Cerebral Protection in TAVR: Studies Presented at London Valves

• SENTINEL

One of the new devices assessed at London Valves was Sentinel, which is made up of two independent filters. The larger filter is deployed in the brachiocephalic trunk, and the smaller filter is deployed in the left common carotid artery. The study included 22 patients and the device was deployed successfully in 20 of them (in the two remaining patients, tortuosity of the brachiocephalic artery prevented filter placement).

Macroscopic debris was observed in filters in 17 patients (77%). There were no strokes or transient ischemic attacks within the first 48 hours after the procedure, neither bleeding nor vascular complications related to the device.

• CLEAN TAVI

One of the largest studies on cerebral protection was CLEAN-TAVI, first presented at the TCT 2014 congress, with subsequent analyses and data registry. Patients who presented stroke while using the device showed reduced cerebral damage and lower new magnetic resonance imaging (MRI) volume than those who did not use it.

• DEFLECT III

These results are similar to those observed in the DEFLECT III trial, which also showed improvements in cognition after transcatheter aortic valve replacement (TAVR).

This could probably be explained by better ejection fraction and better perfusion of the brain after TAVR despite new lesions observed on magnetic resonance imaging. The effect of these new lesions in the long-term is still unclear, but, in the short term, many studies have associated them with postoperative delirium.

A reduction in the rates of delirium is important, since this condition is associated with longer hospital stays and increased mortality.

• OTHER STUDIES

-A study of 217 patients presented at EuroPCR showed debris trapped in the filter in 99% of patients after valve implantation.

Despite that, the expert panel at London Valves continuously highlighted the fact that no study has shown by means of definitive evidence that cerebral protection systems reduce clinical events during TAVR. Using them in all patients would, undoubtedly, increase procedural complexity and costs, and nobody knows which patients would be adequate for these devices.

-Another related study made an attempt to assess the effect of TAVR without cerebral protection on cognitive function using a battery of tests, including the mini mental state examination. Surprisingly enough, despite new cerebral ischemic lesions on imaging, results did not change at 3 and 6 months. Some patients actually showed functional improvement, for example, in immediate recall memory after their procedure.

Original title: Cerebral Protection in TAVR: New Insights, New Questions as First Device Seeks FDA Approval.

Reference: PCR London Valves 2016. London, England.

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