Source / Disclosures
Rodés-Cabau J, et al. Late-Breaking Trials on TAVI. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).
Disclosures: Rodés-Cabau has received institutional research grants from and is a consultant for Edwards Lifesciences and Medtronic. Please see the study for all other authors’ relevant financial disclosures.
Valve-in-valve transcatheter aortic valve replacement with a self-expanding vs. balloon-expandable valve was associated with improved valve hemodynamics and no between-group differences in clinical outcomes, researchers reported at EuroPCR.
In the first prospective randomized controlled trial to compare self-expanding with balloon-expandable valves using a central echocardiographic core laboratory evaluation, researchers also observed the presence of lower echocardiographic gradients associated with the self-expanding valve for treating patients with small failed aortic bioprostheses.
“Data from observational studies suggested a potential hemodynamic advantage of self-expanding supra-annular valve systems in valve-in-valve TAVR procedures, particularly among patients with small surgical valves.” Josep Rodés-Cabau, MD, PhD, director of catheterization and interventional laboratories of the Quebec Heart & Lung Institute at Laval University, and colleagues wrote in a simultaneous publication in the Journal of the American College of Cardiology. However, comparative data in the valve-in-valve TAVR field are of retrospective nature, with a significant heterogeneity of both surgical valve types and mechanism of bioprosthesis dysfunction. These confounding factors may have led to a significant bias when comparing valve performance among different valve types. ”
For the LYTEN trial, Rodés-Cabau and colleagues analyzed data from 98 patients with a failed small (23 mm) surgical valve, randomly assigned to a balloon-expandable valve (Sapien 3 Ultra, Edwards Lifesciences) or a self-expanding valve (Evolut R, Pro or Pro +, Medtronic) in valve-in-valve TAVR. The mean age of patients was 81 years. The primary endpoint was valve hemodynamics, defined as maximal / mean residual gradients, severe prosthesis / patient mismatch or moderate to severe aortic regurgitation at 30 days, as evaluated by Doppler echocardiography.
The valve-in-valve procedure was successful in all cases, with no between-group differences in death or stroke events at 30 days.
Patients in the self-expanding valve group exhibited lower mean and maximal transvalvular gradient values (mean, 15 vs. 23 mm Hg; P < .001; maximal, 28 vs. 40 mm Hg; P < .001), and a tendency toward a lower rate of severe prosthesis / patient mismatch (44% vs. 64%; P = .07). There were no cases of moderate to severe aortic regurgitation.
Within the cohort, 27 patients in the self-expanding valve group and 28 patients in the balloon-expanding valve group underwent invasive valve hemodynamic evaluation during the procedure; there were no between-group differences in mean and peak transvalvular gradients (P = .41 and P = .7, respectively).
“The present study confirmed the very high safety profile of valve-in-valve TAVR procedures in patients with small surgical prostheses irrespective of the transcatheter valve type, with no mortality or stroke events at 30-day follow-up despite most patients exhibiting an intermediate surgical risk, ”the researchers wrote. “Also, there were no differences between groups in other complications like the need for permanent pacemaker implantation, which was extremely low (0%) in both groups.”
The researchers noted that further studies are needed to determine the potential clinical impact of differences in hemodynamics between valves and determine the most appropriate way of measuring valve hemodynamics in valve-in-valve TAVR recipients.