The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device.

Abstract

INTRODUCTION:

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.

• Authors: Kyle M Fargen, J Mocco, Y Pierre Gobin
• Journal: Journal of neurointerventional surgery (J Neurointerv Surg) Vol. 8 Issue 1 Pg. 66-8 (Jan 2016) ISSN: 1759-8486 [Electronic] England
• PMID: 25378638 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Topics

• Cerebrovascular Circulation (physiology)
• Humans
• In Vitro Techniques
• Middle Cerebral Artery
• Models, Neurological
• Prospective Studies
• Single-Blind Method
• Stents
• Thrombectomy (instrumentation)
• Thromboembolism (therapy)
• Vascular Access Devices