Transcatheter embolic protection was safe and did not change neurocognitive function during transcatheter aortic valve replacement (TAVR), according to the results of the SENTINEL Trial presented Nov. 1 at TCT 2016 and simultaneously published in the Journal of the American College of Cardiology.

Samir R. Kapadia, MBBS, FACC, et al., conducted a randomized study of 363 patients with severe symptomatic aortic stenosis undergoing TAVR at 19 centers to evaluate the safety and efficacy of transcatheter embolic protection during TAVR. Patients were randomized into groups for safety (n=123), device imaging (n=121) or control imaging (n=119). The primary safety endpoint was major adverse cardiac and cerebrovascular events at 30-days, while the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on MRI scan at two to seven days.

The results of the study showed that transcatheter embolic protection captured embolic debris in 99 percent of patients undergoing TAVR. Major adverse cardiac and cerebrovascular events at 30-days were non-inferior to the performance goal (7.3 vs. 18.3 percent respectively), and not statistically different from the control (9.9 percent). The authors note that “although neurocognitive function was similar in control and device patients, there was correlation between lesion volume and neurocognitive decline.”

In an accompanying editorial comment, Azeem Latib, MBBCH, FACC, et al., state that “from a logical standpoint, a device that captures cerebral embolic material in 99 percent of cases should prevent ischemic injury of the brain, yet the data from this randomized trial does not appear to support routine cerebral protection with the Sentinel device. However, in our opinion, it would be inappropriate and unfair to close the book on cerebral protection after this chapter.”

They add that “in order to reconnect what logically makes sense with supportive clinical data, larger randomized studies showing not only significant reductions in diffusion-weighted MRI lesions, but also evidence of benefit as regards to neurocognitive dysfunction, will be required.”

Keywords: Transcatheter Cardiovascular Therapeutics, Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement, Diffusion Magnetic Resonance Imaging, Embolism, Intracranial Embolism, Magnetic Resonance Imaging

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