Patients with severe aortic stenosis (narrowing of the aortic valve) undergoing transcatheter aortic valve implantation (TAVI) benefited from using a cerebral protection device. The minimally invasive procedure repairs the old valve without removing the damaged valve. The cerebral protection device captures debris dislodged during the procedure and reduced the number and volume of brain lesions that resulted from the procedure.
This new information appeared in an August 9th issue of Journal of the American Medical Association (JAMA). The procedure wedges a replacement valve into the aortic valve’s place. Though the clinical outcomes of the procedure have improved significantly, the risk of stroke still remains a concern. Ischemic lesions are found in eighty percent of patients who undergo TAVI. Protection devices have been used, but their efficacy is unclear.
Researchers found 100 patients with severe aortic stenosis to undergo TAVI, one group with a cerebral protection device and one group without one. MRIs were performed at entry into the study, two days after the procedure, and seven days after.
After two days, researchers found the number of new lesions were less in the group with the cerebral protection device. The volume of new lesions were also less in the group with the cerebral protection device.
Adverse events during the study included one patient who died before the 30-day follow up. Life-threatening hemorrhages occurred in one patient in the control group and one in the experimental group. Major vascular complications occurred in five patients in the filter group and six in the control group. One patient in the filter group and five in the control group had acute kidney injury. Three patients in the filter group had a thoracotomy (a surgical incision into the chest wall.)
Larger studies are needed to assess the efficacy of a cerebral protection device in patients undergoing TAVI in order to devise more complete coverage of the brain to prevent new lesions.
Several of the study’s authors disclosed financial ties to pharmaceutical companies and medical device companies, including Claret Medical and Medtronic, who funded the study.