2015.03.07, Abstract as Submitted

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General Information Scientific Content Experience with a Novel, Automated, External Cerebrospinal Fluid Drainage Control Device - Submitted: 3/7/2015 Abstract Title: Experience with a Novel, Automated, External Cerebrospinal Fluid Drainage Control Device Study Design: Clinical Trial Preferred Format: Any Format Subject Category: Socioeconomic/CSNS Award Consideration: Samuel Hassenbusch Young Neurosurgeon Award (Socioeconomic) Introduction: Most available lumbar drainage systems are functionally identical to the first gravity-fed device described in 1963. Although lumbar drainage is the standard of care for a variety of pathologies, complication rates are high, up to 40% in some series. Additionally, manually controlled lumbar drains are labor intensive and therefore costly. Gravity-independent, pump-regulated systems have been proposed, but adoption was limited by the risks associated with active CSF removal. We propose the use of a new gravity-fed system that is microprocessor controlled, programmable, and prevents over- or under-drainage. It should improve patient safety and lower treatment costs. Methods: Thirty-five consecutive patients requiring external lumbar drainage were treated using the FlowSafeTM system (BeckerSmith Medical, Irvine, CA). Results: Nineteen men and 16 women, average age 42.6 years, were drained for a mean of 93 hours (range 24 to 144). Drainage rates averaged 8.0 ml/hour (range 5 to 15). A single dose of antibiotics was used in 24 patients. Eleven received antibiotics for 48 to 144 hours. Diagnoses included skull base surgery (18), spontaneous and traumatic CSF fistulas (7), unintentional durotomy (7), normal pressure hydrocephalus (2), and intracranial hypertension due to meningitis (1). Set up times were minimal. Manual interventions, to regulate flow, were not required. There were no mechanical failures. Two individuals (6%) reported headache. Drainage was temporarily discontinued in one and the rate was decreased in the other. In both, headaches resolved promptly. No other complications were observed. Conclusions: The system proved convenient, safe and effective. Our complication rate was lower than in published series for current manual systems. Manual interventions were not required. With this system, ICU level care will not be necessary for many patients. Larger trials are needed, and the efficacy should be evaluated in patients with other diagnoses, including those undergoing aortic surgery.

Transcript of 2015.03.07, Abstract as Submitted

Page 1: 2015.03.07, Abstract as Submitted

General Information

Scientific Content

Experience with a Novel, Automated, External Cerebrospinal Fluid Drainage Control

Device - Submitted: 3/7/2015

Abstract Title: Experience with a Novel, Automated, External Cerebrospinal Fluid

Drainage Control Device

Study Design: Clinical Trial

Preferred Format: Any Format

Subject Category: Socioeconomic/CSNS

Award Consideration: Samuel Hassenbusch Young Neurosurgeon Award

(Socioeconomic)

Introduction: Most available lumbar drainage systems are functionally identical

to the first gravity-fed device described in 1963. Although lumbar

drainage is the standard of care for a variety of pathologies,

complication rates are high, up to 40% in some series.

Additionally, manually controlled lumbar drains are labor intensive

and therefore costly. Gravity-independent, pump-regulated

systems have been proposed, but adoption was limited by the

risks associated with active CSF removal. We propose the use of a

new gravity-fed system that is microprocessor controlled,

programmable, and prevents over- or under-drainage. It should

improve patient safety and lower treatment costs.

Methods: Thirty-five consecutive patients requiring external lumbar drainage

were treated using the FlowSafeTM system (BeckerSmith Medical,

Irvine, CA).

Results: Nineteen men and 16 women, average age 42.6 years, were

drained for a mean of 93 hours (range 24 to 144). Drainage rates

averaged 8.0 ml/hour (range 5 to 15). A single dose of antibiotics

was used in 24 patients. Eleven received antibiotics for 48 to 144

hours. Diagnoses included skull base surgery (18), spontaneous

and traumatic CSF fistulas (7), unintentional durotomy (7), normal

pressure hydrocephalus (2), and intracranial hypertension due to

meningitis (1). Set up times were minimal. Manual interventions,

to regulate flow, were not required. There were no mechanical

failures. Two individuals (6%) reported headache. Drainage was

temporarily discontinued in one and the rate was decreased in the

other. In both, headaches resolved promptly. No other

complications were observed.

Conclusions: The system proved convenient, safe and effective. Our

complication rate was lower than in published series for current

manual systems. Manual interventions were not required. With

this system, ICU level care will not be necessary for many patients.

Larger trials are needed, and the efficacy should be evaluated in

patients with other diagnoses, including those undergoing aortic

surgery.

Page 2: 2015.03.07, Abstract as Submitted

Attachments:

Authors:

Learning Objectives: By the conclusion of this session, participants should be able to:

(1) describe the available CSF drainage systems; (2) discuss the

indications for, efficacy of, and safety of cerebrospinal drainage;

and (3) describe the cost-savings achieved with automated

systems.

Keywords: Cerebrospinal Fluid, Dural Tear, Lumbar Drain, Skull Base Surgery

How will your research improve patient care: The FlowSafe device will improve patient care by providing an

effective and safe method of cerebrospinal drainage in a more cost

-saving manner than achieved with automated systems.

Author Disclosure Presenting Corresponding CoAuthor

Christina Duffin X

Jan Eckermann BeckerSmith Medical,

Inc.,,Ownership

Interest,N/A

X X

Susan Schaufelberger X

Robert Lieberson X

William Meyer X

Tung Trang X