With neurologic events a persistent problem in transcatheter aortic valve replacement (TAVR) and preliminary studies showing some success with the first generation TriGUARD HDH cerebral embolic protection device in reducing measures of cerebral ischemic lesions, findings from the REFLECT II trial presented Oct. 15 during TCT 2020 suggest the new generation TriGUARD 3 (TG3) device is safe in comparison with historical TAVR data. However, the study did not demonstrate superiority of TG3 compared to historical pooled data.

Jeffrey W. Moses, MD, FACC, et al., evaluated the safety of the new TG3 device, along with its efficacy, in reducing clinical events and cerebral lesions during TAVR. Patients from 25 sites in the U.S. with severe native aortic valve stenosis and with planned transfemoral treatment with an U.S. Food and Drug Administration-approved TAVR system were included. Of the 179 patients enrolled, 58 were randomized to the control group.

Overall, the trial met the primary composite safety endpoint, demonstrating that the TG3 device was safe compared with historical TAVR data (15.9% vs. 7.0%; p=0.11). Researchers found that the primary 30-day safety endpoint was higher with the TG3 device, primarily due to TAVR-related vascular complications. They also highlight a post hoc DW-MRI analysis suggesting that TG3 may reduce larger ischemic lesions.

The authors note that further studies are currently in progress which might help further the hypothesis that “improved device stability to achieve reliable, complete cerebral coverage might improve outcomes.”

“Moving forward, adequately powered randomized trials are still needed to demonstrate a clinical benefit of embolic protection devices in TAVR,” said Deepak L. Bhatt, MD, MPH, FACC, senior associate editor of ACC.org Clinical Trials and News.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement

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