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The use of a novel tissue sealant as a hemostatic adjunct in cardiac surgery
J K White1, J S Titus, H Tanabe
1Division of Cardiac Surgery and Department of Pathology, Massachusetts General Hospital, Boston, MA 02114, USA.
Insights
A new polyethylene glycol-based surgical sealant effectively stopped bleeding in canine arterial puncture models. This sealant also showed no adverse tissue reactions or scarring in coronary artery bypass graft anastomoses after three months.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Surgical Hemostasis
Background:
- Hemorrhage remains a significant challenge in cardiac surgery, especially in complex and high-risk patients.
- Minimally invasive cardiac surgery presents unique challenges, increasing the risk of surgical bleeding due to limited exposure and difficulty with precise suturing.
- An effective surgical sealant could be invaluable for cardiac surgeons, potentially facilitating minimally invasive procedures.
Purpose of the Study:
- To evaluate the efficacy of a novel polyethylene glycol-based tissue sealant (FocalSeal) in controlling bleeding from arterial puncture sites.
- To assess the safety and efficacy of the sealant when applied to coronary artery anastomoses in chronic canine studies.
Main Methods:
- Acute canine studies involved applying the sealant to graduated needle puncture sites in arteries of heparinized animals.
- Chronic canine studies involved applying the sealant to the suture line of left internal mammary artery (LIMA) to left anterior descending (LAD) anastomoses.
- Coronary anastomoses were evaluated for patency and tissue reaction after a three-month recovery period.
Main Results:
- The sealant successfully prevented bleeding from arterial puncture wounds up to 2.5 mm in diameter.
- Histologic examination after three months revealed no adverse tissue reactions at the sealant application sites on coronary anastomoses.
- All coronary anastomoses treated with the sealant remained patent throughout the study period.
Conclusions:
- The polyethylene glycol-based sealant functions as an effective hemostatic adjunct to sutures in coronary anastomoses.
- The sealant demonstrates a favorable safety profile, causing no adverse tissue reactions or scarring.
- This surgical sealant shows promise for improving outcomes in cardiac surgery, particularly in minimizing suture line bleeding.
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.
