The Use of TISSEEL [Fibrin Sealant] in Complex Gynecologic Surgery

Many techniques and materials are available to achieve hemostasis during gynecologic surgery.¹ Sutures, hemoclips, and electrocautery are predominantly used, but in situations in which these methods alone are insufficient, topical hemostatic agents can serve as an alternative option to reduce thermal damage, devascularization, and tissue necrosis while also reducing blood loss.^1,2 There are many hemostatic products available today, including fibrin sealants, which are utilized for hemostasis and tissue sealing across a range of surgical procedures, including gynecologic surgery.¹

Complex gynecologic surgeries demand advanced techniques and meticulous planning. In this blog, Dwight D. Im, MD, FACOG,^† a renowned board-certified gynecologic surgeon and leader of the prestigious gynecology and robotic surgery programs at Mercy Medical Center in Baltimore, provides an overview of his systematic approach to navigating challenging pelvic anatomy. Effective hemostasis is a cornerstone of success in these procedures, and Dr. Im relies on fibrin sealant to achieve it.³

Introduction

Bleeding can be a complication of surgery that may lead to substantial morbidity and mortality.⁴ Specifically, 7.5% of US gynecologic patients will experience bleeding-related complications and/or blood transfusions that can increase length of stay, mortality, and resource utilization.⁴ Notably, among adults who had an inpatient gynecologic procedure during 2006–2007, patients with bleeding-related complications had statistically significantly higher average costs ($9,295) relative to patients without complications ($6,490), thus leading to additional costs of up to $2,805.⁴

Moreover, gynecologic surgery can present a wide range of bleeding types, ranging from mild capillary-like oozing across broad surfaces to life threatening spurting or gushing.^5,6 A surgeon-validated scale, known as the Validated Intraoperative Bleeding Scale (i.e., VIBe SCALE tool), is graded on a 5-point scale from 0 (no bleeding) to 4 (life threatening).^5,6 The VIBe SCALE tool provides a standardized, reproducible method for evaluating bleeding severity and is available to help guide surgical teams in the evaluation of bleeding severity in open surgical procedure and to ultimately choose an appropriate agent for effective hemostasis.^5,6

During surgical procedures, bleeding control may be difficult or ineffective.⁷ A potential solution is the use of adjunct topical hemostatic agents to address these challenges in complex gynecologic surgery, such as laparoscopic excision of endometriomas.⁷

Insufficient visualization of the surgical field significantly hinders the procedure and challenging anatomical planes make precise dissection difficult. Below is a diagram of the pelvic anatomy, showing connective tissue planes and spaces of the female pelvis and a diagrammatic cross section of the female pelvis through the cervix (Figure 1). The avascular spaces of the female pelvis include prevesical, vesicovaginal, rectovaginal, retrorectal, paravesical, and pararectal spaces.⁸

Specifically, regarding the challenges of accessing the pararectal space, I would also add that it's a challenging area to develop, requiring careful consideration of several anatomical elements. Successfully accessing and operating in this region may be accomplished as described in my IMSWAY technique.

My IMSWAY technique provides a systematic and reproducible method for accessing the retroperitoneal space during complex hysterectomy, particularly when involving fibroids. The steps involve:

• Infundibulopelvic ligament (IP)
• Medial leaf of peritoneum
• Skeletonize ureter
• Water under the bridge
• At origin of uterine artery
• Yes! A Success!

All pelvic surgery starts with the IP ligament. Identifying and skeletonizing the IP ligament is the foundation of the approach. To skeletonize the ureter, use the IP ligament to help locate and gently dissect the ureter off the medial leaf of the peritoneum. Ensure dissection is lateral to the ureter, while staying close to the ureter. Follow the ureter to the “tunnel” via the vesicouterine ligament and use the ureter as a guide to locate the internal iliac artery and uterine artery/vein in the pararectal space. Then we move into water under the bridge. This refers to the area where the uterine artery crosses anterior to the ureter. Careful dissection around the uterine artery, along with dissection of the hypogastric artery, expands access to the pararectal space. Finally, once the pararectal space is adequately developed, clamp, coagulate, and/or cut the uterine artery at its origin. Securing the uterine artery in this final step helps minimize the bleeding.

