Self-Expanding TAVR performs well in cases of failed aortic bioprostheses: JACC
USA: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) with self-expanding devices in patients with small failed aortic bioprostheses with improved valve hemodynamics as evaluated by echocardiography, says a recent study. There were no differences between groups (self-expanding devices versus balloon-expandable devices) in intra-procedural invasive valve hemodynamics and 30-day clinical outcomes.
Results from the randomized LYTEN trial were presented at EuroPCR 2022 by Josep Rodés-Cabau, Quebec Heart & Lung Institute/Laval University, Canada, and the data were simultaneously published online in the Journal of the American College of Cardiology (JACC).
Retrospective studies have yielded data comparing valve systems in the ViV-TAVR field. Rodés-Cabau and colleagues aimed to compare the hemodynamic results between the balloon-expandable SAPIEN (3/ULTRA) (BEV) and self-expanding Evolut (R/PRO/PRO+) (SEV) valves in ViV-TAVR.
For this purpose, the researchers included patients with a failed small (≤23 mm) surgical valve. They were randomized to receive a BEV or a SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients; severe prosthesis patient mismatch [PPM] or moderate-severe aortic regurgitation [AR]) at 30 days as evaluated by Doppler-echocardiography.
Out of a total of 102 randomized patients, 98 patients finally underwent a ViV-TAVR procedure (BEV: 46, SEV: 52).
The findings of the study were as follows:
- The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events).
- Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15±8 vs 23±8 mmHg, p˂0.001; 28±16 vs 40±13 mmHg), and a tendency toward a lower rate of severe PPM (44% vs. 64%).
- There were no cases of moderate-severe AR.
- 55 consecutive patients (SEV: 27, BEV: 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups.
"ViV-TAVR with a SEV in patients with small failed aortic bioprostheses was associated with improved valve hemodynamics as evaluated by echocardiography," wrote the authors. "There were no differences between groups in intra-procedural invasive valve hemodynamics and 30-day clinical outcomes."
Reference:
Rodés-Cabau J, Abbas A, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- Versus Self-Expanding Valve Systems for Treating Small Failed Surgical Aortic Bioprostheses: The LYTEN Trial. J Am Coll Cardiol. 2022 May 13:S0735-1097(22)04978-6. doi: 10.1016/j.jacc.2022.05.005. Epub ahead of print. PMID: 35597385.
