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

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.

INTRODUCTION

Cerebrospinal fluid (CSF) fistulas and postoperative hematomas constitute two of the major complications of spinal surgery.[21321] Fibrin sealants supplement dural closure and promote hemostasis.[51618] This study reports the preliminary results of utilizing a new fibrin sealant Vivostat® (Vivostat A/S, Alleroed, Denmark) to achieve both hemostasis and facilitate dural repair in spinal surgery.

MATERIALS AND METHODS

From January 2013 to March 2015, 68 patients undergoing spinal surgery received autologous fibrin sealant prepared with the Vivostat® system and applied epidurally, over the resection bed.

Patients population

Upon approval of the local Institutional Review Board, between January 2013 and March 2015 we performed 68 neurosurgical spinal procedures utilizing autologous fibrin sealant/Vivostat® to achieve hemostasis and/or to seal the dura.

In 47% of cases (32 cases), the autologous fibrin glue was used only as an hemostatic agent; in 34% of cases it was used both as an hemostatic and dural sealant agent for strengthening atretic dura (without frank CSF fistula); in 19% of cases the autologous fibrin glue was used to achieve both hemostasis and CSF fistula repair; [Table 1]. In the majority of cases, autologous fibrin glue addressed degenerative disease (43%) or tumor (oncological cases: 32%) [Table 1, Figure 1]. For Vivostat preparation and administration see Graziano et al. and Giugno et al.[678] All patients were monitored postoperatively for an average of 18 months.

Table 1

Patient data including the vertebro-spinal procedures performed

Figure 1

Graph showing the percentage of the pathologies included in the study

RESULTS

Technical and economic considerations

This system was effective in all three circumstances; as a hemostatic alone, as a hemostatic and to strengthen atretic dura, and for hemostasis and dural repair. The Notably, Vivostat® formed an extremely thin white coat and did not compress the neural structures; additionally, it was physiologically eliminated within 24–36 h [Figure 2]. Only in 2 cases postoperative CSF fistulas were encountered; 1 was successfully treated conservatively while the other required additional dural repair [Table 1]. Notably, no local medullar toxicity, allergic reactions, infection, or systemic complications occurred. The cost per kit needed (e.g., automated preparation of 6.5 ml of fibrin glue) is around 700 USD. Each procedure typically requires only kit; only 5–10% of cases may require two kits.

Figure 2

Cauda equina neurinoma. (a) Preoperative Magnetic resonance (MR), T1-weighted sagittal view: An iperintense homogeneous enhancing circular lesion is visible posterior to the disc space L1–L2. (b) Intraoperative picture of the intradural lesion. (c) After the lesion removal, the dura mater is closed in watertight fashion with single stitches. (d) The autologous fibrin glue is applied on the reconstructed dural layer in order to achieve a satisfactory dural sealing

DISCUSSION

Application for durotomies and hemostasis

In spinal surgery, the major intraoperative complications are typically due to accidental durotomies or postoperative hematomas. Cammisa et al. found 66 (3.1%) durotomies occurring during 2144 spinal operations; they were immediately treated with dural suturing and fibrin glue.[4] During minimally invasive spine surgery, the durotomy incidence has been estimated to be 9%, 4% among 563 patients in the case series of Ruban and O’Toole.[17]

Do dural sealants inhibit fusion

Some are concerned whether these sealants on the vertebral fusion rate.[5] Turgut et al. assessed the impact of Tisseel on anterior cervical interbody allograft fusion at the C5–C6 level in cats (12 received Tisseel, 12 did not); it was not suitable for “fixation of bone fragments” for anterior cervical discectomy and fusion in this cat model.[22] Landi et al. determined the efficacy of utilizing a topical platelet gel to supplement posterolateral fusions rates in 14 instrumented fusions; fusion rates were comparable for both groups at 6 postoperative months.[12]

Arguments favoring utilization of Vivostat system

The Vivostat® system is successfully used in several specialties.[13101114151920] The autologous nature of Vivostat® eliminates the risks of bovine or human-borne contaminants, protecting the patient against viral diseases. It provides rapid polymerization, set rapidly, and provides instant tissue-fibrin adhesion, enabling the surgeon to manipulate the treated area early.[923] In our clinical series, the Vivostat® provided immediate hemostasis without compression of neural tissues. Furthermore, there were 2 cases complicated by postoperative CSF fistula out of 68 patients treated, but only one required repeated surgical intervention.

CONCLUSION

Vivostat® system appears to be a safe/effective fully autologous hemostatic and dural sealant agent. Its composition and mechanism of action makes it able to adhere immediately to tissues and its rapid degradation time avoids any potential long-term mass effect.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.