Intrathecal Pump Drug Delivery

Preface
Acknowledgements
Contents
Introduction and Background for Intrathecal Pumps Used for Pain and Spasticity
	1	 Introduction and Background for Intrathecal Pumps Used for Pain and Spasticity
	2	 Historical Background and Perspectives of Intrathecal Drug Delivery
	3	 Intrathecal Drug Delivery for Pain Indications
	4	 Goals of Therapy
	5	 Long-Term Effectiveness
	6	 Types of Intrathecal Systems (Pumps)
	7	 Initial Drug Therapy
	8	 Choice of Medication
	9	 Adverse Events
	10	 Intrathecal Drug Delivery for Spasticity
	11	 Conclusion
	References
Intrathecal Drug Delivery for Cancer-Related Pain
	1	 Introduction and Background for Cancer Pain
	2	 Intrathecal Drug Delivery (IDD) for Cancer-Related Pain
		2.1	 Considerations for Patient Selection
		2.2	 Screening Trial
		2.3	 Considerations for the Type of Intrathecal Drug Delivery System (IDDS) for Cancer Patients
			2.3.1	 Characteristics of Percutaneous Vs Fully Implanted IDDS (Bhatia et al. 2014)
		2.4	 Choice of Intrathecal Drug for Cancer Pain
		2.5	 Complications
	3	 Conclusion
	References
The Components of Intrathecal Drug Delivery
	1	 Intrathecal Pain Pump Models
		1.1	 Medtronic SynchroMed® II Intrathecal Pump
		1.2	 Flowonix Prometra® II Intrathecal Pump
		1.3	 Codman® 3000 Constant Flow Pump
	2	 Intrathecal Catheters and Catheter Insertion Kits
		2.1	 Medtronic Ascenda® Catheter
		2.2	 Prometra® Intrathecal Catheter
	3	 Clinician Programmers and Patient Control Devices
		3.1	 SynchroMed® II Clinician Programmer and Patient Therapy Manager
		3.2	 Prometra® II Clinician Programmer and Patient Therapy Controller
	4	 Flow Rate Accuracy
	5	 Pump Maintenance
	6	 Programming Strategies for Intrathecal Pumps
	7	 Conclusion
	References
Intrathecal Drug Delivery Trialing
	1	 Intrathecal Drug Delivery Trialing
	2	 Intrathecal Baclofen
	3	 Pain Pump Trialing
		3.1	 Trialing and Type of Pain
		3.2	 Trial Dosing and Method
	4	 Whether or Not to Trial
	5	 Dosing and Medication Selection
	6	 Side Effects
	7	 Trial Environment
	8	 Comorbidities and Medication Interactions
	9	 Complications of Trialing
	10	 Catheter Dislodgement
	11	 Conclusion
	References
Targeted Drug Delivery Perioperative Planning Considerations
	1	 Intrathecal Drug Delivery
		1.1	 Indications
		1.2	 Medications
			1.2.1	 Morphine
			1.2.2	 Ziconotide
			1.2.3	 Baclofen
			1.2.4	 Off-Label Therapies and Medication Combinations
			1.2.5	 Novel Agents
		1.3	 Baricity
	2	 Preoperative Management
		2.1	 Patient Selection
		2.2	 Preoperative Patient Workup and Considerations
		2.3	 Comorbidities and High-Risk Patients
		2.4	 Medical Conditions that Prohibit Intrathecal Drug Delivery
		2.5	 Other Considerations in Cancer Patients
		2.6	 Trialing
		2.7	 Preimplantation Planning Considerations
	3	 Intraoperative Management
		3.1	 Sedation Versus General Anesthesia
		3.2	 Prophylactic Medications
		3.3	 Appropriate Patient Positioning
		3.4	 Location and Placement of the Intrathecal Needle and Catheter
		3.5	 Needle Placement
		3.6	 Selecting Catheter Length
		3.7	 Techniques and Considerations for Tunneling Catheters
		3.8	 Anchoring
		3.9	 Wound Closure
		3.10	 Wound Dressing
	4	 Postoperative Management
		4.1	 Postoperative Considerations
			4.1.1	 Postoperative Wound Care and Restrictions
			4.1.2	 Complications and Their Management
		4.2	 Replacements and Revisions
	5	 Conclusion
	References
Key Steps in the Intrathecal Pain Pump Procedure
	1	 Positioning
	2	 Needle/Catheter Placement
	3	 Pump Pocket Creation
	4	 Catheter Tunneling
	5	 Catheter Pump Connection and Pump Placement
	6	 Minimizing Infection
	7	 Closure
	8	 Alternative Pump Location Selection
	9	 Conclusion
	References
Intrathecal Pump Management
	1	 Patient Selection
	2	 Compounded Medications
	3	 Starting Dosages
	4	 Training and Education
	5	 Opioid Tolerance and Its Effect on IT Opioid Therapy
	6	 Conclusion
	References
Pump Management: Intrathecal Baclofen Pumps
	1	 Introduction
	2	 Defining Spasticity: Velocity Dependent
	3	 Assessing Spasticity: Modified Ashworth Scale (MAS)
	4	 Setting Goals: Baseline Function, Management of Expectations, Patient-Centered Focus
	5	 Treatment Options for Spasticity
	6	 Intrathecal Baclofen (ITB) Therapy: Severe, Intractable, Problematic Spasticity
	7	 Indication to Initiate ITB: Failed Oral Medication Management
