S. Hollmann

Time and resources of peripherally inserted central catheter insertion procedures: a comparison between blind insertion/chest X-ray and a real time tip navigation and confirmation system

Background The Sherlock 3CG™ Tip Confirmation System (TCS) provides real-time peripherally inserted central catheter (PICC) tip insertion information using passive magnetic navigation and patient cardiac electrical activity. It is an alternative tip confirmation method to fluoroscopy or chest X-ray for PICC tip insertion confirmation in adults. The purpose of this study was to evaluate time and cost of the Sherlock 3CG TCS and blind insertion with chest X-ray tip confirmation (BI/CXR) for PICC insertions. Methods A cross-sectional, observational Time and Motion study was conducted. Data were collected at four hospitals in the US. Two hospitals used Sherlock 3CG TCS and two hospitals used BI/CXR to place/confirm successful PICC tip location. Researchers observed PICC insertions, collecting data from the beginning (ie, PICC kit opening) to catheter tip confirmation (ie, released for intravenous [IV] therapy). An economic model was developed to project outcomes for a larger population. Results A total of 120 subjects were enrolled, with 60 subjects enrolled in each arm and 30 enrolled at each of the four US hospitals. The mean time from initiation of the PICC procedure to the time to release for IV therapy was 33.93 minutes in the Sherlock 3CG arm and 176.32 minutes in the BI/CXR arm (p < 0.001). No malpositions were observed for PICC insertions using the Sherlock 3CG TCS, while 20% of subjects in the BI/CXR arm had a malposition. BI/CXR subjects had significantly more total malpositions (mean 0.23 vs. 0, p < 0.001). For a hypothetical population of 1,000 annual patients, adoption of Sherlock 3CG TCS was predicted to be cost saving compared with BI/CXR in all three analysis years. Conclusion The results from this study demonstrate that Sherlock 3CG TCS, when compared with BI/CXR, is a superior alternative with regard to time to release subject to therapy, malposition rates, and minimization of X-ray exposure.

Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials

Abstract Background: In addition to rapid and sustained efficacy, ease of use is also an important characteristic of topical hemostats. Objectives: To evaluate clinician-reported ease of use for the Evarrest fibrin sealant patch across various surgical bleeding situations. Methods: An ease of use questionnaire (EUQ) was validated and administered in four randomized studies comparing the fibrin sealant patch to standard of care (SoC) in soft tissue and hepatic surgical bleeding. Three of these randomized studies have been previously published and all have been registered (NCT00658723; NCT00977925; NCT01166243; NCT01993888). The EUQ is a 19 item instrument evaluating clinician’s preferences on five subscales: product ease of use, satisfaction with product properties and efficiency, confidence in product efficacy, global confidence, and global satisfaction. A pair-wise meta-analysis using a random effects model was conducted on EUQ scores for trials that reported data for both treatment arms. Individual scores are presented for each trial. Results: The fibrin sealant patch demonstrated numerically greater scores than SoC in all EUQ subscales. The meta-analysis demonstrated that fibrin sealant patch scores improved for all subscales compared with SoC: satisfaction with product properties (mean difference [MD] = 0.38, 95% CI: 0.04 to 0.73; P = 0.03), confidence in efficacy (MD = 1.10, 95% CI: 0.47 to 1.74; P = 0.0007), global confidence (MD = 0.57, 95% CI: 0.05 to 1.10, P = 0.03), global satisfaction (MD = 0.79, 95% CI: 0.32 to 1.26, P = 0.001), and ease of use (MD = 0.33, 95% CI: -0.29 to 0.94; P = 0.23). Fibrin sealant patch single arm trial results aligned with these findings. Conclusions: Physicians consistently reported high EUQ scores for the fibrin sealant patch across surgical bleeding populations. An important limitation of this study was that the composition of SoC varied across studies and EUQ data were only available for the SoC in two of four trials. Future studies should evaluate ease of use for other hemostats and across other surgical subspecialties, as data are currently limited.

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.

Background Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities. The objective of this study was to conduct a hospital cost analysis of the fibrin sealant patch versus standard of care in soft tissue and hepatic surgical bleeding. Methods The analysis quantified the 30-day costs of each comparator from a hospital perspective. Published US unit costs were applied to resource use (ie, initial treatment, retreatment, operating time, hospitalization, transfusion, and ventilator) reported in four trials. A “surgical” analysis included resources clinically related to the hemostatic benefit of the fibrin sealant patch, whereas a “hospital” analysis included all resources reported in the trials. An exploratory subgroup analysis focused solely on coagulopathic patients defined by abnormal blood test results. Results The surgical analysis predicted cost savings of

Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database

54 per patient with the fibrin sealant patch compared with standard of care (net cost impact: −

Endovascular Interventions for Femoropopliteal Peripheral Artery Disease: A Network Meta-Analysis of Current Technologies

54 per patient; sensitivity range: −

Challenges and Solutions for Lumbar Total Disc Replacement Implantation

1,320 to

Foreword: Proceedings From the First Annual Lumbar Total Disc Replacement Summit

1,213). The hospital analysis predicted further cost savings with the fibrin sealant patch (net cost impact of −

Barriers to and Budget Impact of Lumbar Total Disc Replacement Utilization

2,846 per patient; sensitivity range: −

Process for Consensus Statements on Lumbar Total Disc Replacement

1,483 to −

Modelled U.K. And U.S. Analyses Demonstrate Sherlock 3cg® Tip Confirmation System For Peripherally Inserted Central Catheter Placement Is Associated With Favourable Health Economic Outcomes

5,575). Subgroup analyses suggest that the fibrin sealant patch may provide dramatic cost savings in the coagulopathic subgroup of