- Department of Experimental Biomedicine and Clinical Neurosciences, Neurosurgical Clinic, University of Palermo, Italy
- Neurosurgical Clinic, University of Catania, Italy
- Harvard Medical School, Cambridge, MA, USA and Department of Biomedical Engineering, University of Cagiari, Italy
Domenico G. Iacopino
Department of Experimental Biomedicine and Clinical Neurosciences, Neurosurgical Clinic, University of Palermo, Italy
DOI:10.4103/2152-7806.156871Copyright: © 2015 Graziano. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
How to cite this article: Graziano F, Certo F, Basile L, Maugeri R, Grasso G, Meccio F, Ganau M, Iacopino DG. Autologous fibrin sealant (Vivostat®) in the neurosurgical practice: Part I: Intracranial surgical procedure. Surg Neurol Int 12-May-2015;6:77
How to cite this URL: Graziano F, Certo F, Basile L, Maugeri R, Grasso G, Meccio F, Ganau M, Iacopino DG. Autologous fibrin sealant (Vivostat®) in the neurosurgical practice: Part I: Intracranial surgical procedure. Surg Neurol Int 12-May-2015;6:77. Available from: http://surgicalneurologyint.com/surgicalint_articles/autologous-fibrin-sealant-vivostat-neurosurgical/
Background:Hemorrhages, cerebrospinal fluid (CSF) fistula and infections are the most challenging postoperative complications in Neurosurgery. In this study, we report our preliminary results using a fully autologous fibrin sealant agent, the Vivostat® system, in achieving hemostasis and CSF leakage repair during cranio-cerebral procedures.
Methods:From January 2012 to March 2014, 77 patients were studied prospectively and data were collected and analyzed. Autologous fibrin sealant, taken from patient's blood, was prepared with the Vivostat® system and applied on the resection bed or above the dura mater to achieve hemostasis and dural sealing. The surgical technique, time to bleeding control and associated complications were recorded.
Results:A total of 79 neurosurgical procedures have been performed on 77 patients. In the majority of cases (98%) the same autologous fibrin glue provided rapid hemostasis and dural sealing. No patient developed allergic reactions or systemic complications in association with its application. There were no cases of cerebral hematoma, swelling, infection, or epileptic seizures after surgery whether in the immediate or in late period follow-up.
Conclusions:In this preliminary study, the easy and direct application of autologous fibrin sealant agent helped in controlling cerebral bleeding and in providing prompt and efficient dural sealing with resolution of CSF leaks. Although the use of autologous fibrin glue seems to be safe, easy, and effective, further investigations are strongly recommended to quantify real advantages and potential limitations.
Keywords: Autologous fibrin glue, cerebral hemorrhage, cerebrospinal fistula, dura mater, skull base
Hemorrhages with or without neurological signs, cerebrospinal fluid (CSF) fistula and infections are the most challenging postoperative complications in Neurosurgery. Fibrin sealant agents have been developed with the aim to provide efficient hemostasis and safe dural closure. In this study we report our preliminary results using the Vivostat® System (Vivostat A/S, Alleroed, Denmark) in achieving hemostasis and CSF leakage repair during cranio-cerebral procedures. We describe and show the unique features of this autologous fibrin sealant, pioneered with stunning success in many surgical procedures known to be at high risk of peri- and postoperative bleeding (i.e. nephrectomies, pulmonary lobectomies, ballistic injuries, arthroplasties, coronary bypass grafting, etc.), but still not exploited at its best in the field of Neurosurgery.[
Upon approval of the local Institutional Review Board, between January 2012 and March 2014 we performed 79 neurosurgical procedures in 77 patients testing the capability of the autologous fibrin sealant in achieving hemostasis and dural sealing in different kinds of cranial surgical scenario. Given the purposes of this study no inclusion criteria such as age, medical conditions, type and location of the pathology or symptomatology were considered, and patients were enrolled consecutively. Autologous fibrin sealant was prepared with the Vivostat® system and during all surgeries no other sealant or hemostatic agents were used in combination with the fibrin glue. Patients with major intracranial procedures, after surgery, were moved for 24 h intubated, under pharmacological coma, to the intensive care unit (ICU) in order to gain a continued monitoring of the hemodynamic parameters and to provide a controlled and graduated awakening. At the end of the surgical procedures, all patients underwent CT scan to verify potential hemorrhages in the surgical site. Within 3 days from the procedure, the majority of patients (70%) underwent brain magnetic resonance imaging (MRI) with and without the Gadolinium administration.
