TAVR: Study shows benefit of Claret Medical’s Sentinel cerebral protection device

A study released this week reported that the use of Claret Medical‘s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions.

The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The Journal of the American Medical Association.

“First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with TAVI. 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,” study authors wrote.

Data from the 100-patient trial indicated that the number of new brain lesions after the TAVI procedure was lower in the cerebral protection filter group than in in the control group, with new lesion volume at 242 mm3 in protected patients versus 527 mm3 in the control.

A single patient in the control group died prior to a 30-day follow up visit, and life-threatening hemorrhages occurred in 1 patient in each group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. A single patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy.

“Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions,” study authors wrote.

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