HealthDay News — The use of cerebral embolic protection (CEP) does not have a significant impact on the incidence of periprocedural stroke among patients with aortic stenosis undergoing transfemoral transcatheter aortic-valve replacement (TAVR), according to a study published online Sept. 17 in the New England Journal of Medicine to coincide with the annual Transcatheter Cardiovascular Therapeutics conference, held from Sept. 16 to 19 in Boston.
Samir R. Kapadia, M.D., from the Cleveland Clinic Foundation, and colleagues randomly assigned patients with aortic stenosis to undergo transfemoral TAVR with CEP or without CEP (control; 1,501 and 1,499 patients, respectively). A CEP device was successfully deployed in 94.4 percent of the patients in whom an attempt was made.
The researchers observed no significant difference between the groups in the incidence of stroke within 72 hours after TAVR or before discharge (2.3 versus 2.9 percent; difference). Disabling stroke occurred in 0.5 and 1.3 percent of the CEP and control groups, respectively. There were no substantial differences seen between the groups in terms of the percentage of patients who died; had a stroke, transient ischemic attack, or delirium; or had acute kidney injury.
“Although the trial did not definitively identify a role for CEP in all patients undergoing TAVR, the CEP device was safe and may be a reasonable choice for some patients and physicians,” the authors write.
Several authors disclosed financial ties to pharmaceutical, medical device, and biomedical companies, including Boston Scientific, which funded the study.