Cerebral embolic protection during transcatheter aortic valve replacement |  NEJM

Cerebral embolic protection during transcatheter aortic valve replacement | NEJM

Summary

Background

Transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis may result in debris embolization. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.

Methods

We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary endpoint was stroke within 72 hours of TAVI or before discharge (whichever comes first) in the intention-to-treat population. Disabling strokes, death, transient ischemic attacks, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all patients at baseline and after TAVI.

Results

A total of 3,000 patients in North America, Europe and Australia were randomized; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVI or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; range 95% confidence, -1.7 to 0.5; P=0.30). Disabling strokes occurred in 0.5% of patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% versus 0.3%); had a stroke, transient ischemic attack or delirium (3.1% versus 3.7%); or had acute kidney injury (0.5% versus 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.

conclusion

Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural strokes, but based on the 95% confidence interval around this result, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)

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