Transcript Cyberknife treatment of refractory Cluster Headache.

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;
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
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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
Spine
Stereotac
tic/Functi
onal
Tumor
Outcomes
Research
Critical
Care
Vascular/
Endovascular
Peripheral
Nerve
Pediatrics
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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.
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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.
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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.
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Results

Hospital geography- Percentage of US Procedures:
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Results
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National demographics for the procedure included:
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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)
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Results
Any Complications
(Acute)
Cardiac
6.2%
0.33%
Infection
0.93%
Neurologic
0.52%
Pulmonary
2.1%
Renal
1.5%
Venous Thromboembolism
1.1%
Wound Complication
0.58%
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)
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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?
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Biodesign Process: Invention & Innovation
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Biodesign Process: Invention & Innovation
Surgeons are in a unique position to be that link
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Intrathecal Therapies: Future Directions
Certain biological
components
• Cells (RBC, T/B-cell)
• Soluble factors (cytokine, Ab)
when present in CSF
Neuroinflammatory &
Neurodegenerative
Conditions
Emerging
Concept
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Future Directions
Unmet Need
Neurotoxic
Components
in CSF
Current Therapy
TYSABRI
IV IgG
Steroids/
Interferon
Plasmapheresis
RBC
Lumbar
Drainage
Needed
Therapy
X
T-cell
X
X
X
B-cell
(X)
X
X
Antibody
Inflammation
/Cytokines
X
X
X
X
Rapid, broad spectrum approach to treat
neurological disorders via removal of all classes of
neurotoxic agents
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Future Directions

Direct removal of pathogens from CSF
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Targeted drug delivery and circulation
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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.
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Thank You.
Manuscript in progress.
[email protected]
Intrathecal Therapies:
Local and National Trends and Complications
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