Evaluation of a polymer implanted port access device.

Abstract

UNLABELLED: The implanted port vascular access system has provided many patients with safe and reliable vascular access. Its implanted design provides improved body image, reduced maintenance and a better quality of life. The Huber needle has been the standard means of accessing the implanted port system. Because of the problems associated with the Huber needle system, current standards recommend that the Huber needle be changed every 7 days. This evaluation examines the use of a polymer cannula to access the implanted port system. This polymer cannula eliminates many of the problems associated with the Huber needle and provides longer dwell times without increased complications. Seventy nine patients were accessed for a total of 1533 days with the mean dwell time being 19.4 days with no increase in complications associated with port access. OBJECTIVE: To establish implanted port access times of greater than 7 days without increased complications. DESIGN: A multicenter voluntary enrollment evaluation of a medical device. PATIENTS: Patients were offered the opportunity to participate in the evaluation if they had an implanted port and were going to be accessed for therapy for periods of 7 days or more. MEASUREMENTS: Patients were observed for adverse cutaneous reactions at the insertion site and any port access complications such as sepsis, leakage, changes in portal chamber integrity, and implant pocket integrity. RESULTS: From October 1994 through November 1995, 79 L-Cath for Ports (Luther Medical Products) polymer catheter port access devices (Illustration 1) were inserted in 54 patients. This polymer port access device was used instead of a rigid metal Huber needle for port access. The total number of access days was 1533 days with the mean duration of access being 19.4 days. Two patients experienced blood stream infections while they were accessed with the polymer port access device. These infections ensued with fever of unknown origin as the presenting symptom during neutropenic episodes after chemotherapy treatment. The port access device was removed and the port access device tip was cultured with culture results being negative. No other patients experienced complications related to the port access device. CONCLUSION: The polymer port access device provided a safe and effective means of extending port access times. This reduced the number of restarts for the patients and could extend portal septum life by exposing the portal septum to fewer accesses.