How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics
BACKGROUND: Despite the popularity of peripherally inserted central catheters (PICCs), recent literature highlights their potential injurious complications. Innovative PICC materials have been developed to prevent thrombosis and infection formation (Endexo®) and antireflux valves to prevent occlusion (pressure-activated safety valve®). No large randomized controlled trial has assessed these technologies. Our primary aim was to evaluate the feasibility of a large randomized controlled efficacy trial of PICC materials and design to reduce PICC complication in pediatrics.
METHODS: A randomized controlled feasibility trial was undertaken at the Lady Cilento Children’s Hospital in South Brisbane, Australia, between March 2016 and November 2016. Consecutive recruitment of 150 pediatric participants were randomly assigned to receive either (1) polyurethane PICC with a clamp or (2) BioFlo® PICC (AngioDynamics Inc, Queensbury, NY). Primary outcomes were trial feasibility, including PICC failure (thrombosis, occlusion, infection, breakage, or dislodgement). Secondary outcomes were PICC complications during use.
RESULTS: Protocol feasibility was established, including staff and patient acceptability, timely recruitment, no missing primary outcome data, and 0% attrition. PICC failure was 22% (16 of 74, standard care) and 11% (8 of 72, BioFlo®) corresponding to 12.6 and 7.3 failures per 1000 hours (risk ratio 0.58; 95% confidence interval, 0.21-1.43; P = .172). PICC failures were primarily due to thrombosis (standard care 7% versus BioFlo® 3%) and complete occlusion (standard care 7% versus BioFlo® 1%). No blood stream infections occurred. Significantly fewer patients with BioFlo® had PICC complications during use (15% vs 34%; P = .009).
CONCLUSION: BioFlo® PICCs appear potentially safer for pediatrics than traditional standard care PICCs with a clamp. Further research is required to definitively identify clinical, cost-effective methods to prevent PICC failure and improve reliability.
© 2018 Society of Hospital Medicine
BioFlo® PICC material offers a major advancement in PICC material through the incorporation of AT technologies into catheter materials, such as PICCs. Endexo® is a low molecular–weight, fluoro-oligomeric additive that self-locates to the top few nanometers of the material surface. When added to power-injectable polyurethane, the additive results in a strong but passive, nonstick, fluorinated surface in the base PICC material. This inhibits platelet adhesion, suppresses protein procoagulant conformation, and thereby reduces thrombus formation in medical devices. Additionally, Endexo® is not a catheter coating; rather, it is incorporated within the polyurethane of the PICC, thereby ensuring these AT properties are present on the internal, external, and cut surfaces of the PICC. If this technology can reduce complication during treatment and reduce failure from infection, thrombosis, occlusion, fracture, and dislodgement, it will improve patient outcomes considerably and lower health system costs. Previous studies investigating valve technology in PICC design to reduce occlusion have been inconclusive.12-14,35,36 Occlusion (both partial and complete) was less frequent in our study with the BioFlo® group (n = 3; 4%) compared to the standard care group (n = 6; 8%). The results of this pilot study suggest that either the Endexo® material or PASV® technology has a positive association with occlusion reduction during PICC treatment.
Thrombosis was the primary failure type for the standard care PICCs, comprising one-third of failures. All but one patient with radiologically confirmed thrombosis required the removal of the PICC prior to completion of treatment. The decision to remove the PICC or retain and treat conservatively remained with the treating team. Raffini et al.7 found thrombosis to increase in patients with one or more coexisting chronic medical condition. Slightly more standard care than BioFlo® patients were free of such comorbidities (25% vs 16%), yet standard care patients still had the higher number of thromboses (7% vs 3%). Morgenthaler and Rodriguez37 reported vascular access-associated thrombosis in pediatrics to be less common than in adults but higher in medically complex children. Worryingly, Menendez et al.38 reported pediatric thrombosis to be largely asymptomatic, so the true incidence in our study is likely higher because only radiologically confirmed thromboses were recorded.
Occlusion (partial or complete) was the predominant complication across the study, being associated with one-third of all failures. When occlusion complications during the dwell (some of which were resolved with treatment), in addition to those causing failure, were considered, this number was even greater. Occlusion complications are prevalent and costly. Smith et al.24 reported that occlusion was the most common reason for PICC removal and the most likely complication to delay treatment. Both the BioFlo® and standard care PICCs are pressure rated with good tensile strength; however, fracture occurred in 4% (n = 3) of standard care PICCs compared to no fractures in BioFlo® PICCs. Although the numbers are small, it may suggest a superior tensile strength of the BioFlo® material.
This study reinforces previously published results24,38 that PICC tip position is important and can influence complications, such as occlusion and thrombosis. In addition, we found a significant association with failure when PICCs did not have a continuous infusion. These findings reinforce the need for optimal tip location at insertion and ongoing flushing and maintenance of PICCs not used for infusions.
Limitations of this study include the small sample size, which was not designed to detect statistical differences in the primary outcome between groups. Despite randomization, there were slight imbalances at baseline for inserter type and leukocyte count, although these were not significantly associated with PICC failure in the Cox regression (data not shown), and thus were unlikely to influence findings. Additionally, a difference of <10% was associated with PICC tip position, favoring the BioFlo® group. PICC tip position outside the cavoatrial junction was positively associated with failure; therefore, the effect of tip positioning on outcomes is difficult to ascertain given the small sample size and feasibility nature of the study. Further study is warranted to further explore this effect. The population sampled was pediatric medical and surgical inpatients with a vessel size >2 mm attending the operating theater suite for PICC insertion, thereby limiting the study’s generalizability to adults and other populations, including neonates and those with PICCs inserted in the pediatric intensive care unit. The study could not be blinded because study products had to be visible to the clinical and research staff. However, it is unlikely that staff would intentionally sabotage PICCs to bias the study. Blinding was possible for the assessment of blood culture and ultrasound reports to diagnose infection and thrombosis. Strengths of this study included 100% protocol adherence, and no patients were lost to follow-up.
