In patients with aortic stenosis undergoing transfemoral transcatheter aortic-valve replacement (TAVR), the use of cerebral embolic protection (CEP) does not have a significant impact on the incidence of periprocedural stroke, according to study findings published in The New England Journal of Medicine.
It is well known that the use of TAVR to treat aortic stenosis can result in embolization of debris from the valve or the vascularization, which can lead to periprocedural stroke. The capture of that debris by devices that provide CEP may help to decrease a person’s risk for stroke. The Sentinel CEP device has been approved by the US Food and Drug Administration (FDA) for the capture and the removal of embolic material during TAVR, in order to reduce the risk for periprocedural ischemic injury to the brain.
For the study, a prospective, postmarket, multicenter, randomized controlled trial, researchers evaluated the use of the Sentinel CEP device in patients with aortic stenosis undergoing TAVR.
The Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR; ClinicalTrials.gov Identifier: NCT04149535) trial was conducted to evaluate whether the use of CEP decreases the risk for periprocedural stroke among individuals undergoing a TAVR procedure. Participants were assigned in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group).
The primary study endpoint was stroke within 72 hours following TAVR or before hospital discharge (whichever occurred first) in the intention-to-treat population. The occurrence of disabling stroke, transient ischemic attack (TIA), delirium, major or minor vascular complications at the CEP access site, acute kidney injury (AKI), and death were evaluated as well. All of the study participants were examined by a neurology professional at baseline and following the TAVR procedure.
A total of 3000 participants from 51 centers in North America, Europe, and Australia were enrolled and underwent randomization between February 2020 and January 2022. In the intention-to-treat population, 1501 individuals were assigned to the CEP group and 1499 to the control group. Among those who underwent randomization, 21 individuals did not undergo a TAVR procedure. CEP was successfully used in 94.4% (1406 of 1489) of the patients in whom an attempt was carried out.
The mean participant age was 78.9±7.8 years. The mean Society of Thoracic Surgeons surgical risk score, which represents the predicted risk for death after surgery, was 3.4±2.7%. These scores range from 0% to 100%, with higher values indicative of higher risk. A higher percentage of women participants were enrolled in the CEP group vs the control group (42.0% vs 37.8%, respectively).
The researchers found that the incidence of stroke within 72 hours following the TAVR procedure or prior to hospital discharge did not differ significantly between the CEP group and the control group (2.3% vs 2.9%, respectively; difference, –0.6 percentage points; 95% CI, –1.7 to 0.5; P =.30).
Disabling stroke was reported among 0.5% of participants in the CEP group compared with 1.3% of patients in the control group. No substantial differences between the CEP group and the control group were reported with respect to the percentage of patients who died (0.5% vs 3.7%, respectively); experienced a stroke, TIA, or delirium (3.1% vs 3.7%, respectively); or experienced AKI (0.5% vs 0.5%, respectively). Only 1 patient (0.1%) experienced a vascular complication at the CEP access site — that is, a major bleeding event at the radial access site during sheath removal. The CEP device could not be deployed in 5.5% (83 of 1501) of the patients who were randomized to the CEP group.
Limitations of the present study warrant mention. Granular data on clinical outcomes were restricted to a small number of endpoints, with only short-term follow-up available. Because the neurologic professionals were aware of a patient’s clinical course and hospital record, this might have impacted the reporting of strokes. Further, although a large number of patients were involved and randomization was utilized, the CEP group included a larger proportion of women patients than the control group. Female sex has been reported to be a risk factor for stroke with TAVR, which was recognized in the current study as well.
“The ultimate decision regarding the use of a CEP device during TAVR should be based on careful discussions between caregivers and patients about the risks and benefits and should incorporate personalized interpretation of the data from this and other trials of CEP, as well as other factors, including device cost,” the researchers acknowledged.
They concluded that “The use of a CEP device during TAVR did not lead to a significantly lower incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR.”
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Kapadia SR, Makkar R, Leon M, et al; PROTECTED TAVR Investigators. Cerebral embolic protection during transcatheter aortic-valve replacement. N Engl J Med. 2022;387(14): 1253-1263. doi:10.1056/NEJMoa2204961