Initial results of a first-in-human study on the PlasmaWire™ System, a new radiofrequency wire for recanalization of chronic total occlusions

Abstract

Objectives: To examine the safety, efficacy, and efficiency of the PlasmaWire^TM System to recanalize coronary chronic total occlusions (CTO) using controlled ablation inside the CTO.

Background: The PlasmaWire^TM System is a new bipolar radiofrequency (RF) wire system utilizing plasma-mediated ablation to facilitate wire crossing in CTOs. Two independent PlasmaWire^TM wires are used in tandem for channel creation by applying RF energy between the tips so as to localize the ablation.

Methods: Prospective, nonrandomized, single-arm, multicenter study in seven patients with CTOs indicated for percutaneous coronary intervention (PCI).

Results: In this study, both wires were antegradely delivered to the distal end of CTO for antegrade re-entry in two cases and bidirectionally (antegrade and retrograde) delivered to the CTO for retrograde re-entry in five cases. In all cases, channel creation was achieved within a few seconds and was confirmed on angiogram or intravascular ultrasound (IVUS) and CTO recanalization was successfully achieved without any major adverse cardiac and cerebrovascular events (MACCE) or other minor complications. The clinical follow-up showed no clinical event at 1 month.

Conclusions: The PlasmaWire^TM System was shown to be safe and effective in obtaining CTO recanalization through a re-entry channel utilizing plasma-mediated ablation while reducing procedure time. The PlasmaWire™ System is a new bi-polar RF wire system utilizing plasma-mediated ablation for channel creation to facilitate CTO recanalization. This first-in-human study in which seven patients were enrolled was conducted to demonstrate the safety, efficacy, and efficiency of this system for CTO recanalization. Channels through the CTOs were successfully created within a few seconds by applying RF energy between the tips of two independent PlasmaWire^TM wires and recanalization was achieved in all cases without any complication. The PlasmaWire^TM System may safely facilitate CTO recanalization with less vessel injury and improve initial results of CTO PCI while reducing procedure time.

Keywords: ablation; catheter/cryoblation/RF; coronary artery disease; new devices (in general); percutaneous coronary intervention.