By Dr Jonathan Shurlock, edited by Dr. Ahmed El-Medany
Since its findings were presented at TCT 2022 the results of the PROTECTED TAVR trial have caused widespread discussion and debate. In brief the international muti-centre study enrolled 3,000 participants (mean age 79 years; 40% women) undergoing TAVI. Participants were randomised to TAVI with or without the Sentinel cerebral embolic protection device. The Sentinel system was successfully utilised in 94.4% of patients in whom it was attempted.
There was no difference in all-cause mortality between groups. The primary end point of difference in the rate of stroke within 72 hours of the procedure was not different between the two groups (2.3% Sentinel device versus 2.9% without. P = 0.30).
Presenting the findings Dr Samir Kapadia (Global PI) described how the study showed a lower rate of disabling stroke (0.5% vs 1.3%; P = 0.02), which was presented as a secondary endpoint and critics argue that the study was not powered for. Dr Kapadia also highlighted that the use of the Sentinel device could be considered safe with no major complications in their data.
Those who are supportive of the use of cerebral embolic protection devices argue that the findings show that the Sentinel system is safe and feasible to use. While acknowledging that the primary end point was missed, they suggest that due to the association of strokes with significant morbidity and mortality the use of CEP should still be considered.
Critics of the conclusions drawn from the study are less certain of the benefits of ubiquitous CEP use during TAVI. Some have drawn attention to the wording of the abstract conclusion in the NEJM publication: “…the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the result may not rule out a benefit of CEP during TAVR.”
The use of CEP during TAVI remains a topic for debate following this study.
The full study can be found here: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2204961
