Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison

Abstract

Purpose To determine whether the use of a magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS) is safe and noninferior to fluoroscopy concerning positioning accuracy of a peripheral inserted central catheter (PICC). Methods In this prospective, randomized, single-center study, adult patients scheduled for PICC insertion were assigned 1:1 either to TCS or fluoroscopy. The primary objective was a noninferiority comparison of correct PICC tip position confirmed by X-ray obtained immediately after catheter insertion. Time needed for PICC insertion and insertion-related complications up to 14 days after the procedure were secondary outcomes to be assessed for superiority. Results A total of 210 patients (62.3 ± 14.4 years, 63.8% male) were included at a single German center between June 2016 and October 2017. Correct PICC tip position was achieved in 84 of 103 TCS (82.4%) and 103 of 104 fluoroscopy patients (99.0%). One-sided 95% lower confidence limit on the difference between proportions was −23.1%. Thus, noninferiority of TCS was not established (p > 0.99). Insertion of PICC took longer with TCS compared to fluoroscopy (8.4 ± 3.7 min vs. 5.0 ± 2.7 min, p < 0.001). Incidence of complications within a mean follow-up of 5.0 ± 2.3 days did not differ significantly between groups. Conclusion Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached. Ancillary benefit of TCS over fluoroscopy including less radiation exposure and lower resource requirements may nonetheless justify the use of TCS. The study is registered with Clinical.Trials.gov (Identifier: NCT02929368).

Experience of Radiology Technologists Performing Peripherally Inserted Central Catheters (PICC)

“…8 10 11 12 Several previous studies excluded patients with abnormal heart rhythm from ECG-guided insertions. 1 8 10 11 12 14 15 One study performed ECG-guided insertions on 118 atrial fibrillation patients; they relied on the amplitude of the f-wave. 16 We performed ECG-guided insertions in 39 patients with atrial fibrillation, and we relied on the location and direction of movement of the tip of the sensor stylet inside the catheter.…”

Knot quite right: Implications for central venous access in the presence of an RVAD

“…Employment of shorter midline catheters in the presence of an RVAD may be beneficial where possible in this patient cohort. Alternatively, the use of fluoroscopic guidance at the time of PICC insertion may assist in achieving SVC rather than right atrial tip position at placement 3,4 …”

A comparative study on the tip position of peripherally inserted central catheter inserted at two forward P-wave amplitudes by intracavitary electrocardiogram in cancer patients

“…The autonomous peak of the forward P-wave represents the CAJ (1), which is considered to be the ideal position for the PICC tip (2,3). The tip position has almost been determined when the forward P-wave amplitude is 50-80% of the QRS main wave of IC-EKG, which is located in the lower third of the SVC in many studies (4,5).…”