The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device.
BACKGROUND
The use of retrievable stents for acute ischemic stroke (AIS) may result in the release of distal emboli in 12-22% of cases. The Lazarus Funnel is a novel CE-marked thrombectomy assist device designed to capture the stentriever and thrombus to minimize the likelihood of distal embolization. To study this technology, we performed a randomized blinded in vitro evaluation of this device.


METHODS
A cerebral flow model was used as an in vitro simulator for cerebral arterial thrombectomy procedures. Stratified block randomization was performed following embolus injection into one of three cohorts: Solitaire stentriever plus guide catheter (control); control plus proximal Funnel placement; or control plus distal Funnel placement. Time to embolectomy, recanalization, and incidence of distal emboli were determined by a blinded observer.


RESULTS
Forty-five thrombectomy trials were performed (15 in each group). The average time required for thrombectomy in each group was 8 min 26 s, 11 min 0 s and 9 min 24 s, respectively (p=NS). Use of the Funnel was associated with significantly improved recanalization compared with stentriever alone (p<0.01). Use of the proximal Funnel resulted in a 25% increase in successful recanalization and a 20% reduction in distal emboli. Use of the distal Funnel resulted in a 200% increase in successful recanalization and a 60% reduction in emboli.


CONCLUSIONS
In this AIS embolism flow model with Solitaire thrombectomy, the Lazarus Funnel resulted in a significant increase in recanalization and significant reduction in distal emboli without increase in time to recanalization.
Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
Kyle M
KM
Fargen
Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA.
J
J
Mocco
Department of Neurosurgery, Weill Cornell Medical College, New York, New York, USA.
Y Pierre
YP
Gobin
D002560:Cerebrovascular Circulation / Q000502:physiology*; D006801:Humans; D066298:In Vitro Techniques; D020768:Middle Cerebral Artery; D008959:Models, Neurological; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D017131:Thrombectomy / Q000295:instrumentation*; D013923:Thromboembolism / Q000628:therapy*; D062666:Vascular Access Devices
Device; Embolic; Intervention; Stroke; Thrombectomy