TAVR Long-Term Durability: from the Cath Lab to Real Life

Nominally deployed transcatheter heart valves SAPIEN 3 has shown excellent durability in accelerated testing to an equivalent 25 year-wear. S3 durability resulted comparable to surgical biological valve durability. Non-nominal implants (overexpansion, underexpansion, and elliptical) also showed excellent durability to an equivalent 5 year-wear. 

The aim of this study was to test nominally deployed S3 durability to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) to an equivalent 5 year-wear. 

All S3 sizes were tested: 20, 23, 26 and 29. Nominally deployed valves underwent hydrodynamic performance and mechanical durability to 1 billion cycles, and non-nominal valves were tested to 200 million cycles. Surgical Magna Ease valves were used as comparators. 

After one billion cycles, the regurgitant fraction of nominally deployed S3 for 20, 23, 26 and 29 sizes, was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46% y 2.47 ± 0.15%, respectively.  

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For the same sizes of non-nominal overexpanded S3, the regurgitant fraction was 4.36 ± 0.53%, 7.68 ± 1.39%, 6.80 ± 1.17% and 9.00 ± 0.37%, respectively. For the underexpanded valves, which showed similar results as the elliptical’s, the regurgitant fraction was lower (3.06 ± 0.28%, 4.46 ± 0.45%, 7.72 ± 0.48% and 8.65 ± 2.01% respectively). Non-nominal valve outcomes at 200 million cycles also resulted excellent. 

The Magna Ease surgical valve used as comparator showed similar results. 

Conclusion

The nominally deployed SAPIEN 3 showed excellent durability in accelerated testing for all the available sizes when tested to equivalent 25 year-wear cycles.  Non-nominal deployments also reached excellent result at 200 million cycles (5 year-wear).

Original Title: Long-Term Durability of Transcatheter Heart Valves Insights From Bench Testing to 25 Years.

Reference: Janarthanan Sathananthan et al. J Am Coll Cardiol Intv 2020, article in press.

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