Intraosseous vascular access using the EZ-IO can be safely maintained in the adult proximal humerus and proximal tibia for up to 48 h: Report of a clinical study.

BACKGROUND: Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers. METHODS: A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States. Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes. Subjects were randomized to receive IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA) in the proximal humerus or the proximal tibia and maintain the indwelling catheter for 48 h. Subjects were monitored for the entire dwell time. A culture specimen was drawn from the indwelling catheter tip before removal and insertion site x-rays were taken. RESULTS: 121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency. The mean catheter dwell time was 48.0 ± 0.2 h. Overall first attempt success rate was 98.4%. Infusion pain was the most commonly reported adverse event. There were no serious complications or unanticipated adverse events. CONCLUSIONS: This is the first known study examining the safety of IO access over a 48-h dwell time. The study corroborates the literature findings, demonstrates device safety, and provides evidence supporting the extended indication for a dwell time to 48 h in adult patients. IO placement and infusion best practices/guidelines were confirmed or established.

Longitudinal dialysis adequacy and clinical performance of the VectorFlow hemodialysis catheter: a prospective study.

PURPOSE: To report clinical performance and longitudinal assessment of hemodialysis adequacy with the Arrow-Clark VectorFlow catheter, a symmetrical-tip device with a distal lumen configuration designed to reduce platelet shear stress and catheter thrombosis. METHODS AND MATERIALS: We prospectively enrolled patients who required de novo placement of a chronic tunneled catheter for hemodialysis or exchange of a dysfunctional catheter as part of an Institutional Review Board (IRB)-approved protocol. Catheter patency, Kt/V, mean blood-flow (Qb), and pump pressures were obtained at baseline and at monthly intervals to 90 days. RESULTS: Forty-six subjects were enrolled into the study. During the 90-day observation period, maximum blood-flow rate averaged 355-398 mL/minute; mean Qb averaged 333-392 mL/minute. Mean Kt/V values were consistently ≥1.5. Dwell-time was 15-114 days, for a total of 2997 catheter days (mean 71.4 days). Excluding patients who died during the study and those receiving surgical access, overall intervention-free catheter patency rate was 94.9%, 92.2% and 88.8% at days 30, 60, 90, respectively. There were no acute complications. During the follow-up period, three patients developed complications (6.5%). Two catheter infections occurred (0.7/1000 catheter days) and one catheter malfunctioned; a rate of 1.0/ 1000 catheter days for all complications. CONCLUSIONS: The VectorFlow catheter produced safe, effective hemodialysis with Kt/V ≥1.5. A single catheter occlusion occurred and a low rate of infection was seen. Results support the hypothesis that the VectorFlow design reduces thrombogenic risk during clinical performance.

Powered bone marrow biopsy procedures produce larger core specimens, with less pain, in less time than with standard manual devices.

Bone marrow sampling remains essential in the evaluation of hematopoietic and many non-hematopoietic disorders. One common limitation to these procedures is the discomfort experienced by patients. To address whether a Powered biopsy system could reduce discomfort while providing equivalent or better results, we performed a randomized trial in adult volunteers. Twenty-six subjects underwent bilateral biopsies with each device. Core samples were obtained in 66.7% of Manual insertions; 100% of Powered insertions (P=0.002). Initial mean biopsy core lengths were 11.1±4.5 mm for the Manual device; 17.0±6.8 mm for the Powered device (P<0.005). Pathology assessment for the Manual device showed a mean length of 6.1±5.6 mm, width of 1.0±0.7 mm, and volume of 11.0±10.8 mm(3). Powered device measurements were mean length of 15.3±6.1 mm, width of 2.0±0.3 mm, and volume of 49.1±21.5 mm(3) (P<0.001). The mean time to core ejection was 86 seconds for Manual device; 47 seconds for the Powered device (P<0.001). The mean second look overall pain score was 33.3 for the Manual device; 20.9 for the Powered (P=0.039). We conclude that the Powered biopsy device produces superior sized specimens, with less overall pain, in less time.

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy.

INTRODUCTION: Bone marrow aspiration and biopsy is an invasive procedure associated with morbidity and mortality risk. We compared a powered bone marrow aspiration and biopsy device to the traditional method by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, and safety and operator satisfaction. METHODS: Two large academic medical centres participated in this trial. Patients were randomised to have procedures carried out using the powered system or the manual technique. A visual analogue scale pain score was recorded immediately following skin puncture and once again at the end of the procedure for each patient. Procedure time was measured from skin puncture to core specimen acquisition. Pathologic assessment of 30 randomised samples was carried out. Operator satisfaction with devices was measured on a scale of 0-10, with 10 as the highest rating. RESULTS: Five operators from two sites enrolled 50 patients (powered, n=25; manual, n=25). Groups were evenly matched, with no significant differences in the means for age, weight and height. The powered system was superior to the manual system with respect to patient perceived pain from needle insertion (2.6±2.0 vs 4.1±2.5, p=0.022) and procedural time (100.0±72.8 s vs 224.1±79.0 s, p<0.001). Overall pain scores at the end of both procedures were comparable (3.2±2.2 vs 3.8±3.0, p=0.438). No complications were observed in either arm of the study. Blinded pathologic analysis of the specimens retrieved revealed that cores obtained using the powered system were longer and wider than those obtained using the manual technique (25.4±12.3 mm² vs 11.9±5.6 mm², p=0.001). For marrow aspiration, no difference was seen between groups for clot/particle spicules or smear spicules. Operator assessment favoured the use of the powered device. CONCLUSIONS: Results of this trial suggest that the use of a powered bone marrow biopsy device significantly reduces needle insertion pain and procedural time when compared to a manual technique. The superior size and overall quality of core specimens retrieved by the powered device provides more material for pathologic evaluation, thereby increasing diagnostic yield and reducing the need for repeat procedures.