Transforming Bleeding Control in Cardiac Surgery with SURGISPON® Patch

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Introduction

In cardiac surgery, the effective management of bleeding is vital not only for the success of the procedure but also for the patient’s recovery and long-term health. Hemorrhagic complications during open-heart surgeries present substantial risks, with incidence rates between 5-9%, and in severe cases, possibly reaching 16%. While blood transfusions are often essential, they carry risks such as adverse reactions and potential pathogen transmission. Patients who require reoperation due to bleeding face a three-fold increase in mortality risk. Postoperative bleeding is attributed to surgical causes in 66% of cases, while 33% are due to coagulation disorders.

As we explore the methods employed in cardiac surgery for bleeding control, it is important to first acknowledge the traditional techniques that have long been the cornerstone of surgical practice. Although these methods are often effective, they underscore the need for innovations like the SURGISPON® Patch when dealing with more complex challenges.

Traditional Methods for Controlling Bleeding

Bleeding control in cardiac surgery has traditionally involved both systemic and local approaches, each offering its own benefits and limitations.

Systemic Approaches

  • Blood Transfusions: Administration of red blood cells, platelets, plasma, and cryoprecipitate to provide essential clotting factors and volume support.
  • Pro-Coagulant Medications: Including anti-fibrinolytics like tranexamic acid and aminocaproic acid to prevent clot breakdown.
  • Recombinant Factor VII: A synthetic clotting factor used to promote coagulation, especially in severe bleeding cases.

Local Approaches

  • Direct Surgical Techniques
    • Suturing: Involves manually closing bleeding vessels or tissues, which can be time-consuming and requires precision.
    • Vessel Ligation: Ties off blood vessels to control bleeding but can be difficult in deep or small vessels.
    • Electrocautery: Uses electric current to coagulate blood and seal vessels quickly, though it may cause tissue damage.
  • Haemostatic Maneuvers
    • Digital Pressure Application: Uses fingers to apply pressure to bleeding sites for immediate control, though it is not sustainable for long periods and may be ineffective in severe cases.
    • Warm Saline Irrigation: Flushes the area to manage bleeding sources, providing temporary hemostasis.
    • Bone Wax: A mixture of beeswax and paraffin or vaseline used to control hemorrhage from the sternum by mechanically blocking the bone’s spongiosa.

While traditional methods provide a solid foundation, they are sometimes inadequate, particularly in cases involving complex coagulation disorders or significant bleeding. To address these limitations, topical haemostatic agents have been developed, offering more precise and effective solutions in challenging surgical situations.

Haemostatic Agents and Their Use in Cardiac Surgery

The development and application of haemostatic agents have significantly enhanced the ability to control bleeding in cardiac surgery. These agents can be classified based on their composition and mode of action.

Haemostatic Agents with Active Mechanisms These agents operate independently of coagulation mechanisms by introducing external clotting factors that mimic various stages of the clotting process upon application.

Examples:

  • Thrombin Sealants: Recothrom, Thrombogen, Thrombostat introduce thrombin directly to the wound site to promote clot formation.
  • Fibrin Sealants: Tisseel combines fibrinogen and thrombin to form a fibrin clot, simulating the body’s natural clotting process.
  • Fibrin Patches: TachoSil, TachoComb provide a physical matrix to support clot formation.
  • Autologous Fibrin and Thrombocyte Concentrates: Vivostat uses the patient’s own blood components to promote haemostasis.
  • Gelatin-Thrombin Matrix Sealant: FLOGEL® and Floseal combine gelatin and thrombin to create a flexible, adherent matrix that promotes clot formation.

Haemostatic Agents with Inactive Mechanisms These agents lack clotting factors and function by creating physical lattices that promote clot formation.

Examples:

  • Gelatin Sponges: Gelfoam, Gelaspon, provide a scaffold for clot formation.
  • Microfibrillar Collagens: Avitene Flour MCH, Colgel, Helitene attract and activate platelets to form a clot.
  • Oxidized Regenerated Cellulose: Surgicel provides a physical barrier to aid in clot formation.
  • Microporous Polysaccharide Hemispheres: Arista rapidly absorbs blood and concentrates clotting factors.

SURGISPON® Patch – A Vital Tool in Cardiac Surgery

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

Benefits of SURGISPON® Patch

  • 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, adheres firmly to the bleeding suture site, and promotes faster healing by sealing it. Its design creates a protective layer that stabilizes stitches, minimizes movement, and prevents displacement, improving suture retention. The patch’s minimal thickness prevents significant swelling and avoids exerting pressure on surrounding tissues.
  • Ease of handling: Requires no rinsing before procedures, can be easily trimmed to the desired size, and adapts well to cardiovascular anatomy.
  • Reliable performance: Enhanced suture retention, low thrombogenicity, and resistance to aneurysmal dilation.
  • Durability: The non-fraying property ensures reliable performance during surgery.

Clinical Evaluation

A 2023 study by Elkhouly et al. assessed the effectiveness of gelatin patches in managing sternal bleeding during cardiac surgery. Patients were divided into two groups: one treated with traditional methods alone and the other with the addition of gelatin patches. The results indicated 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 underscore the practical benefits of integrating gelatin patches into surgical protocols, highlighting their role in enhancing patient safety and recovery in cardiac surgery.

Conclusion

Effective bleeding management is critical in cardiac surgery to ensure patient safety and recovery. The SURGISPON® Patch offers surgeons a reliable option, particularly in challenging cases where traditional methods may fall short. By supporting clot formation and reducing the risk of complications, the SURGISPON® Patch plays a significant role in improving surgical outcomes. As cardiac surgery continues to evolve, tools like the SURGISPON® Patch remain essential for achieving successful results.

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