3rd Generation Valves in Large and X-Large Annuli

In patients with large and extra-large annuli, transcatheter aortic valve replacement (TAVR) is safe and feasible with 3rd generation valves: the 29mm balloon expandable valve Sapien-3, and their competitor, the self-expandable 34mm Evolut R. 

The largest size of both devices was designed specifically for patients with large or extra-large annuli. However, one of them seems to work better.  

One-year outcomes of both prosthetic valves in patients with large (≥575 mm2 area or ≥85 mm perimeter) and extra-large annuli (≥683 mm2 or ≥94.2 mm) undergoing TAVR were looked into.

A total of 833 patients with severe symptomatic aortic stenosis and large annuli from 12 centers were included. 640 received the 29mm Sapien 3 and 193 received the 34mm Evolut R. 

VARC 2 device success was 94.3% for Sapien 3 and 89.3% for Evolut R (p=0.001). This minor technical success was due to more paravalvular leak (p=0.004), the need for a second valve (p=0.013) and device embolization (p=0.009) with Evolut R.

Read also: TAVR in Extremely Large Annuli: Different Patients Might Need Different Prostheses.

Mortality at 30 days and one year was 2.4% and 9.2% respectively, with no differences between devices. 

Valve hemodynamics was excellent (8.8±3.6 mmHg gradient and 3.3% moderate to severe paravalvular leak) in the x-large annuli group. With no differences with the large annuli group. 

Following publication, and similarly to what happened after the article on outflow tract calcification came out, new information has started coming out on specific subgroups of patients that might benefit more with one or the other device. 

Read also: TAVR in Small Annuli: Is There a Better Valve?

For most patients, choosing one or the other might not make a difference, and this will depend on operator experience, rather than patient anatomy. 

For a few minorities, the choice will be more directed. 

Conclusion

Patients with large and x-large annuli can receive TAVR safely with any of the market’s two most preferred valves.  There were differences in clinical outcomes that could help guide device selection. 

Original Title: Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra- Large Aortic Annuli From the TAVR-LARGE Registry.

Reference: Germán Armijo et al. Circ Cardiovasc Interv. 2020;13:e009047. DOI: 10.1161/CIRCINTERVENTIONS.120.009047.

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