Intrathecal Therapies: Intrathecal Therapies: Local and National Trends and Local and National Trends and

ComplicationsComplications

NANS 2010NANS 2010

Nandan Lad, MD, PhDNandan Lad, MD, PhD; Robert T. Arrigo, MS; ; Robert T. Arrigo, MS; Melanie Hayden,MD; Melanie Hayden,MD; Paul Kalanithi, MDPaul Kalanithi, MD; Chirag G. ; Chirag G.

Patil, MD; , Maxwell Boakye, MD, Patil, MD; , Maxwell Boakye, MD, Jaimie Jaimie Henderson,MDHenderson,MD

Stanford University Medical CenterStanford University Medical CenterDept of Neurosurgery; Outcomes Research Lab; Dept of Neurosurgery; Outcomes Research Lab;

Biodesign Surgical Innovation Program; Biodesign Surgical Innovation Program;

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DisclosureDisclosure

Outcomes ResearchOutcomes ResearchRationale:Rationale:

Trusted resource to improve Trusted resource to improve health through the best use of health through the best use of neurosurgical modalities.neurosurgical modalities.

Advance the optimal use of Advance the optimal use of medical devices, procedures and medical devices, procedures and biological products, by:biological products, by:

-Developing knowledge-Developing knowledge

-Managing risk-Managing risk

-Improving practice-Improving practice

-Informing policy makers-Informing policy makers

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Outcomes

Research

44

Intrathecal therapies

55

A retrospective cohort study was performed by using A retrospective cohort study was performed by using the California State and Nationwide Inpatient Sample the California State and Nationwide Inpatient Sample over a six year period (2003-2008).over a six year period (2003-2008).

The NIS is a nationwide database of hospital inpatient The NIS is a nationwide database of hospital inpatient stays. Largest all-payer inpatient care database, stays. Largest all-payer inpatient care database, representing approximately 20% of all inpatient representing approximately 20% of all inpatient admissions to nonfederal hospitals in the United States.admissions to nonfederal hospitals in the United States.

Data from approximately 8 million annual discharges Data from approximately 8 million annual discharges from 1004 hospitals in 37 states.from 1004 hospitals in 37 states.

We filtered all-listed diagnoses for only neuro-related We filtered all-listed diagnoses for only neuro-related diagnoses and icd9 procedure code 03.90 (placement diagnoses and icd9 procedure code 03.90 (placement of intrathecal catheter/pump)of intrathecal catheter/pump)

We examined trends, cost, demographics and short-We examined trends, cost, demographics and short-term complications associated with intrathecal term complications associated with intrathecal therapies for pain and spasticity.therapies for pain and spasticity.

MethodsMethods

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The national sample included a total of 33,187 The national sample included a total of 33,187 procedures performed. procedures performed.

There was a nearly 35% decrease in the annual There was a nearly 35% decrease in the annual number of procedures over this period with 6920 number of procedures over this period with 6920 procedures in 2003 and 4492 in 2008. procedures in 2003 and 4492 in 2008.

ResultsResults

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Hospital geographyHospital geography- Percentage of US - Percentage of US Procedures:Procedures:

ResultsResults

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National demographics for the procedure included:National demographics for the procedure included:

67% less than 65 years of age, 67% less than 65 years of age, 55% female, 55% female, 64% Caucasian, 64% Caucasian, Comorbidities Comorbidities

(0: 33%, 1: 27%, 2: 20%, 3: 11%, 4+:7%) (0: 33%, 1: 27%, 2: 20%, 3: 11%, 4+:7%) Insurance status Insurance status

(39% private, 44% Medicare/Medical, 17% other)(39% private, 44% Medicare/Medical, 17% other)

ResultsResults

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ResultsResults

Any Complications(Acute)

6.2%

Cardiac 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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Intrathecal therapy has improved over the last Intrathecal therapy has improved over the last several decades, and implantable drug delivery several decades, and implantable drug delivery devices have become increasingly sophisticated devices have become increasingly sophisticated and safe. and safe.

Morbidity rates are in-range as those previously Morbidity rates are in-range as those previously reported in large single institution series. reported in large single institution series.

Physicians and patients currently have many Physicians and patients currently have many options for treating pain and spasticity with options for treating pain and spasticity with various old and new agents and their combination.various old and new agents and their combination.

Where do we go from here? What’s next? Where do we go from here? What’s next?

ConclusionsConclusions

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Biodesign Process: Invention & Biodesign Process: Invention & InnovationInnovation

Des

ired

Tiss

ue

Eff

ect

MechanicalPrinciple

Access

Method

Drug

Material

The

Missing

Link

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Biodesign Process: Invention & Biodesign Process: Invention & InnovationInnovation

DesiredTissueEffect

MechanicalPrinciple

AccessMethod

Drug

Material

TheMissing

Link

Surgeons are in a unique position to be that link

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Intrathecal Therapies: Future Intrathecal Therapies: Future DirectionsDirections

Emerging Concept

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Future DirectionsFuture Directions

Unmet NeedUnmet Need

Neurotoxic Component

s in CSF

Current TherapyNeeded TherapyTYSABR

IIV IgG

Steroids/ Interferon

Plasma-pheresis

Lumbar Drainage

RBC X

T-cell X X X

B-cell (X) X X

Antibody X X

Inflammation/Cytokines X X

Rapid, broad spectrum approach to treat Rapid, broad spectrum approach to treat neurological disorders via neurological disorders via removalremoval of of all all

classes of neurotoxic agentsclasses of neurotoxic agents

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Future DirectionsFuture Directions

Direct removal of pathogens from CSFDirect removal of pathogens from CSF

Targeted drug delivery and circulationTargeted drug delivery and circulation

Versatile platform that can treat a Versatile platform that can treat a spectrum of CNS diseases* spectrum of CNS diseases*

Customized, Integrated Customized, Integrated Disposable/Implantable SystemDisposable/Implantable System

Acute-Subacute-Chronic Acute-Subacute-Chronic

Initial target: Multiple Sclerosis (MS)Initial target: Multiple Sclerosis (MS)

**Neurofluidics, Inc.Neurofluidics, Inc.

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Thank You.Thank You.

Manuscript in progress. Manuscript in progress. NEUROLAD@GMAIL.COM NEUROLAD@GMAIL.COMIntrathecal Therapies:

Local and National Trends and Complications