Pooled Analysis Supports Keystone Heart's TriGuard Cerebral Protection Device in TAVR Procedures

May 23, 2016—Keystone Heart, Ltd. announced the presentation of a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter aortic valve replacement (TAVR) in the United States and Europe. Alexandra J. Lansky, MD, presented the analysis at the EuroPCR 2016 conference held May 17–20 in Paris, France. Dr. Lanksy is from the Division of Cardiology at Yale School of Medicine and Yale Cardiovascular Research Group in New Haven, Connecticut.

The company advised that the findings further corroborate that TriGuard protection significantly reduces the stroke rate, lowers central nervous system (CNS) infarction, and reduces total lesion volume without adversely impacting the safety of the TAVR procedure. 

The aim of the analysis was to evaluate the safety and effectiveness of the TriGuard cerebral protection device compared to no protection. 

The patient-level data were pooled from three studies that included a total of 142 patients undergoing TAVR with TriGuard protection (n = 59) versus no protection (n = 83). The trials (DEFLECT I, DEFLECT III, and Neuro TAVR) evaluated neurologic complications with and without cerebral protection during TAVR. All three trials mandated predischarge diffusion-weighted magnetic resonance imaging (DW-MRI) and performed serial neurologic assessments using the same methods and core laboratories.

Keystone Heart reported that TriGuard protection significantly reduced in-hospital Valve Academic Research Consortium-2–defined stroke (0% vs 6%; P = .05) and the rate of stroke, as defined by worsening National Institutes of Health Stroke Scale (NIHSS) with DW-MRI lesions (0% vs 19%; P = .002). 

Additionally, TriGuard-protected patients showed higher absence of CNS infarction (28% vs 8%; P = .008), and total lesion volume was reduced significantly with TriGuard versus no protection (315 + 620 mm³ vs 511 + 893 mm³; P = .04). None of the TriGuard-protected patients had worsened NIHSS score, as compared with 17.1% of the patients without protection (P = .001).

The investigators concluded that these clinically meaningful outcomes demonstrate the importance of using TriGuard and the potential consequences of unprotected procedures, advised Keystone Heart.