Embolic Protection Use During TAVI Declined After PROTECTED TAVR

US hospitals pulled back on their use of cerebral embolic protection during TAVI after publication of the PROTECTED TAVR results, a new analysis affirms.

The proportion of procedures done with the Sentinel cerebral protection system (Boston Scientific) fell from 13.5% in the year prior to publication to 10.2% over the next year (P < 0.001) after the trial failed to demonstrate a significant reduction in periprocedural stroke with the device.

The trend was driven mostly by drops at centers that had been using the Sentinel device in more than 50% of their TAVI cases, Marwan Saad, MD, PhD (Rhode Island Hospital, Providence), and colleagues report in a research letter published online this week in JACC: Cardiovascular Interventions.

Still, embolic protection continues to be deployed in at least some TAVI cases, possibly due to the lower rate of disabling stroke seen with the Sentinel device in PROTECTED TAVR and a subsequent observational analysis, suggest the researchers.

“I think some clinicians believe that capturing debris in the device should translate to a clinical benefit, probably based on the difference in disabling stroke between the two arms, even though the trial was not powered to examine that outcome,” Saad told TCTMD. He added that “some other clinicians may be selectively using it in certain patient populations, but I am not sure we have good evidence for that.”

The researchers note that the results of BHF PROTECT-TAVI, a larger trial of embolic protection, will help guide use of such devices moving forward. As announced in October 2024, that trial was stopped early after an interim analysis of data from 7,490 patients showed that embolic protection was unlikely to reduce the incidence of periprocedural stroke and “could not rule out potential for harm.” The results are set to be presented during a late-breaking clinical trials session at the upcoming meeting of the American College of Cardiology (ACC).

BHF PROTECT-TAVI “will help reach a final consensus about the use of embolic protection devices among the community, especially if it shows any potential for harm,” Saad said.

I think the majority of clinicians are using it less and less because it’s an additional cost. Marwan Saad

For the current study, Saad et al turned to the Vizient Clinical Database, which contains information from more than 1,000 US academic medical centers and affiliated hospitals. The analysis included 88,158 TAVIs performed at 321 hospitals that used embolic protection in at least some of their cases—the overall rate was 11.9%.

In the year before publication of PROTECTED TAVR, most of these centers (85.1%) used embolic protection in less than 25% of their TAVI cases, 6.9% used it in 25-50% of cases, 6.2% in 50-75% of cases, and 1.9% in more than 75% of cases.

Overall, there was a “modest” decline in use of embolic protection in the year after the PROTECTED TAVR results were released, with the proportion of centers deploying it in less than 25% of cases climbing to 89.4%. The percentage of centers using the devices for a greater share of their TAVI cases declined.

For instance, among hospitals that had been using embolic protection in 25-50% of their cases, 45.5% started using it in less than 25%, and among those that had been using protection in 50-75% of their cases, nearly two-thirds started deploying it in fewer than half of procedures after PROTECTED TAVR.

Only six hospitals had been using embolic protection in more than 75% of their cases, and of these, half moved into a lower-use category after the trial results were released.

Seventeen centers included in this analysis participated in PROTECTED TAVR, with 88.2% initially using embolic protection in less than 25% of TAVIs and the rest using it in 25-50%. In the year after the trial was published, all deployed protection in less than 25% of procedures.

The overall trend “was actually what we expected to see—that there will be a decline in embolic protection device use as many clinicians perceived this trial as a negative trial,” Saad said. “But we were a little bit surprised that the decline is modest, and still a good percentage of TAVRs, about 10%, were being performed with embolic protection devices.”

Nonetheless, he said, “I think the majority of clinicians are using it less and less because it’s an additional cost. It has not been shown to really benefit all-cause stroke and the number needed to treat to prevent one disabling stroke was 125 patients.”

After the results of BHF PROTECT-TAVI are released, professional societies like the ACC and the Society for Cardiovascular Angiography and Interventions should come together to provide a consensus statement or guideline on the use of cerebral embolic protection during TAVI, Saad suggested.

And in the meantime, researchers might consider performing additional trials of embolic protection in more selected patient populations, he said. “If we do it in selective populations like bicuspid aortic valves or valve-in-valve procedures, we may see a benefit, but that is something that has to be proven in a dedicated clinical trial.”