Abstract
Background: FlowSafeTM (BeckerSmith Medical, Irvine, CA, USA) is a novel, robotic, external lumbar drainage (ELD) system, which was designed to control cerebrospinal fluid (CSF) drainage, reduce complications, and decrease treatment costs.Methods: Forty-seven consecutive neurosurgical patients requiring ELD were treated using the FlowSafe system.Results: In 39 of 40 patients with traumatic and surgical dural openings, potential CSF leaks were avoided. In seven patients with suspected normal pressure hydrocephalus, post-infectious ventriculomegaly, or pseudotumor cerebrum, we were able to assess the likelihood of improvement with shunting. The system, therefore, produced what we considered to be the “desired result” in 46 of 47 patients (98%). Our one treatment failure (2%) involved a patient with unrecognized hydrocephalus who, following a Chiari repair with a dural patch graft, was drained for six days. A persistent CSF leak eventually required a reoperation. Two patients (4%) described low-pressure headaches during treatment. Both responded to temporarily suspending or reducing the drainage rate. We saw no complications. Required nursing interventions were minimal. Conclusions: The FlowSafe system was safe and effective. In our experience, there were fewer complications compared to currently available ELD systems. The FlowSafe was well tolerated by our patients. The near elimination of nursing interventions should allow lumbar drainage to be delivered in less costly, non-intensive care unit settings. Larger trials will be needed.
Highlights
IntroductionAvailable external lumbar drainage (ELD) systems are primitive and essentially identical to the pressure-regulated drains first described in 1963 [1]
We describe a novel robotic system that can lower complications and costs
external lumbar drainage (ELD) is used to treat spontaneous and iatrogenic dural openings [2,3], to determine if shunting might be of benefit in patients with ventriculomegaly or pseudotumor [4,5,6], for patients following subarachnoid hemorrhage [7,8,9], and to decrease intracranial pressure [10]
Summary
Available external lumbar drainage (ELD) systems are primitive and essentially identical to the pressure-regulated drains first described in 1963 [1]. We describe a novel robotic system that can lower complications and costs. A more recently described, inexpensive, flowregulated ELD system claimed a similar safety profile but was difficult to assemble and was not suitable for patients with increased intracranial pressure [15]. The system we trialed was connected and fully programmable, designed to prevent over- and under-drainage, allowed patients to remain ambulatory during treatment, required almost no oversight, and could have been used outside of the ICU setting. FlowSafeTM (BeckerSmith Medical, Irvine, CA, USA) is a novel, robotic, external lumbar drainage (ELD) system, which was designed to control cerebrospinal fluid (CSF) drainage, reduce complications, and decrease treatment costs
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