Central venous catheters in home infusion care: outcomes analysis in 50,470 patients.

PURPOSE: Outpatient home infusion therapy is increasing; however, little data exist on the outcomes of patients receiving care. The purpose of this study was to document the natural history of central venous catheters (CVCs) used in home infusion care to determine the rate and type of catheter complications. MATERIALS AND METHODS: Data from the Strategic HealthCare Programs National Database from April 1999 to September 2000 were analyzed. Primary study objectives were to identify (i) types of CVCs and principal diagnoses, (ii) type and rate of catheter complications, and (iii) outcomes in managing thrombotic catheter complications. Event rates were calculated per 1,000 catheter days; 50,470 patients representing 2.83 million catheter days met study criteria. RESULTS: The rates of complications (per 1,000 catheter days) for the most common events were: catheter dysfunction (0.83 total; 0.6 nonthrombotic, 0.23 thrombotic), catheter site infections (0.26), and bloodstream infections (BSIs; 0.19). A total of 4,138 complication events were identified (event rate per 1,000 days: 1.5). The total rates of complications with each catheter type were: midline catheters (4.5), PICCs (2.0), nontunneled central catheters (1.1), tunneled catheters (1.0), and chest ports (0.52). Catheter dysfunction with loss of patency was the most common group of complications. Thrombotic occlusion was the principal cause of catheter dysfunction, occurring in 28% of patients in this group, typically within 7 days of catheter insertion. BSI was reported in 541 patients, generally more than 30 days after catheter insertion. Catheter thrombosis outcomes resulted in therapy interruption (43%), catheter replacement (29%), premature CVC removal (14%), unscheduled emergency room visits (9%), and/or hospitalizations (6%). CONCLUSION: Catheter dysfunction is the most frequent complication of all CVCs in this population, almost twice that of infections. Outpatient home infusion catheter dysfunction results in delays to therapy, unscheduled hospitalizations, and need for device replacement.

Recombinant tissue plasminogen activator (alteplase) for restoration of function to occluded central venous catheters in pediatric patients.

PURPOSE: To evaluate the safety and efficacy of alteplase for restoring function to occluded central venous catheters in a pediatric population. PATIENTS AND METHODS: A phase III, open-label, single-arm, multicenter trial was performed in 995 adult and pediatric patients with dysfunctional nondialysis catheters and ports. This report is a subset analysis of subjects between 2 and 18 years of age (N = 122) who were enrolled in the study. Alteplase (2 mg/2 mL) was instilled into the dysfunctional catheter lumen and assessed at 30 and 120 minutes. Subjects weighing > or =30 kg received 2 mL of alteplase; subjects <30 kg received 110% of the internal lumen volume (not exceeding 2 mL). Alteplase dosing was repeated once after 120 minutes if the catheter remained dysfunctional. The primary safety endpoint was the rate of intracranial hemorrhage (ICH) within 5 days of treatment. RESULTS: The overall efficacy following up to two instilled doses of alteplase was 87%. In 70 patients (57%), restoration of catheter flow occurred by 30 minutes following a single dose of alteplase. Restoration of function was related to the duration of occlusion (P = 0.04). For catheters with occlusions of 0, 1 to 14, and >14 days duration, the efficacy was 91%, 78%, and 60%, respectively. Success was independent of the patient's age, sex, body weight, CVC type, or catheter age. There were no cases of death, ICH, major bleeding episodes, or embolic events attributable to treatment. CONCLUSIONS: An alteplase regimen of up to two 2-mg doses is safe and effective for restoration of function to occluded central venous catheters in a pediatric population.