Effective, but not worth the cost: CEPD use during TAVR fails to make a significant difference
Using a cerebral embolic protection device (CEPD) can effectively capture debris during transcatheter aortic valve replacement (TAVR) procedures. However, according to one interventional cardiologist, there is still not much clinical evidence that CEPD use can improve patient outcomes.
Hani Jneid, MD, chief of cardiology and medical director of the cardiovascular care line with The University of Texas Medical Branch in Galveston, shared his perspective in The New England Journal of Medicine.[1]
Jneid began by highlighting the importance of reducing the risk of stroke after TAVR. These incidents are growing less and less common in modern practice, he wrote, but they can still be fatal or result in permanent disability when they do occur.
It makes perfect sense, he added, that there is so much interest in the potential of CEPDs. And repeated studies have shown that, yes, the devices are able to consistently capture debris as intended. The data just has not shown that they are worth the additional costs.
“Although biologically plausible and technically successful in capturing debris, CEPDs during TAVR do not appear to lead to measurable clinical benefit in an unselected population,” Jneid wrote. “It is important to note that the incidence of TAVR-related stroke has declined considerably over the past decade, owing to advances in valve technology, the use of lower-profile sheaths, operator experience and procedural planning. It is therefore not surprising that the usefulness of any adjunctive neuroprotection strategy is likely to diminish, perhaps below the threshold of cost-effectiveness or clinical justification.”
Reviewing recent evidence from BHF PROTECT-TAVI
One of the clinical trials that inspired Jneid’s analysis was BHF PROTECT-TAVI, a new analysis funded by the British Heart Foundation. The full results, published in March in The New England Journal of Medicine, showed that CEPD use did not significantly increase a patient’s 72-hour risk of stroke following TAVR.[2]
BHF PROTECT-TAVI, like the PROTECTED TAVR trial before it, focused on patients treated with the Sentinel device from Boston Scientific. Boston Scientific provided devices for the trial. BHF PROTECT-TAVI included data from more than 7,000 patients who underwent TAVR in the U.K.
“The results of BHF PROTECT-TAVI are consistent with the reported results of the PROTECTED TAVR trial, which also showed no evidence of a treatment effect with CEP for the primary outcome of stroke,” wrote first author Rajesh K. Kharbanda, PhD, a cardiologist with John Radcliffe Hospital, and colleagues. “We saw no apparent decrease in the incidence of disabling stroke with cerebral embolic protection.”
What’s next?
Researchers and device manufacturers have not given up on the potential of these devices to boost patient outcomes. Other cerebral embolic protection devices are being studied and developed, for example, and there is still plenty of room for research teams to learn more about this topic.
“The present findings highlight the need for future research to identify patient subgroups most likely to benefit from embolic protection, enhance device coverage and deployment efficiency, and incorporate stroke-prevention strategies into personalized TAVR care pathways,” Jneid wrote. “Until additional data become available, the current body of evidence does not support the universal application of CEPDs in contemporary TAVR practice.”
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.