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106
Safety and Efficacy of Intrathecal Drug Delivery with On-Demand Bolus Option “PTM”

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Introduction: Implanted intrathecal drug delivery (ITDD) systems

enable administration of spinal analgesics to patients with refractory

pain conditions. Historically, any demand for breakthrough pain control

or increase in the basal ITDD rate required a physician’s office visit to

prescribe oral opiates or reprogram the device, generating

inconvenience to patients and costs to the health care system.

Recently, a personal therapy manager (PTM; Medtronic, Minneapolis,

Minnesota) was introduced enabling patients to deliver a prescribed

bolus to manage fluctuating pain. The aim of the present study was to

measure oral opiate requirements amongst the two groups and

compare pain relief measured by numerical rank scale (NRS) and

functionality measured by pain disability index (PDI) amongst those who

have a PTM and matched controls.

Methods: 92 patients with ITDD systems (15/77 PTM/nonPTM)

implanted and followed by a single implanter (N.M.) at the Cleveland

Clinic were included in the analysis. The predominant indications for

ITDD were (1) spine pain including postlaminectomy syndrome, (2)

neuropathic pain including complex regional pain syndrome (3) cancer

related pain and (4) other conditions including spasticity. Retrospective

data included opiate intake via oral and intrathecal routes, percentage of

opiate administered via PTM, NRS pain score and PDI. Student’s t-test

was utilized to assess differences amongst the groups.

Results: Mean NRS pain scores decreased from 7.1 at the time of

implant to 6.5 at present in the PTM group, and from 7.5 to 5.4 in the

nonPTM group. Mean PDI decreased from 45 at the time of implant to

34 at last visit in the PTM group, and from 49 to 35 in the nonPTM

patients. 57% of patients with simple continuous infusions required

supplemental oral opiates, averaging 57mg (range: 0-225) morphine

equivalents per day. PTM was supplemental by oral opiates in only one

patient who has terminal rectal cancer with invasion into the sacrum and

sacral nerve roots. The median PTM daily opiate dose was 8.9%

(range:0.4-30.2%) of the total daily intrathecal opiate dose.

Conclusion: A decrease in pain and improvement in function was

observed in both groups. PTM obviated the need for oral breakthrough

opiates in 91% of patients given the bolus option. Amongst PTM treated

patients, there were no safety-related concerns or side effects owing to

the PTM over 6,051 sequential days of continuous use. We

hypothesize that the addition of PTM may provide a significant cost

savings by enabling elimination of supplemental oral analgesics, and we

plan to investigate the economic impact of PTM in a future prospective

study.

Population Demographics

Methods

Conclusions

Introduction:

q Implanted ITP delivers preset volumes of

medication

q Analgesic requirements fluctuate over time

q With changing demand, an MD office visit was

previously required for titration & reprogramming

Personal Therapy Manager (PTM):

q Bolus device with preset parameters (dose,

frequency)

q Wireless, portable, discrete, simple to use

q Patient chooses to match demand with PRN

analgesic bolus

Retrospective Cohort:

q Tertiary care referral center, single implanter, single prescriber

q 15 PTM / 77 simple continuous infusion patients

Data Collection:

q Demographic data, indication for intrathecal therapy

q Opiate intake via oral route and intrathecal routes (morphine

milligram Equivalents)

q Frequency & quantity of PTM bolus analgesics

q Numerical Rank Scale (NRS) pain scores, Pain Disability Index (PDI)

Hypothesis:

q PTM decreases the need for supplemental oral

analgesics

q NRS pain scores and pain disability index will be

decreased in PTM patients when compared with

counterparts receiving continuous infusion

Statistical Analysis:

q Comparison between groups was performed using independent

students T-test or Wilcoxon Rank Sum Test as appropriate for

continuous data and Chi square test for categorical data

q Statistical significance is defined as p<0.05

q Significant difference in use of post op opioids between groups was

p<0.0001

q No difference was found between groups in recent pain or PDI

scores

Future Directions: goodRx.com / ePocrates

q Follow NRS, PDI and other functional outcomes measures in a

prospective cohort

q Quantify cost savings of a PTM, calculate a break-even point

q Assess difference in dose escalation amongst PTM & simple

infusion cohorts

q Both simple continuous and PTM treated patients had decreased

pain and increased function

q The need for oral opiates were eliminated in 91% of the PTM cohort

q Safety was observed throughout 6,051 of continuous PTM use