Cervical Plasma disc decompression (Nucleoplasty): Indications Results and Limits. Alessandro Cesaroni

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1 Cervical Plasma disc decompression (Nucleoplasty): Indications Results and Limits Alessandro Cesaroni

2 PRESSURER Change in Temperature (ºC) Nucleoplasty Porcine Intradiscal Thermal Mapping Is a minimally invasive technique 20 for disc decompression that Temperature Gradient 15 utilizes Coblation technology for ablating soft tissue by means of a 10 low temperature (52 C) molecular 5 dissociation process to create small channels within the disc. Distance from tip (mm) By the tissue removal (from 10 to 20 %) we obtain a disc reduction and the decompression of the root VOLUME REDUCTION

3 Decompression Intradiscal pressure was markedly reduced in non severe degenerate discs Nucleoplasty treatment for herniated discs immediately (within two channels) and dramatically reduced intradiscal pressure Nucleoplasty has the potential to be a viable, effective and safe treatment for lower back pain resulting from disc disease. PSI Nucleo PSI Control PSI Nucleoplasty Intradiscal Pressure Non-Severe Degeneration Number of Coblation Channels Intradiscal pressure study of percutaneous disc decompression with Nucleoplasty in human cadavers. Y. Chen, S. Lee and D. Chen, SPINE, (2003) 28:

4 PRESSURERE Decompression Pre P.O. 0,1 CHANNELS Intradiscal pressure study of Nucleoplasty in 60 live patients. Dr A. Cesaroni, Rome, Italy, Unpublished results.

5 Nucleoplasty Università degli studi di Roma Tor Vergata : Facoltà di ingegneria Radiofrequenza ablativa nel trattamento mininvasivo del dolore discogenico: Modellazione e simulazione

6 Indications Symptomatic patients with contained herniated disc Integrity of the annulus Failure of 6 weeks of conservative therapy MRI evidence of contained herniated disc protrusion (degree 2 and 3 Pfirmann s classification) Contraindications Extruded hernia or with a free fragment Reduction more than 1/3 diameter of the spinal canal Spinal or foraminal stenosis, Osteophytosis Spinal instability and >50% loss of disc height

7 MRI Classification I II III IV V Pfirmann Classification of disc degeneration with MRI Pfirrmann CWA, Metzdorf A, Zanetti M, Hodler J, Boos N: Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine 26:

8 Indications

9 Disc Pain Herniated Disc Degenerative Disc Disease Conservative Care (Medications,PT, Steroid injection) Conservative Care (Medication, PT) Contained Non contained Other Surgical Technique Nucleoplasty Disc/Nucleus Replacement Fusion

10 Surgical Technique Patient in supine position with head slightly hyper extended, under fluoroscopic LL vision The needle is inserted by an anterior lateral approach, medially to the SCM and vessels Introduced the wand, the ablation starts for 3 cycles in withdrawal, rotating the wand for 360 in each cycle

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12 Complications The percentage of secondary discitis detected is the same for a normal discography (0.25% per patient or 0.14% per disc). Usually a temporary local pain in the side of the skin entry point is referred. At present no other complications are reported. Guyer et al. Lumbar discography. Position statement from the North American Spine Society Diagnostic and Therapeutic Committee. Spine vol 20, N 18, pp , Slipman et al. Early-term side effects and complications of lumbar nucleoplasty : preliminary series. ISPRM 2nd world congress.

13 Results The results in over 1 year follow up shows a significative improvement in pain between 85 and 91% in cervical Singh et al. Percutaneous disc decompression in the treatment of chronic discogenic pain. Pain Physician Vol 5, N 3, pp , Sharps et al. Percutaneous disc decompression using Nucleoplasty. Pain Physician Vol 5, N 2, pp , 2002.

