Safety and efficacy of cerebral embolic protection devices during TAVI: a meta-analysis and sequence analysis of trials.

What was studied

This review looked at devices that guard the brain during TAVI. TAVI is a valve implant done through a catheter. The devices aim to cut brain harm after the procedure. Their effect is controversial. The team pooled randomized trials. It looked at strokes, disabling strokes, TIAs, death and vascular complications. 11,589 patients were randomized. 5,943 used the devices. 5,646 did not. It also ran a trial sequential analysis.

What they found

Device use was not linked to fewer strokes of any kind. Disabling strokes were not clearly cut either. Odds ratios were 0.92 and 0.80. Death rates did not differ with device use. The sequential analysis found too little evidence on strokes. It found futility for lowering death.

What it means for patients

The authors say the data on the devices are not enough for firm stroke conclusions. They say the sequential analysis supports futility for lowering death.

Why it is not certain yet

The sample sizes needed for strokes were far above the data. They were 38,626 for all strokes and 59,732 for disabling strokes. The effect of devices on strokes remains unclear. The abstract names no other limits.

Source

Safety and efficacy of cerebral embolic protection devices during TAVI: a meta-analysis and sequence analysis of trials.

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