Researchers at the University of Wisconsin (Madison, USA) conducted a prospective, multicenter clinical trial involving 324 consecutive participants with of carotid artery disease (CAD). The first 220 subjects underwent an embolic protection device (EPD) placement with the Emboshield Pro, a new large-diameter filter, while the second cohort underwent placement of an older EPD no longer manufactured. All were to be treated with a dedicated CAS with a tapered, small, closed-cell design, and were to be included in the long-term evaluation. Independent neurologic assessment was performed before placement and at 1 day, 30 days, and annually after CAS placement. The periprocedural composite end point included 30-day death, stroke, and myocardial infarction (DSMI).

The composite end point of DSMI in the first 220 participants who were treated with Emboshield Pro was 2.3%; three patients had a minor stroke (1.4 %), one had a major stroke (0.5%), and one had a myocardial infarction (0.5%), for an overall DSMI rate of 2.3%, the lowest rate of complications ever recorded for the procedure in similar multicenter, high-risk patient populations. When using the DSMI periprocedural composite end point plus ipsilateral stroke at up to 3 years for long-term evaluation, the complication freedom rate was 95.4%, with an annualized ipsilateral stroke rate of 0.4%. The study was published early online on January 5, 2012, in the Journal of Vascular Surgery.

“Recent improvements in devices designed specifically for carotid artery stenting have resulted in safer procedures and better clinical outcomes. These technological advances, combined with a stronger understanding of patient risk factors, have also improved our ability to select which patients are best suited for the less invasive procedure,” said lead author Jon Matsumura, MD, head of the division of vascular surgery. “This is very good news for high-risk patients suffering with carotid artery disease, who only a decade ago had limited treatment options and poor long-term outcomes.”

The Emboshield Pro, a product of Abbott Vascular (Abbott Park, IL, USA), is designed to be more radiopaque than its predecessor, the Emboshield Embolic Protection System, providing better visibility during X-ray angiography. The device’s shorter length and enhanced profile are intended to allow it to cross tighter blockages and be delivered more easily in patients with challenging carotid anatomies. The Emboshield Pro also features Barewire, a proprietary technology that allows the filter to remain stable during the normal guide wire movements that occur during device exchanges in carotid procedures.

Related Links:
University of Wisconsin
Abbott Vascular