A randomized trial of valved vs nonvalved implantable ports for vascular access.

BACKGROUND Vascular access devices placed into the central venous system are used routinely in the medical management of many patients. Catheter tip occlusion is a common complication of open-ended catheters, causing difficulty with blood withdrawal and infusion. This study evaluated whether a valved subcutaneous port system would have fewer associated complications than a standard nonvalved port. METHODS Study subjects requiring port placement were randomized to receive a PASV (valved) port or a nonvalved BardPort. Standard technique was used to place both types of ports. Patients were monitored for 180 days after implantation, and data on major complications were collected. Difficulty with blood return and excess time spent accessing the port were studied as indicators of catheter tip occlusion. This study is an interim analysis of an ongoing prospective study, with an anticipated accrual of 100 patients. RESULTS Fifty-four patients were randomized to receive either the PASV port (n = 27) or a BardPort (n = 27). All patients required venous access for treatment of malignancy. No major complications were identified from port placement. No patient had major sepsis due to infected catheters. Overall complications included catheter leakage in 1 patient (3.7%, BardPort) and venous thrombosis in 1 patient in each group (3.7% per group). Difficulty in blood draw was noted in the PASV group on 16 of 273 (5.9%) port accessions and in the BardPort group on 30 of 266 (11.3%) accessions (P = 0.04). Thrombolytic agents were required in 14 (5.1%) port accessions in the PASV group and 21 (7.9%) port accessions in the BardPort group (P = 0.25). Significantly more total time was spent ensuring adequate blood draw from BardPorts as opposed to PASV ports (870 vs 435 minutes, respectively) (P = 0.01). CONCLUSION This initial analysis reveals that the valved PASV port system is associated with significantly fewer instances of poor blood return and thus decreases the time required for nurses to obtain blood return before infusion.