PVL Rates Across Studies

LOTUS has consistently demonstrated surgical-like PVL rates in clinical studies. The latest data presented on LOTUS Edge shows a 97.1% rate of None/Trace PVL, as presented at PRC London Valves 2018.

PVL Rates Across Studies PVL Rates Across Studies

REPRISE III Trial: Analysis of Predictors of Stroke

As shown in the REPRISE III data, the LOTUS Valve showed a significantly lower disabling stroke rate and a numerically lower overall stroke rate, at one year.

  LOTUS Evolut R / CoreValve P Value
Stroke 7.5% 9.8% P = 0.28
Disabling Stroke 4.0% 7.4% P = 0.03

Presented by A. Linke, MD at EuroPCR 2018

In this analysis, predictors of late stroke included:

Multivariate analysis including baseline parameters only

  P Value
Ejection Fraction 0.01
Treatment with Evolut R / CoreValve 0.01

 

Multivariate analysis including 30-day parameters

Mild or Greater PVL at 30 days 0.005
Ejection Fraction 0.03
SOV area (cm2) 0.049

 

Presented by A. Linke, MD at EuroPCR 2018

 

Rates of Mild or Greater PVL at 30 days were four times lower with LOTUS.

Rates of Mild or Greater PVL at 30 days were four times higher with Evolut R / CoreValve. Rates of Mild or Greater PVL at 30 days were four times higher with Evolut R / CoreValve.