Objectives

To compare the efficacy and adverse effects of two cerebral embolic protection devices versus a shared control group in reducing ischemic central nervous system injury during surgical aortic valve replacement.

Background

Improvements in surgical techniques and perioperative management have improved survival and quality of life for patients undergoing surgical aortic valve replacement (SAVR). However, concerns remain about the incidence of central nervous system (CNS) infarction, a serious complication of SAVR.

These concerns stimulated the development of cerebral embolic protection devices. At the time of this study, two devices were approved for use in the United States. One of the approved devices captures emboli with a heparin-coated polyester mesh filter. The other approved device extracts both particulate and gaseous emboli through suction-based extraction. Although these devices had been used in small trials, more rigorous data were needed on the value of cerebral embolic protection devices in reducing ischemic CNS injury documented by clinical and radiographic means. The CTSN-NP trial was initiated to evaluate the efficacy and adverse effects of these cerebral embolic protection devices among patients undergoing SAVR.

Participants

Patients aged 60 years or older undergoing SAVR for aortic stenosis with minimal or no deficits within 7 days of randomization according to the preoperative scores on the NIH Stroke Scale (NIHSS; score ≤1) and the modified Rankin Scale (score ≤2) were eligible to enroll. Key exclusion criteria included clinical stroke during the 3 months prior to randomization, cardiac catheterization, cerebral or aortic arch angiography within 3 days of planned SAVR, and active endocarditis.

A total of 383 patients were randomized. 118 patients were randomized to the suction-based extraction group, 133 patients to the intra-aortic filtration group, and 132 patients to the control group.

Design

The CTSN-NP study was a multicenter randomized clinical trial. Patients were randomized to receive the intra-aortic filtration device, the suction-based extraction device, or standard aortic perfusion cannula in a 1:1:1 ratio.

Patients were assessed at baseline and at postoperative days 1, 3, 7, 30, and 90. The NIHSS was used for neurological assessment. Quality of life (physical and mental subscales from the 12-Item Short-Form Health Survey) and cognition in 6 domains (verbal memory, visual memory, executive functioning, visuospatial or constructional praxis, attention, and information processing speed) were assessed at 90 days.

The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. The composite secondary end point was mortality, clinical ischemic stroke (including newly MRI-detected CNS infarcts associated with focal findings by the NIHSS before postoperative day 7), or acute kidney injury within 30 days after surgery.

Conclusions

Among patients undergoing surgical aortic valve replacement, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days.

Mack MJ, Acker MA, Gelijns AC, et al. Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017;318(6):536-547. doi:10.1001/jama.2017.9479

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