Key Points:
- Stroke remains one of the most feared complications of transcatheter aortic valve implantation (TAVI), prompting interest in cerebral embolic protection (CEP) devices.
- The BHF PROTECT-TAVI trial studied the routine use of the Sentinel CEP device amongst 7,635 patients across 33 UK centers. The results showed that the routine use of the CEP device did not significantly reduce clinical stroke rates (2.1% vs. 2.2%) or improve outcomes across subgroups.
- The investigators findings do not support routine CEP use, though selective strategies for high-risk patients may still warrant study.
As transcatheter aortic valve implantation (TAVI) becomes increasingly common in elderly patients with severe aortic stenosis, peri-procedural stroke remains one of the most feared complications. Cerebral embolic protection (CEP) devices are designed to capture or deflect embolic debris during TAVI. Prior trials on the routine use of CEP devices during TAVI have been inconclusive.
The BHF PROTECT-TAVI trial, presented as a late-breaking clinical trial at the American College of Cardiology Scientific Sessions on March 30, 2025 and with a simultaneous publication in the New England Journal of Medicine, enrolled 7,635 patients across 33 centers in the UK. Participants were randomized to undergo TAVI with or without the Boston Scientific Sentinel CEP device. Median patient age was 81, and 39% were women. The median aortic valve mean gradient was 43 mmHg. Procedural success (>99% deployment of the valve in both arms) and complication rates (0.6% in the CEP arm, 0.3% in the control arm) were similar across groups, and deployment of CEP filters was achieved in over 80% of cases.
The primary outcome—stroke within 72 hours or prior to hospital discharge—occurred in 2.1% of patients in the CEP arm versus 2.2% in the control group (P = 0.94). There were also no significant differences in disabling stroke (1.2% vs. 1.4%), death, or composite secondary outcomes (death, non-fatal stroke, or TIA). A third interim analysis concluded that the futility boundary had been met, prompting early termination of enrollment in the trial. There were also no differences in primary outcome across all studied subgroups.
Limitations of the trial include potential underrepresentation of high-risk patients and reliance on clinical—rather than imaging—definitions of stroke. Additionally, the trial was conducted during the coronavirus pandemic which may have limited clinical research activity. Finally, there was some heterogeneity in clinical site experience with Sentinal Implantation, with only 1/3 of sites have experience prior to the trial.
Lead investigator Dr. Rajesh Kharbanda stated, “in our population, a routine strategy of cerebral embolic protection did not reduce the rate of stroke. Our study provides convincing evidence that there is no value in the routine use of this device during TAVI.”
These results mirror the earlier PROTECTED TAVR trial – conducted in North America, Europe, and Australia, further calling into question the routine use of CEP in standard TAVI practice. Further investigation into whether the CEP device may be used in a selected group of high-risk patients is warranted.