Preveleak Surgical Sealant and Bioglue Surgical Adhesive

PREVELEAK Surgical Sealant and BIOGLUE Surgical Adhesive: The Use of Surgical Sealants and Adhesives in Cardiac Surgery 

The control of intraoperative and postoperative bleeding is essential in the practice of cardiovascular surgery because reoperation and  transfusion of blood products are both associated with poor outcomes.¹ Managing the bleeding site with sutures and staples is often the first line of defense if the source of bleeding can be staunched surgically.² However, surface area, proximity to surrounding structures, patient pathophysiology and source may limit the surgeon’s ability to gain control of bleeding using traditional methods.³

Over the past few decades, sealants and adhesives have been widely adopted to reinforce tissue and seal suture lines in cardiovascular surgery. ² Among these, Preveleak Surgical Sealant is indicated specifically for adjunctive sealing in cardiovascular surgery,⁴ while BioGlue Surgical Adhesive is commonly used as an adjunctive tissue adhesive in cardiac surgery.⁵ As a medical professional, understanding the key differences between these two products is crucial for making informed decisions tailored to the specific needs of each surgical scenario. Here, Michael P. Salna, MD, MBA†, provides an overview of both products empowering you with the knowledge needed to elevate your surgical practice.  

 Please see Preveleak Surgical Sealant Indications and Important Risk Information to follow.

Introduction

Bleeding continues to be a significant complication of cardiac surgical procedures and effective management is important to prevent serious postoperative comorbidity or fatal consequences as well as adverse physiological effects associated with blood loss and transfusion. ² Closing the bleeding site with sutures is often the first line of defense if the source of the bleeding can be stopped surgically.² Sealing at the suture line is critical for patients undergoing cardiac surgical procedures, as many are at risk for poor hemostasis.²

Most cardiac procedures are performed using a cardiopulmonary bypass machine.⁶ The blood-plastic interface within this extracorporeal circulation, however, potentiates inflammation and coagulopathy for the patient.⁶ In aortic surgery, suture-line hemostasis is paramount. Failure to achieve hemostasis at anastomoses, particularly in fragile tissue, may lead to additional operative time, transfusion requirements, and possibly reoperation for bleeding.⁷ The introduction of advanced surgical sealants and adhesives, such as Preveleak Surgical Sealant and BioGlue Surgical Adhesive, have improved the ability to manage bleeding and reinforce fragile tissues.^8,9 Understanding the differences between these products is essential for surgeons to make informed decisions tailored to specific clinical scenarios.

What is the Indication?

Preveleak Surgical Sealant is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage. ⁴

​Selected Risk Information for Preveleak Surgical Sealant: Do not use in patients with known allergies to materials of bovine or shellfish origin.⁴

PREVELEAK Surgical Sealant in Aortic Surgery

In a HemoVision event presented by Baxter Healthcare, “Navigating the Industry: Guidelines and Surgical Challenges in Type A Aortic Dissections,” a round table discussion included Dr. Christopher K. Mehta, Dr. Joseph Bavaria, and Dr. Nimesh Desai. The program provided an overview of challenges, unmet needs, current guidelines and surgical approaches using visual media and live discussion to create an engaging learning environment. There was also a discussion of hemostatic agents and sealants and the role these agents play in cardiovascular surgery, especially in major aortic procedures, like type A dissections and aneurysm repairs. Watch below or listen on Spotify. 

What is the Clinical Evidence?

Preveleak Surgical Sealant has been tested in clinical settings to establish its safety and effectiveness to achieve adjunctive hemostasis in vascular and cardiac reconstructions. ⁴ The pivotal clinical study was a prospective, randomized, controlled, multicenter trial in 217 subjects undergoing vascular surgical procedures.⁴ The study compared Preveleak Surgical Sealant to a control device (Gelfoam® Plus), focusing on sealing suture lines at the anastomosis between native vessels and synthetic vascular grafts or patches​​.⁴

The primary effectiveness endpoint was the achievement of immediate sealing, defined as no bleeding after clamp release during the surgical procedure. ⁴ The multicenter study showed that Preveleak Surgical Sealant achieved immediate sealing in 60.5% of sites compared to 39.6% in the control group, demonstrating superior performance (95% CI 20.8% [10.3, 31.4]) (Figure 2)​.⁴

Additionally, the cumulative incidence of significant bleeding, infection, neurological deficit, or immune/inflammatory allergic response observed within 6 weeks post-treatment was significantly lower in the Preveleak Surgical Sealant group (46.4%) compared to the control group (59.8%, p <0.05).⁴

BioGlue Surgical Adhesive is a two-component surgical adhesive composed of solutions of purified bovine serum albumin (BSA) and glutaraldehyde.⁵ The solutions are dispensed by a controlled delivery system, composed of a double-chambered syringe, applicator tips, and optional applicator tip extenders.⁵ Once dispensed, the adhesive solutions (in a predefined ratio) are mixed within the applicator tip where cross-linking begins.⁵

What is the Indication?

