Researchers assessing the long-term durability of nominally deployed transcatheter heart valves (THV) to an equivalent of 25 years wear, and non-nominal (overexpansion, under-expansion and elliptical) THV deployments equivalent to five years wear, found "excellent durability" in both cases. These findings were presented Sept. 25 at TCT 2019 and simultaneously published in JACC: Cardiovascular Interventions.

The study compared SAPIEN 3 THVs (sized 20mm, 23mm, 26mm and 29mm) with Magna Ease surgical valves. Accelerated wear testing (AWT) to one billion cycles (equivalent of 25 years) was used to assess nominally deployed THVs, while AWT to 200 million cycles (equivalent of five years) was used to test durability of non-nominal THV deployments.

Results from the nominally deployed THV assessment found that at 1 billion cycles the regurgitant fraction for the 20mm, 23mm, 26mm and 29mm SAPIEN 3 was 0.92 ± 0.47 percent, 1.29 ± 0.04 percent, 1.73 ± 0.46 percent and 2.47 ± 0.15 percent, respectively, which was similar to the comparator surgical valves tested. Similarly, the regurgitant fraction of non-nominal over-expanded, under-expanded and elliptical THVs "were excellent at 200 million cycles," researchers said.

"This bench study demonstrates that the nominally deployed S3 THV has excellent long-term durability, as assessed by AWT, to an equivalent of 25 years (1 billion cycles)," noted Janarthanan Sathananthan, MBChB, MPH, and colleagues. "…Non-nominal THV deployments also had excellent durability to an equivalent of 5 years wear, with similar performance to nominally deployed THVs. In younger patients with longevity, durability is an important consideration when determining valve choice." They note that further clinical studies are needed to understand long-term durability in THVs, particularly in younger patient populations.

In a related editorial comment, Julinda Mehilli, MD, notes that "Sathananthan and colleagues help clinicians to better understand challenges with in vitro durability testing." She also writes that the study "highlights some limitations of traditional in vitro testing protocols which are calibrated to test circular surgical bioprostheses without additional fabrics and stent. In addition, transcatheter bioprosthesis systems are much more prone to valve thrombosis than surgical ones. Modern hydrodynamic testing protocols in addition to platelet activation testing are required to more fully evaluate transcatheter bioprostheses durability."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: TCT19, Transcatheter Cardiovascular Therapeutics, Angiography

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