TAVR is a valid alternative to treat failed surgical bioprosthetic valves, but one of its biggest challenges is patients with a small annulus.
When using self-expanding valves, supra-annular implantation is recommended. However, at present, we only have retrospective, observational studies, not large enough.
The LYTEN Trial is a randomized study in patients presenting failed bioprosthetic surgical valves used to treat a small annulus (<23 mm, <21 mm internal diameter).
102 patients were randomized. 49 received a balloon-expandable valve (BEV) SAPIENS 3/ULTRA and 53 self-expanding valve (SEV) EvolutR/PRO/PRO+. 3 patients were excluded from the BEV group and 1 from the SEV.
Primary end point was maximal and median transvalvular residual gradient and moderate/severe prosthetic mismatch, according to VARC criteria, at 30 days. Secondary end points were clinical events at 30 days and valve hemodynamics obtained by catheterization during procedure.
The populations were well balanced. Mean age was 80, half were men, STS was 5.4%, surgical valve dysfunction was mainly stenosis (66%) and ventricular function was conserved.
Read also: EuroPCR 2022 | Galileo Trial: Mortality Predictors after Successful TAVR.
At 30 days, primary end point gradient resulted in favor of SEV, with lower maximal gradient (40 mmHg vs. 28 mmHg p=0.001 and 23 mmHg vs. 15 mmHg p=0.001) and lower moderate/severe prosthetic mismatch. There were no divergencies in trivial or mild AR and no patients presented moderate to severe leak.
On the other hand, there were no deaths, strokes or pacemaker implantation. In the BEV group, 1 patient exhibited major bleeding, 1 a vascular complication and 1 in the SEV group presented AMI.
When looking at mean gradient obtained by catheterization during procedure there was no difference, but and these gradients were lower when compared to gradients measured with echocardiography. Hemodynamically measured gradient was lower to eco-Doppler’s.
Authors have concluded that V-in-V in small annuli present a very low rate of complications at 30 days, the EVOLTER/PRO/PRO+ valves are associated with lower residual gradient and tend to have less severe prosthetic mismatch.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
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