The intracranial procedures included 60 supratentorial and 17 infratentorial lesions [
Vivostat® system administration
Vivostat® (Vivostat A/S, Alleroed, Denmark) is a system for on-site preparation of autologous fibrin sealant or platelet-rich fibrin (PRF®) The fully automated system prepares 5–6 ml of autologous fibrin sealant from 120 ml of the patients own blood in 23 min. In our study, the fibrin sealant was prepared directly from patient's own blood on the day scheduled for the surgical procedure. Whenever the autologous fibrin glue was used as hemostatic agent, it was sprayed uniformly in the resection bed, taking care to wait almost 30 s before washing out the blood clots formed afterwards around the surgical cavity. During this time, the autologous fibrin becomes a thin, dense, and white coat covering completely the cavity or the dura, avoiding the potential leakage of blood or CSF [
All patients were monitored for a median follow-up of 18 months. Five patients died for reasons not related to the surgical procedures, whereas one patient died following surgical complications [
The autologous fibrin glue was used mostly in oncological cases, specifically the most common procedure was the resection of fronto-temporal meningiomas, always with satisfactory results and, thanks to the elevated biocompatibility of this autologous fibrin glue and to its rapid degradation, no local parenchymal toxicity and no CSF obstruction have been documented [
(a-d) Pre- and postoperative MRI images and postoperative CT scan. (a) Axial view, postcontrast: Left sphenoid wing meningioma surrounded by edema. (b) Immediate postoperative TC control: Hyperintense region corresponding to hemostatic materials applied. (c) One month postoperative CT control: A fluid extracranial subcutaneous collection is depicted. Thus, the surgical site was reopened; dural patch was applied and sealed with autologous fibrin glue. (d) Postoperative MRI control, axial view, T2: Eight months after the fistula repair, subcutaneous fluid was completely reabsorbed
In the entire series, we did not count any cases of local parenchymal toxicity, allergic reactions, infection, or systemic complications. The immediate hemostatic effect of the Vivostat® agent avoided symptomatic postoperative cerebral hemorrhages, moreover, even in all cases when the fibrin glue was applied along the surgical bed, the gentle and thin distribution of the product eliminated the potential risk of epileptic seizures. Unfortunately, in four cases where Vivostat® was applied with a hemostatic intent only, CSF fistulas occurred in the postoperative period. In two of those cases, we successfully used again the Vivostat® to achieve a surgical repair of the fistula during dural repair. In two other cases (case Nos. 14, 34) a bulge underneath the skin flap formed in the early postoperative days but it resolved with a conservative treatment, including compressive medications, syringes aspirations, and semi-sitting position. Definitely, considering that in two out four cases, the CSF collections resolved spontaneously, we had a 1.5% incidence of CSF fistula, which were managed with the same product.
In patients operated for skull base craniectomies, without application of artificial bone, the Vivostat® was able to achieve a durable tissues sealing without any difference with the other craniotomy cases. No differences were appreciated between the cases in whom artificial dura was placed above the proper dura previously closed in a watertight fashion, respect cases in whom artificial dura was instead just placed above the proper dura.
Economic advantages and limitations
The cost per kit needed for automated preparation of 6.5 ml of fibrin glue is around 700 USD. This price is slightly superior considering other industrial pharmaceutical nonautologous fibrin glue preparations. Autologous fibrin glue can also be produced in another way that is cheaper (10 dollars/10 ml of plasma): From pooled plasma (at least eight donors), precipitating fibrinogen by protamine sulfate. In the near future it will be interesting to compare the economic burden of these devices in relation to clinical outcome.
Postoperative hemorrhagic risk represents one of the most challenging complications during major intracranial procedures, and several studies have demonstrated the significant mortality and morbidity associated with this postoperative complication.[
Vivostat® (Vivolution A/S, Alleroed, Denmark) is a system for on-site preparation of autologous fibrin sealant and PRF®.[
Nowadays, the Vivostat® system is widely used in several specialties with high rate of postoperative satisfaction.[
Vivostat® system is a fully autologous hemostatic and sealant agent. In our opinion, the advantages in the use of this product are based on four principle features:
The unique composition and mechanism of action which makes it able to adhere on the tissues forming a compact thin velum suddenly after its application; The possibility to apply it on wet or dry tissues; The capability to act independently of the hemostatic pattern of the patient; The possibility to use it, in the same time, as hemostatic and as sealing agent.
The unique composition and mechanism of action which makes it able to adhere on the tissues forming a compact thin velum suddenly after its application;
The possibility to apply it on wet or dry tissues;
The capability to act independently of the hemostatic pattern of the patient;
The possibility to use it, in the same time, as hemostatic and as sealing agent.
Despite the limitations related to the design of observational studies such as the one conducted in our Department, the results achieved in our neurosurgical series are highly encouraging. Nonetheless, it is important to point out that even if this system presents unique features, which potentially may make it an efficacious substitute of other hemostatic and sealant agents, further studies are warranted to test its efficacy and convenience.
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