Purpose: : Vascular access specialists are responsible for assessing the patient in their unique situation and determining the correct vascular access device to complete the therapeutic goal without complication or failure. This study compared the failure rates of polyurethane (PU) peripheral midline catheters and catheters constructed of an emerging hydrophilic biomaterial (HBM).
Methods: : This retrospective cohort study assessed 205 patients who received a midline and were situationally randomized by the facility where they received the catheter. Patients who had received a midline between March 2021 and May 2021 were assessed for catheter-related failures leading to increased staff time, delays in treatment or replacement with a new vascular access device to complete the therapy. Failures collected were upper extremity venous thrombosis, occlusions, leaking of fluid at the insertion site, phlebitis, and any other event causing removal and replacement of the catheter. A sample size targeting at least 100 subjects in each cohort, projecting a therapy completion rate of 90% in the HBM cohort, had 80% power to detect a statistically significant difference. The PU cohort rate was 75% on a two-sided 0.05 comparison using the Pearson Chi-Square test. P-values were for likelihood-ratio chi-square test, and P < .05 was considered statistically significant.
Results: : There were 101 patients in the PU cohort group and 104 patients in the HBM cohort group, and there were no significant difference between the two cohorts for whether the MC was a replacement, arm inserted, vein accessed, number of insertion attempts, initial arm circumference, and type of stabilization device. Comparing overall failure rates between the groups revealed a 23.8% failure rate in the PU control group and only a 3.8% failure rate in the HBM group (P < .001). The HBM cohort also showed a significant reduction of failures requiring MC replacement (P < .001). Occlusion rates were significantly reduced in the HBM cohort (P = .003). There were also significant reductions in upper extremity venous thrombosis (P < .001), phlebitis (P < .001), and leaking from the insertion site (P < .001). Neither group had documentation of laboratory sample hemolysis, bloodstream infections, or pulmonary emboli.
Limitations:: Catheter material utilized was controlled, all other variables progressed as they would in the real world and were equally variable, including staff experience and catheter maintenance practices. Future research should include prospective, randomized, controlled clinical trials to enhance reliability and validity of these initial findings.
Conclusions: : Over the past decades the engineers of vascular access catheters have evolved from silicone to polyurethane along with multiple coatings and modifications to minimize negative patient outcomes. Based on these early results, the HBM catheter material appears to be the next evolution in creating better outcomes for the patient. There is a high probability that the material matters in the success or failure of therapy completion with midlines.This research suggests that a midline catheter constructed of HBM biomaterial is associated with significantly lower rates of failure, thereby improving patient experience and healthcare economics.
