Debris captured by the dual-filter cerebral embolic protection device during transcatheter aortic valve replacement (TAVR) varied by TAVR device, according to new findings presented Aug. 25 at ESC Congress 2018 and simultaneously published in JACC: Cardiovascular Interventions.

Researchers analyzed captured debris from the Claret Sentinel cerebral embolic dual-filter protection device in 100 consecutive patients who were implanted with three different valve types: 1) Edwards Sapien 3 balloon-expandable device (N=42); 2) Medtronic Evolut R self-expandable device (N=35); and 3) the Boston Scientific Lotus mechanically implantable device (N=23). There was no difference in baseline data including STS score for mortality, calcification or predilation between the three groups.

Overall results found that the type of captured debris did not differ between the three valve types in the proximal or distal filter. However, researchers noted, significantly more patients in the balloon-expandable device group with large debris measuring ≥1000μm. Additionally, the total tissue area in the proximal filter was significantly smaller in mechanically implantable device group compared with the other two valve types. There were no differences in terms of total tissue area, particle sizes and number of particles with the distal filter.

Researchers did caution that their findings are based only on a single-center experience and 200 analyzed filters, so any findings should be considered hypothesis generating. They suggest that larger, randomized controlled trials are needed, particularly those that look at implantation technique, including predilation, postdilation, size of valve, and type of valve.

In a related editorial, Didier Tchetche, MD, and Chiara de Biase, MD, write that the findings from this latest study suggest "it is probably time to update our practice and protect the brain of our TAVI patients, independently of the type of [transcatheter heart valves] we use for the procedure." They note: "In anticipation of an expansion of TAVI indication to lower risk patients with greater life expectancy, stroke and its consequence should be prevented as much as possible. Currently, the extra-cost represented by CPD partly prevents their wider adoption. A first step could be to identify the patients at higher risk of stroke for a systematic use before a broader utilization."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: ESC18, ESC Congress, Transcatheter Aortic Valve Replacement

< Back to Listings