Aortic Valve System

LOTUS™ Valve Clinical Trial: Sub-Analyses

Explore the sub-analyses of LOTUS Valve clinical trial data, including stroke, paravalvular leak (PVL) and permanent pacemaker (PPM) rates.
LOTUS Valve Clinical Trial: Sub-Analyses

LOTUS Edge Demonstrates Reduced Rates of Permanent Pacemaker vs. LOTUS1

Data from Dr. David Rizik at HonorHealth (AZ). 
Baseline Characteristics (N = 43)  

Age (in years)

79.8 ± 6.8

Female %


STS Score %

3.7± 2.6

Pacemaker %


Effective Orifice Area (cm2)

0.7 ± 0.2

Mean Aortic Valve Gradient (mmHg)

46.4 ± 11.5


57.5 ± 11.2

Afib %




Median Clinical Follow-Up 163 Days (30 - 285 days)

LotusEdge_Pacemaker Data



Paravalvular Leak*

Paravalvular Leak

* Adjudicated by TEE.
1David Rizik MD. SIF 2020


REPRISE III Clinical Trial: Analysis of Predictors of Stroke

As shown in the REPRISE III clinical trial data, the LOTUS Valve platform showed a significantly lower disabling stroke rate and a numerically lower overall stroke rate at one year, compared to Evolut™ R/CoreValve™.

Stroke Rates at 1 Year


P = 0.28

Stroke - 7.5% LOTUS Valve, 9.8% Evolut R/CoreValve

Disabling Stroke

P = 0.03

Disabling Stroke - 4.0% LOTUS Valve, 7.4% Evolut R/CoreValve
Presented by A. Linke, MD at EuroPCR 2018.

Predictors of Stroke: Analysis Parameters

In this analysis, predictors of late stroke included the following parameters:

Multivariate Analysis: Baseline Parameters


P Value

Ejection Fraction


Treatment with Evolut R/CoreValve


Multivariate Analysis: 30-Day Parameters


P Value

Mild or Greater PVL 0.005
Ejection Fraction 0.03
SOV Area (cm2) 0.049
Presented by A. Linke, MD at EuroPCR 2018.

PVL Rates at 30 Days

Rates of mild or greater paravalvular leak at 30 days were four times lower for patients with LOTUS than those with Evolut R/CoreValve.

≥ Mild PVL at 30 Days

P < 0.0001*

≥ Mild PVL at 30 Days - 10.7% LOTUS Valve, 58.3% Evolut R/CoreValve
Asch F, Mani V, Singh A, et al. 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 AHA. 2018;118.034129, originally published March 12, 2018.
* Includes comparison of number of patients with mild PVL [P < 0.0001] and patients with moderate or greater PVL [P < 0.0001] treated with LOTUS vs.  Evolut R/CoreValve.

PVL in Patients with High Calcium Burden

In the REPRISE III Clinical Trial, the LOTUS Valve platform had significantly lower paravalvular leak rates in patients with high calcium burden than Evolut R/CoreValve. This data is consistent with the superior PVL performance of LOTUS in the broader REPRISE III Trial.

REPRISE III: High Calcium Cohort

REPRISE III: High Calcium Cohort
Makkar R., MD. The impact of calcium burden on clinical outcomes and paravalvular regurgitation in the REPRISE III randomised controlled clinical trial; PCRLV 2017; London, United Kingdom.

LOTUS Valve PPM Rates

Data shows a downward trend in permanent pacemaker (PPM) rates for the LOTUS Valve platform.

30-Day PPM Rates

30-Day PPM Rates
* Rate of PPM among all patients; PPM among patients who did not have a pacemaker at baseline was 10.5%
1. Falk V., MD. The RESPOND Study: Safety and Efficacy of a Fully Repositionable and Retrievable Aortic Valve Used in Routine Clinical Practice; EuroPCR 2016; Paris, France.
2. Blackman D., MD. Thirty-day outcomes in patients treated with a repositionable and fully retrievable aortic valve designed to reduce the incidence of conduction disturbances (RESPOND Extension study); EuroPCR 2017; Paris, France.
3. Walters D., MD. First Report of Clinical Outcomes with the Next-Generation LOTUS Edge Valve System: Results from the LOTUS Edge Feasibility Trial; ACC 2017; Washington, DC.

Surgical-Like PVL

Surgical-Like PVL

Learn how our unique Adaptive Seal™ and braided valve frame conform to each patient’s anatomy, virtually eliminating paravalvular leak.

Stable Delivery

Stable Delivery

Discover how our exclusive deployment technology was designed to provide complete control, precise placement and stable deployment.

100% Repositionable

100% Repositionable

Find out how LOTUS Edge enables you to assess final valve position after 100% deployment with the option to recapture and reposition.