Cerebral protection device reduces post-TAVI lesions
medwireNews: Use of a cerebral protection device during transcatheter aortic valve implantation (TAVI) significantly reduces the number and volume of ischaemic cerebral lesions in patients with severe aortic stenosis, research shows.
The researchers are now calling for larger studies “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.”
The Claret Embolic Protection and TAVI (CLEAN-TAVI) trial randomly assigned 100 higher-risk patients with severe aortic stenosis to undergo TAVI with or without the Claret Montage Dual Filter System (Claret Medical Inc, Santa Rosa, California, USA), which covers both carotid arteries and the right vertebral artery.
Brain diffusion-weighted magnetic resonance imaging, performed on day 2 post-TAVI, showed that the median number of new lesions in potentially protected regions was significantly lower in the filter group than in the control group at four versus 10, while median new lesion volume was 242 mm3 versus 527 mm3, also a significant difference.
The significant differences remained at day 7, with three new lesions detected in potentially protected areas in the filter group, compared with seven in the control group, while new lesion volumes were 101 mm3 and 292 mm3, respectively.
Axel Linke (University of Leipzig, Germany) and co-researchers also observed similar significant effects for the whole brain, with the total numbers of new lesions at eight versus 16, and lesion volume at 466 mm3 versus 800 mm3 at day 2, in the filter and control groups, respectively.
Procedure-related complications were similar between the groups, with one patient in each experiencing life-threatening haemorrhages and five patients in the filter group and six in the control group having major vascular complications.
There were also five patients in each group with mild symptoms indicative of stroke at days 2 and 7. The researchers note, however, that study was not powered to assess differences in stroke rates between groups.
Writing in JAMA, Linke et al say that although post-TAVI neurological events can be delayed and have multifactorial aetiology, which may dilute the treatment effect of the filter, the notable difference between the groups in the primary endpoint underlines “the value of cerebral filter protection to prevent brain injury during TAVI.”
They caution, however, that “the results cannot be necessarily generalized to a broader patient population, other transcatheter heart valves, or a multicenter setting.”
Editorialists Steven Messé (Hospital of the University of Pennsylvania, Philadelphia, USA) and Michael Mack (The Heart Hospital Baylor Plano, Texas, USA) say that the findings “represent a compelling and encouraging start” but further work is needed to determine whether the reductions in lesions observed here “translates to a meaningful improvement in clinical outcomes.”
By Laura Cowen
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