Meta-Analysis of Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement

[...]randomized controlled trials (RCTs) that investigated the efficacy and safety of these devices have been underpowered for clinical end points.2–6 The Randomized Evaluation of Triguard 3 Cerebral Embolic Protection after Transcatheter Aortic Valve Implantation (REFLECT II) trial was recently presented at the Transcatheter Cardiovascular Therapeutics annual scientific meeting.7 Therefore, we performed an updated aggregate data meta-analysis of RCTs that evaluated EPDs during TAVR. In a previous real world observational study, involving more than 400 US academic centers, no difference in stroke rates were observed in patients who underwent TAVR with or without EPDs.8 The SENTINEL CEP device (Boston Scientific, Marlborough, Massachusetts) is the only EPD cleared by the US Food and Drug Administration based on surrogate effectiveness of capture of embolic debris in 99% of filters, and may reduce ischemic brain injury detected by diffusion-weighted magnetic resonance imaging.3 However, the clinical significance of embolic debris and new brain lesion on diffusion-weighted magnetic resonance imaging in patients who underwent TAVR is not firmly established. [...]the totality of the data does not support the use of EPDs in TAVR to reduce the risk of hard clinical end points such as death or stroke.