Real-World Data Affirms Next-Gen TAVR Device Advantage

PHOENIX -- The newer generation Evolut transcatheter aortic valve replacement (TAVR) device improved on procedural and possibly safety characteristics, the TVT registry showed.

The Evolut FX device reduced need for device repositioning and cut procedure time, without a change in valve hemodynamics, at 30 days compared with the Evolut Pro+ device, reported Wah Wah Htun, MD, of Gundersen Health System in La Crosse, Wisconsin, at the annual TVT conference hosted by the Cardiovascular Research Foundation.

Evolut FX also trended toward less moderate or severe paravalvular regurgitation at 30 days than the Pro+ device (1.5% vs 2.5%, P=0.057).

Moreover, the FX valves had fewer cases of major or life-threatening bleeding (4.2% vs 5.6%, P=0.03).

It was good news to see a trend for less of the clearly-problematic degrees of paravalvular leak (PVL), noted session panelist Philippe Pibarot, PhD, of the Quebec Heart and Lung Institute in Quebec City.

"However, you see that mild PVL is still close to 25% in both groups," he said. "And we don't know if mild PVL in the long term will not have any impact. So this portion of mild PVL seems to be difficult to address with the new generation of valves."

And that's especially the case as the field is weighing use in broader populations. The pivotal trial for Evolut Pro+ and FX in the moderate, symptomatic aortic stenosis population is underway.

"We tolerate a lot of mild PVL in the older population," said session moderator Dharam J. Kumbhani, MD, SM, of the UT Southwestern Medical Center in Dallas. "But I think if we're doing this in low-risk patients, that's really something that we need to be thinking about."

The data looks "very scary in terms of potential TAVR-in-TAVR down the road and inability to use leaflet modification techniques in the setting of commissural misalignment," he said at the session. "In many ways, as TAVR is migrating to younger populations, commissural alignment and misalignment is now, I guess, the next frontier after all."

John K. Forrest, MD, of Yale School Of Medicine in New Haven, Connecticut, noted that "the valve itself is unchanged in terms of how it functions, the size, the wrap, but what's changed is the delivery system has made it much easier to navigate, to get around, it's more consistent."

Other refinements that have "made a huge difference with positioning" are the single spine shaft and addition of three radiopaque dots to indicate where the 3-mm mark is from inflow, noted session co-moderator Isaac George, MD, of New York-Presbyterian Columbia University Irving Medical Center in New York City.

"The importance of those three markers is they facilitate not just your evaluation of depth... but also commissural alignment, which is quite nice," added Forrest.

Device capture and repositioning was less common with the newer device (12.6% vs 18.7%, P<0.001), and median procedure time was shorter than with the Evolut Pro+ (62.0 vs 66.0 min, P<0.001). Mean gradient at 30 days was actually lower with the Evolut FX (7.9 vs 8.3 mm Hg, P=0.006).

The Society of Thoracic Surgeons/American College of Cardiology TVT database included all 1,700 Evolut FX implants and 4,058 Pro+ TAVR procedures from July 1, 2022 through Sept. 30, 2022 -- nearly all done in the U.S. since FDA approval of the newer device in August 2021 and the first U.S. commercial use on June 24, 2022.

But there's still room for improvement in the next generation of TAVR devices, Forrest suggested. "Next generations across the spectrum are now allowing us to not only evaluate how we are [on position] as we are coming up and potentially sort of twist and turn to get commissural alignment when we're in there."

"In the end, what is most important for these patients is how long do these valves last for. It's that next procedure that we're worried about, regardless of the device."

And that is not going to be answered with the TVT registry, with its follow-up that ends at 30 days, Kumbhani told MedPage Today.

"It doesn't have 1-year outcomes, 2-year, 5-year outcomes," he said. "We really need that, and we won't necessarily get that with what we have right now. But at least it tells you it's safe. We haven't seen any sort of drastic, significant increase in needing a valve-in-valve reintervention at that time or change in PVL rates, that kind of stuff."

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