New cerebral lesions detected with magnetic resonance imaging (MRI) are reported in 67-100% of patients after transcatheter aortic valve implantation (TAVI)1. Large population-based studies associate such MRI lesions with cognitive decline, stroke, and mortality2. The embolisation of debris originating from the aortic root and arch are considered responsible for most periprocedural lesions; hence, cerebral embolic protection (CEP) devices were developed to capture/deflect debris en route to the cerebral circulation.
The PROTEMBO C Trial was an international, multicentre, single-arm trial evaluating the safety and feasibility of the ProtEmbo (Protembis GmbH) CEP system, compared to historical controls (non-inferiority). The COVID-19 pandemic interrupted the PROTEMBO C Trial, and interim results were reported3. This correspondence reflects the final presentation of the results from the completed study in compliance with the original study protocol.
Patients with symptomatic severe aortic stenosis undergoing transfemoral TAVI were eligible for inclusion. The primary safety endpoint was the incidence of major adverse cardiac and cerebrovascular events (MACCE) at 30 days and was compared to a performance goal (PG) of 25%, derived from historical data. A sample size of 60...
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