Best Practices for Intrathecal Drug Delivery Systems

1. Intrathecal Drug Delivery Systems: Best Practices Alon Y. Mogilner, MD, PhD Director, Center for Neuromodulation NYU Langone Medical Center

2. Disclosures Medtronic neurological: Consultant, fellowship/grant support St. Jude Medical: Grant support, consultant Boston Scientific Grant Support

3. Overview Patient selection General Considerations for pump placement Infection Prevention Surgical Technique Prevention of follow-up complications

4. Patient Selection First step in minimizing complications Chronic non-malignant pain: Appropriate candidate Adequate trial Appropriate follow-up care CSF leak Assess for occult hydrocephalus (children, adults with spasticity s/p TBI)

5. Complication avoidance: Infection History: Frequent wound infections Cellulitis Diabetes Other immunosuppression Examine for: Pressure ulcers Non-healing wounds Preoperative skin swab for MRSA/MSSA: pre-operative decontamination routine Bactroban ointment Oral antibiotics (controversial) Appropriate perioperative antibiotics (Vancomycin vs. cephalosporin) Revisions following infection: Make sure all hardware has been removed

6. Pump Location Patient comfort Ease of access Minimize impingement on ribs or iliac crest Stability Morbidly obese patients: prone to pump flipping Consider Infraclavicular placement or scapular placement Mark position with patient standing

7. Complication avoidance: Thin patients Consider subfascial implantation

8. Catheter-Related Complications Follett KA, Burchiel K, Deer T, et al. Prevention of Intrathecal Drug Delivery Catheter-Related Complications. Neuromodulation 2003; 6(1): 32- 41

9. Low Complication Technique for Catheter Implant

10. Minimizing Complications Paramedian oblique entry (compared to midline entry) May minimize catheter dislodgement Reduces wear on catheter Anchoring may reduce catheter dislodgements V-wing anchor at fascial entry point Catheter connector/primary anchor Catheter slack at specific locations may reduce kinks Loop catheter under pump Slack in catheter by connector Anchoring pump may reduce catheter kinks and dislodgements Suture loops or mesh pouch Product designs intended to reduce catheter kinks and holes Thick wall proximal catheter Strain-relief sleeve on catheter tubing

11. Prep patient Image courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR. Mark pocket site Position patient lateral position lumbar region slightly flexed Adjust table and drapes to view fluoroscopy Administer anesthesia

12. Place needle Spinous Processes Pedicles Needle

13. Place needle (continued) Paramedian Oblique ~ 30

14. Place needle (continued)

15. Thread catheter through needle Avoid pulling catheter back while threading Introducer Needle Catheter

16. Attach the Sutureless Pump Connector to the Pump Sutureless Pump Connector Catheter Port Connector Seal Catheter Lumen Enlargement of the Connection Image inside the Connection Sutureless Connector (SC) Intrathecal Catheters (Models 8709SC, 8731SC, 8596SC, 8578): Recommendations for Implant Techniques . June 2008: 1-4.

17. Correct Sutureless Catheter Connection 1. Verify CSF backflow through the catheter. 2. Ensure alignment of Sutureless Connector to the pump. 3. Firmly squeeze precisely on the oval marks of the pump connector and press connector onto the catheter port until the connector fully covers the catheter port. The connector snaps into place. 4. Tug and rotate to check the connection. Sutureless Connector (SC) Intrathecal Catheters (Models 8709SC, 8731SC, 8596SC, 8578): Recommendations for Implant Techniques . June 2008: 1-4.

18. Pump anchoring Pouch vs. Suture loops Surgeon preference Pouch can be problematic at time of replacement/re moval

19. Place and suture pump into the pocket, coiling excess catheter behind pump Image Courtesy of Dr. Alessandro Dario, Centro di Neuromodulazione, Divisone di Neurochirurgia, Ospedale Macchi, Varese, Italy.

20. Overview for low complication implant technique Adapted from Follett KA, Burchiel K, Deer T, et al. Prevention of Intrathecal Drug Delivery Catheter-Related Complications. Neuromodulation 2003; 6(1): 32-41.

21. Improved Catheter Design

22. Granuloma prevention Granulomas have now been reported with most medications (including baclofen) and concentrations Prevailing wisdom suggests that the incidence is higher with higher doses/concentrations

23. Best practices To date, a collection of consensus panel recommendations No evidence at any level to suggest any of these recommendations Many of them common sense recommendations Patient selection and continued follow-up care by trained practitioners remains a key

24. Thank you