14 Results Prospective longitudinal cohort study Retrospective study of 67 patients with primary radicular pain due to contained disc herniations. Evaluation at 3 and 6 months using SF36, VAS, and EuroQol 5D (EQ5D). No infections, nerve root injuries or complications associated with the procedure. Statistically significant improvement in all outcome Mean EQ5D Scores measures. 0,5 0,4 0,3 0,2 0,1 0 Baseline 3-month Quality of life assessment in patients undergoing Nucleoplasty-based percutaneous discectomy. P. C. Gerszten, W. C. Welch and J. T. King Jr. J of Neurosurgery: Spine (2006) 4:

15 Results Case study of 55 patients with cervical soft disc protrusion and associated radicular pain. Clinical outcomes were graded by using the Macnab criteria, at 6 months, 44 (85%) patients (n = 52/55) had good or excellent outcomes. Entire procedure took no longer than minutes to complete from administration of local anesthetic to withdrawl of SpineWand device. Plasma radio-frequency based discectomy for treatment of cervical herniated nucleus pulposis; Feasibility, safety and preliminary clinical results. G. Bonaldi, F. Baruzzi, A. Facchinetti, P. Fachinetti and S. Lunghi Am J. Neuroradiol., (2006) 27:

16 Percent Percent Results Comparitive study of cervical nucleoplasty (n=50) vs conservative care (n=20) with three month follow up. Nucleoplasty group - 80% complete resolution of symptoms (VAS) at 3 months. CC group 25% resolution of symptoms, 75% persistent symptoms. Average return to work for Nucleoplasty = 21 days, Conservative care = 46 days (with no amelioration of symptoms) Nucleoplasty Group Conservative Care Group Hours 7 Days Later 60 Days Later Good Results Poor Results No amelioration Hours 60 Days Later Good Results Poor Results No amelioration Percutaneous cervical Nucleoplasty using Coblation technology. Clinical results in fifty consecutive cases. P.V. Nardi, D. Cabezas, and A. Cesaroni Acta Neurochir (2005) [Suppl] 92: 73-78

17 Mean Pain VAS Baseline 6 Weeks 3 Months 6 Months 1 Year NPL CCC Pain VAS Score Reduction from Baseline NPL (n=43) CCC (n=32) p-value 6 Weeks post-op 46 ± 21 (39, 52) 3 Months 53 ± 21 (47, 60) 6 Months 54 ± 22 (48, 61) 1 Year 63 ± 3 (57, 69) 17 ± 13 (11, 22) 33 ± 18 (27, 39) 41 ± 19 (34, 48) 35 ± 22 (28, 43) <0.001 < <0.001

18 Quality Of Life NPL Group Best Health Norm Poorest Health PF RP BP GH VT SF RE MH Pre-treatment 6 weeks 3 months 6 months 1 year PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT: Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health

19 Quality Of Life CCC Group Best Health Norm Poorest Health PF RP BP GH VT SF RE MH Pre-treatment 6 weeks 3 months 6 months 1Year PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT: Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health

20 1 year 2 year 3 years 4 years 5 years Good (mean VAS <2.5) 59.9% 56.9% 56.7% 62.1% 60.8% Satisfactory (mean VAS >2.5<4.5) 35.5% 38.4% 38.6% 31.4% 30.6% No results 4.6% 4.7% 4.7% 6.5% 8.6%

21 Concentration Biological Effects Significant decrease in Interleukin-1 IL-1 associated with tissue degeneration Significant increase in Interleukin-8 IL-8 associated with tissue angiogenesis Disc BioChemistry IL-1 Degenerative Trend IL-1 Nucleoplasty Impact IL-8 Degenerative Trend IL-8 Nucleoplasty Impact Baseline 6 Weeks 12 Weeks Time Our results suggest that Nucleoplasty may be capable of initiating a repair response in the disc. Conor O Neill, Jeff Lotz, Percutaneous plasma decompression alters cytokine expression in injured porcine intervetebral discs. The Spine Journal 4 (2004)

22 % change in level Biological Effects Graph illustrating percentage change in inflamatory mediators for normal nucleus cells at 3 and 6 days post ablation (Corrected against sham) Difference in inflammitory mediator levels in normal nucleus pulposis cells (normalized to sham) 3 Day 6 Day Il-8 Hsp70 NO PGE2 These results support the hypothesis that Nucleoplasty can relieve pain by direct biologic effects The short-term effects of electrosurgical ablation on proinflammitory mediator production by intervertebral disc cells in tissue culture. K-W. Rhyu, A. Walsh, C. O Neill, J. Lotz, and D. Bradford.

23 Conclusions Nucleoplasty is a minimally invasive technique for disc decompression in contained hernia with radicular pain. The integrity of the annulus is the basis for success Nucleoplasty does not substitute conventional open procedures required for extruded disc The limits of this technique are related to the level of the disc degeneration.

24 Thank You For Your Attention