Slide 1: DurAVR THV: LV Reverse Remodeling After TAVR Using a Novel Biomimetic Valve Design
DurAVR® THV: LV Reverse Remodeling After TAVR Using a Novel Biomimetic Valve Design Amar Krishnaswamy, MD Section Head, Interventional Cardiology Director, Sones Cardiac Catheterization Laboratories T.V. Connelly Family Chair in Interventional Cardiology Cleveland Clinic, Cleveland, USA D u r A V R
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships Within the prior 24 months, I have had a relevant financial relationship(s) with an ineligible company(ies) listed below. Nothing to disclose D u r A V R ® I N V E S T I G A T I O N A L U S E O N L Y . N O T A V A I L A B L E F O R C O MME R C I A L S A
Slide 3: DurAVR THV: A New Class of TAVR
DurAVR THV: A New Class of TAVR Single-piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve D u r A V R ® I N V E S T I G A T I O N A L U S E O N L Y . N O T A V A I L A B L E F O R C O MME R C I A L S A L E . E U : E xc l u s i v e l y f o r c l i n i c a
Slide 4: DurAVR FIH & EFS: Favorable Hemodynamic Results in Over 50 Patients with Small Annuli
DurAVR® FIH & EFS: Favorable Hemodynamic Results in Over 50 Patients with Small Annuli in Combined Studies EFS 30 Days (to date) FIH 1 Year (to date) 3.0 50 2.5 60 2.20 2.13 41.0 49.8 2.02 2.5 2.4 2.00 50 2.18 40 2.0 2.0 40 EOA (cm2) & DVI Mean Annulus MPG (mmHg) MPG (mmHg) 30 1.5 EOA (cm2) Mean Ann
Slide 5: LV Mass is an Important Consideration in AS Patients
LV Mass is an Important Consideration in AS Patients • LVH in AS patients is linked to progressive HF and worse outcomes Généreux P et al JACC 2022 Aug 23;80(8):783-800 • AVR -> LV mass regression in some pts • Clinical outcomes after TAVR are correlated to degree of LVM regression PARTNER Series
Slide 6: Flow Dynamics are Linked to AS and LV Mass
Flow Dynamics are Linked to AS and LV Mass • Disordered aorta flow is seen in AS and associated w LVH von Knobelsdorff-Brenkenhoff, et al CIRC CV IMAG 2016 • Could restoration of laminar flow affect LV mass regression? D u r A V R ® I N V E S T I G A T I O N A L U S E O N L Y . N O T A V A I L A B L
Slide 7: Degree of Laminar Flow Achieved with Currently Available Platforms is Still Not Comparable to Healthy AV
Degree of Laminar Flow Achieved with Currently Available Platforms is Still Not Comparable to Healthy AV Normal Flow-- Impaired Aortic Flow-- Healthy Aortic Valve Sapien 3 Evolut R CE Magna Ease SFD = 10% SFD = 48% SFD = 25% SFD = 27% FRR = 1% FRR = 35% FRR = 4% FRR = 30% SFD: Systolic Flow Displace
Slide 8: CMR Study Designed to Evaluate Flow Dynamics of DurAVR and Impact on LV
CMR Study Designed to Evaluate Flow Dynamics of DurAVR and Impact on LV ▪ Baseline and 6-month Cardiac Magnetic Resonance (CMR) Imaging incorporating standard cines and 2D contrast acquisition at the ascending aorta. ▪ Age- and gender- matched healthy cohort from Norwich (UK) ▪ Root/ascending dimens
Slide 9: Biomimetic DurAVR Restores post-TAVR Laminar Flow Comparable to Healthy Aortic Valve
Biomimetic DurAVR Restores post-TAVR Laminar Flow Comparable to Healthy Aortic Valve * * Indexed Systolic Flow Reversal Ratio Indexed Systolic Flow Displacement * * P<0.05 * * P<0.05 (%/cm2) (%/cm2) Pre-intervention DurAVR® THV Healthy Control Courtesy of Dr. Pankaj Garg, Norwich University Hospital
Slide 10: CMR After DurAVR TAVR Demonstrates LV Reverse Remodeling
CMR After DurAVR® TAVR Demonstrates LV Reverse Remodeling LV End-Diastolic Volume LV End-Systolic Volume LV Mass (mL) (mL) (g) 250 140 250 120 200 P=0.04 P=0.04 200 P<0.01 8% 100 150 150 22% 80 19% 60 100 100 40 50 50 20 0 0 0 Pre-intervention Post-DurAVR® Pre-intervention Post-DurAVR® Pre-intervent
Slide 11: CMR After DurAVR TAVR Demonstrates Comparable LV Findings to Healthy Controls
CMR After DurAVR® TAVR Demonstrates Comparable LV Findings to Healthy Controls LV End-Diastolic Volume LV End-Systolic Volume LV Mass (mL) (mL) (g) 250 100 200 200 P=0.95 80 P=0.51 160 P=0.96 150 60 120 100 40 80 50 20 40 0 0 0 Healthy Post-DurAVR® Healthy Post-DurAVR® Healthy Post-DurAVR® (N=20) (N
Slide 12: Conclusions
Conclusions ▪ DurAVR® has demonstrated favorable hemodynamics and safety in FIH/EFS ▪ Post-TAVR CMR imaging analysis with the DurAVR® Biomimetic System demonstrates: ▪ Restoration of laminar flow similar to individuals with a healthy aortic valve ▪ Early LV reverse remodeling compared with pre-TAVR
Slide 13: Restoring Laminar Flow May Reduce LV Workload
Restoring Laminar Flow May Reduce LV Workload ▪ Abnormal aortic flow -> energy loss1,2 ▪ Restoration of laminar flow may impact the workload of the Left Ventricle2,3 ▪ LV mass regression is associated with improved patient outcomes4,5 ▪ Laminar flow may impact SVD / durability6 Garg P. et al., Nat R