Results from a First-in-Human Trial of a Novel Vascular Sealant

Abstract

BackgroundSuture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX®) is a polyaldehyde–bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study.Materials and methodsA prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance.ResultsFifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10 min of observation. The three most common adverse events were graft or bypass occlusion (n = 5 patients), infection (n = 4), and seroma (n = 3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts.ConclusionPreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial.

Polymeric Tissue Adhesives

“…Due to the higher molecular weight of polyaldehyde relative to glutaraldehyde, leaching of the reactive species from PreveLeak is much less than that from BioGlue. 366 PreveLeak elicits only minimal inflammation, compared to BioGlue. The adverse events in patients treated with PreveLeak have been reported to be consistent with those commonly observed in patients undergoing surgical procedures.…”

“…To circumvent the toxic effects caused by glutaraldehyde, PreveLeak exploits an alternative form of aldehyde, polyaldehyde. Due to the higher molecular weight of polyaldehyde relative to glutaraldehyde, leaching of the reactive species from PreveLeak is much less than that from BioGlue . PreveLeak elicits only minimal inflammation, compared to BioGlue.…”

Use of surgical sealant in the prevention of pharyngocutaneous fistula after total laryngectomy

“…11 The use of biological tissue adhesives and surgical sealants of various types is well established in many fields of surgery, including otorhinolaryngology. 23 Recent research has evaluated the use of surgical sealants to prevent pharyngocutaneous fistula. In the context of the support of a suture repair, the need for tensile strength may be of less importance; however, sealing properties are key.…”

“…This sealant is proven to work in a bloody or dry environment, whereas other sealants, such as cyanoacrylate, require drier conditions. 23 Recent research has evaluated the use of surgical sealants to prevent pharyngocutaneous fistula. An animal study compared the use of 3 tissue glues (a fibrin adhesive, a synthetic adhesive, and a protein-based albumin glutaraldehyde adhesive) and platelet-rich plasma applied over a sutured pharyngotomy with a control group (suture repair only).…”

Real-world Bleeding Outcomes and Costs Following Vascular Graft Anastomosis Using PROLENE Sutures with HEMO-SEAL Technology in Patients Undergoing Abdominal Aortic Aneurysm Repair

“…1,2,4,5 Use of conventional synthetic grafts such as polytetrafluoroethylene [PTFE] grafts further exacerbate NHB. 3,[5][6][7][8] Early research demonstrated that using sutures with a small needle-to-suture (N:S) diameter ratio (eg, 1:1) reduces the discrepancy between the diameter of the needle hole and the diameter of the suture filling it, thereby significantly reducing NHB. 8,9 The ROLENE suture with HEMO-SEAL technology (HEMOSEAL suture) represents the latest breakthrough in suture technology.…”