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General Thoracic and Cardiovascular Surgery
Published in: General Thoracic and Cardiovascular Surgery 9/2023

Open Access 14-03-2023 | Original Article

A sealant with a hemostatic mechanism independent of the blood coagulation function was effective in both elective and emergency surgery for thoracic aorta

Authors: Shigeki Morita, Hitoshi Yaku

Published in: General Thoracic and Cardiovascular Surgery | Issue 9/2023

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Abstract

Objectives

Matsudaito is a unique surgical sealant with a powerful hemostatic effect that works independent of a patient’s blood coagulation function. Because of its mechanism, this sealant is expected to be particularly useful in patients with a poor blood coagulation function, such as in cases of acute aortic syndrome requiring emergency surgery. We, therefore, evaluated the hemostatic static effect of the sealant in both emergency and elective surgery of the thoracic aorta.

Methods

We used data obtained from post-marketing surveillance of the sealant. Patients who underwent replacement of the thoracic aorta were enrolled. The hemostatic effect was evaluated as effective if a further hemostatic procedure was not performed after applying the sealant.

Results

From 46 hospitals in Japan, a total of 542 patients (327 elective and 215 emergency cases) were enrolled. Hospital mortality was 4.0% and 11.6% in elective and emergency cases, respectively (p < 0.05). Among the 1039 anastomoses (609 elective and 430 emergency cases), effective hemostasis was confirmed in 436 (71.6%) elective and 259 (60.2%) emergency cases. The data from the clinical trial of the sealant showed a hemostatic rate of 44.4% in elective control cases without the sealant.

