The use of fibrin sealants in spinal surgery

Introduction

In the last 20 years, there has been rapid progress in the area of spinal surgery. Without advancements in the fields of anaesthesiology, intensive care medicine and the cre- ation of special implants and instrumentation systems for the spine and a much better knowledge of the anatomical and fundamental biomechanical principles of the spine construct, the developments of modern-day spinal surgery could not have been achieved.

The concept of spinal surgery today centres on the treatment and correction of defects in the posterior and anterior parts of the spinal column, where malformations and instabilities can develop and where even the spinal cord and nerve roots can be affected. In the treatment of the more frequent disorders, spinal surgery involves the correction of congenital malformations such as scoliosis, kyphosis, hemivertebra, wedge-shaped vertebra and, es- pecially, malformations at the craniocervical junction.

A further large group of disorders comprises degenera- tive changes or maladies of the spine. In the cervical spine area these include degenerative changes in the cervical disc, with marked reactive bony changes, such as uncover- tebral arthrosis, or slipped cervical discs (with increasing frequency) and spinal stenosis. Similar changes in the area of the lumbar spine, such as degenerative lumbar scoliosis in older people, ventral or lateral spinal stenosis or spondylolisthesis frequently require surgical treatment.

Another large group of spinal surgical maladies com- prises bone and soft-tissue destruction and deformities re- sulting from trauma, infections and tumour manifestations and those associated with systemic diseases such as rheuma- toid arthritis.

Adequate operative measures to restore the function of the spine can be jeopardized by serious complications ow- ing to its complex anatomy. The spinal cord and its branching nerve roots pose one important challenge, and the peculiar system of blood circulation poses another. As we know, the spine is constructed in segments and, corre-

ogy and intensive care therapy as well as improved instrumentation have been responsible for the rapid development of spinal surgery during the past 15 years. Pathological lesions of the spinal column often demand partial or complete resection of the vertebral body, which in turn requires its replacement. The extraordinary vascular supply of the vertebral body and of the spinal canal often results in profuse bleeding in the environs of sensitive structures such as the spi- nal cord. Electrocoagulation is of lim- ited use, for fear of causing thermal injury. While preoperative embolisa- tion can considerably reduce the ten-

dency to bleed in such instances, bleeding from the epidural venous plexus may be unavoidable, e.g., in spondylitis and tumour surgery. In such instances, fibrin sealants have proved to be an excellent means of control- ling diffuse bleeding. Fibrin sealants have also proved to be effective in controlling diffuse bleeding during cervical disc surgery, which occasion- ally necessitates preparation and identification of the vertebral artery.

The resulting spectrum of applications of fibrin sealants are presented here.

Keywords Collagen matrix ·

Fibrin sealants · FloSeal matrix · Haemostasis · Spine surgery

:

D. Stoltze J. Harms

The use of fibrin sealants in spinal surgery

D. Stoltze

Abt. Orthopädie-Traumatologie I Wirbelsäulenchirurgie/Paraplegologie SRH Klinikum

Karlsbad-Langensteinbach GmbH 76300 Karlsbad, Germany Tel.: ++49-7202-613346 Fax: ++49-7243-13944

e-mail: kd.stoltze.md@t-online.de J. Harms

Abt. Orthopädie-Traumatologie I Wirbelsäulenchirurgie/Paraplegologie SRH Klinikum

Karlsbad-Langensteinbach GmbH 76300 Karlsbad, Germany Tel.: ++49-7202-613346 Fax: ++49-7202-616166

e-mail: juergen.harms@kkl.srh.de

spondingly, the blood circulation is also segmental in nature, comprising an arterial and venous ring system. Figures 1 and 2 impressively show the great extent to which the spi- nal canal is supplied with blood vessels and the epidural plexus with veins.

It is easy to understand that an injury to this plexus of vessels can lead to extensive bleeding, confronting us with considerable problems in terms of haemostasis. Within a short time, the loss of blood can be considerable and be- come life threatening. The intraspinal and the intraforam- inal courses of these vessels pose the main problem in sur- gical treatment.

