A study published in the American Journal of Cardiology indicates that 94% of patients have evidence of new brain lesions after undergoing transcatheter aortic valve implantation (TAVI). According to a press release from Keystone Heart, this supports the potential need for their cerebral protection device TriGuard.
The press release reports that the observation study, conducted in five studies across the USA, evaluated 44 consecutive patients who had undergone TAVI and findings demonstrated:
- An average of at least 10.4 new lesions per patient with a mean of 295mm3 (71.6 to 799.6mm3) total lesion volume was seen among the 34 patients evaluated with DWI-MRI post-TAVI
- 3% of these patients (n=34) experienced an ischaemic stroke, as defined by Valve Academic Research Consortium (VARC) 2 definitions at 30 days post-TAVI
- Neurologic impairment, based on a worsening National Institutes of Health Stroke Scale (NIHSS), accompanied by DWI-MRI-documented cerebral infarction, was detected in 22.6% of patients undergoing DW-MRI (n=34) at discharge and in 14.8% at 30 days
- Systematic use of serial NIHSS evaluation in all patients undergoing DW-MRI uncovered additional neurologic deficits in 16% of patients before discharge
- 4% of patients had worsening of scores when evaluated by National Institutes of Health Stroke Scale (NIHSS) or Montreal Cognitive Assessment (MoCA) prior to discharge, and 40.7% of patients at 30 days
- 33% of all patients (n=44) had a worsening MoCA score from baseline to discharge and a 41% worsening to 30 days.
- A consistent decrease in cognitive measures was found in 20% to 56% of all patients (n=44) at 30 days compared to pre-TAVR baseline, based on paper and pencil neuropsychological testing.
Additionally, the press release reports that the results may underestimate the true degree of cognitive decline because patients with larger cerebral infarctions were less likely to complete subsequent cognitive assessments, according to study authors.
“These data underscore the wide spectrum of neurologic injury after TAVI and emphasise the critical need for meaningful standardised assessment methods and definitions – that incorporate neurology expertise – in reporting neurologic outcomes in clinical trials” says lead author Alexandra Lansky (Yale University School of Medicine, USA).