Background and purpose: This is the first single center experience illustrating the effectiveness of the penumbra system (PS) in the treatment of large vessel occlusive disease in the arena of acute ischaemic stroke. The PS is an innovative mechanical thrombectomy device, employed in the revascularization of large cerebral vessel occlusions in patients via the utilization of an aspiration platform.
Methods: This is a prospective, non-randomized controlled trial evaluating the clinical and functional outcome in 29 patients with acute intra-cranial occlusions consequent to mechanical thrombectomy by the PS either as mono-therapy or as an adjunct to current standard of care. Patients were evaluated by a neurologist and treated by our in house interventional neuro-radiologists. Primary end-points were revascularization of the occluded target vessel to TIMI grade 2 or 3 and neurological outcome as measured by an improvement in the NIH Stroke Scale (NIHSS) score after the procedure.
Results: Complete revascularization (TIMI 3) was achieved in 21/29 (72.4%) of patients. Partial revascularization (TIMI 2) was established in 4/29 (13.8%) of patients. Revascularization failed in four (13.8%) patients. Nineteen (19) patients (65.5%) had at least a four-point improvement in NIHSS scores. Modified Rankin scale scores of < or =2 were seen in 37.9% of patients. There were no device-related adverse events. Symptomatic intra-cranial hemorrhage occurred in 7% of patients.
Conclusions: The PS has the potential of exercising a significant impact in the interventional treatment of ischaemic stroke in the future.