In the cervical spine area, special attention must be paid to the vertebral artery. Care must be taken to protect this important artery and to carry out haemostasis of the deviat- ing branches, as well as of the easily injured plexus around it. In the operative treatment of many conditions – such as degenerative changes, tumours and inflammatory diseases – this artery should be exposed as a precautionary measure.

In the lumbar spine area, attention should be paid to the plexus of vessels in the spinal canal and in the fora- men nervosa area.

Methods of haemostasis in spine surgery

Controlling intraoperative bleeding is extremely important in spine surgery. In the case of osseous bleeding and in-

(SC spinal cord, WB vertebral body). (Kindly provided by Prof.

Lang, Institute of Anatomy, Würzburg, Germany)

Fig. 2 Extent of the intraspinal plexus of veins (arrows) in the mid-thoracic spine area (SC spinal cord, VA vertebral arch) (Kindly provided by Prof. Lang, Institute of Anatomy, Würzburg, Germany)

traspinal or epidural vascular bleeding, quick and safe haemostasis is mandatory to ensure adequate visualization and safe preparation so as to avoid damaging nerves and spinal medulla. In addition, quick and safe haemostasis reduces the duration of surgery. Efficient control of bleed- ing is also a prerequisite for the realization of the planned therapeutic procedure, i.e., the result of surgery, and can thereby reduce perioperative morbidity.

To reduce the risk of bleeding, the preoperative meth- ods available to us are selective or superselective emboli- sation [7, 11, 21], as in the case of hypervascular patholo- gies (tumour surgery). Intraoperatively, in turn, we have the option of placing ligatures around segmental vessels, although this method or pericentesis is hardly ever an op- tion for local spinal bleeding. When confronted with the intraspinal and intraforaminal plexus of veins, we suture where possible but frequently with great difficulty, be- cause of the acute lack of space. As for electric bipolar co- agulation and microcoagulation, it may lead to thermal in- juries of nerve structures and is not very efficient against parenchymal or diffuse haemorrhagic oozing.

For the local management of intraspinal/intraforaminal and perivascular bleeding, gelatin and collagen sponges were developed and are often used in combination with thrombin preparations [5, 19, 25]. The use of resorbable fibrin seal- ant, also referred to as fibrin glue or fibrin tissue adhesive, as a natural or synthetic haemostatic agent has become widely established in all areas of surgery [3, 6, 7]. This applies to vascular or cardiac surgery for sealing anastomosis [10, 13], as well as to neurosurgery [15, 16] for percutaneous dural fistula occlusion [1, 9, 14, 22] and for cavity sealing, in reconstructive bone surgery and general surgery of paren- chymal organs. As early as in 1993, Vaguero [33] pointed out that the use of fibrin glue was not associated with any additional induction of intraspinal scar tissue formation.

Our indications for use of fibrin sealant in spinal sur- gery include:

1. Haemostasis [3, 6, 16, 27]

(a) Perivascular vessels (e.g., vertebral artery) (b) Intraspinal vessel systems (especially venous) (c) Diffuse and widespread bleeding from tumours or

infected osseous or soft tissues, including rheuma- toid manifestations of the spine

2. Suture reinforcement in combination with autologous tissue or collagenous material [7, 8]

(a) Suturing of dura or dura reconstruction (Figs. 6, 7) (b) Suturing of blood vessels

3. Cavity sealing [16, 26, 27]. The closure of remaining cavities or layers prone to complications, mostly in tran- soral spinal surgery (soft palate, back wall of the phar- ynx, etc.)

