Transforming Bleeding Control in Cardiac Surgery with SURGISPON® Patch

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Introduction

In cardiac surgery, controlling bleeding is critical not just for the success of the procedure, but also for the patient’s recovery and long-term health. Hemorrhagic complications during open-heart surgeries carry substantial risks, with occurrence rates between 5-9%, and in severe cases, up to 16%. Blood transfusions, though often necessary, have their own risks, such as adverse effects and the transmission of pathogens. Patients needing reoperation due to bleeding are three times more likely to face increased mortality. While surgical issues cause 66% of postoperative bleeding, the remaining 33% are due to coagulation disorders [1].

Before exploring modern techniques for bleeding control in cardiac surgery, it’s important to understand the traditional methods that have been the foundation of surgical practice for decades. While these methods are effective in many instances, the advent of tools like the SURGISPON® Patch highlights the need for advanced solutions when dealing with more complex challenges.

Traditional Methods for Controlling Bleeding

Bleeding control in cardiac surgery traditionally includes both systemic and local approaches, each with unique benefits and limitations.

Systemic Approaches

  • Blood Transfusions: Red blood cells, platelets, plasma, and cryoprecipitate are administered to supply essential clotting factors and volume support.
  • Pro-Coagulant Medications: Anti-fibrinolytics like tranexamic acid and aminocaproic acid are used to prevent clot breakdown.
  • Recombinant Factor VII: A synthetic clotting factor that promotes coagulation, particularly in severe bleeding cases.

Local Approaches

  • Direct Surgical Techniques

    • Suturing: Closes bleeding vessels or tissues manually, though it is time-consuming and demands precision.
    • Vessel Ligation: Ties off blood vessels to stop bleeding but can be difficult in deep or small vessels.
    • Electrocautery: Uses electric current to coagulate blood and seal vessels quickly, though it can cause tissue damage.
  • Haemostatic Maneuvers

    • Digital Pressure Application: Applying pressure to bleeding sites with fingers offers immediate control but isn’t sustainable for long and may not work in severe cases.
    • Warm Saline Irrigation: Flushing the area to manage bleeding sources offers temporary hemostasis.
    • Bone Wax: Made from beeswax and paraffin or vaseline, often used to control hemorrhage from the sternum by mechanically blocking the bone’s spongiosa [2, 3].

While these traditional methods provide a solid foundation, they may not always suffice, especially in cases involving complex coagulation disorders or extensive bleeding. To overcome these limitations, topical haemostatic agents have been developed, offering more targeted and effective solutions in challenging surgical scenarios.

Haemostatic Agents and Their Use in Cardiac Surgery

The development and application of haemostatic agents have significantly advanced bleeding control in cardiac surgery. These agents can be categorized by their composition and mechanism of action.

Haemostatic Agents with Active Mechanisms These agents work independently of the body’s coagulation mechanisms by introducing extrinsic clotting factors directly, simulating various stages of the coagulation process.

Examples

  • Thrombin Sealants: Products like Recothrom, Thrombogen, and Thrombostat introduce thrombin at the wound site, promoting clot formation [4].
  • Fibrin Sealants: Tisseel combines fibrinogen and thrombin to form a fibrin clot, replicating the body’s natural clotting process [5].
  • Fibrin Patches: TachoSil and TachoComb provide a physical matrix that supports clot formation [6].
  • Autologous Fibrin and Thrombocyte Concentrates: Vivostat uses the patient’s own blood components to promote haemostasis [7].
  • Gelatin-Thrombin Matrix Sealant: Products like FLOGEL® and Floseal combine gelatin and thrombin to create a flexible, adherent matrix that aids clot formation [8].

Haemostatic Agents with Inactive Mechanisms These agents lack clotting factors and work by forming physical structures that support clot formation.

Examples

  • Gelatin Sponges: Products like Gelfoam and Gelaspon provide a scaffold for clot formation [9].
  • Microfibrillar Collagens: Avitene Flour MCH, Colgel, and Helitene attract and activate platelets to form a clot [10, 11].
  • Oxidized Regenerated Cellulose: Surgicel provides a physical barrier that aids in clot formation [12].
  • Microporous Polysaccharide Hemispheres: Arista rapidly absorbs blood and concentrates clotting factors [13].

SURGISPON® Patch – A Vital Solution in Cardiac Surgery

Aegis Lifesciences offers the SURGISPON® Patch, an absorbable hemostatic gelatin patch designed for cardiovascular applications including cardiac, great vessel, and peripheral vascular repair and reconstruction.

SURGISPON® Patch Benefits

  • Superior Haemostasis: Forms a stable clot, reducing the risk of excessive bleeding and minimizing the need for blood transfusions.
  • Advanced Design: The patch is thin and adheres firmly to the bleeding suture site, sealing it to promote faster healing. Its design creates a protective layer that keeps the stitches stable, minimizing movement and preventing displacement, thus improving suture retention. The patch’s minimal thickness prevents significant swelling and avoids putting pressure on nearby tissues.
  • Ease of Handling: Requires no rinsing before procedures, can easily be trimmed to the desired size, and accommodates cardiovascular anatomy.
  • Reliable Performance: Improved suture retention, low thrombogenicity, and resistance to aneurysmal dilation.
  • Durability: Non-fraying properties ensure reliable performance during surgery.

Clinical Evaluation

A 2023 study by Elkhouly et al. assessed the efficacy of gelatin patches in managing sternal bleeding during cardiac surgery. Patients were divided into two groups: one using traditional methods alone, and the other incorporating gelatin patches. The results showed that the patches significantly reduced sternal bleeding, the need for reoperation, total blood drainage, blood transfusions, and the incidence of cardiac tamponade compared to traditional methods alone. These clinical findings highlight the practical benefits of incorporating gelatin patches into surgical protocols. In conclusion, it’s evident that such tools are essential in enhancing patient safety and recovery in cardiac surgery [2].

Conclusion

Effective bleeding management is essential in cardiac surgery to ensure patient safety and recovery. The SURGISPON® Patch provides a reliable option for surgeons, particularly in challenging cases where traditional methods may not suffice. By supporting clot formation and reducing the risk of complications, the SURGISPON® Patch plays a crucial role in improving surgical outcomes. As the needs of cardiac surgery continue to evolve, tools like the SURGISPON® Patch remain vital in achieving successful results.

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