Safety and Efficacy Data Presented for Keystone Heart's TriGuard Cerebral Protection Device in TAVR Procedures

September 19, 2016—Keystone Heart Ltd. announced the presentation of preliminary safety and efficacy data from real-world experience in 51 patients with the company's TriGuard cerebral embolic protection device when used during transcatheter aortic valve replacement (TAVR). The findings were discussed at the PCR London Valves 2016 conference held September 18–20 in London, United Kingdom.

According to the company, the results demonstrated a significant difference in the number of patients with brain lesions incurred during the TAVR procedure, with 68% of unprotected patients experiencing new lesions compared to only 20% of patients in whom the TriGuard embolic deflection device was used (P = .004). These findings were based on magnetic resonance imaging (MRI) evaluations of patients conducted by Joachim Schofer, MD, Professor, Hamburg University Cardiovascular Center and Department of Structural Heart Disease in Hamburg, Germany.

Alexandra J. Lansky, MD, commented in Keystone Heart’s announcement, “These data, together with previously reported positive safety and clinically meaningful outcomes, reinforce the importance of using TriGuard to protect the brain from damage potentially incurred during TAVR procedures.” Dr. Lansky is with the Division of Cardiology, Yale School of Medicine and Yale Cardiovascular Research Group in New Haven, Connecticut.

The aim of the study was to evaluate the safety and effectiveness of the TriGuard HDH embolic deflection device in protecting the brain from lesions during TAVR procedures compared to no cerebral protection, which is the current standard of care during these procedures in the United States and Europe. The TriGuard cerebral protection device is commercially available in Europe, but it is not yet commercially available in the United States.

As summarized by Keystone Heart, this real-world study was conducted by physicians at two institutions who enrolled a total of 51 patients undergoing TAVR (age, 80 ± 8 years; 51% men; logistic EuroSCORE, 12.6 ± 8.3) via either transfemoral (96%) or transapical (4%) access. 

Prof. Schofer enrolled 10 patients who were also tested with post-TAVR MRI using clinical criteria and were compared to 150 historical controls from the same institution. 

Peter R. Stella, MD, who is with the Department of Cardiology at University Medical Center Utrecht in Utrecht, The Netherlands, enrolled 41 patients.

Of the 51 patients protected by the TriGuard device in this study, none experienced strokes, and there was 100% successful device performance without interference during TAVR procedures.

In the MRI arm of the study, additional endpoints comparing unprotected historical controls versus protected patients demonstrated clear a improvement in the mean number of new lesions, (2.1 vs 0.06; P = .06), mean total lesion volume (206 mm³ vs 44 mm³; P = .08), and mean single-lesion volume (74 mm³ vs 15 mm³; P = .05).

The TriGuard cerebral protection device has been granted European CE Mark approval and is commercially available in Europe. In the United States, the device is currently available for investigational use only, advised Keystone Heart.