4. Sanitation/fusion of osseous defects (in combination with spongiosa) [2, 17, 18, 28, 32]

(a) Formation and stabilization of spongy bone grafts to avoid dislocation and damage to surrounding nerve structures [27]

Fig. 3 Nonspecific spondylitis C7/T1 with an intraspinal abscess (arrows)

Fig. 4 Abscess-opening via an anterior approach

(b) Reduction of blood loss at multilevel posterior cor- rective spinal fusion (scoliosis surgery) [32]

5. As a transport medium for the application of antibi- otics to inflammatory processes or spaces where infec- tion is likely to occur, or in combination with both an- tibiotics and spongiosa [4, 12, 19, 20]

6. Haemostasis and local infection therapy in combina- tion with a collagenous material impregnated with an- tibiotics [19, 24, 28]

Fibrin sealant and collagen matrix are ideal haemostats that can be used simultaneously as drug carriers. For the treatment of infections of the vertebral column, a resorbable collagen carrier impregnated with antibiotic has been available since 1986 as a drug carrier in order to achieve high local concentrations of the bactericidal agent, in ad- dition to systemic antibiotic treatment [19]. Our experi- ence – more than 400 cases, with an infection-free healing rate of more than 97 % [28, 29, 30] – shows that this ther- apy has proved its worth in ”one-step” surgery involving

radical débridement and abscess removal with autologous- bone defect repair and instrumentation. Diffuse bleeding is an additional problem frequently associated with the sur- gical treatment of infections of the vertebral column. Con- sequently, the collagen carrier, in combination with fibrin sealant, may prove highly useful for haemostasis, apart from its antibiotic treatment effect. We use an equine col- lagen impregnated with gentamycin (Genta-Coll resorb) [24].

Nonetheless, the use of collagen sponges, alone or com- bined with fibrin adhesive, to achieve haemostasis can be problematic and ineffective. The expansion of collagen sponges can compress and damage surrounding nerve structures. At the same time, removal of the sponges to prevent compression frequently leads to persistent if not worsening bleeding. A new haemostatic agent can offer major advantages in this regard – it is a high-viscosity gel combining collagen-derived granules and topical throm- bin (FloSeal). Studies showed [5, 8, 10, 23] that this

canal (VB vertebral body, D dura with remainder of the infectious membrane). Arrow: vertebral artery with venous plexus

Fig. 6 Haemostasis with help of fibrin glue and antibiotic-impreg- nated collagen for an additive local therapy against infection (Genta- Coll resorb) (VB vertebral body, K collagen matrix)

gelatin-based haemostatic sealant is significantly more effective, in less time, than other haemostyptic agents (Gelfoam + thrombin combination), and that it provides considerably more durable haemostasis. Another advan- tage of FloSeal is that, after application in the spinal or foraminal space where resulting compression could dam- age nerve structures, FloSeal can be irrigated away while maintaining haemostasis.

Our own clinical experience shows that the additional use of this product in the vicinity of the spinal cord and nerve roots is an efficient means of creating a dry and clear operating field, enhancing the safety of the operation while reducing its duration. FloSeal may also help to significantly reduce overall blood loss in major or multilevel surgical procedures and, particularly, in tumour surgery. In 1990 Tredwell [32] reported a major reduction in perioperative blood loss (approximately 25%) during multilevel dorsal fusion in scoliosis surgery, when a fibrin sealant was used for fusion to cancellous bone. Shortened operating times and the prevention of haematoma formation both serve to reduce perioperative and postoperative morbidity and, as a result, lead to better outcomes and cost savings.

Conclusion

Efficient and safe haemostasis, in the spinal canal and around the neuroforamen, is a prerequisite for successful spinal surgery. It facilitates the avoidance of intraopera-

of the distraction injury. De- picted is the status after bony decompression. The arrows show an extensive tear of the dura and tearing out of the nerve root L1. The transpedic- ular screws for dorsal stabiliza- tion are in place

Fig. 8 After closing the dura with a patch (DP), the instrumenta- tion is completed. Finally, the dura suture is secured with fibrin ad- hesive and covered with a fat-tissue graft

tive complications, reduces the need for blood transfu- sions and prevents postoperative haematoma formation and its concomitant risks, wound healing disorders and in- fections. Given the increase in procedures involving older

patients, these considerations continue to take on even greater importance. Indeed, modern spinal surgery with- out these products for haemostasis is hard to imagine.

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