Conclusion

Given that the hemostatic rate in emergency surgery with the sealant seemed to be better than that in elective surgery without the sealant (determined from the clinical trial), we concluded that the sealant was effective in both emergency and elective thoracic surgery of the aorta.
Literature
1.
Coselli JS, Bavaria JE, Fehrenbacher J, Stowe CL, Macheers SK, Gundry SR. Prospective randomized study of a protein-based tissue adhesive used as a hemostatic and structural adjunct in cardiac and vascular anastomotic repair procedures. J Am Coll Surg. 2003;197:243–52.CrossRefPubMed
2.
Borst HG, Haverich A, Walterbusch G, Maatz W. Fibrin adhesive: an important hemostatic adjunct in cardiovascular operations. J Thorac Cardiovasc Surg. 1982;84:548–53.CrossRefPubMed
3.
Bachet J, Goudot B, Dreyfus G, Banfi C, Ayle NA, Aota M, et al. The proper use of glue: a 20-year experience with the GRF glue in acute aortic dissection. J Card Surg. 1997;12:243–53.PubMed
4.
Lumsden AB, Heyman ER. Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions. J Vasc Surg. 2006;44:1002–9.CrossRefPubMed
5.
Horowitz B, Busch M. Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin. Transfusion. 2008;48:1739–53.CrossRefPubMedPubMedCentral
6.
Cardillo G, Carleo F, Carbone L, De Massimi R, Lococo A, Santini PF, et al. Adverse effects of fibrin sealants in thoracic surgery: the safety of a new fibrin sealant: multicentre, randomized, controlled, clinical trial. Eur J Cardiothorac Surg. 2012;41:657–62.CrossRefPubMed
7.
Weiner J, Widman S, Golek Z, Tranquilli M, Elefteriades JA. Role of Bovine Serum albumin-glutaraldehyde glue in the formation of anastomatic pseudoaneurysms. J Card Surg. 2011;26:76–81.CrossRefPubMed
8.
Fujiwara H, Oda K, Saiki Y, Sakamoto N, Ohashi T, Sato M, et al. The wrapping method using biodegradable felt strips has a preventive effect on the thinning of the aortic wall: Experimental study in the canine aorta. J Vasc Surg. 2006;43:349–56.CrossRefPubMed
9.
Oda S, Morita S, Tanoue Y, Eto M, Matsuda T, Tominaga R. Experimental use of an elastomeric surgical sealant for arterial hemostasis and its long-term tissue response. Interact Cardiovasc Thorac Surg. 2010;10:258–61.CrossRefPubMed
10.
Matsuda T, Nakajima N, Itoh T, Takakura T. Development of a compliant surgical adhesive derived from novel fluorinated hexamethylene diisocyanate. ASAIO Trans. 1989;35:381–3.CrossRefPubMed
11.
Morita S, Matsuda T, Tashiro T, Komiya T, Ogino H, Mukohara N, et al. Randomized clinical trial of an elastomeric sealant for hemostasis in thoracic aortic surgery. Gen Thorac Cardiovasc Surg. 2020;68:112–21.CrossRefPubMed
12.
13.
Shimizu H, Okada M, Tangoku A, Doki Y, Endo S, Fukuda H, et al. Thoracic and cardiovascular surgeries in Japan during 2017: Annual report by the Japanese Association for Thoracic Surgery. Gen Thorac Cardiovasc Surg. 2020;68:414–49.CrossRefPubMed
14.
Basu S, Marini CP, Bauman FG, Shirazian D, Damiani P, Robertazzi R, et al. Comparative study of biological glues: cryoprecipitate glue, two-component fibrin sealant, and “French” glue. Ann Thorac Surg. 1995;60:1255–62.CrossRefPubMed
15.
Nenezić D, Ayguasanosa J, Menyhei G, Tamás H, Mátyás L, Muluk S, et al. A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery. J Vasc Surg. 2019;70:1642–51.CrossRefPubMed
16.
Minato N, Katayama Y, Yunoki J, Kawasaki H, Satou H. Hemostatic effectiveness of a new application method for fibrin glue, the “rub-and-spray method”, in emergency aortic surgery for acute aortic dissection. Ann Thorac Cardiovasc Surg. 2009;15:265–71.PubMed
17.
Ueda T, Shimizu H, Hashizume K, Koizumi K, Mori M, Shin H, et al. Mortality and morbidity after total arch replacement using a branched arch graft with selective antegrade cerebral perfusion. Ann Thorac Surg. 2003;76:1951–6.CrossRefPubMed
18.
19.
Oda T, Minatoya K, Kobayashi J, Okita Y, Akashi H, Tanaka H, et al. Prosthetic vascular graft infection through a median sternotomy: A multicentre review. Interact Cardiovasc Thorac Surg. 2015;20:701–6.CrossRefPubMed
20.
Nakae M, Toda K, Yoshioka D, Miyagawa S, Kainuma S, Kawamura T, et al. Sutureless patch repair with a novel adhesive for postinfarction ventricular septal rupture. Ann Thorac Surg. 2022;113:e33–6.CrossRefPubMed
21.
Ishii H, Endo H, Tsuchiya H, Inaba Y, Terakawa K, Kubota H. Off-pump hemostasis for left ventricular rupture after myocardial infarction with Hydrofit ® and Surgicel ®. Gen Thorac Cardiovasc Surg. 2018;66:753–5.CrossRefPubMed
22.
Umeda Y. Distal stump construction for acute aortic dissection by pre-gluing felt strip with Hydrofit® during systemic cooling. J Cardiovasc Surg (Torino). 2021;62:408–10.PubMed
23.
Kawashima T, Hatori K, Mizoguchi T, Oda Y, Arakura M, Hagiwara N, et al. In vitro evaluation of the hemostatic effect of method involving the combined use of Hydrofit ® and Spongel ®. Gen Thorac Cardiovasc Surg. 2020;68:932–7.CrossRefPubMed
24.
Shimura S, Odagiri S, Okada K, Keisuke O, Takayoshi Y, Goro K, et al. Closure of aortic root false lumen using Hydrofit in type A acute aortic dissection (Abstract in Japanese). Japanese J Vasc Surg. 2020;29:22–5.
Metadata
Title
A sealant with a hemostatic mechanism independent of the blood coagulation function was effective in both elective and emergency surgery for thoracic aorta
Authors
Shigeki Morita
Hitoshi Yaku
Publication date
14-03-2023
Publisher
Springer Nature Singapore
Published in
General Thoracic and Cardiovascular Surgery / Issue 9/2023
Print ISSN: 1863-6705
Electronic ISSN: 1863-6713
DOI
https://doi.org/10.1007/s11748-023-01918-7

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