Title : Novel procedure: Spinal epidural balloon decompression and adhesiolysis
Abstract:
Nonsurgical treatments, such as nerve block, in chronic pain patients with severe adhesions are reported to have a relatively low effect and a high risk for relapse. This may be attributed to the fact that epidural adhesions themselves are difficult to remove through such methods, and also that they interfere with the effective spread of a therapeutic agent to the lesion. If a simple nerve block does not have a sufficient effect in a patient with pain caused by adhesions or stenosis, it is important to confirm whether pain is associated with adhesion and where the adhesion, suspected of being a lesion, is positioned. Once adhesions or stenosis are confirmed as a cause of pain, neuroplasty may be performed to relieve them. Conventional neuroplasty may be divided into either chemical adhesiolysis using hypertonic saline or mechanical adhesiolysis using a catheter that can be moved laterally. Conventional neruoplasty has shown good short-term analgesic effects; however, functional improvement has not been enough.
We hypothesized that the balloon dilatation used for the relief of vascular stenosis may be applied to the epidural space to enable relief of spinal stenosis by more extensive epidural adhesiolysis and by expansion of the marginal space around the nerve as much as possible in the stenotic intervertebral foramen. We also hypothesized that balloon dilatation enables minimization of the nerve damage during adhesiolysis. Based on the aforementioned premises, we conducted the following clinical study. The subjects included patients with only intractable neural foraminal stenosis who were nonresponsive to conventional transforaminal epidural block or whose alleviation of pain did not continue for 1 month or more. We compared two procedures: in one group, transforaminal balloon catheter was inserted to the intervertebral foramen, balloon dilatation was performed, and the asteroid was injected; in the control group, the same procedure was performed excluding the balloon dilatation. When conventional transforaminal block is performed in patients with severe neural foraminal stenosis or having epidural adhesions, a contrast agent is sometimes not introduced into the epidural space through the intervertebral foramen. In that case, even the trial to insert and withdraw a thin catheter may introduce the contrast agent into the epidural space. The reason may be that the action of inserting and withdrawing the catheter partially relieves stenosis and eliminates epidural adhesions. The control group procedure without balloon dilatation might be more effective than conventional transforaminal block in the sense that the catheter was inserted into and withdrawn. Nevertheless, the pain relief and functional improvements were much greater in the group in which the balloon dilatation was performed, with the effects lasting for 3 to 4 months after the procedures. In addition, the ratio of patients whose pain decreased by more than 50% for 1 year or more was 18.8% in the group with balloon dilatation and 0% in the group without balloon dilatation.
In cases of spinal stenosis, most conventional nonsurgical procedures have shown good short-term analgesic effects; however, functional improvement has not been enough. The procedure used in our study has great clinical significance in the sense that it greatly improved not only pain but also functions such as neurogenic claudication in even cases of intractable spinal stenosis. In the control group, where balloon dilatation was not performed, the catheter was inserted into and withdrawn from the intervertebral foramen in a manner similar to mechanical adhesiolysis in conventional neuroplasty. The fact that such a powerful procedure was less effective than the procedure with balloon dilatation indicated that balloon dilatation is likely more effective than pre-existing procedures.
To test whether the positive outcome was the result of marginal space expansion in the intervertebral foramen by balloon dilatation, as well as to examine how the marginal space around nerve may expand, the spread of contrast agent in the intervertebral foramen before and after balloon dilatation were reconstructed three-dimensionally in four patients. Comparing the degree of expansion of the marginal space showed that the diameter of the region where the contrast agent spread was increased by 28% and the diffusion volume was increased by 98% after the procedure.
Based on the finding that balloon dilatation in the epidural space can relieve not only adhesions but also stenosis, a novel catheter (Ziazag-Inflatable Neuroplasty: ZiNeu, JUVENUI, Korea) was developed by adding the balloon dilatation function to the same type of video-guide catheter used for conventional epiduroscopy. As this catheter has the additional function of balloon dilatation, it may eliminate an adhesion more effectively, causing less neural damage or dural injury. It may even be used to relieve the neural foraminal stenosis. Moreover, as this catheter has the function of leaving a thin epidural catheter for precise drug injection at the target lesion, it may be used to perform chemical adhesiolysis at once.
Also, the ZiNeuF catheter, which can be accessed directly to the intervertebral foramen, has been developed and used extensively in Korea. The ZiNeu catheter has 18 SCI(S) articles and 3 Korean papers have been published since it was marketed in 2013 in Korea. Recently, the ZiNeu catheter has obtained CE certification and started to be used in Italy and Singapore.
