Aquabrid™
Clinical Results
Click on each headline to read a summary of the clinical study.
Özcan et al., 2023, Sage Journals, https://doi.org/10.1177/15569845231194613
Case report
Minimally invasive robotic mitral repair with hemostasis achieved without surgical techniques and with the aid of a surgical sealant.
Figure: Application of the surgical sealant by transfer technique via its rectangular transparent silicon sheath to the bleeding cardioplegia needle puncture hole.
Intervention
Surgical sealant applied with silicone rubber sheet (accessory to press the applied sealant) to the cardioplegia puncture hole site of bleeding.
Outcome
AQUABRID™ is a simple and safe tool to control aortic bleeding in robotic or minimally invasive cardiac surgery. This product may potentially help achieve hemostasis and decrease the rate of conversion during these kinds of operations.
Matsuoka et al., 2022, Journal of Cardiac Surgery, https://doi.org/10.1111/jocs.17208,
Objectives
To assess the benefit of AQUABRID on outcomes in patients with acute aortic dissection (AAD), this study was conducted with a focus on volume of intraoperative blood transfusion and operative time, in emergency surgery cases.
Methods
The design was a multicenter retrospective cohort study, which ran from 2007 to 2021 and included 387 patients who underwent aortic dissection repair. After the grouping, a propensity score matching was performed to maximize the comparability. Leading to two groups (each with 47 patients) with no significant differences in demographic, clinical and surgical characteristics.
Results
The matched groups showed a significant difference in the volume of blood transfusion (AQUABRID vs. control, unit, median (IQR); total: 34 (26-38) vs. 50 (38-60), p < 0.001; red blood cells: 8 (4-10) vs. 10 (6-12), p = 0.025; fresh frozen plasma: 6 (6-10) vs 10 (8-12), p < 0.001; platelets: 20 (20-20) vs. 30 (20-40), p < 0.001 (Figure 2, 3 A-D).
Figure 1: Primary and secondary outcomes.
Comparison of the volume of blood transfused intraoperatively. (A) Total volume. (B) Red blood cells. (C) Fresh frozen plasma. (D) Platelet. *p < .05 compared with the control group as analyzed using the Mann–Whitney U‐test. The horizontal line in the middle of each box is the median; box length is the interquartile range; whiskers represent the range of the data within the 10th and 90th percentiles. Please note that the units for blood transfusions (BTF) mentioned are specific for Japan and are approximately 140ml (red blood cell (RBC)), 120ml (fresh frozen plasma (FFP)) and 20ml (platelet (PLT)).
Conclusion
The results showed that AQUABRID is effective to facilitate hemostasis in emergency aortic reconstructive surgery and was associated with a significant decrease in blood transfusion units and operating time. The clinical application of these results may decrease the mortality of patients undergoing AAD.
Sonoda et al., 2021, Asian Cardiovascular & Thoracic Annals., https://doi.org/10.1177/0218492320962339, Location: Department of Cardiovascular Surgery, kyushu University Hospital, Fukuoka, Japan
Introduction
Hemostasis is an important factor affecting the success of the aortic surgery. Hydrofit was developed in Japan and consists of a urethane-based polymer without blood products. By applying Hydrofit gel to an anastomosis site on the aorta, water contact initiates a chemical change in the forming elastomer which adheres rapidly and tightly.
Case report
A 42-year-old woman underwent redo aortic valve replacement 4 years and 8 months after the initial surgery because of recurrence of the aortitis syndrome. At the initial surgery, the aortic valve and the ascending aorta were replaced and Hydrofit gel was applied to both ends of the aortic graft.
At re-surgery, the Hydrofit gel covered with thin fibrous tissue was in place around the suture line without infection or deterioration. The surface of the graft and native aorta to which Hydrofit had been applied maintained a continuous adhesive condition as a thin-elastic sealant.
Figure 1: (a). Gross finding of the removed Hydrofit gel that had turned a yellow color due to immersion in tissue fluid around the graft. (b). Histopathological image of the removed Hydrofit, revealing fibrin deposition around the Hydrofit (asterisk); inflammatory cell infiltration inside the Hydrofit was not observed
Conclusion
The Hydrofit applied around the aortic graft suture line was without infection and functioned very well as an elastic sealant for a long period.
*Aquabrid™ is commercially available in Japan under the name of HYDROFIT® since 2014.
Morita et al., 2020, General Thoracic and Cardiovascular Surgery, https://doi.org/10.1007/s11748-019-01169-5
Objectives
This 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.
Methods
This 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, but who were allowed to be treated with any other hemostatic method or other material (Group C, 27 patients).
Figure 1: Patient allocation
The primary endpoints were bleeding from each anastomosis at two time points: immediately before applying protamine and 15 min after applying protamine. The patients were followed for 6 months.
Figure 2: Process of the sealant reaction
Figure 2 shows a schematic presentation of the process of the sealant reaction when applied to tissue. Because the tissue surface is always moistened and covered with water, the sealant starts reacting immediately when applied to the tissue surface. The sealant penetrates places where water molecules exist due to its hydrophilic nature and starts reacting with the water to form a seal tightly attached to the tissue. During the reaction, small carbon dioxide gas bubbles are generated by the sealant.
Results
The 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.
Figure 3: Percentage of complete hemostasis between the two groups
Conclusion
The sealant is effective in achieving hemostasis, even under fully heparinized conditions. The sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.
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