EVOLUTClinicaltrialthebest hemodynamics.ppt

TAVI pptx

1. EvolutPRO: The Best Hemodynamics
Pieter Kappetein,
CMO, VP Medical Affairs Medtronic

2. I, Pieter Kappetein, MD, PhD.
I have relevant financial relationships:
Full time employee of Medtronic

3. The concept of patient prosthesis mismatch (PPM) was introduced in the 1970s and has
remained a SAVR focus area for decades.
1
Rahimtoola. Circulation. 1978 Jul;58(1):20-4.

4. Clinical Impact of PPM
The concept of patient prosthesis mismatch (PPM) was introduced in the
1970s and has remained a SAVR focus area for decades
1
Rahimtoola. Circulation. 1978 Jul;58(1):20-4.
With PPM, “The patient is exchanging one disease process for another”

5. PPM is common post-SAVR, especially in those with valves sizes 23 mm or smaller
1
Fallon et al., Ann Thorac Surg. 2018 Jul;106(1):14-22
% of Valve Size by PPM Group
STS Registry of 59,779 SAVR patients

6. Clinical Impact of PPM
An analysis from the U.S. STS Registry in 59,779
patients showed
•PPM is common post-SAVR, especially in those with
valves sizes 23 mm or smaller
1
Fallon et al., Ann Thorac Surg. 2018 Jul;106(1):14-22
% of Valve Size by PPM Group

7. 1
Fallon et al., Ann Thorac Surg. 2018 Jul;106(1):14-22
No PPM
Moderate
Severe
Patients with any degree of PPM had worse survival out to ten years
Patients with moderate or severe PPM had higher risk of readmission for heart failure and redo AVR

8. Clinical Impact of PPM
A meta-analysis of 27,168 SAVR patients:
•Any PPM was significantly associated with all-
cause mortality
•Higher rates of hospital readmissions and redo
AVR
•Other studies have found PPM negatively
impacts
–Quality of life
–Exercise tolerance
–Left ventricular mass regression
–Structural valve deterioration
Pooled Estimate for Impact of Any PPM on
All-Cause Mortality
1
Head et al., Eur Heart J. 2012 Jun;33(12):1518-29

9. TVT registry
36,770 patients in TVT registry
showed severe PPM was
associated with
•increased mortality
•heart failure
rehospitalizations
Herrmann et al., J Am Coll Cardiol. 2018 Sep 18
Mortality
17.2% Severe
15.9% None
Mortality (%)
15.6% Moderate
The negative impact of PPM is not unique to SAVR

10. Evolut TAVI Platform Hemodynamics
The self-expanding, supra-annular design of the EvolutTAVI platform offers industry-
leading durability and hemodynamic performance supported by years of clinical trial
data and real-world experience.
CoreValve Evolut REvolut PRO

11. Evolut Platform vs. SAVR
The Evolutplatform has shown better
hemodynamic outcomes compared to
SAVR in randomized clinical trials.
The EvolutTAVI platform is the only TAVI
platform to show hemodynamic
superiority to SAVR in low risk patients
Popma et al. New Engl J Med. 2019; 380: 1706-15

12. Durability
The hemodynamic benefit of the Evolut TAVI platform shows excellent mid-term durability.
The randomized CoreValve High-Risk and NOTION trials showed better hemodynamics
compared to SAVR at 5 and 6 years.
Sondergard, presented at EuroPCR 2018

13. Evolut vs. SAPIEN Platform
The unique design of the Evolut
TAVI Platform differentiates it from
other TAVI valves.
The self-expanding, supra-annular
design allows for optimal flow and
valve area that intra-annular TAVI
devices have not achieved.

14. •Hemodynamics of balloon-
expandable valves versus self-
expanding valves were
adjudicated at a single core lab by
field leaders in echocardiography
•Balloon-expandable TAVI had
higher mean gradients and
smaller EOAs across all annulus
ranges compared to the Evolut
platform
Hahn et al., JACC Cardiovascular Imaging. 2019;12:24-34
Normal Reference Values Table for Sapien 3 valves
Normal Reference Values Table for Evolut R valves
Evolut vs. SAPIEN Platforms

15. Comparison of Evolut R and SAPIEN 3 in the CHOICE Extend Registry showed significantly
larger EOAs and less PPM in patients implanted with Evolut R across all valve sizes.
Valve Size 26mm 23mm 29 mm 26mm 34 mm 29mm
N 24 89 54 145 22 112
6.1
7.3
5.9
13.3
11.5
10
0
5
10
15
Small Valves Medium Valves Large Valves
mmHg
Evolut R
SAPIEN 3
p<0.001
p<0.001
p<0.001
Evolut vs. SAPIEN Platforms
1
Abdgelghani, et. al. JACC Cardiovasc Interv 2018;11:2507-18.

16. Evolut PRO vs. Acurate Neo
The Evolutplatform has also
demonstrated significantly better
hemodynamic performance when
compared to the supra-annular
AcurateNeo
The propensity-matched NEOPRO
study found EvolutPRO+ had
significantly lower mean gradients
than AcurateNeo
P=0.003
Latib, presented at TCT 2018
N=251 N=251
Mean Gradient (mm HG)

17. Implications for Your Practice
Optimal hemodynamics are important for all patients, especially younger patients with
longer life expectancies. Current clinical evidence shows excellent hemodynamics for
the EvolutPlatform and less hemodynamic SVD than SAVR and other TAVI devices.
Gleason, presented at TCT 2018; Abdel-Wahab, presented at EuroPCR 2019
CHOICE 5 Year Outcomes

18. TAV in SAV
Similarly, TAV-in-SAV patients are constrained by the surgical valve and often result in sub-
optimal hemodynamics.
The Evolutplatform has demonstrated excellent hemodynamic outcomes in TAV-in-SAV
patients and should be preferred in these patients.
Tuzcu et al., J Am Coll Cardiol. 2018 Jul 24;72(4):370-382

19. Similarly, TAV-in-SAV patients are constrained
by the surgical valve and often result in sub-
optimal hemodynamics.
The Evolutplatform has demonstrated
excellent hemodynamic outcomes in TAV-in-
SAV patients and should be preferred in these
patients.
TAV in SAV
Tuzcu et al., J Am Coll Cardiol. 2018 Jul 24;72(4):370-382
Mean Gradients at Discharge According to Valve Size (STS/ACC Registry)
Balloon-Expandable
Mean Gradient (mm Hg) Mean Gradient (mm Hg)
Self-Expanding

20. Conclusions
•Hemodynamic outcomes are important for patient survival
and quality of life.
•The Evolut TAVI platform has demonstrated superior
hemodynamic performance compared to SAVR across the
risk spectrum.
•The Evolut TAVI platform provides industry-leading
hemodynamic outcomes and durability.
•The safety, efficacy, and hemodynamic advantages of the
Evolut TAVI platform make it an excellent valve choice for all
patients, especially those who are young, have small annuli,
or are undergoing TAVin-SAV.

21. Conclusion
The Evolut platform continues to provide meaningful innovation with hemodynamic
outcomes a priority for future design iterations

22. Thank you!