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Review
. 2020 Dec 9:61:161-168.
doi: 10.1016/j.amsu.2020.12.003. eCollection 2021 Jan.

Comparison of fibrin sealants in peripheral vascular surgery: A systematic review and network meta-analysis

Affiliations
Review

Comparison of fibrin sealants in peripheral vascular surgery: A systematic review and network meta-analysis

Walter Danker Iii et al. Ann Med Surg (Lond). .

Abstract

Background: Evidence comparing fibrin sealants (FSs) in surgery are limited. This study evaluated the efficacy and safety of FSs, and manual compression in peripheral vascular surgery.

Methods: A systematic review of randomized trials was conducted in Medline, Embase, and Cochrane databases within the last 15 years. Data were available to conduct a network meta-analysis (NMA) in peripheral vascular surgery. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-min [2C] or 1-min [1C]). The primary efficacy outcome was the proportion of patients achieving hemostasis by 4 min (T4). Treatment-related serious and non-serious adverse events (AEs) were qualitatively assessed.

Results: Five studies (n = 693), were included in the NMA. Results predicted VISTASEAL 2C, followed by EVICEL 1C, had the highest probability of achieving T4. Compared with manual compression, significant improvements in T4 were found with VISTASEAL 2C (relative risk [RR] = 2.67, 95% CrI: 2.13-3.34), EVICEL 1C (RR = 2.58, 95% CrI: 2.04-3.23), VISTASEAL 1C (RR = 2.00, 95% CrI: 1.45-2.65), and TISSEEL 2C (RR = 1.99, 95% CrI: 1.48-2.60). TISSEEL 1C was not significantly different than manual compression (RR = 1.40, 95% CrI: 0.70-2.33). Among FSs, VISTASEAL 2C was associated with a significant improvements in T4 compared with VISTASEAL 1C (RR = 1.33, 95% CrI: 1.02-1.82), TISSEEL 2C (RR = 1.34, 95% CrI: 1.05-1.77), and TISSEEL 1C (RR = 1.90, 95% CrI: 1.18-3.74). Treatment-related serious and non-serious AE rates were typically lower than 2%.

Conclusions: In peripheral vascular surgeries, VISTASEAL 2C and EVICEL 1C were shown to have the highest probabilities for achieving rapid hemostasis among the treatments compared. Future studies should expand networks across surgery types as data become available.

Keywords: Fibrin tissue adhesive; Hemostasis; Network meta-analysis; Systematic review; Vascular surgical procedures.

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Conflict of interest statement

CRG-EVERSANA (N. Ferko, D. Garcia, and A. Hogan) was provided consulting fees from 10.13039/100009933Ethicon Inc., for analysis and development of the manuscript. W. Danker III and A. DeAnglis are employees of Ethicon Inc., the manufacturer for VISTASEAL and EVICEL.

Figures

Fig. 1
Fig. 1
Prisma flowchart.
Fig. 2
Fig. 2
Evidence network for hemostasis success at both 4 and 10 min. Note: In the evidence networks, the width of the lines for each connection is proportional to the number of randomized controlled trials comparing each pair of treatments. The size of each treatment node is proportional to the number of randomized participants (sample size). Abbreviations: 1C = 1-min clotting time; 2C = 2-min clotting time.
Fig. 3
Fig. 3
a) Fixed-effects network meta-analysis for hemostasis success by 4 min: a) for all comparators (RR, 95% CrI), b) for VISTASEAL 2C versus comparators (RR, 95% CrI). Abbreviations: 1C = 1-min clotting time; 2C = 2-min clotting time; CrI = credible interval; RR = relative risk. *Indicates statistically significant differences vs. comparator to the far right.
Fig. 4
Fig. 4
a) Fixed-effects network meta-analysis for hemostasis success by 10 min: a) for all comparators (RR, 95% CrI), b) for VISTASEAL 2C versus comparators (RR, 95% CrI). Abbreviations: 1C = 1-min clotting time; 2C = 2-min clotting time; CrI = credible interval; RR = relative risk. *Indicates statistically significant differences vs. comparator to the far right.

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References

    1. Corral M., Ferko N., Hollmann S., Broder M.S., Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409–421. - PMC - PubMed
    1. Corral M., Ferko N., Hogan A., Hollmann S.S., Gangoli G., Jamous N., Batiller J., Kocharian R. A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding. Clinicoecon Outcomes Res. 2016;8:507–519. - PMC - PubMed
    1. Ghadimi K., Levy J.H., Welsby I.J. Perioperative management of the bleeding patient. Br. J. Anaesth. 2016;117:iii18–iii30. - PMC - PubMed
    1. Stokes M.E., Ye X., Shah M., Mercaldi K., Reynolds M.W., Rupnow M.F., Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv. Res. 2011;11:135. - PMC - PubMed
    1. Miyasaka Y., Barnes M.E., Gersh B.J., Cha S.S., Bailey K.R., Abhayaratna W.P., Seward J.B., Tsang T.S. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006;114:119–125. - PubMed