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

Alessandro Cesaroni

Is a minimally invasive technique

for disc decompression that

utilizes Coblation technology for

ablating soft tissue by means of a

low temperature (52

C) molecular

dissociation process to create

small channels within the disc. 1 2 3 4 5

0

5

10

15

20

Ch

an

ge in

Tem

pera

ture

(ºC

)

Distance from tip (mm)

Porcine Intradiscal Thermal Mapping

Temperature Gradient

By the tissue removal (from 10 to 20 %)

we obtain a disc reduction and the

decompression of the root

VOLUME REDUCTION

PR

ES

SU

RE

RE

Nucleoplasty

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”.

0 1 2 3 4 5 6

0

5

10

15

20

25

30

PSI

Number of Coblation Channels

Nucleoplasty Intradiscal Pressure

Non-Severe Degeneration

Nucleo PSI

Control PSI

Intradiscal pressure study of percutaneous disc decompression with Nucleoplasty in human cadavers. Y. Chen, S. Lee and D. Chen, SPINE, (2003) 28: 661-665

Decompression

0,1

1

10

100

Pre 1 2 3 4 5 6 P.O.

CHANNELS

PR

ES

SU

RE

RE

Intradiscal pressure study of Nucleoplasty in 60 live patients.

Dr A. Cesaroni, Rome, Italy, Unpublished results.

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20

40

60

80

100

120

140

Nucleoplasty

Università degli studi di Roma “Tor Vergata”:

Facoltà di ingegneria

Radiofrequenza ablativa nel trattamento

mininvasivo del dolore discogenico:

Modellazione e simulazione

• 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

Indications

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 26:4873-4878. 2001

MRI Classification

I II III

IV V

Indications

Disc Pain

Herniated Disc Degenerative Disc Disease

Conservative Care (Medications,PT, Steroid injection)

Conservative Care (Medication, PT)

Contained Non contained

Nucleoplasty

Other Surgical Technique

Disc/Nucleus Replacement

Fusion

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

Surgical Technique

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 2048-2059, 1995.

Slipman et al. Early-term side effects and complications of lumbar nucleoplasty :

preliminary series. ISPRM – 2nd world congress.

Complications

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 250-259, 2002.

Sharps et al. Percutaneous disc decompression using Nucleoplasty. Pain Physician Vol

5, N

2, pp 121-126, 2002.

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

measures.

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: 36-42.

0

0,1

0,2

0,3

0,4

0,5

Baseline 3-month

Mean EQ5D Scores

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 10-12 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: 2104-2111

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)

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40

60

80

Pe

rce

nt

24 Hours 7 Days Later 60 Days Later

Nucleoplasty Group

Good Results Poor Results No amelioration

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20

40

60

80

Pe

rce

nt

24 Hours 60 Days Later

Conservative Care Group

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

Results

1910

37

20

73

27 31

39

55

72

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60

70

80

Baseline 6 Weeks 3 Months 6 Months 1 Year

NPL CCC

Mea

n P

ain

VA

S

Pain VAS Score Reduction from

Baseline

NPL

(n=43)

CCC

(n=32)

p-value

6 Weeks post-op 46 ± 21

(39, 52)

17 ± 13

(11, 22)

<0.001

3 Months 53 ± 21

(47, 60)

33 ± 18

(27, 39)

<0.001

6 Months 54 ± 22

(48, 61)

41 ± 19

(34, 48)

0.004

1 Year 63 ± 3

(57, 69)

35 ± 22

(28, 43)

<0.001

Quality Of Life – NPL Group

20

30

40

50

60

70

PF RP BP GH VT SF RE MH

Pre-treatment 6 weeks 3 months 6 months 1 year

Best

Health

Poorest

Health

Norm

PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT:

Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health

20

30

40

50

60

70

PF RP BP GH VT SF RE MH

Pre-treatment 6 weeks 3 months 6 months 1Year

Quality Of Life – CCC Group

Best

Health

Norm

Poorest

Health

PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT:

Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health

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%

Biological Effects

Disc BioChemistry

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Baseline 6 Weeks 12 Weeks

Time

Co

nc

en

tra

tio

n

IL-1 Degenerative Trend

IL-1 Nucleoplasty Impact

IL-8 Degenerative Trend

IL-8 Nucleoplasty Impact

“Our results suggest that Nucleoplasty may be capable of initiating a repair response in the disc”.

•Significant decrease in Interleukin-1

IL-1 associated with tissue degeneration

•Significant increase in Interleukin-8

IL-8 associated with tissue angiogenesis

Conor O’Neill, Jeff Lotz, Percutaneous plasma decompression alters cytokine expression in injured porcine intervetebral discs. The Spine Journal 4 (2004)

Biological Effects Difference in inflammitory mediator levels in normal nucleus pulposis

cells (normalized to sham)

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200

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300

Il-8 Hsp70 NO PGE2

% c

ha

ng

e in

le

ve

l

3 Day

6 DayGraph illustrating percentage change in inflamatory mediators for normal nucleus cells at 3 and 6 days post ablation (Corrected against sham)

“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.

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.

Thank You For Your Attention