Aulogous fibrin sealant (Vivostat®) in the neurosurgical practice: Part II: Vertebro-spinal procedures

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Abstract

Background:

Epidural hematomas, cerebrospinal fluid fistula, and spinal infections are challenging postoperative complications following vertebro-spinal procedures. We report our preliminary results using autologous fibrin sealant as both fibrin glue and a hemostatic during these operations.

Methods:

Prospectively, between January 2013 and March 2015, 68 patients received an autologous fibrin sealant prepared with the Vivostat ^® system applied epidurally to provide hemostasis and to seal the dura. The surgical technique, time to bleeding control, and associated complications were recorded.

Results:

Spinal procedures were performed in 68 patients utilizing autologous fibrin glue/Vivostat ^® to provide rapid hemostasis and/or to seal the dura. Only 2 patients developed postoperative dural fistulas while none exhibited hemorrhages, allergic reactions, systemic complications, or infections.

Conclusions:

In this preliminary study, the application of autologous fibrin sealant with Vivostat ^® resulted in rapid hemostasis and/or acted as an effective dural sealant. Although this product appears to be safe and effective, further investigations are warranted.

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Most cited references 22

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Incidental durotomy in spine surgery.

H Parvataneni, H Sandhu, P Sangani … (2000)

Retrospective review of a large series of patients who underwent spinal surgery at a single institution during a 10-year period. To further clarify the frequency of incidental durotomy during spine surgery, its treatment, associated complications, and results of long-term clinical follow-up. Incidental durotomy is a relatively common occurrence during spinal surgery. There remains significant concern about it despite reports of good associated clinical outcomes. There have been few large clinical series on the subject. A retrospective review was conducted of clinical and surgical records and radiographic data for consecutive patients who underwent spinal surgery performed by the two senior surgeons from January 1989 through December 1998. A total of 2144 patients were reviewed, and 74 were found to have dural tears occurring during or before surgery. Incidental durotomy occurred at the time of surgery in 66 patients (3.1% overall incidence). Incidence varied according to the specific procedure performed but was highest in the group that underwent revision surgery. The incidence of clinically significant durotomies occurring during surgery but not identified at the time was 0.28%. All dural tears that occurred during surgery and were recognized (60 of 66) were repaired primarily. Pseudomeningoceles developed in five of the remaining six patients. All six patients had subsequent surgical repair of dural defects because of failure of conservative therapy. A mean follow-up of 22.4 months was available and showed good long-term clinical results for all patients. Incidental durotomy, if recognized and treated appropriately, does not lead to long-term sequelae.

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A new classification of complications in neurosurgery.

Federico Ibañez, Santiago Hem, Pablo Ajler … (2011)

To define and grade neurosurgical and spinal postoperative complications based on their need for treatment. Complications were defined as any deviation from the normal postoperative course occurring within 30 days of surgery. A four-grade scale was proposed based on the therapy used to treat the complications: grade I, any non-life-threatening complications treated without invasive procedures; grade II, complications requiring invasive management such as surgical, endoscopic, and endovascular procedures; grade III, life-threatening adverse events requiring treatment in an intensive care unit (ICU); and grade IV, deaths as a result of complications. Each grade was classified as a surgical or medical complication. An observational test of this system was conducted between January 2008 and December 2009 in a cohort of 1190 patients at the Hospital Italiano de Buenos Aires. Of 167 complications, 129 (10.84%) were classified as surgical, and 38 (3.19%) were classified as medical complications. Grade I (mild) complications accounted for 31.73%, grade II (moderate) complications accounted for 25.74%, and grade III (severe) complications accounted for 34.13%. The overall mortality rate was 1.17%; 0.84% of deaths were directly related to surgical procedures. The authors present a simple, practical, and easy to reproduce way to report negative outcomes based on the therapy administered to treat a complication. The main advantages of this classification are the ability to compare surgical results among different centers and times, the ability to compare medical and surgical complications, and the ability to perform future meta-analyses. Copyright © 2011 Elsevier Inc. All rights reserved.

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Biochemical characterization of autologous fibrin sealants produced by CryoSeal and Vivostat in comparison to the homologous fibrin sealant product Tissucol/Tisseel.

Heinz Redl, P Höcker, Christoph Buchta … (2005)

Different principles for production of "autologous fibrin sealant" have been established, and commercial devices employing these methods are nowadays available and used in clinical routine. Users might anticipate for these autologous fibrin sealants features comparable to commercial homologous fibrin sealants, used in surgical routine for many years. However, only little is known about biochemical properties, formation, cross-linking and stability of fibrin sealant clots produced for autologous use with the aid of commercially available devices. We have investigated protein composition, formation and stability of clots obtained from autologuous fibrin sealants produced with commercially available devices (CryoSeal and Vivostat) and compared these parameters to those of the industrially produced homologous fibrin sealant Tissucol/Tisseel. The CryoSeal product is a mixture of many plasma proteins; the Vivostat product and Tissucol/Tisseel appear as comparatively pure plasma derivatives. The products differ in their protein composition and concentrations, including their concentration in fibrin. Significant fibrin alpha and gamma-chain cross-linking by FXIIIa occurs only in Tissucol/Tisseel clots. In test tubes CryoSeal and Vivostat (tranexamic acid-free formulation) fibrin clots liquefy within 1-2 days, but Vivostat (tranexamic acid containing formulation) clots were stable for 4 days and showed partial liquefaction after 5 days. Tissucol/Tisseel clots, containing the protease inhibitor aprotinin, appeared unchanged over the observation period of 5 days. In an in vitro model mimicking in vivo conditions (diffusion of protease inhibitors and proteolytic digestion) clot liquefaction occurs at day 1 for all autologous fibrin sealants clots, with an observable delay for the tranexamic acid containing Vivostat, and day 5 for Tissucol/Tisseel clots. Characterization of the CryoSeal and Vivostat fibrin sealants and Tissucol/Tisseel and their performance show a clear difference in biochemical properties.

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Author and article information

Contributors

Francesca Graziano

Rosario Maugeri

Luigi Basile

Favia Meccio

Domenico Gerardo Iacopino

Journal

Journal ID (nlm-ta): Surg Neurol Int

Journal ID (iso-abbrev): Surg Neurol Int

Journal ID (publisher-id): SNI

Title: Surgical Neurology International

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 2229-5097

ISSN (Electronic): 2152-7806

Publication date Collection: 2016

Publication date (Electronic): 25 January 2016

Volume: 7

Issue: Suppl 3 , SNI: Spine, a supplement to Surgical Neurology International

Pages: S77-S82

Affiliations

[1]Department of Experimental Biomedicine and Clinical Neuroscience, Neurosurgical Unit, University Hospital, Paolo Giaccone, Palermo, Italy

Author notes

[* ]Corresponding author

Article

Publisher ID: SNI-7-77

DOI: 10.4103/2152-7806.174894

PMC ID: 4743263

PubMed ID: 26904371

SO-VID: 2869789d-aa8b-4439-800a-8fbf58c51bde

License:

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.