Percutaneous treatment of lumbar disc herniation with gelified ethanol/ a preliminary study

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Percutaneous treatment of lumbar disc herniation with gelified ethanol/ a preliminary study Poster No.: C-0223 Congress: ECR 2015 Type: Authors: Keywords: DOI: Scientific Exhibit M. Runge; Besançon/FR Outcomes, Efficacy studies, Percutaneous, Neuroradiology spine, Musculoskeletal spine 10.1594/ecr2015/C-0223 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. www.myesr.org Page 1 of 11

Aims and objectives Many therapies are available to treat lumbar disc herniation (LDH) ranging from medical therapies to minimaly invasive percutneous treatments and surgery A wide range of minimaly invasive percutaneous treatments for LDH have been used: chemonucleolysis with chymopapain, percutaneous lumbar discectomy, laser disc decompression, intra discal oxygen-ozone therapy After the withdrawal of chymopapin, a new substance (Discogel ) is available using the properties of ethanol without its high diffusibility Discogel is made up of ethanol (96%) with ethylcellulose to increase the viscosity and enhanced with a radiopaque substance (tungsten) The objectives of this study are: 1. Evaluate the safety of disc nucleolysis using gelified ethanol in the treatment of LHD when the medical treatment is ineffective 2. Demonstrate the efficacy of gelified ethanol in patients with radicular pain non responding to medical treatment Images for this section: Fig. 1 Page 2 of 11

Methods and materials From march 2010 to july 2013, 42 consecutive patients (22 male, 20 female) aged 22-80 years (mean age 45,1y) with a symptomatic LDH, were included in this study and were treated in ambulatory condition under local anesthesia with an intradiscal discogel injection For all patients, the symptomatic level was identifed by clinical examination, computed tomography (CT) or magnetic resonance imaging (MRI) and the radicular pain was resistant to conservative management, medication, physical therapies or steroid injections (2 or more) Exclusion criteria for nucleolysis are: calcified herniated disc or free disc fragment, important disc degeneration, important degenerative vertebral disease, lumbar stenosis, major neurological deficit with impaired lower limber mobility Discal puncture was performed under fluoroscopic guidance with an posterolateral extraspinal approach and 0,9 to 1,2 ml were injected into the disc (fig 2) A CT scan was performed after the injection to appreciate the Discogel diffusion into the treated disc (fig.3) All patients underwent clinical and MRI folow up four months after the nucleolysis to appreciate the follow up of LDH and to evaluate the possible signal changes of the treated disc and surrounding endplates Outcomes were assessed by visual analog scale (VAS), modified MacNab method (fig 4), questionnaire and direct patient interview Images for this section: Page 3 of 11

Fig. 2: X ray after intradiscal Discogel injection Page 4 of 11

Fig. 3: CT scan performed after nucleolysis Fig. 4 Page 5 of 11

Results The discogel chemonucleolysis can be performed under local anesthesia on a day hospital basis Very good results with total disappearance of radicular pain were obtained in 54,8% of cases (24/42) (fig 5, 6) Good results with a significant reduction of symptoms and medications were obtained in 33,3% (14/42) (fig 7) Bad results with the persistence of radicular pain and recourse to surgery in 11,9% (5/42) 2 patients underwent discolysis in 2 levels and no difference was observed in the results in comparaison to those treated at one level The patients who subsequently underwent surgery had no negative effect on the successful outcome of surgical treatment Short terme follow up (3-4 months) with MRI exam ( fig 8, 9) showed in al patients with very good or good clinical results a complete LDH disappearance in 16,7% of cases (7/42), a minimal reduction of hernia size (lessthan a quarter of hernia size) in 21,4% (9/42) and no change in 61,9% (26/42) The first sign of improvement respondig to Discogel chemonucleolysis occured from one week to two months after the procedure No treatment-linked complications occured in any patient: 1. No pain during or after Discogel injection 2. No allergic reaction 3. No change in the intersomatic disc space height 4. No aseptic inflammatory complication or chemical discitis 5. No signal change of intervertebral disc signal intensity 6. No change of articular processes 7. No change of bone marrow signal intensity of the surrounding endplates Images for this section: Page 6 of 11

Fig. 5 Page 7 of 11

Fig. 6 Fig. 7 Fig. 8 Page 8 of 11

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Fig. 9: CT before and MRI 4 months after nucleolysis showed a decrease of herniated disc Page 10 of 11

Conclusion 1. This preliminary study shows the efficacy and the inocuity of nucleolysis with gelified ethanol in the treatment of any kind of LDH 2. Discogel is safe and easy to handle and there were no complications related to product diffusivity in or outside the treament site 3. The therapeutic success rate of Discogel nucleolysis in patients unresponsive to medical therapies was satisfactory 4. Discogel nucleolysis can be an intermediate procedure bringing conservative medical treatments and surgery Personal information No direct or indirect financial relationship pertinent with this study References 1. Ricquelme C., Musacchio M., Mont'Alverne F., Tourned A. Chemonucleolysis off lumbar disc herniation with ethanol. J. Neuroradiol. 2001; 28: 219-229 2. Stagni S., De Santis L., Cirillo M et al. A minimally invasive treatment for lumbar disc herniation: Discogel chemonucleolysis in patients unresponsive to chemonucleolysis with oxygen-ozone. Interventional Neuroradiology 2002; 18:97-104 3. Theron J., Cuellar H., Sola T et al. Percutaneous treatment of cervical disk hernias using gelified ethanol. Am J Neuroradiol (AJNR) 2010; 31:1454-1456 4. Theron J., Guimaraens L., Casasco A et al. Percutaneous treatment of lumbar intervertebral disk hernias with radiopaque gelified ethanol: A preliminary study. J Spin. Disord Techn. 2007; 20:526-532 Page 11 of 11