The Use of a Novel Tissue Sealant as a Hemostatic Adjunct in Cardiac Surgery

(#2000-8999 ... January 13, 2000)

Jennifer K. White, MD, James S. Titus, Hiroake Tanabe, MD, H. Thomas Aretz, MD, David F. Torchiana, MD

Division of Cardiac Surgery and Department of Pathology, Massachusetts General Hospital, Boston, MA 02114

ABSTRACT

Background: In spite of advances in the management of bleeding associated with cardiac surgery, hemorrhage remains a troublesome problem, particularly in complex cases and high risk patients. In minimally invasive cardiac surgery, limited exposure and tight quarters may make accurate suturing difficult, and increase the risk of surgical bleeding. A surgical sealant that effectively prevents suture line bleeding would be a valuable resource for cardiac surgeons and might help to facilitate minimal access cases.

Methods: We undertook acute canine studies with a new polyethylene glycol-based tissue sealant (FocalSeal™, Focal, Inc., Lexington, MA) to determine its effectiveness in controlling bleeding from graduated needle punctures sites in the arteries of heparinized animals. For chronic canine studies, the sealant was applied to the suture line of a left internal mammary artery (LIMA) to left anterior descending (LAD) anastomoses. The anastomoses were then evaluated for patency and tissue reaction after a three-month recovery period.

Results: The sealant prevented bleeding from arterial puncture wounds up to 2.5 mm in diameter. Three months following the application of sealant to coronary anastomoses, no adverse tissue reaction was found on histologic examination. All anastomoses treated with the sealant remained patent.

Conclusion: When applied as a hemostatic adjunct to sutures at a coronary anastomosis, the sealant appears to be an effective means of preventing bleeding without adverse tissue reaction or scarring.

AUTHOR/ARTICLE INFORMATION

Reprint requests to: David F. Torchiana, MD, Chief, Division of Cardiac Surgery, Bullfinch 119, Massachusetts General Hospital, Boston, MA 02114, Phone: (617) 726-5175, Fax: (617) 726-1821, Email: DTORCHIANA@PARTNERS.ORG

Submitted on: Peer reviewed and accepted at the third annual New Era Cardiac Care Conference, San Diego, California, January 13-16, 2000

Keywords: surgical sealant, hemostasis, bleeding, glue, anastomoses, hydrogel, FocalSeal, coronary artery bypass.