2. Northwestern University Department of Neurosurgery Paddle SCS Leads: Advantages and Limitations Joshua M. Rosenow, MD, FAANS, FACS Director, Functional Neurosurgery Associate Professor of Neurosurgery, Neurology and Physical Medicine and Rehabilitation Northwestern Memorial Hospital

3. Northwestern University Department of Neurosurgery Disclosures Corporate Ownership, Equity, Stocks, BondsNone Corporate Consultant Contracts – Boston Scientific NeuromodulationYes Corporate Fiduciary or Board PositionsNone Non-Profit Board Positions –Medical Advisory Board, Epilepsy Foundation of Greater Chicago Yes Grants – Co-investigator on grants from brain research foundation, NMH Dixon Fund, DoD, NIDDR, Christopher Reeve Foundation Yes PatentsNone

4. Northwestern University Department of Neurosurgery Disclosures  I place both paddle and percutaneous leads  I think the current generation of leads/IPGs are all actually rather good  While I am not happy paying ARod to undergo another hip surgery, the Yankees total OPS may have just increased. Of course we still need a catcher and outfielder.

5. Northwestern University Department of Neurosurgery Why use paddles?  Previous difficulties with perc leads  Preference of implanter  ?lower current requirement  ?less interference by epidural fat

6. Northwestern University Department of Neurosurgery Paddle Trial  Lumbar fusion or laminectomy precluding percutaneous insertion  Inability to access the epidural space percutaneously  Bony anatomy  Obesity  Prior procedure in the region of the implant  Tumor resection, etc.

7. Northwestern University Department of Neurosurgery Paddle Trial: Limitation  Limited ability to test multiple locations  For paddle trial – essentially have to guess the level  If good coverage not achieved, the procedure starts to turn into a big deal

8. Northwestern University Department of Neurosurgery Limitation: Guess the level!

9. Northwestern University Department of Neurosurgery Communication is key T9 T10

10. Northwestern University Department of Neurosurgery Paddle Lead: Innovation  Now possible to place 1x8 paddle via percutaneous approach using epidural access dilator  Long term data as to issues/complications not available

11. Northwestern University Department of Neurosurgery Paddle leads: Fallacy “Don’t worry that we didn’t cover that area in the trial, the paddle lead will fix everything.”

12. Northwestern University Department of Neurosurgery Paddle Leads: Contact Proliferation

13. Northwestern University Department of Neurosurgery You CAN mess up a paddle  Paddle placed under GETA  Awoke with right thoracic radicular pain  Never had good coverage with stim  Surgeon told him to “wait a year and see if the coverage and pain improve”

14. Northwestern University Department of Neurosurgery Paddle Lead Injuries  Levy, et al Neuromodulation 2011  Data obtained from manufacturers’ database  3 years (2007-2010), 44,587 paddle lead implants  239 (0.54%) neurologic complications.  21 (0.05%) cases of CSF leak  Epidural hematoma 83 of 44,587 cases (0.19%)  major motor deficit in 52/83 patients (63%)  Permanent motor deficit with or without EDH - ranges from 0.022% to 0.067%.

15. Northwestern University Department of Neurosurgery Paddle Lead Injuries

16. Northwestern University Department of Neurosurgery Paddle Lead Injuries

17. Northwestern University Department of Neurosurgery Preop imaging is essential  You would never do any other spine case without adequate preop imaging – DON’T START NOW  Preop imaging makes sure something asymptomatic doesn’t become symptomatic  Aids in counseling patient preop if procedure needs to be altered to deal with anatomic issue

18. Northwestern University Department of Neurosurgery Complication avoidance  Don’t be overzealous  Don’t push a bad situation  If it won’t go, it won’t go…  Caution when dissecting laterally – epidural veins  Poor coverage despite radiographic adequacy  check trial fluoros  make sure c-arm aligned in both planes

19. Northwestern University Department of Neurosurgery Paddle Implant – Anesthesia Technique MAC  Allows intraoperative testing  Quicker recovery  May be more difficult in chronic pain patients General Anesthesia  Physiologic monitoring to verify midline placement  Does not allow geographic coverage verification  May be better for difficult patients or those requiring more extensive procedures

20. Northwestern University Department of Neurosurgery SCS Electrodes Lead Location HardwareCervicalThoracolumbar ThoracicTotal PercutaneousInitial911919291 (74.2%) Revision33671101 (25.8%) Total12425810392 (81.3%) ResumeInitial1215128 (39.7%) Revision2219041 (60.3%) Total3434169 (14.1%) SpecifyInitial1708 (36.4%) Revision48214 (63.6%) Total515222 (4.6%) TOTALInitial10421310327 (67.6%) Revision59943156 (32.4%) Total16330713483 Rosenow, et al JNS Spine 2006

21. Northwestern University Department of Neurosurgery Electrode Migration Location of electrode Hardware Cervical ThoracolumbarThoracic Total Percutaneous 21 (16.9) 28 (10.9) 0 47 (12.0) Resume II 7 (20.6) 4 (11.8) 1 12 (19.1) Specify 0 1 (6.7) 1 2 (9.1) p=NS Rosenow, et al JNS Spine 2006

22. Northwestern University Department of Neurosurgery Poor Coverage Lead Location (%) HardwareCervical ThoracolumbarThoracic Total Percutaneous13 (10.5)43 (16.7)2 58 (14.8) Resume II2 (5.8)4 (11.8)0 6 (8.7) Specify1 (20)1 (6.7)0 2 (9.1) P<0.001 Rosenow, et al JNS Spine 2006

23. Northwestern University Department of Neurosurgery Hardware Breakage Hardware Location (%) HardwareCervical Thoracolumbar Thoracic Total Percutaneous13 (10.5)12 (4.7)0 25 (6.4) Surgical8 (20.5)2 (4.1)0 10 (11.0) Extension851 14 P=0.004 Rosenow, et al JNS Spine 2006

24. Northwestern University Department of Neurosurgery Conclusion  Paddle leads not perfect  With proper technique, complications can be minimized  Unknown if more contacts really improve outcome

25. Northwestern University Department of Neurosurgery E-mail: jrosenow@nmff.org Thank you for coming! Phone: 312-695-0495

26. Northwestern University Department of Neurosurgery