Background: Use of Embolic Protection Devices (EPDs) during Percutaneous Coronary Intervention (PCI) of occluded SVGs dramatically decreases the risk of distal embolization, no-reflow, and Major Adverse Coronary Events (MACE). Performance of the WIRION System when used during carotid artery stenting is presently evaluated in a pivotal FDA clinical trial. Interim results are very encouraging.
Aim: To evaluate for the first time the performance of the WIRION EPD during PCI of SVGs.
Methods and Results: WIRION™ is a temporary distal EPD. The device consists of a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wire and a dedicated retrieval catheter.
The WIRION™ remotely activated filter-locking mechanism allows the stand-alone filter unit to be positioned in any location along the vessel on the guide wire.
Like any interventional vascular device and for the first time in EPDs, the filter-locking mechanism enables standard vessel engagement with a bare guide wire prior to locking the filter. This enables increased ease of use and deliverability.
Data was collected prospectively in 10 patients who underwent SVG intervention with the WIRION System in two medical centers. Lesion length was ≥15cm in 50% of the patients; thrombi were seen in 30%. Moderate to severe tortuosity was found in 30% of treated vessels. Average stenosis rate was 78%; mean baseline TIMI grade flow was 2.7.
Filter was successfully deployed in all patients. In one case a retrieval catheter failure occurred requiring the use of an alternative retrieval catheter. Angiographic success was obtained in all patients with mean residual stenosis of 3%. No MACE including death and myocardial infarction occurred in any patient during the 30-days follow-up period.
Conclusions: Our study in a small patient cohort suggests that the use of WIRION EPD for SVG revascularization is safe and feasible even in challenging anatomies.
