Intrathecal Drug Delivery Systems: Best Practices

Alon Y. Mogilner, MD, PhDDirector, Center for Neuromodulation

NYU Langone Medical Center

Disclosures

• Medtronic neurological:– Consultant, fellowship/grant support

• St. Jude Medical:– Grant support, consultant

• Boston Scientific– Grant Support

Overview

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

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)

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

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

Complication avoidance: Thin patients– Consider subfascial

implantation

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

Low Complication Technique for Catheter Implant

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

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

Place needleSpinous Processes

Pedicles

Needle

Place needle (continued)

Paramedian Oblique

~ 30°

Place needle (continued)

Thread catheter through needle Avoid pulling catheter back while threading

Introducer Needle

Catheter

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.

Correct Sutureless Catheter Connection1. 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.

Pump anchoring

• Pouch vs. Suture loops– Surgeon

preference– Pouch can be

problematic at time of replacement/removal

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.

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.

Improved Catheter Design

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

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…

Thank you