Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial
Dariusz Jagielak, Radosław Targoński, Christian Frerker, Mohamed Abdel‐Wahab, Johannes Wilde, Nikos Werner, Michael Lauterbach, Juergen Leick, Marek Grygier, Marcin Misterski, Andrejs Ērglis, Inga Narbute, Adam Ryszard Witkowski, Matti Adam, Derk Frank, Fernando Gatto, Tobias Schmidt, Alexandra J. Lansky
Abstract
BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: . There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).