Catheter-based system for the treatment of left ventricular assist device thrombosis

Abstract

Background: Thrombotic complications continue to pose challenges to patients on left ventricular assist device (LVAD) support. The Hoplon system was developed to administer catheter-based lytic therapy with a novel approach to embolic protection.

Methods: Two porcine non-survival surgeries were performed in which off-pump LVAD insertion was followed by injection of thrombus into the impeller, isolation of the pump using the Hoplon system, and administration of lytic therapy to the pump chamber. Successful thrombus resolution was confirmed by pathological examination of the LVAD and brain tissue after animal sacrifice.

Results: Limitations of the prototype design resulted in the extrusion of thrombus from around the catheter in the first animal. Subsequent device modifications resulted in the resolution of LVAD thrombus as confirmed on removal and examination of the pump. Pathological examination of the brain tissue revealed the absence of any embolic or hemorrhagic complications.

Conclusions: Early animal studies suggest feasibility in restoring function to an LVAD while at the same time preventing cerebroembolic events using the Hoplon system.

Keywords: Food and Drug Administration; Interagency Registry for Mechanically Assisted Circulatory Support; cerebrovascular accident; heartware ventricular assist device; left ventricular assist device; revolutions per minute.