Michael J et al. – This study evaluated the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during surgical aortic valve replacement (SAVR). The authors concluded that there was no significant reduction in the risk of CNS infarction at 7 days among patients undergoing SAVR with cerebral embolic embolism protection devices compared with a standard aortic cannula. Hence, larger trials with longer follow–up are required to demonstrate potential benefits of SAVR for reduction in delirium, cognition, and symptomatic stroke.

Methods

• Randomized clinical trial of patients (N = 383; mean age, 73.9 years) with calcific aortic stenosis undergoing SAVR at 18 North American centers (March 2015 to July 2016) with the end of follow–up in December 2016.
• 1 of 2 cerebral embolic protection devices were used (n = 118 for suction–based extraction and n = 133 for intra–aortic filtration device) versus standard aortic cannula (control n = 132) during SAVR.

Results

• Of the 96.1% patients who completed the trial, rate of freedom from CNS infarction at 7 days was 32.0% with suction–based extraction versus 33.3% with control (between–group difference, –1.3%; 95% CI, –13.8% to 11.2%) and 25.6% with intra–aortic filtration versus 32.4% with control (between–group difference, –6.9%; 95% CI, –17.9% to 4.2%).
• There was no significant difference in the 30–day composite end point between suction–based extraction and control (21.4% vs 24.2%, respectively; between–group difference, –2.8% [95% CI, –13.5% to 7.9%]), nor between intra–aortic filtration and control (33.3% vs 23.7%; between–group difference, 9.7% [95% CI,–1.2% to 20.5%]).
• Mortality was not significantly different between suction–based extraction versus control (3.4% vs. 1.7%) and intra–aortic filtration (2.3%) versus control (1.5%); a similar trend was reported with respect to clinical stroke (5.1% for suction–based extraction vs 5.8% for control; and 8.3% for intra–aortic filtration vs 6.1% for control).
• On post–operative day 7, delirium was 6.3% and 15.3% with suction–based extraction and control, respectively (between–group difference, –9.1%; 95% CI, –17.1% to –1.0%) and 8.1% and 15.6% with intra–aortic filtration and control, respectively (between–group difference, –7.4%; 95% CI, –15.5% to 0.6%).
• No significant difference was reported across the groups in mortality and overall serious adverse events at 90 days.
• Patients in the intra–aortic filtration group experienced significantly more acute kidney injury events and cardiac arrhythmias compared with patients in the control group (14 vs 4; P = .02, and 57 vs 30; P = .004, respectively).