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Cardiac Restoration Starts with Healthy Flow

Aortic stenosis is more than a valve disease


Aortic stenosis (AS) extends beyond being solely a valvular condition; it also affects other parts of the cardiovascular system, influencing both upstream and downstream structures such as the arteries and the heart muscle.

  • ​​​The aortic valve calcifies and narrows, disrupting blood flow.
     
  • ​​​​​​​​​​​​Altered blood flow from a stenotic valve increases wall shear stress, which can lead to aortic dilation and potentially dangerous aortic dissection.1
     
  • ​​​Due to valve narrowing and stiffening, the left ventricle must generate higher pressure, leading to thickening of its muscular walls (hypertrophy).2

LV Hypertrophy

The real endpoint isn't the valve—it's the ventricle

The impact of left ventricular hypertrophy on patient outcomes has already been demonstrated in analyses from the PARTNER trials. Greater left ventricular (LV) mass before TAVR is linked to increased mortality and rehospitalization at five years.3 In addition, a greater reduction in LV mass one year after TAVR is associated with improved long-term outcomes.4

Beyond the Gradient: 
The Science of Flow

Mean pressure gradients (MPG) are helpful and easy measurements before and after a TAVR procedure. However, they don't tell the full story when it comes to optimal flow. Patients may have good gradients (<10 mmHg) following a TAVR procedure, but they may still experience symptoms and may not experience LV mass regression. Flow dynamics may be an important missing piece of the puzzle.

A New Discovery

Laminar Flow Associated with Improved LV Mass Regression

 

In a statistical analysis of echo and CMR data from 39 paired patients pre-and post-DurAVR® implantation, both change in mean pressure gradient AND change in flow reversal ratio were significantly and independently correlated with the extent of LV mass regression. (Endpoint: ≥10g LV mass regression)5

What the MRI data reveal 
about post-TAVR flow

When compared to a healthy aortic valve using cardiac MRI, DurAVR® THV showed no significant difference in flow. 

In addition, baseline 4D cardiac MRI from the DurAVR® THV EFS study shows turbulent flow with helical and vortical flow patterns, while imagery taken 6 months post-DurAVR® THV implantation shows evidence of healthy laminar flow through the valve and into the ascending aorta. Cardiac MRI is considered the gold standard for assessing and quantifying valve flow dynamics.

 

 
FD = Flow Displacement
FRR = Flow Reversal Ratio

FIH Study, Presented at New York Valves 2024.

EFS Study, Presented at New York Valves 2024.

From Replacement 
to Restoration

DurAVR® THV has demonstrated a restorative effect on Left Ventricular Mass

 

DurAVR® THV has demonstrated a restorative effect on Left Ventricular Mass

Patients treated with DurAVR® THV have experienced significant left ventricular (LV) mass regression, measured on cardiac MRI. Matched analysis also confirmed that the LV mass after treatment with DurAVR® THV was comparable to levels seen in healthy controls.

Patients treated with DurAVR® THV have experienced significant left ventricular (LV) mass regression, measured on cardiac MRI. Matched analysis also confirmed that the LV mass after treatment with DurAVR® THV was comparable to levels seen in healthy controls.

LV Mass Pre- and Post-DurAVR® THV

LV Mass Pre- and Post-DurAVR® THV

LV Mass 
(g)

LV Mass Post-DurAVR® THV Matched to Healthy Controls

LV Mass Post-DurAVR® THV Matched to Healthy Controls

LV Mass 
(g)

 

FIH Study, Presented at TCT 2024

The Anteris Hypothesis

The Next Chapter in TAVR

The PARADIGM Trial*  is the first head-to-head trial of its kind, aiming to also uncover the clinical impact of restoring physiologic laminar flow.

 

The PARADIGM Trial will investigate the safety and efficacy of the first-in-class biomimetic DurAVR® Transcatheter Heart Valve compared to commercially available TAVR devices in patients with severe aortic stenosis. 

 

About the PARADIGM Trial

 

*now enrolling in select geographies
About DurAVR THV
The PARADIGM Trial* is the first head-to-head trial of its kind, aiming to also uncover the clinical impact of restoring physiologic laminar flow.

Resources

Check out these resources to dive deeper into key topics like laminar flow and LV mass regression.

Biomimetic transcatheter aortic valve replacement restores ascending aortic flow towards native physiology: a first-in-human prospective imaging study

In this first‑in‑human, prospective imaging study, the authors assess whether the biomimetic DurAVR® transcatheter heart valve restores ascending aortic flow toward native physiology and examine the relationship between post‑implant laminar flow patterns and left ventricular mass regression.

 

Read the report
Biomimetic transcatheter aortic valve replacement restores ascending aortic flow towards native physiology: a first-in-human prospective imaging study

Studying the Clinical Impact of Restoring Native Flow with DurAVR® THV

AS affects the valve, vessels, and myocardium. This webinar discusses how DurAVR® THV restores laminar flow, improving LV function and mass regression in AS patients, shifting focus from traditional metrics to whole-heart function.

 

Watch Webinar Series

References

  1. Garg P, Markl M, Sathananthan J, Sellers SL, Meduri C, Cavalcante J. Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention. Nat Rev Cardiol. 2024;21(4):264-273 
  2. Bornstein AB, Rao SS, Marwaha K. Left Ventricular Hypertrophy. Treasure Island (FL): StatPearls Publishing. 2023. https://www.ncbi.nlm. nih.gov/books/NBK557534/
  3. Gonzales H, Douglas PS, Pibarot P, et al. Left Ventricular Hypertrophy and Clinical Outcomes Over 5 Years After TAVR: An Analysis of the PARTNER Trials and Registries. JACC Cardiovasc Interv. 2020;13(11):1329-1339. doi:10.1016/j. jcin.2020.03.011 
  4. Chau K, Douglas P, Pibarot P, et al. Regression of left ventricular mass after transcatheter aortic valve replacement: The PARTNER trials and registries. JACC. 2020;75(19): 2446–2458. doi:10.1016/j.jacc.2020.03.042
  5. Garg P, Meduri CU, Rogers T, Asgar AW, Rommel KP, Attizzani G, et al. Biomimetic transcatheter aortic valve replacement restores ascending aortic flow toward native physiology: a first-in-human prospective imaging study. Eur Heart J Valv Heart Dis. 2026;2(1)