Insertion of Totally Implantable Venous Access Devices: An Expertise-Based, Randomized, Controlled Trial (NCT00600444)

Objective:Comparison of two different insertion techniques for implantation of totally implantable access ports (TIAP). Background:TIAP are introduced through different open and closed cannulation strategies and by various medical experts. The aim of this expertise-based randomized trial was to compare venous cutdown approach with puncture of subclavian vein. Methods:One hundred and ten patients scheduled for primary implantation of a TIAP were randomly assigned to either open insertion technique performed by surgeons or puncture of the subclavian vein under fluoroscopic guidance by radiologists at an outpatient single university center. The primary endpoint was the primary success rate of the cannulation strategy. A logistic regression model was used for analysis adjusting for age, Karnofsky index, body mass index and surgeons', and the radiologists' experience. Results:Percutaneus cannulation was not superior to surgical venous cutdown in the intention-to-treat analysis (odds ratio, 0.37; 95% CI, 0.07; 2.15) and the as-treated analysis (odds ratio, 0.16; 95% CI, 0; 1.28). The procedure was shorter with surgery (median, 21 minutes; 95% CI, 14; 30) than with radiology (median, 45 minutes; 95% CI, 43; 50) (P < 0.001), and the dose of radiation was lower with surgery (median, 37 cGy/cm2; 95% CI, 26; 49) than with radiology (200 cGy/cm2; 95% CI, 200; 300) (P < 0.001). Conclusion:Central venous cannulation for insertion of TIAPs can be performed safely and effectively with both approaches. The open direct surgical access requires further strategies for successful placement of a TIAP, and percutaneous Seldinger technique requires more time and a higher dose of radiation and is associated with risk of pneumothorax.