Abstract
ObjectivesThis study aimed to demonstrate the efficacy and safety of a newly developed elastomeric sealant, which does not require any blood coagulation system to exert its effect, during thoracic aortic surgery.MethodsThis is a multicenter, randomized study conducted in six hospitals in Japan. A total of 81 patients undergoing replacement surgery of a thoracic aortic aneurysm using cardiopulmonary bypass were randomized with a ratio of 2–:1 for those patients designated to receive the sealant (Group S, 54 patients) or those without the usage of the sealant (Group C, 27 patients). The primary endpoints were bleeding from each anastomosis at two time points: (1) immediately before applying protamine and (2) 15 min after applying protamine. The patients were followed for 6 months.ResultsThe number of anastomoses checked for bleeding was 196 in Group S and 117 in Group C. Before protamine sulfate administration, complete hemostasis was obtained in 155 anastomoses (79%) in Group S compared to 45 anastomoses (38%) in Group C (p < 0.001). Fifteen minutes after the administration of protamine sulfate infusion, bleeding stopped completely in 173 anastomoses (88%) in Group S and in 71 anastomoses (61%, p < 0.001) in Group C. Between the two groups, there were no marked differences in the patient background or in the incidence of major adverse events.ConclusionsThe sealant is effective in achieving hemostasis, even under fully heparinized conditions. The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.
Highlights
Effective hemostasis is the key to the success of aortic surgery
Several surgical sealants have been introduced clinically [1–4], each has a number of limitations such as the inherent risk of infection due to the biological nature of the sealant, the requirement of an intact hematological coagulation system for the sealants to function, a weakened hemostatic function with the presence of liquid, and a lack of an elastomeric property causing compliance mismatch with the native aorta
In the present study of aortic aneurysm repair using cardiopulmonary bypass, patients whose anastomoses were treated with the sealant showed a significantly higher complete hemostasis rate than the control group patients who received standard surgical care
Summary
Effective hemostasis is the key to the success of aortic surgery. In patients undergoing thoracic aorta replacement using cardiopulmonary bypass, the mandatory usage of heparin and occasional complication of coagulopathy make it difficult to achieve hemostasis. Several surgical sealants have been introduced clinically [1–4], each has a number of limitations such as the inherent risk of infection due to the biological nature of the sealant, the requirement of an intact hematological coagulation system for the sealants to function, a weakened hemostatic function with the presence of liquid, and a lack of an elastomeric property causing compliance mismatch with the native aorta. The sealant is provided as a General Thoracic and Cardiovascular Surgery (2020) 68:112–121
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