1066 THE USEFULNESS OF CEREBRAL PROTECTION DURING TAVR: A METANALYSIS

Abstract

Abstract Introduction although transcatheter aortic valve replacement (TAVR) represents a milestone in the treatment of degenerative aortic stenosis, stroke remains an important complication compared to surgical aortic valve replacement (SAVR). Multiple magnetic resonance imaging (MRI) studies demonstrated a substantial rate of new cerebral ischemic lesions after TAVR. In order to avoid debris passage into the circulation and to prevent procedure-related embolic stroke, cerebral embolic protection (CEP) devices were developed. However, their safety and efficacy remain controversial. Very recently, new studies provided additional evidence on this topic. Aim to assess the entire body of evidence from randomized controlled studies about neurological outcomes after TAVR. Materials and Methods a systematic meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched MEDLINE, Scopus, and Google Scholar for randomized controlled studies. The following keywords were used for the search: “transcatheter aortic valve implantation” or “stroke prevention” or “embolic protection” and “cerebral protection”. Study groups were defined as a the “CEP group” and the “control group”. Non-randomized studies reporting outcomes with cerebral embolic protection (CEP) during TAVR were excluded to reduce the selection and confounding bias of observational pilot studies. The primary outcome was post-procedural stroke. Secondary outcomes included total lesion volume on MRI and new ischemic lesions on MRI. Results nine trials including 4077 patients were eligible for analysis and included to the meta-analysis. Of those, 2203 patients were randomized to cerebral embolic protection and 1874 patients to control group. Despite the rate of post-procedural stroke was higher in the CEP arm (2.27%) compared to the control arm (2.87%, p<0.001), the use of cerebral embolic protection was not associated with a significantly lower risk of stroke (OR=0.82, 95% CI 0.59-1.15; p=0.255). Cumulative meta-analysis revealed a trend towards a lower impact on stroke prevention with more recent trials. Conclusions use of cerebral embolic protection devices during TAVR is a safe procedure. However, the current outline of results from all randomized controlled trials available does not support its routine use, as no significant reduction of stroke risk was evident. The use of these devices might be considered in selected high-risk patients, such as in the setting of heavy calcified cusps or atherosclerotic aortic lesions.