Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement

Abstract

IMPORTANCE Stroke is a major complication of surgical aortic valve replacement. OBJECTIVE To determine the effectiveness and safety of cerebral embolic protection devices in reducing ischemic central nervous system injury during surgical aortic valve replacement DESIGN, SETTING and PARTICIPANTS A parallel-group trial conducted in 18 North American centers, randomizing patients with calcific aortic stenosis undergoing surgical aortic valve replacement between March 2015 and July 2016. INTERVENTIONS Use of one of two cerebral embolic protection devices (suction-based extraction;n=118 or intra-aortic filtration device;n=133) versus a standard aortic cannula (n=132) at the time of surgical aortic valve replacement. MAIN OUTCOMES AND MEASURES The primary endpoint was freedom from clinical or radiographic central nervous system (CNS) infarction at 7±3 days post-procedure. Secondary endpoints included a composite of clinical ischemic stroke, acute kidney injury, and death ≤30 days after surgery; delirium; mortality; serious adverse events and neurocognition. RESULTS Among 383 randomized patients (mean age 73.9, 38.4% women), freedom from CNS infarction at 7 days did not differ between suction-based extraction and controls (32.0 vs. 33.3%,difference −1.3,95%CI−13.8, 11.2) nor between intra-aortic filtration and controls (25.6% vs 32.4%, −6.9,95%CI−17.9, 4.2). Clinical stroke occurred in 5.1% suction-based extraction vs 5.8% controls (−0.7, 95%CI −6.5, 5.1) and 8.3% intra-aortic filtration vs. 6.1% controls (2.2, 95%CI −4.1, 8.4). Delirium trajectories (baseline to day 7) differed for suction-based extraction vs. control (p= 0.03) and intra-aortic filtration vs. control (p=0.02); by day 7, 6.3% of suction-based extraction vs 15.3% of control patients (−9.1, 95%CI −17.1, −1.0), and 8.1% of intra-aortic filtration vs 15.6% of control patients (−7.4, 95%CI−15.5, 0.6) experienced delirium. The 30-day composite endpoint did not differ between suction-based extraction and controls (21.4% vs 24.2%; −2.8, 95%CI −13.5,7.9) nor between intra-aortic filtration and controls (33.3% vs 23.7%; 9.7, 95%CI −1.2,20.5). Neurocognitive outcomes were not different between groups except for less decline in executive function in intra-aortic filtration vs controls (p=0.05). CONCLUSIONS AND RELEVANCE The incidence of CNS infarction after surgical aortic valve replacement was not altered by either embolic protection device. Potential benefits for delirium reduction, cognition and symptomatic stroke merit larger trials with longer follow-up.

Cerebral embolic protection systems for transcatheter aortic valve replacement

“…More recently published data showed the opposite results with more favorable clinical outcomes after stroke following TAVR (Table ) . On the other hand, the evaluation of embolic protection during SAVR have shown a substantial number of debris captured in most patients with embolic protection device, without significant reduction in silent or clinical stroke at either 7 or 30 days . As many as 625 patients have been randomized across several clinical trials evaluating cerebral protection during TAVR .…”

“Not in my brain”: The use of embolic protection devices to prevent brain embolization during cardiovascular procedures

“…Identifier: NCT02389894), the use of cerebral EPD failed to demonstrate a decreased number of clinical or radiologic strokes after isolated surgical aortic valve replacement or combined aortic valve replacement and coronary artery bypass graft surgery. 6 The study demonstrated that although EDP captured embolic material in 74% to 99% of the patients, only 5% of patients have clinically apparent strokes even with a rigorous stoke adjudication process. Meanwhile, at least 70% of the patients had new ''bright lesions'' on dw-MRI, and their incidence was not different between the study and control groups.…”

“…Yet, these ''bright lesions'' on dw-MRI are unlikely to make anybody any brighter because their volume is correlated with worse neuropsychologic and cognitive outcomes. 6,7,9 Do you want them in your brain? I don't.…”

Understanding neurologic complications following TAVI

“…The trial was stopped early due to an interim analysis for futility. Though the devices captured debris in most patients, freedom from clinical or radiographic CNS infarction, the primary endpoint, was not observed 68. MoCA score of 26 as the threshold for impairment, impaired patients had higher total median lesion volumes (163.18 cm 3 ) compared to unimpaired patients (130.05 cm 3 ) 15.…”