Key result
TAVR with Lotus, Evolut-R, and ACURATE neo in bicuspid aortic stenosis yielded comparable device success (P=0.085); Lotus had lower moderate paravalvular leak than Evolut-R (0% vs 30%, P=0.027).
Why the study?
The study aimed to compare device success and paravalvular leak rates of three new-generation transcatheter aortic valve replacement devices in bicuspid aortic valve stenosis and evaluate their biomechanical performance in computer simulation models.
Do Lotus and ACURATE neo devices improve device success and reduce paravalvular leak compared to Evolut-R in patients with bicuspid aortic valve stenosis undergoing TAVR?
Observational (n=56)
Yes
Do Lotus and ACURATE neo devices improve device success and reduce paravalvular leak compared to Evolut-R in patients with bicuspid aortic valve stenosis undergoing TAVR?
p-value: p=0.085
In patients with bicuspid aortic valve stenosis, TAVR with Lotus and ACURATE neo devices showed comparable device success but better adaptability and lower paravalvular leak rates compared to Evolut-R.
May suggest Lotus preference to minimize PVL in bicuspid TAVR; leaves open randomized confirmation before practice change.
OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. RESULTS: Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS: Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.
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Gorla et al. (2020) conducted an observational in bicuspid aortic valve stenosis (n=56). New-generation transcatheter aortic valve replacement devices (Lotus, Evolut-R, ACURATE neo) vs. Compared against each other was evaluated on Device success and paravalvular leak rates (p=0.085). TAVR with Lotus, Evolut-R, and ACURATE neo in bicuspid aortic stenosis yielded comparable device success (P=0.085); Lotus had lower moderate paravalvular leak than Evolut-R (0% vs 30%, P=0.027).
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