BioGlue Surgical Adhesive is indicated for use as an adjunct to standard methods of achieving hemostasis (such as suture and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral, and carotid arteries).⁵  

How Does It Work?

The glutaraldehyde molecules covalently bond (cross-link) the BSA molecules to each other and, upon application, to the tissue proteins at the repair site, creating a flexible mechanical seal independent of the body's clotting mechanism.⁵ The delivery device-mediated application is designed to provide reproducible mixing of the components in vitro.⁵ BioGlue Surgical Adhesive begins to polymerize within 20 to 30 seconds and reaches its bonding strength within 2 minutes, and it also adheres to synthetic graft materials via mechanical interlocks within the interstices of the graft matrix.⁵  

What is the Clinical Evidence?

BioGlue Surgical Adhesive has been evaluated through clinical trials to determine its efficacy and safety as an adjunct in surgical procedures.⁵ The pivotal clinical trial investigated use in the surgical repair of acute, Stanford Type A aortic dissections. ⁵ This study included 175 patients, comprising 54 nonrandomized (lead-in) patients, 60 patients randomized to standard surgery plus BioGlue Surgical Adhesive, and 61 patients randomized to standard surgery alone​​.⁵

The primary endpoint of early mortality showed no statistically significant difference between the groups.⁵ However, BioGlue Surgical Adhesive-treated patients required fewer pledgets, hemostatic agents, and make-up stitches compared to the control group, indicating improved hemostasis.⁵ Furthermore, there were no confirmed unanticipated adverse device effects, and the incidence of adverse events was similar between groups.⁵

Black Box Warning and Complications Associated with BioGlue Surgical Adhesive

Despite its potential advantages, there are many warnings (including a Black Box Warning), precautions, and contraindications associated with BioGlue Surgical Adhesive.⁵ Please see the full Instructions for Use for full details.⁵

The Black Box Warning States:

• Polymerized BioGlue Surgical Adhesive has space occupying properties. When used improperly, or applied incorrectly, serious adverse events have been reported relating to compression of adjacent anatomic structures. It should be used only when complete visualization of the target application location is possible, when it is properly primed to achieve optimal viscosity, and a minimal amount is used.⁵
• Animal studies have shown that direct application to the exposed phrenic nerve can cause acute nerve injury. Application to the surface of the heart can cause coagulation necrosis that extends into the myocardium, which could reach underlying conduction tissue and may cause acute, focal sinoatrial node degeneration.⁵ ​

BioGlue Surgical Adhesive has been used to glue the dissected layers of the aortic root and create stronger tissue for sewing.¹⁵ However, there is currently general consensus that it should not be applied in the distal false lumen to promote thrombosis because of the risk of embolization.¹⁴ Although it can be useful for this application, there are reports indicating BioGlue Surgical Adhesive can weaken local tissue, impair healing, and predispose patients to late complications such as pseudoaneurysm formation (Figure 4).¹

Sealant Polymerization Time and Surgical Environment Needs

Preveleak Surgical Sealant forms a seal in 60 seconds while BioGlue Surgical Adhesive achieves full strength in 120 seconds.^4,5 In addition, Preveleak Surgical Sealant can be applied effectively in a wet field, whereas BioGlue Surgical Adhesive needs the field to be dry prior to application. ^4,5

Important Findings and Limitations

The flexibility of Preveleak Surgical Sealant offers material benefits, particularly in dynamic vascular environments.^4,5 In contrast, the rigidity of BioGlue Surgical Adhesive may restrict natural vascular movement and, together with its decreased biocompatibility compared to Preveleak Surgical Sealant, can lead to potential long-term complications.¹³

Clinical Evidence and Safety

Preveleak Surgical Sealant has demonstrated a minimal inflammatory response and no tissue necrosis in clinical studies, making it a viable option for surgical applications.^4,15 BioGlue Surgical Adhesive, although effective, has documented cases of inflammatory responses and tissue necrosis, necessitating careful consideration of its use.^5,9,10

Tabular Comparative Overview

To better compare the products, a tabular overview has been provided in Table 1.

Both Preveleak Surgical Sealant and BioGlue Surgical Adhesive offer unique properties in relation to surgical hemostasis.^4,5 Preveleak Surgical Sealant stands out for its rapid sealing, flexibility and biocompatibility, making it a versatile choice for diverse cardiovascular surgical needs, including aortic repair and construction.⁴ BioGlue Surgical Adhesive with its strong adhesion, remains a valuable tool for specific applications, but requires careful handling due to its potential for rigidity and long-term biocompatibility issues.⁵ Surgeons must weigh these factors to select the most appropriate sealant for their specific clinical scenarios, ensuring optimal patient outcomes.

†Dr. Salna was compensated for his time developing this blog.