New Embolic Protection Device promising in providing embolic protection during TAVR Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is a life-saving procedure for patients with aortic valve disease, but it comes with certain risks, including the potential for embolic complications like stroke.

Researchers have found in a new study that the Captis full-body embolic protection system successfully collected a lot of debris from transcatheter aortic valve replacement. It is promising in providing embolic protection during TAVR.

The study was published in EuroIntervention by Danenberg H. and colleagues. The study aimed to investigate the safety, feasibility, and debris-capturing ability of the CAPTIS complete cerebral and full-body embolic protection system during TAVR. The researchers enrolled 20 patients who underwent TAVR using either balloon-expandable or self-expanding valve systems. The primary endpoints were device safety and cerebrovascular events at 72 hours post-procedure.

The results were promising. The CAPTIS device was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR procedures were completed without device-related complications. Most importantly, no cerebrovascular events were observed among the patients who received TAVR with CAPTIS. Additionally, the device effectively captured a significant number of debris particles during the procedures.

This first-in-human study of the CAPTIS embolic protection system during TAVR demonstrated both safety and efficacy. The device successfully prevented cerebrovascular events and captured debris, which could potentially reduce the risk of stroke and other embolic complications in TAVR procedures.

The findings suggest that the CAPTIS device holds promise as a valuable tool to enhance the safety of TAVR. However, further research is needed to confirm its efficacy. A randomized clinical trial is warranted to provide more comprehensive data on the device's impact on patient outcomes during TAVR procedures.

Reference:

Danenberg, H., Vaknin-Assa, H., Makkar, R., Virmani, R., Manevich, L., Codner, P., Patel, V., Finn, A. V., Landes, U., Rubinshtein, R., Bar, A., Barnea, R., Mezape, Y., Teichman, E., Eli, S., Weisz, G., & Kornowski, R. (n.d.). First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement,2023. Pcronline.com. https://doi.org/10.4244/EIJ-D-23-00465