Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with a self-expanding Evolut valve was associated with better hemodynamics on echocardiography than a balloon-expandable Sapien valve in patients with small failed surgical valves in the LYDEN trial.
Intraprocedural invasive valve hemodynamics and 30-day clinical outcomes were not significantly different in the study — the first randomized comparison of the two valve types for ViV.
Observational studies suggest a potential hemodynamic advantage of self-expanding supra-annular valves in ViV, particularly in small surgical valves. The retrospective comparative data, however, had significant heterogeneity of surgical valve types and mechanism of bioprosthesis dysfunction, which may have led to a significant bias when comparing valve performance, suggested lead author Josep Rodés-Cabau, MD, PhD, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada.
To prospectively study the matter, the LYDEN trial randomized 102 patients with a small (≤23 mm) failed surgical valve to receive either a 20 mm or 23 mm Sapien 3/Ultra valve (Edwards Lifesciences) or a 23 mm or 26 mm CoreValve Evolut R/Pro/Pro+ valve (Medtronic). Their mean age was 80 years and median Society of Thoracic Surgeons score was 5%.
The primary endpoint was maximal and mean residual gradients, severe prosthesis/patient mismatch (PPM), or moderate to severe aortic regurgitation assessed by Doppler-echocardiography at 30 days.