Medical Policy

Policy Num:      05.001.047
Policy Name:    Fibrin Sealant
Policy ID:          [05.001.047] [Ac / L /  M+ / P-]  [0.00.00]

Last Review:       October 24, 2024
Next Review:      October 20, 2025
 

Related Policies: None

Fibrin Sealant 

Summary

Various electrosurgical instruments are available and are used for dissection and sealing vascular structures, while topical hemostatic agents, including fibrin sealants, are used to manage bleeding from surfaces or cavities that are not amenable to suturing, electrosurgery, or other specialized instruments (eg, argon plasma coagulator).

Fibrin sealants are a two-component system comprised of a solution of concentrated fibrinogen and factor XIII that is combined with a solution of thrombin and calcium to form a coagulum. Once combined, a fibrin clot forms in seconds, or somewhat more slowly if a more diluted form of thrombin is used. Because fibrin sealants have fibrinogen concentrations that are higher than physiologic concentrations at the site of bleeding (particularly for commercial preparations), clot formation with fibrin sealants is faster than the native coagulation process . The contribution of flow to clot retraction was discovered using a microfluidic device capable of flowing human blood over a side channel plugged with collagen . This device was used in one study to measure thrombus permeability and contraction in the presence of platelet binding to collagen alone or in the presence of thrombin and fibrinogen. Collagen supported formation of a 20-micrometer thick platelet layer, which retracted significantly upon cessation of flow but resulted in a 5.34-fold increase in permeability because of reconfiguration of the supporting collagen. The presence of thrombin and fibrinogen allowed isotropic contraction of platelets, creating an impermeable clot. Although not the purpose of this study, these results would seem to predict that applying a combination of thrombin and fibrinogen promotes a more hemostatic clot than using a collagen alone as a mechanical barrier to flow.

The use of fibrin sealants is reviewed here. The use of other topical hemostatic agents and tissue adhesives or sealants, including topical thrombin as a single-component topical agent, is discussed separately

OBJECTIVE

The objective of this review is to evaluate the use of fibrin sealants in various surgical  scenarios where  capillary bleeding is massive and  the control is dificult.

Policy Statements

The use of fibrin sealants is considered medically necessary  in situations where usual  and standard surgical hemostasis is not suficcient to control bleeding.

Policy Guidelines

There are no reliable guidelines about when fibrin sealants are best used or which products are optimal for specific indications. The choice of fibrin sealant should be based on the individual's preference, experience, cost, and institutional or hospital acceptance. Fibrin sealants do appear to be effective hemostatic and/or adhesive agents capable, in some settings, of contributing to a decrease in allogeneic blood exposure, but there is little information linking the use of these products to improved patient outcomes.

benefit Application

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

 Fibrin sealant has been used to control bleeding in a variety of surgical applications (suture hole bleeding, bleeding from raw surfaces). The use of fibrin sealants appears to reduce the need for transfusion, though the effect varies widely depending upon the type of surgery

The search for the perfect operative sealant began in the first decade of the 20^th century. By the 1940s, fibrinogen and thrombin were combined in operative settings. Once Cohn fractionation led to the ability to generate highly concentrated fibrinogen preparations (in the 1960s), fibrin sealants were used to promote wound healing, skin grafting, and dural sealing; to provide hemostasis in microvascular surgery and parenchymal injury; and to serve as a matrix for bony chips and fragments in the repair of bone defects .Fibrin sealants simulate the final stage of the clotting cascade .

Components - Fibrin sealant preparations  contain fibrinogen, thrombin, and other components such as ionized calcium, as a coagulation protein cofactor, factor XIII, fibronectin, and often, but not always, an antifibrinolytic agent (eg, aprotinin).

Contraindications-Fibrin sealants made from donor plasma or cryoprecipitate should not be used in patients with a history of prior anaphylactic reactions to plasma products or in those with IgA deficiency. 

Fibrin sealants should never be injected intravenously or allowed to enter cell saver or cardiopulmonary bypass circuits because of the risks of thrombosis.

Regulatory Status

FDA approved Fibrin Sealants: Fibrin Sealant (Human) - Topical Use

ARTISS, EVICEL, FIBRIN SEALANT (Human), RAPLIXA, TISSEEL

Rationale

The most recent literature update was performed through February 24, 2023. 

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 

Bleeding  with cardiac, thoracic, or vascular surgery 

Population Reference No. 2 

Hemorrhage associated with trauma, including liver and spleen lacerations

Population Reference No. 3 

Dental extractions in general, and in hemophiliacs

Population Reference No. 4 

Burn wound debridement and skin donor harvesting.  Skin graft fixation using fibrin sealant has been widely performed since the late 2000s. It has also recently become a novel autograft fixation method. Fibrin sealants are human-derived factors that are designed to reproduce the final steps of the physiologic coagulation cascade of a stable clot. The substance’s physical attributes make it suitable for affixing skin grafts to recipient wound beds; it creates an ultrafine matrix structure to diffuse nutrients and cytokines, promote neovascularization, and facilitate growth of fibroblasts and capillary endothelial cells by serving as a scaffold. This structure promotes phagocytosis and blocks sources of infection

Population Reference No. 5 

Hemostasis at cannulation sites in ECMO. 

Of the 149 ECMO episodes (111 VA ECMO and 38 VV ECMO) performed in 147 adults, 89 episodes (60 %) were complicated by at least one bleeding event. The most common bleeding sources were: ECMO cannula (37 %)

Population Reference No. 6 

During orthopedic surgery, including knee and hip replacement

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1.Fibrin sealants Up to Date 2020  Elizabeth Peralta, MD ;Amalia Cochran; Steven Kleinman, MD;Kathryn A. Collins,MD,PhD. FACS

2American Association of Blood Banks, (2011). Standards for Blood Banks and Transfusion Services, (27th ed.). Bethesda, MD: Author.

3Canadian Standards Association, (2010). CAN/CSA-Z902-10, Blood and Blood Components. Mississauga, ON: Author. Canadian Society for Transfusion Medicine, (2011). Standards for Hospital Transfusion Services, Version 3.0. Ottawa, ON: Author..

4.Filardo, T., et al. (2006). Stedman's Medical Dictionary (28th Ed). Baltimore MD: Lippincott Williams and Wilkins.

5.Provincial Blood Coordinating Program (2011). Policy for consent or refusal to administration of blood components and blood products, NL 2011.023. Available at http://www.health.gov.nl.ca/health/bloodservices/resources/informed_consent.html

6.Roback, J., Grossman, B.J., Harris, T., and Hillyer, C.D., (2011). Technical Manual, (17th ed.). Betheseda, MD: American Association of Blood Banks.

Codes

Applicable Modifiers

Some modifiers

Policy History