First-in-Human Use of the Next-generation ProtEmbo Cerebral Embolic Protection System During Transcatheter Aortic Valve-in-valve Implantation

Abstract

Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm³) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.

Keywords: Aortic valve stenosis; embolic protection; transcatheter aortic valve implantation (TAVI); valve-in-valve.