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Intrathecal Therapies: Local and National Trends and Complications. NANS 2010 Nandan Lad, MD, PhD ; Robert T. Arrigo, MS; Melanie Hayden,MD; Paul Kalanithi, MD ; Chirag G. Patil, MD; , Maxwell Boakye, MD, Jaimie Henderson,MD Stanford University Medical Center

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intrathecal therapies local and national trends and complications
Intrathecal Therapies: Local and National Trends and Complications

NANS 2010

Nandan Lad, MD, PhD; Robert T. Arrigo, MS;

Melanie Hayden,MD; Paul Kalanithi, MD; Chirag G. Patil, MD; , Maxwell Boakye, MD, Jaimie Henderson,MD

Stanford University Medical Center

Dept of Neurosurgery; Outcomes Research Lab; Biodesign Surgical Innovation Program;

slide2

Disclosure

  • Conflict of Interest:
              • None
  • Grants:
              • NIH, AHA, NCIIA
  • Consultant for:
              • Neurofluidics, Inc.
  • I will discuss the following investigational use in my presentation:
              • Future Directions-NeuroApheresis
  • Treatment of:
              • Spasticity
              • Complementary management of
              • malignant (cancer) pain and nonmalignant (non-cancer) pain.
              • Reduces need for high-dose opioid therapy and its associated toxicity.
outcomes research
Outcomes Research

Rationale:

  • Trusted resource to improve health through the best use of neurosurgical modalities.
  • Advance the optimal use of medical devices, procedures and biological products, by:

-Developing knowledge

-Managing risk

-Improving practice

-Informing policy makers

Outcomes Research

slide4

Intrathecal therapies

  • Current treatment for:
              • Spasticity, Cancer/Nonmalignant pain
              • Reduces need for high-dose opioid therapy and systemic toxicity.
  • Continuous infusion or bolus trial
  • Determine dosing, responsiveness and increase long-term success.
  • Currently a last resort, used only for medically refractory patients.
slide5

Methods

  • A retrospective cohort study was performed by using the California State and Nationwide Inpatient Sample over a six year period (2003-2008).
  • The NIS is a nationwide database of hospital inpatient stays. Largest all-payer inpatient care database, representing approximately 20% of all inpatient admissions to nonfederal hospitals in the United States.
  • Data from approximately 8 million annual discharges from 1004 hospitals in 37 states.
  • We filtered all-listed diagnoses for only neuro-related diagnoses and icd9 procedure code 03.90 (placement of intrathecal catheter/pump)
  • We examined trends, cost, demographics and short-term complications associated with intrathecal therapies for pain and spasticity.
slide6

Results

  • The national sample included a total of 33,187 procedures performed.
  • There was a nearly 35% decrease in the annual number of procedures over this period with 6920 procedures in 2003 and 4492 in 2008.
slide7

Results

  • Hospital geography- Percentage of US Procedures:
slide8

Results

  • National demographics for the procedure included:
  • 67% less than 65 years of age,
  • 55% female,
  • 64% Caucasian,
  • Comorbidities
  • (0: 33%, 1: 27%, 2: 20%, 3: 11%, 4+:7%)
  • Insurance status
  • (39% private, 44% Medicare/Medical, 17% other)
slide9

Results

Several studies with 1-3 year followup from institutional studies have reported overall complication rates ranging from 15-40%, including catheter malfunction, pump failure and infection (Fluckiger 2008, Borowski 2008, Ward 2009)

slide10

Conclusions

  • Intrathecal therapy has improved over the last several decades, and implantable drug delivery devices have become increasingly sophisticated and safe.
  • Morbidity rates are in-range as those previously reported in large single institution series.
  • Physicians and patients currently have many options for treating pain and spasticity with various old and new agents and their combination.
  • Where do we go from here? What’s next?
slide11

AccessMethod

Desired

TissueEffect

TheMissing

Link

Material

MechanicalPrinciple

Drug

Biodesign Process: Invention & Innovation

slide12

Biodesign Process: Invention & Innovation

MechanicalPrinciple

Drug

TheMissing

Link

Desired

TissueEffect

Material

AccessMethod

Surgeons are in a unique position to be that link

slide13

Intrathecal Therapies: Future Directions

Neuroinflammatory &

Neurodegenerative

Conditions

Certain biological components

• Cells (RBC, T/B-cell)

• Soluble factors (cytokine, Ab)

when present in CSF

Cause

Emerging Concept

unmet need

Future Directions

Unmet Need

Rapid, broad spectrum approach to treat neurological disorders via removal ofall classes of neurotoxic agents

slide15

Future Directions

  • Direct removal of pathogens from CSF
  • Targeted drug delivery and circulation
  • Versatile platform that can treat a spectrum of CNS diseases*
  • Customized, Integrated Disposable/Implantable System
  • Acute-Subacute-Chronic
  • Initial target: Multiple Sclerosis (MS)

*Neurofluidics, Inc.

slide16

Thank You.

Manuscript in progress. NEUROLAD@GMAIL.COM

Intrathecal Therapies:

Local and National Trends and Complications