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Cerebral Protection Device Effects on Brain Lesions After TAVR
Study Questions:
Does the use of a cerebral protection device affect the number and volume of cerebral lesions among patients undergoing transcatheter aortic valve replacement (TAVR)?
Methods:
In CLEAN-TAVI, an investigator-initiated, single-center, blinded, randomized clinical trial of higher-risk patients with severe aortic stenosis undergoing TAVR; brain magnetic resonance imaging (MRI) was performed at baseline, 2 days, and 7 days after TAVR; and blinded neurological testing was performed at 2 days and 7 days post-procedure. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVR with a cerebral protection device (Claret Montage Dual Filter System [Claret Medical, Inc.] filter group) or without a cerebral protection device (control group). The primary endpoint was the numerical difference in new positive post-procedure diffusion-weighted MRI (DWMRI) brain lesions at 2 days after TAVR in potentially protected territories; the secondary outcome was the difference in volume of new lesions after TAVR in potentially protected territories.
Results:
Among the 100 enrolled patients, mean age was 80.0 ± 5.1 years in the filter group (n = 50) and 79.1 ± 4.1 years in the control group (n = 50); the mean logistic EuroScores were 16.4 ± 10.0% in the filter group and 14.5% ± 8.7% in the control group. The number of new lesions was lower in the filter group (4.00, interquartile range [IQR 3.0-7.3] vs. 10.0 [IQR 6.8-17.0] in the control group; difference 5.0 [IQR, 2.0-8.0]; p < 0.001). New lesion volume after TAVR also was lower in the filter group (242 mm3; 95% confidence interval [CI], 159-353) versus in the control group (527 mm3; 95% CI, 364-830; difference 234 mm3; 95% CI, 91-406; p = 0.001). At 2 and 7 days, the number of patients with neurological symptoms indicative of stroke was five in the filter group and five in the control group; all were minor and nondisabling. Considering adverse events, one patient in the control group died prior to the 30-day visit; life-threatening hemorrhage occurred in one patient in the filter group and one in the control group; major vascular complications occurred in five patients in the filter group and six patients in the control group; one patient in the filter group and five in the control group had acute kidney injury; and three patients in the filter group underwent thoracotomy.
Conclusions:
Among patients with severe aortic stenosis undergoing TAVR, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. The authors suggest that larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVR, and to devise methods that will provide more complete coverage of the brain to prevent new lesions.
Perspective:
Although the rate of neurological events complicating TAVR is decreasing as a function of device evolution and operator experience, it remains a serious risk of the procedure. This single-center, blinded study revealed fewer and smaller MRI abnormalities when TAVR was performed in conjunction with a cerebral protection filter, although clinical neurological events did not differ.
Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Cognition, Embolic Protection Devices, Geriatrics, Heart Valve Diseases, Magnetic Resonance Imaging, Neurologic Manifestations, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement
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