	8	 Contraindications to Baclofen and ITB
	9	 Efficacy
	10	 Pharmacology and Drug Delivery
		10.1	 Baricity
	11	 Catheter Tip Placement
	12	 Cervical Vs Thoracic Placement
	13	 Optimal Timing
	14	 Adjunctive Therapies to ITB
	15	 Oral Antispasmodics: Baclofen, Tizanidine, Diazepam
		15.1	 Conversion from Oral to IT Baclofen
		15.2	 Prior to Trial
		15.3	 Approach to Baclofen Trials
		15.4	 Prior to Implantation
		15.5	 Oral Medications After Implantation
		15.6	 Compounding Baclofen with Other Agents
	16	 ITB Pump Management
	17	 Dosing Options
	18	 Initial Dosing: Commonly Available Dosing Concentrations: 500, 1000, and 2000 mcg/mL. Starting Concentration Is Typically 500 mcg/mL
	19	 Dose Adjustments
	20	 Dose Increases
	21	 Arriving at Therapeutic State
	22	 Tolerance
	23	 Complications of the ITB Delivery System
	24	 Outpatient Follow-Up for Pump Refill
	25	 Optimal Time to Schedule Refill Appointments
	26	 Ongoing Management
	27	 Maintenance: Use the Lowest Dose Possible
	28	 General Dosing Rules of Thumb
	29	 How to Provide Ongoing Monitoring: Assess for New Adverse Effects
	30	 Discontinuing Care
	31	 Conclusion
	References
Postoperative Care and Complication
	1	 Infection
	2	 Catheter Issues
	3	 Granuloma
	4	 Cerebrospinal Fluid Leak
	5	 Seroma
	6	 Pump Complications
	7	 Baclofen
	8	 Miscellaneous
	9	 Magnetic Resonance Imaging
	10	 Conclusion
	References
Intrathecal Pump and Catheter Troubleshooting
	1	 Catheter and Rotor Study
	2	 Conclusion
	References
Current Intrathecal Pump Costs, Coding, and Reimbursement
	1	 Introduction
	2	 Intrathecal Drug Delivery Versus Conventional Pain Therapy: Evidence-Based Approach to the Cost-Effectiveness of Intrathecal Drug Therapy
		2.1	 Patient Selection for IT Therapy
	3	 2019 Current Procedural Terminology (CPT) Codes and Medicare Physician Payment Schedule Payment Information
	4	 Comparison of Reimbursements for IDD Versus Other Interventional Pain Procedures
		4.1	 Annual Reimbursement Per Patient for Interventional Pain Procedures
		4.2	 Intrathecal Drug Delivery Versus Neuromodulation Reimbursements Per Patient
	5	 Conclusion
	References
Interventional Pain Management in Palliative Care
	1	 Intrathecal Infusions in Palliative Care
	2	 Collaboration with the Palliative Care Team
	3	 History of Palliative Care
	4	 What Is Palliative Care?
	5	 The Importance of Correct Terminology
	6	 Specialist Non-interventional Therapies
		6.1	 Adjuvant Analgesics
		6.2	 Methadone
		6.3	 Sublingual Sufentanil
		6.4	 Lidocaine Infusion
		6.5	 Ketamine
		6.6	 “Total Pain”
	7	 Interventional Pain Management Options
		7.1	 Cementoplasty ± Cryoablation
		7.2	 Nerve Blocks
		7.3	 Neurolytic Procedures
		7.4	 Spinal Cord Stimulation
	8	 Case Conferencing
	9	 Case Examples
		9.1	 “David”
		9.2	 “Karen”
		9.3	 “Malcolm”
	References
The Use of Ziconotide in Intrathecal Drug Therapy
	1	 History of the Use of Ziconotide for Intrathecal Therapy
	2	 Characteristics of the Medication Ziconotide
		2.1	 Structure of the Medication
		2.2	 Mechanism of Action
		2.3	 Select Literature Review of Ziconotide
		2.4	 Ziconotide for Chronic Nonmalignant Pain: Wermeling 2003 (Wermeling et al. 2003)
		2.5	 Ziconotide Versus Placebo for Pain in Cancer or AIDS: Staats 2003 (Staats et al. 2003)
		2.6	 Ziconotide Versus Placebo: Rauck 2006 (Rauck et al. 2006)
		2.7	 External Catheter Evaluation of Ziconotide for Malignant and Nonmalignant Pain: Ver Donck 2008 (Ver Donck et al. 2008)
		2.8	 High- and Low-Dose Ziconotide Trialing: Abramoff 2014 (Abramoff and Shaw 2014)
		2.9	 Nocturnal Flex Dosing: Pope 2015 (Pope and Deer 2015)
		2.10	 Open-Label Observational Study: Deer 2018 (Deer et al. 2018)
		2.11	 Ziconotide for Axial Nonmalignant Pain: Lindley 2019 (Lindley 2019)
		2.12	 The Use of Ziconotide in Patients with Spinal Cord Injury: Brinzeu 2019 (Brinzeu et al. 2019)
		2.13	 The Distal Segmental Spread of Intrathecal Ziconotide: Staub 2019 (Staub et al. 2019)
	3	 Study-Based Discussion of the Clinical Use of Ziconotide
		3.1	 Trial Dosing
		3.2	 Dose-Efficacy Comparisons
		3.3	 Dose-Adverse Effects Comparisons
		3.4	 Comparison of Bolus Dosing Versus Continuous Infusion
		3.5	 Comparison of High Versus Low Concentration Infusion
		3.6	 Programmed Bolus Versus Patient Administered Bolus Techniques
		3.7	 Spinal Segmental Spread of Ziconotide
	4	 Conclusions
	References