallic vascular access port systems, the Multipurpose Access Port (MPAP) and Miniport, developed by CORDIS S.A., France, have been evaluated clinically in 78 cancer patients. During the investigational period covering a total experience of 369 treatment cycles and 1,370 infusion days, no cases of infection or septicemia were observed. Serious complications such as drug extravasation and catheter occlusion occurred, although the incidence was relatively low (+/- 1%) when compared with the number of treatment courses (cycles), but in relation to the number of patients included in this study, the procedure-related complication rate was 17.5% for the MPAP and 15.8% for the Miniport. Procedure-related complications can be avoided by proper handling and use of suitable drug combinations to minimize crystallization reactions within the port-catheter systems. The final complication rate (total minus procedure-related) in terms of termination of treatment, i.e. explantation of the port-catheter system was 12.1% for the MPAP and 12.5% for the MINIPORT, which generally confirms the results of other groups. More than 87% of both port-catheter systems were still functional at the end of evaluation.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.