Valvular & structural heart disease
Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial
Authors' conclusion
Lotus had significantly greater freedom from moderate or severe paravalvular leak and smaller valve area and higher gradients than CoreValve. The hemodynamic differences were not associated with any clinical differences in the composite end point of mortality, disabling stroke, and moderate paravalvular leak or with quality of life at 1 year of follow-up.
Study context
- Population
- Patients with extreme- and high-risk ASrandomised 2:1
- Participants
- 912 patients
- Comparison
- Lotus vs CoreValve TAVR
- Lotusn = 607
- CoreValven = 305reference
- Primary endpoint
- Doppler-derived valve hemodynamics (mean gradient, aortic valve area, Doppler velocity index, paravalvular leak) and impact on outcomes
- Follow-up
- Up to 12 months
Methodological detailsmulticentre, 55 centres, core laboratory echocardiography
- Multicentre
- 55 centres
- Core laboratory echocardiography
Primary result
As reported in the abstract
Valve hemodynamics
- CoreValve had lower gradients and larger aortic valve area and Doppler velocity index than Lotus at discharge; difference decreased up to 1 year
- all P<0.01
- Lotus had lower rates of paravalvular leak, persisting over time
- P<0.05
Further findings
All-cause mortality
- No differences for aortic valve area >1.1 vs <1.1 cm² or Doppler velocity index >0.35 vs <0.35
- all P=not significant
- Not different between groups in any of the 3 valve sizes
- Not different for normal (<20 mm Hg, n=780) vs abnormal (>20 mm Hg, n=48) gradients, overall or per valve type
Original publication
Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. Published 12 March 2018. doi:10.
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