Abstract WMP2: A New Device to Prevent Embolization in New Territories During Mechanical Thrombectomy
Introduction: Embolic events can occur in up to 12% of cases of stent retriever thrombectomy and are associated with a 2-fold increase in mortality compared with cases without embolic complications. The COVER embolization protection device (Lazarus Effect, Campbell, California, USA) is a novel nitinol-braided mesh device that surrounds stent retriever (SR) devices and thrombus during thrombectomy to mitigate clot fragmentation and embolization.
Hypothesis: Our goal was to evaluate the performance of this new COVER device in mechanical thrombectomy procedures for ischemic stroke therapy.
Methods: We investigated the use of the Lazarus COVER device in combination with SR for mechanical thrombectomy. We report our initial experience including rates of target vessel recanalization and embolization in new territories (ENT). An independent core lab reviewed case images and films and adjudicated safety and efficacy endpoints. Thrombectomy procedures were initiated per standard approach. Once the SR was in place, the delivery microcatheter was removed. The Lazarus COVER device rapid exchange catheter was then delivered over the stent retriever pusher wire and advanced to the proximal end of the SR. The SR and Lazarus COVER were then pulled back as a system.
Results: In a total of 20 patients, 20 thrombectomy procedures were performed from March through June 2015. Large vessel occlusions concerned 9 M1, 8 M2, 2 M1/M2 and 1 tandem (ICA + M1). Five operators in 20 cases and 35 total deployments with SR devices deployed the Lazarus COVER device successfully. There were no device-related complications, adverse events or serious adverse events. A TICI 2b/3 was obtained in 95% of cases (19/20), TICI 2a in 1 case. Neither ENT nor angiographic vascular damage occurred. Three-month mRS was obtained in 15/20 patients to date (mean: mRS 2, range:0-6).
Conclusions: Application of the Lazarus COVER device when performing acute stroke thrombectomy with SR is feasible, appears to be safe, and may result in good successful recanalization rates with less embolic events.
Author Disclosures: M. Piotin: Honoraria; Modest; Penumbra. Ownership Interest; Modest; lazarus Effect. Consultant/Advisory Board; Modest; Medtronic, Stryker, Microvention. H. Redjem: None. G. Ciccio: None. S. Smajda: None. R. Blanc: Honoraria; Modest; Penumbra, General Electric. Ownership Interest; Modest; Lazarus Effect. Consultant/Advisory Board; Modest; Medtronic, Stryker, MIcrovention.
- © 2016 by American Heart Association, Inc.