The SENTINEL trial was the first large-scale randomized controlled trial to evaluate embolic protection devices for the reduction of stroke during TAVR. The Sentinel transcatheter cerebral embolic protection (TCEP) device is a transradial basket-filter device positioned in the right brachiocephalic and left carotid arteries to prevent emboli to the cerebral circulation. The trial randomized 363 patients under-going transfemoral TAVR to a safety arm (n=123), device imaging arm (n=121), and control imaging arm (n=119). The primary safety endpoint of major adverse cardiac and cerebrovascular events (MACCE) at 30-days was not different between the TCEP (7.3%) and control (9.9%) was not statistically significant (p=0.41). There was no statistical difference between new brain lesion volume on MRI (p=0.33) between the TCEP (178.0 mm3) and control imaging arms (102.8 mm3). Clinical strokes at 30 days occurred in 9.1% of control subjects and 5.6% of patients treated with TCEP (p=0.25). There were no differences in neurocognitive function in control subjects and treated subjects. Debris was found in 99% of explanted devices and consisted of a wide variety of material; thrombus, calcification, valve tissue, artery wall, myocardium, and foreign material.
PROTECTED TAVR is a large randomized clinical trial evaluating the use of the Sentinel embolic protection device during transfemoral TAVR for the reduction of peri-procedural strokes at 72 hours. The primary endpoint is the rate of all strokes a 72 hours post-procedure. Key inclusion criteria include suitable transfemoral anatomy, suitable brachiocephalic and left common carotid artery anatomy for Sentinel placement, and absence of bleeding disorders. The study is planned for 3000 subjects and anticipates enrollment completion in June 2022.
REFLECT is a randomized controlled trial involving the use of the TriGuard embolic protection device for the prevention of embolic strokes during transfemoral TAVR. TriGuard is a mesh barrier positioned in the aortic arch via a femoral approach that covers the ostia of the right brachiocephalic, left carotid, and left subclavian, thus covering all vessels with cerebral perfusion. The trial will have a primary safety combined endpoint of all-cause mortality, all stroke, bleeding, acute kidney injury, coronary obstruction, vascular complication, and valve related dysfunction. The primary efficacy endpoint is a hierarchical composite endpoint of all-cause mortality or any stroke, worsening cognitive function, or total volume of cerebral ischemic lesions. The study was planned for 478 subjects and has completed enrollment.