ABSTRACT
INTRODUCTION: Effective treatment for severe ischemic stroke continues to be largely an unmet medical need. Using a nonvascular (paravascular cerebrospinal fluid) pathway to provide oxygen and nutrients to ischemic tissues may be a means of treating this disease. The primary objective of this study was to evaluate the safety and technical feasibility of ventriculo-lumbar perfusion with the oxygenated fluorocarbon nutrient emulsion (OFNE) perfusion system in the treatment of patients with severe hemispheric cerebral ischemia. RESULTS: Four patients were enrolled in this pilot study. At admission, patients' National Institutes of Health Stroke Scale scores ranged from 16 to 24. The perfusion pathway was successfully established in all four patients. Maximum perfusion rates varied from 25 to 40 mL/minute; total volume perfused over the 24-hour period ranged from 30.6 to 45.8 L. ICP ranged from -3 to 16 mmHg during the perfusion. The 24-hour perfusion was successfully completed in all four patients with no serious adverse events during the perfusion. CONCLUSION: It is technically feasible and safe to establish a ventriculo-lumbar perfusion pathway using a specially designed lumbar drainage catheter and to control intracranial pressure while perfusing large volumes of OFNE.
