Matrix Vascular Sealing Gel

A promising alternative to access site closure.

By ULRICH GERCKENS, MD, AND RALPH MUELLER, MD
 

To view the figures related to this article, please refer to the print version of our April issue, page 52.

Although vascular sealing devices have shown a clear improvement in terms of efficacy (time to hemostasis, time to ambulation, time to discharge), significant safety risks are associated with these devices. No currently approved devices have proven to be as safe as the gold standard, with complication rates as high, if not higher, as manual compression. Suture/staple-based devices provide faster ambulation and a confident closure; however, they pose significant risks in the event of device failure and leave behind a permanent foreign body in the artery. Arterial plugs are typically comprised of collagen and pose significant safety risks due to the thrombogenic nature of the devices. Even manual compression has been associated with a 5% complication rate at the groin.1 We recently evaluated a novel approach called the Matrix VSG (Vascular Sealing Gel) (Access Closure Inc., Palo Alto, CA), which is comprised of a synthetic polymer and delivery catheter. Matrix VSG was developed to meet the need for an access site sealing technology that provides a secure seal without compromising patient safety.

DEVICE DESCRIPTION
Matrix VSG (Figure 1) is a tissue-adherent, flexible sealant consisting of two fully synthetic, nonthrombogenic liquids that, when mixed together, rapidly crosslink to form a biocompatible absorbable poly(ethylene glycol)-based hydrogel.2 The gel solidifies within seconds of injection and provides secure hemostasis within 1 minute. Animal studies have shown that even in the case of intentional injection of the sealant directly into the artery, no occlusion or subsequent ischemic complication occurred.
After rapid hemostasis and ambulation, Matrix VSG resorbs into the tissue providing a bioinert foundation, which promotes healing (Figure 2).3

CLINICAL DATA
Thirty-three consecutive patients (21 diagnostic; 12 percutaneous coronary intervention) were treated at Siegburg Heart Center, Siegburg, Germany, with use of Matrix VSG after routine angiography/angioplasty. To achieve hemostasis, Matrix VSG was injected through a standard introducer sheath while the delivery catheter provided temporary hemostasis. After injection of the polymer, the delivery catheter was removed and nonocclusive pressure was maintained for 1 to 3 minutes (Figures 3 and 4).

RESULTS
Hemostasis was achieved successfully in all patients (100%). Time to ambulation in every case was <2 hours, per study protocol and was achieved in all patients (100%). There were two complications (6%). One case resulted in a small pseudoaneurysm (3%) and one case resulted in a 6-hour rebleed (3%), both of which were treated successfully with additional compression. In this first-ever human experience, both complications were associated with the learning curve; therefore, they were technique-related.

CONCLUSION
Matrix VSG appears to be a promising new alternative for access site closure. It appears safe, easy-to-use, and effective. It represents a novel and unique approach to vascular access site treatment after diagnostic and interventional catheterization, and it reduces the risk of distal embolization and ischemic complications. n

Ulrich Gerckens, MD, is from the Department of Cardiology/Angiology, Heart Center Siegburg, Siegburg, Germany. He has no financial interest in any product or manufacturer listed herein.

Ralph Mueller, MD, is from the Department of Cardiology/Angiology, Heart Center Siegburg, Siegburg, Germany. He has no financial interest in any product or manufacturer listed herein.

1. Caputo RP, Ebner A, Piemonte T. Percutaneous ateriotomy repair with a novel staple closure device. Cath Lab Digest. 2001;9.
2. Ferland R, Mulani D, Campbell PK. Evaluation of a sprayable polyethylene glycol adhesion barrier in a porcine efficacy model. Hum Reprod. 2001;12:2718-23.
3. Dunn R, Lyman MD, Edelman PG, et al. Evaluation of the SprayGel adhesion barrier in the rat cecum abrasion and rabbit uterine horn adhesion models. Fertil Steril. 2001;75:411–416.

 

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About Endovascular Today

Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22,000 members of the endovascular community.