First-in-Man Study Shows Embolic Debris Capture In >50% Of TAVI Patients Using Claret Filter

In short

The use of a cerebral embolic protection device dur­ing transcatheter aortic valve implantation (TAVI) system is feasible and safe, according to a study published in EuroIntervention.

Background

Last November we covered the news that Claret Medical had gained CE mark approval for its second generation Montage Embolic Protection system for use during Transcatheter Aortic Valve Intervention(TAVI). Now we report on the first-in-man experience of the original version, the CE Pro cerebral protection device, which has been reported by Christoph K Naber, Contilia Heart and Vascular Center, Elisabeth Krankenhaus Essen, Essen, Germany, and Alexander Ghanem, Department of Medicine/Cardiology, University of Bonn, Bonn, Germany.

Patients scheduled for TAVI were prospectively enrolled at three centres (Essen, Bonn and Sao Paulo, Brazil). The Claret CE Pro cerebral protection device was placed via the right radial/brachial artery prior to TAVI and was removed after the procedure. The primary endpoint was technical success rate. Secondary endpoints encompassed procedural and 30-day stroke rates, as well as device-related complica­tions.

Deployment of the Claret CE Pro cerebral protection device was intended for use in 40 patients, 35 devices were implanted into the aortic arch. Technical success rate with delivery of the proximal and distal filter was 60% for the first generation device and 87% for the second-generation device. Delivery times for the first-generation device were 12.4±12.1 minutes and 4.4±2.5 minutes for the second-generation device (p<0.05). The quantity of contrast used related to the Claret CE Pro System was 19.6±3.8ml. Captured debris was docu­mented in at least 19 of 35 implanted devices (54.3%).

No procedural transient ischaemic attacks, minor strokes or major strokes occurred. Thirty-day follow-up showed one minor stroke occurring 30 days after the procedure, and two major strokes both occurring well after the patient had completed TAVI.

Investigator comments

The authors wrote that capture of debris “in more than half of the patients provides evidence for the potential to reduce the procedural cerebral embolic burden utilising this dedicated filter system during TAVI.”

To see a video of the procedure, visit the company’s website here.

Source: Claret Medical Inc., Cardiovascular News International