Use of ACTIVE Fluid Exchange to Treat Intraventricular Hemorrhage

Intraventricular extension of hemorrhage (IVH) is a particularly poor prognostic sign, with expected mortality between 50% and 80%. IVH is a significant and independent contributor to morbidity and mortality, yet therapy directed at ameliorating intraventricular clot has been limited. Conventional therapy centers on managing hypertension and intracranial pressure while correcting coagulopathy and avoiding complications such as rebleeding and hydrocephalus. Surgical therapy alone has not changed the natural history of the disease significantly. Although ventriculostomy appears to be effective in controlling ICP, this technique does little to reduce morbidity and does not address the inflammatory process. The severity of communicating hydrocephalus appears to be related to IVH volume and the duration of exposure of CSF to clotted blood.

Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of intracranial pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after intracerebral hemorrhage (ICH).

There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and intracranial pressure (ICP) monitoring. Routinely, ICP is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP.

The IRRAflow system performs active, controlled fluid exchange, based on the notion that it is faster to wash out IVH, compared to gravity drainage alone. IRRAflow combines periodic, controlled irrigation and aspiration of the catheter probe with neutral physiological fluids. The continuous perfusion cleans the entire inner catheter probe's surface while the fluid movement helps to disrupt potential clot or bacteria colony formation on the catheter probe's intracranial external surface, thereby eliminating the underlying reasons for the problems associated with passive drainage: blockage and infection. Furthermore, IRRAflow perfusion is combined with continuous ICP monitoring that includes safety alarms. Contrary, with passive drainage, such as today's standard of care, the external ventricular drain (EVD), is inherently inefficient because of its inability to overcome blood clot adhesion. As a result, EVD's generally need a lot of treatment time for the evacuation of a clinically significant blood volume and often leave enough volume of residual blood to create secondary adverse effects, like hydrocephalus. IRRAflow was designed to increase drainage efficiency by means of gradual and continuous dilution of the pathological intracranial fluids through irrigating the catheter with physiological fluids as well as the continuous pressure fluctuations inside the pathological collection, which are created by the appropriate irrigation patterns. By design, the IRRAflow catheter probe is irrigated regularly in a way that maintains its patency. Catheter blockages are theoretically very unlikely since any material build-up at the catheter's tip is washed away during the next irrigation phase, which will occur in, at most, a couple of minutes. Additionally, the volume and flow rate of each irrigation is such that the length of the IRRAflow catheter probe's outer surface is washed by backflow, thus arguably reducing the chance for bacterial colonisation (Data on File at IRRAS). As for safety, IRRAflow automatically, reliably, and continuously monitors ICP and alerts hospital personnel with visual and sound alarms immediately when the patient's ICP is out of the pressure range set by the treating neurosurgeon, which eliminates any delay in detecting under or over drainage and any treatment's compromise.

The clinical efficacy of the IRRAflow system is currently validated to a limited extent based on case series (Evidence grade 4) with a total number of patients around 200 distributed across multiple countries including in Greece, India, Sweden, Germany, UK, USA, and Finland. The system has been used to treat subarachnoid, intraventricular, intraparenchymal, and subdural hemorrhages. The system was CE Marked in 2014 and began limited market release in Germany in 2017. It received US FDA clearance in July of 2018 and began to be used commercially based on the conclusion that the device was safe. Case report data on the 200 initial patients has been collected by the company and maintained on file. The data has shown that zero IRRAflow catheter occlusions have been experienced when the irrigation setting has been activated (unpublished). Furthermore, treatment times were much shorter and posttreatment residual blood volumes were less than expected by the treating neurosurgeons (31), (Data on File at IRRAS). To date there have not been any documented blockages or probe associated infections detected in any IRRAflow treatment.