LYTEN: Better Hemodynamics With Self-Expanding vs. Balloon-Expanding Valves in ViV-TAVR
In the setting of a failed small (<23 mm) surgical valve, a self-expanding Evolut (R/PRO/PRO+) valve (SEV) compared with a balloon-expandable SAPIEN (3/ULTRA) valve (BEV) for a valve-in-valve (ViV) TAVR was associated with greater improvements in the primary endpoint of valve hemodynamics measured by Doppler echocardiography, according to a late-breaking clinical trial presented May 18 at EuroPCR 2022 and simultaneously published in the Journal of the American College of Cardiology.
Josep Rodes-Cabau, MD, PhD, and colleagues conducted what they say is the first randomized comparison of the SEV and BEV ViV-TAVR systems and the first to use a central echo core lab evaluation. The primary endpoint was valve hemodynamics defined as maximal/mean residual gradients, severe prosthesis-patient mismatch (PPM) or moderate-severe aortic regurgitation (AR) at 30 days by Doppler echocardiography. The study was conducted at 11 centers in Canada, Europe and the U.S., experienced with both valve systems and patients with a small failed surgical valve were accepted by the heart team for the procedure.
A total of 98 patients underwent ViV-TAVR (52 with an SEV [23-26 mm]; 46 with a BEV [20-23 mm]). The procedure was successful for all patients and clinical outcomes at 30 days were similar; there were no deaths or strokes.
Results showed that patients in the SEV group compared with the BEV group, respectively, had a lower mean and maximal transvalvular gradient values (15±8 vs. 23±8 mm Hg; p˂0.001 and 28±16 vs. 40±13 mm Hg; p˂0.001). A tendency towards a lower rate of severe PPM was also seen in the SEV group (44% vs. 64%; p=0.07). No moderate-severe AR was seen.
Among 55 consecutive patients (SEV, 27; BEV, 28) who underwent invasive valve hemodynamic evaluation during ViV-TAVR, no between-group differences were seen in mean and peak transvalvular gradients (p=0.41 and p=0.70, respectively).
Among the limitations noted by the researchers were a lack of a clinical adjudication committee and too few patients to detect between-group differences in clinical events, as well as the inability to exclude a type II error regarding some variables like severe PPM and the fact that invasive hemodynamic measurements were obtained in about half of the population, although this was systematically implemented in the second half of the study and in consecutive patients.
"ViV-TAVR in patients with small failed surgical bioprostheses was associated with a very low rate of periprocedural complications and 30-day adverse events irrespective of transcatheter valve type," the authors conclude. While the SEV system provided improved valve hemodynamics as evaluated by Doppler echocardiography compared with the BEV system, valve hemodynamics were similar with both systems when measured by invasive catheterization, "suggesting some differences in the degree of discordance and pressure recovery between these [two] valve systems."
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve, Aortic Valve Stenosis, Cardiology, Surgical Instruments, Catheterization, Echocardiography, Doppler, Stroke, Hemodynamics, Aortic Valve Insufficiency, Bioprosthesis, Transcatheter Aortic Valve Replacement, ACC International
< Back to Listings