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Cerebral protection device reduces brain injury after TAVR
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Patients who underwent transcatheter aortic valve placement with a cerebral protection device had a reduction in the frequency of ischemic cerebral lesions compared with patients in whom the cerebral protection device was not used, according to data from the CLEAN-TAVI trial published in JAMA.
The primary endpoint — difference in new positive brain lesions on diffusion-weighted MRI at 2 days after TAVR — was higher in the group that did not receive cerebral protection compared with those in whom the device (Claret Montage Dual Filter System, Claret Medical Inc.) was used. The mean number of new positive brain lesions was 4 in the filter group (interquartile range [IQR], 3-7.25) vs. 10 in the control group (IQR, 2-8; P < .001 for comparison).
Results of the CLEAN-TAVI trial were initially presented at TCT 2014.
The trial enrolled 100 high-risk patients with severe aortic stenosis. All patients were undergoing TAVR at the University of Leipzig Heart Center, with brain MRI performed at baseline, 2 days and 7 days following TAVR. The patients had a mean age of 80 years.
According to other data published in JAMA, new lesion volume after TAVR was higher in the control group (527 mm3 vs. 242 mm3; P = .001).
One patient in the control group died within 30 days. One patient in each group had life-threatening hemorrhages. Six patients in the control group and five in the filter group experienced major vascular complications. Five patients in the control group and one in the filter group developed acute kidney injury. Thoracotomy was required in three patients in the filter group, according to the published study.
“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,” Stephan Haussig, MD, from the University of Leipzig Heart Center, and colleagues wrote in JAMA.
The results of the CLEAN-TAVI trial demonstrate two important points, Steven R. Messé, MD, from the University of Pennsylvania, and Michael J. Mack, MD, from the Heart Hospital Baylor Plano, Texas, wrote in a related editorial.
“First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with [TAVR]. In this trial, acute lesions on MRI were present in virtually all patients enrolled, although the vast majority of these lesions were quite small. Second, use of an embolic protection device can successfully reduce cerebral infarct number and volume. Whether that reduction translates to a meaningful improvement in clinical outcomes will require more study, but the findings represent a compelling and encouraging start,” they wrote.
Disclosure: Several researchers report financial ties with Claret Medical Inc. Please see the full study for a list of the researchers’ relevant financial disclosures. Mack reports receiving grant support as co-principal investigator of the PARTNER 3 study and as local principal investigator of the NIH-sponsored CT Surgery Network. Messé reports financial ties with GlaxoSmithKline and the NIH on studies of embolic protection devices for surgical AVR and neurological/cognitive outcomes for patients undergoing surgical AVR.
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