Established TAVR Platforms Evolving for Lifetime Management

— New additions to Sapien, Evolut, Navitor lines aim to ensure coronary access


NEW YORK CITY -- With valve-in-valve procedures becoming a key concern for patients with aortic stenosis, familiar transcatheter aortic valve replacement (TAVR) devices are being tweaked to facilitate future operations that patients may need as they age.

The future of TAVR rests on acute procedural optimization (e.g., reducing paravalvular leak, pacemaker rates) and device durability and lifetime management issues such as ensuring coronary access for future percutaneous coronary intervention, said Tamim Nazif, MD, of New York-Presbyterian/Columbia University Irving Medical Center in New York City, at the New York Valves meeting hosted by the Cardiovascular Research Foundation.

During the session, the importance of lifetime patient management was emphasized repeatedly in a discussion of how the more established TAVR platforms in the U.S. market are evolving to anticipate the needs of a wider pool of patients.

The general consensus among session panelists was that a single bioprosthetic valve is not expected to last a lifetime for the young, lower-risk patients who are increasingly being treated with these technologies.

"No matter how durable, the valve will fail," argued panelist Stanley Chetcuti, MD, of the University of Michigan in Ann Arbor. He suggested better understanding of the transcatheter aortic valve (TAV)-in-TAV phenomenon, including which valve to choose first if a patient is expected to require a second one down the line.

First to share a program update was Pradeep Yadav, MD, of Piedmont Heart Institute in Atlanta, who described the latest addition to the Sapien line of balloon-expandable valves: Sapien X4.

This transcatheter heart valve has a "completely redesigned" stent frame featuring adjustable sizing, he said, with a low frame height and large cells for future coronary access. Also intended to help coronary access are markers for commissural alignment, which can be imaged without changing any views.

As for the self-expanding TAVR Evolut platform, the new Evolut FX+ was designed to have an opening for future re-access to the coronaries and three radiopaque dot markers for commissural alignment, among other features, according to John Forrest, MD, of Yale School of Medicine in New Haven, Connecticut.

Evolut operators have already seen improvements in pacemaker rates with existing valves and knowledge that the valves should be implanted higher. However, Forrest acknowledged that TAV-in-TAV represents a major challenge.

Panelist Vivian Ng, MD, also of New York-Presbyterian/Columbia University Irving Medical Center, explained a problem facing supra-annular valves: balancing short- and long-term goals of care. How high can the valves be placed if they are going to block coronary access for future procedures?

"I think, over time, we're going to be pulled in multiple directions for how to maintain good 30-day outcomes and improve patient lifetime management," Ng said.

Meanwhile, the Navitor valve developers have come out with the Navitor Vision, featuring a large cell design to minimize coronary obstruction and intra-annular leaflets, among other features. Future goals for this device line include active commissural alignment and an option for treating larger annuli, reported Bassem Chehab, MD, of Ascension Via Christi St. Francis Hospital in Wichita, Kansas.

Ng suggested that the possibility of TAVR for patients with asymptomatic severe aortic stenosis, who have cardiac damage before symptoms manifest, may also be considered lifetime management.

The trial of the Sapien 3/Sapien 3 Ultra TAVR versus surveillance for patients with asymptomatic severe aortic stenosis is expected to have main results reported later this year at the Transcatheter Cardiovascular Therapeutics annual meeting, Yadav said.

Also anticipated is the trial, which is looking at the newer-generation Sapien valves in moderate aortic stenosis, he said.

Forrest also shared progress on the trial studying Evolut PRO+ and FX systems in moderate aortic stenosis.

If the signals are positive, Ng suggested, the guidelines may move to consider TAVR for treating disease over a lifetime, not just when aortic stenosis is severe and symptomatic.

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    Nicole Lou is a reporter for ľֱ, where she covers cardiology news and other developments in medicine.


Nazif reported receiving personal fees from Edwards Lifesciences, Medtronic, Boston Scientific, Encompass Technologies, and Teleflex.

Chetcuti reported receiving personal fees from Medtronic, Boston Scientific, Edwards Lifesciences, and Pi-Cardia, and grant support from Abbott, JenaValve, and W.L. Gore & Associates.

Yadav reported receiving personal fees from Edwards Lifesciences, Abbott, and Boston Scientific, and equity in DASI Simulations and Opus.

Forrest reported receiving grant support from Medtronic and Edwards Lifesciences.

Ng reported receiving personal fees from Edwards Lifesciences, Medtronic, xDot Medical, and Boston Scientific.

Chehab had no disclosures.