IntraDiscal ElectroThermal Therapy

1
IntraDiscal ElectroThermal Therapy (The IDET?
Procedure)
2
SpineCATHIntraDiscal ElectroThermal Therapy
(IDET) Procedure

• Received FDA 510k clearance and CE Mark in 1998
• Over 45,000 IDET procedures performed to date
• Over 4,000 physicians trained

3
The IntraDiscal ElectroThermal (IDET) Procedure

• An Innovative Thermal Therapy
• To Modify Annular Collagen Fibers
• For Chronic, Symptomatic Discogenic Back Pain

4
(No Transcript)
5
(No Transcript)
6
Click on box to start animation
7
(No Transcript)
8
(No Transcript)
9
Pathoanatomy of Discogenic Pain

• Tears or fissures in the annulus are present in
  painful discs
• The disc annulus is innervated with unmyelinated
  nerve fibers (nociceptors)
• Stimulation of sensitized annulus nociceptors in
  the region of the annulus fissure plays an
  important role in discogenic pain

10
Disc Annulus

• Disc annulus composed mostly of type 1 collagen
• Triple helix molecule
• Heat sensitive bonds
• Held in extended conformation under tension
• Hydrogen bonds begin to break at 60ºC

HEAT
Collagen triple helix molecule
Hect P, et al The thermal effect of
radiofrequency on joint capsular properties an
in vivo histological study using a sheep model.
AMJ Sports Med 26 808-814, 1998.
11
Nerve Ingrowth Into Diseased Disc

• 57 biopsy samples of anterior L3 to L5
  intervertebral discs obtained during combined
  anterior/posterior fusion surgery for chronic
  (gt12 months) back pain
• Confirmed ingrowth of unmyelinated nerve tissue
  into annulus fissures
• The Lancet, 1997 350 178-81, A J Freemont, T E
  peacock, P Goupille, J A Hoyland, J OBrian, M I
  V Jayson

12
Thermocoagulation of Nociceptors in the
Posterior Annular Wall can be Achieved at Target
Temperatures of 42- 45C

• Lechter F, Goldring S The effect of
  radiofrequency current and heat on
• peripheral nerve action potential in the cat.
  J Neurosurg 2942-47, 1968.
• Smith H, McWhorter J, Challa V. Radiofrequency
  neurolysis in a clinical
• model Neuropathological correlation. J
  Neurosurg 55246-253, 1981.

13
SpineCATH Intradiscal Catheter

• Cover broad area
• Elevate annular temperature
• above 60 and 42 degree thresholds

14
In Vivo Temperature Mapping
A
B
C
D
When catheter temperature 90 C Tissue adjacent
to catheter, A 69 C Center of annular wall, B
60 C Outer annular wall, C 42 C Epidural
space, D 38 C
Source Saal, J.A. and Saal J.S., Operative
Techniques in Orthopaedics, Vol 10, No 4, 2000,
pp 271-281
15
Intradiskal Electrothermal Therapy
A Preliminary
Histologic Study
Rinoo Shah, MD, Gregory E. Lutz, MD, Joe Lee, MD,
Stephen Doty, MD, Scott Rodeo, MD Hospital for
Special Surgery, New York, NY

• IDET induced histologic changes of collagen
  fibril denaturation in the posterior annulus
  fibrosis.
• Gross macroscopic changes were evident in a
  circumferential area, approximately 6 x 9mm,
  around the heating probe in the posterior aspect
  of the disc

Source Shah RV, Lutz GE, Lee J, Doty SV, Rodeo
S. Intradiskal electrothermal therapy a
preliminary histologic study. Arch Phys Med Rehab
2001 1230-1237
16
Intradiskal Electrothermal Therapy A
Preliminary Histologic Study
Rinoo Shah, MD, Gregory E. Lutz, MD, Joe Lee, MD,
Stephen Doty, MD, Scott Rodeo, MD Hospital for
Special Surgery, New York, NY
Treated (100x) Arrow shows collagen denaturation
Untreated (100x) No histologic change
Source Shah RV, Lutz GE, Lee J, Doty SV, Rodeo
S. Intradiskal electrothermal therapy a
preliminary histologic study. Arch Phys Med Rehab
2001 1230-1237
17
SpineCATH? Advantages

• Positive clinical data and low complications
• Easy to place in disc
• Broad target zone (2 heating length)
• Validated thermal heating method
• Temperature control allows for precise
  treatment with low complications along entire
  posterior annulus

18
IDET? Procedure Candidacy

• Internal Disc Disruption Yes
• Contained Disc Herniation Yes
• Multi-Level DDD Maybe
• Post-Operative Disc Maybe
• Sequestered Herniation No
• Spinal Stenosis No
• Disc Levels Above Fusion Yes
• DDD with Severe Disc Space Maybe
• Collapse (gt50)

19
(No Transcript)
20
(No Transcript)
21
(No Transcript)
22
Pre-Procedure

• Outpatient Hospital or ASC
• Conscious Sedation
• Prone Patient Position

23
(No Transcript)
24
(No Transcript)
25
(No Transcript)
26
(No Transcript)
27
(No Transcript)
28
(No Transcript)
29
(No Transcript)
30
(No Transcript)
31
Thermal Delivery

• 17 Minute Protocol
• Target 90 degree Catheter Temperature
• Monitor Patient Feedback Closely

32
Bracing and Rehab

• Lumbar Corset for 6-8 weeks
• Lumbar stabilization therapy program beginning
  after 4-8 weeks
• Let it stiffen, no mobilization
• Advanced exercises e.g. swimming and bike riding,
  at 12-16 weeks

33
Activity Restrictions

• During the first 6-8 weeks
• Limited Sitting
• No Twisting or Lifting
• Walking Encouraged
• No Golf, Tennis, Skiing, etc. for 4 to 6 months

34
Return to Work

• Sedentary Work 1 to 2 weeks
• Heavy Work 4 to 6 months
• Accommodate Activity Restrictions

35
Patient Comments

• My Back Does Not Feel Fragile Anymore
• I Still Get Some Flare-Ups But They Are Not
  Severe and They Resolve Quickly
• Tylenol Works Now

36
(No Transcript)
37
We are smithnephew