Retrospective observational assessment of the safety, performance, and utility of an antimicrobial/antithrombogenic peripherally inserted central catheter in pediatric patients

BackgroundTo determine the safety and performance of an antimicrobial/antithrombogenic peripherally inserted central catheter, a retrospective cohort study was conducted.MethodsData were collected using chart audits by clinicians in the US, UK, and EU in 2021 and 2022 for patients requiring an antimicrobial/antithrombogenic peripherally inserted central catheter. The primary outcome endpoint was successful completion of treatment without elective device removal due to adverse events. The secondary outcome endpoint was the incidence of device-related adverse events. Following the initial analysis of the index study, which included adult and pediatric patients, data from additional pediatric cases were collected. Charts lacking primary endpoint data were excluded. Standard descriptive statistics and analyses of categorical variables were performed without adjustment and with minimal stratification.ResultsA total of 38 healthcare providers collected data for 175 evaluable cases, of which 54.3% were male. The duration of use ranged from less than 1 day to 253 days. Treatment was successfully completed without elective device removal due to adverse events in 90.3% of cases. In 18 cases (10.3%), the patients experienced adverse events, with a total of 21 device-related adverse events reported, corresponding to 5 events per 1000 catheter days. None of the reported events were deemed serious or unexpected.ConclusionsThese findings suggest the potential for safe use of the antimicrobial/antithrombogenic peripherally inserted central catheter in the pediatric patient population, with no elective device removal due to adverse events in 90% of cases. No cases of central line-associated bloodstream infection, thrombosis, or anaphylaxis were reported; however, these findings should be interpreted with caution given the moderate sample size and the rarity of such events in general practice. Owing to the limitations of this study, including the risk of bias inherent to retrospective studies, prospective controlled trials with rigorous outcome assessments are needed to confirm these observations.