Bleeding control may be difficult or ineffective in differing surgical procedures and approaches.⁷ Thus, securing hemostasis can be a challenge,⁷ but many techniques, materials, and hemostatic agents are available to achieve hemostasis during gynecologic surgery.¹ Sutures, hemoclips, and electrocautery are predominantly used, but in situations in which these methods alone are insufficient, topical hemostatic agents may be useful adjuncts for achieving hemostatis.^1,2,3,7 Many types of topical hemostatic agents are available today, including fibrin sealants, which are utilized for hemostasis across a range of surgical procedures, including gynecologic surgery.^1,3

TISSEEL [Fibrin Sealant] Indication

Tisseel [fibrin sealant] is indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.³ Tisseel [fibrin sealant] is effective in heparinized patients and is also indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.³

Tisseel [fibrin sealant] Important Risk Information and accompanying Prescribing Information to follow.

Composition of TISSEEL [Fibrin Sealant]

Tisseel [fibrin sealant] is a two-component fibrin sealant made from pooled human plasma.³ When combined, the two components, a human sealer protein and human thrombin mimic the final stage of the blood coagulation cascade.³ The sealer protein is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. The sealer protein also contains a fibrinolysis inhibitor, aprotinin, that is synthetic and completely of non-human/non-animal origin.³ The thrombin is also a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. In the presence of small amounts of calcium and Factor XIII, the thrombin converts fibrinogen into insoluble fibrin, the final stable form of the agent.³ Details of the composition of Tisseel [fibrin sealant] are provided in Figure 2.³

Figure 2: Tisseel [fibrin sealant] Composition: Dual-Chambered Syringe³

How TISSEEL [Fibrin Sealant] Works

Upon mixing the human sealer protein and thrombin, soluble fibrinogen is transformed into fibrin, forming a rubber-like mass that adheres to the wound surface and achieves hemostasis and sealing or gluing of tissues.³ Tisseel [fibrin sealant] mimics the final coagulation cascade step as it has all relevant components to form a clot.³ Thrombin is a highly specific protease that transforms the fibrinogen contained in Sealer Protein into fibrin. Fibrinolysis inhibitor, aprotinin (synthetic), is a polyvalent protease inhibitor that prevents premature degradation of fibrin. Preclinical studies have shown that incorporation of aprotinin increases resistance of the fibrin sealant clot to degradation in a fibrinolytic environment.³

Formation of a Physiologic Clot

When comparing scanning electron microscope (x10,000) images of the clot formed by Tisseel [fibrin sealant] as compared to a physiologic clot, the clot formed by Tisseel [fibrin sealant] closely resembles a physiologic clot (Figure 3).^9-11

Figure 3: Comparison of Fibrin Clot with a Physiologic Clot^9-12

Scanning electron microscope (SEM) images

The Use of TISSEEL [fibrin sealant] in Complex Gynecologic Surgery: Case Studies

The use of Tisseel [fibrin sealant] has demonstrated benefits in reducing bleeding in complex gynecologic surgeries.¹³ Below we present two case studies of patients who received Tisseel [fibrin sealant] for adjunctive hemostasis.

Selected Risk Information for Tisseel (fibrin sealant): Do not use where the minimum recommended distance from the applicator tip to the target site cannot be reassured. Please see full IRI and link to Prescribing Information to follow.

In my experience, complex hysterectomies, especially those involving fibroids, demand meticulous attention to detail. Successfully navigating challenging pelvic anatomy requires a systematic approach, and I have found that beginning with precise identification and skeletonization of the IP ligament is key. My IMSWAY technique provides a reproducible method for accessing the retroperitoneal space, crucial for managing situations where fibroids present significant challenges. Using vasopressin and a single-tooth tenaculum (for traction) aid in exposure during the gynecological procedures as well.

Effective hemostasis is paramount for successful and efficient surgery. While sutures, hemoclips, and electrocautery are predominantly used, in complex cases where bleeding is more significant or challenging, a topical hemostatic agent can be an invaluable adjunct.^1,2,3 In my practice, we utilize Tisseel [fibrin sealant] to manage generalized oozing, finding it particularly effective in these situations. The case studies presented, along with video demonstrations, showcase the practical application of these techniques and highlight the effectiveness of Tisseel [fibrin sealant] in managing surgical bleeding. Combining precise surgical technique (IMSWAY) with an appropriate adjunctive hemostatic agent supports surgeons in achieving the surgical outcomes they desire with complex gynecologic procedures.

*Dr. Im was compensated for his time developing the content for this blog.