Cerebral embolic protection during transcatheter aortic-valve replacement.

methods

We randomly assigned patients with aortic stenosis to undergo transfemoral TAVR at a 1:1 ratio with or without CEP (CEP group) or CEP (control group). The primary end point was stroke in the intended-to-treat population within 72 hours after TAVR or before discharge (whichever came first). Stroke, death, transient ischemic attack, delirium, disabling major or minor vascular complications, and acute kidney injury at the CEP access site were also evaluated. A neurology professional examined all patients at baseline and after TAVR.

Result

A total of 3000 patients were randomized in North America, Europe and Australia; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 out of 1489 patients (94.4%), in which an attempt was made. The incidence of stroke after TAVR or within 72 hours before discharge was significantly different between the CEP group and the control group (2.3% vs 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P) was not different. = 0.30). Disabling stroke occurred in 0.5% of patients in the CEP group and in 1.3% of patients in the control group. There was no significant difference in the percentage of patients who died between the CEP group and the control group (0.5% vs 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% versus 3.7%); or had acute kidney injury (0.5% vs 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.

conclusion

In patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but based on the 95% confidence interval around this result, the results cannot rule out a benefit of CEP. During TAVR (funded by Boston Scientific; protected TAVR ClinicalTrials.gov number, NCT04149535.)