the right choice for low risk aortic stenosispatients tavi

The Right choice for Low Risk aortic stenosis patients TAVI?

“Heart Team decisions in times of evolving indications”

thomas modine MD PhD MBA

UMC, Hôpital Haut Leveque

CHU bordeaux, France

Jiao Tong university, shanghai, China

Potential conflicts of interest

Speaker's name: Thomas Modine

I have the following potential conflicts of interest to report:

Affiliation/Financial Relationship Company

Grant/Research Support

Consulting Fees / Honoraria

Major Stock Shareholder/Equity

Royalty Income

Ownership/Founder

Intellectual Property Rights

Other Financial Benefit

• Edwards• Boston Scientific, Medtronic, Edwards, Cephea,

Microport, GE, Abbott• VALMY• Nil• VALMY• Yes• YES• Nil

Event TAVR SAVR Risk Ratio Risk Ratio 95% CI P -Value

Partner 31.8%

(9/496)4.8%

(22/454)0.37

[0.17-0.80]0.009

EvolutLow Risk*

2.7% (12/435)

4.6% (17/373)

0.59[0.29-1.22]

0.171

Combined2.3%

(21/931)4.7%

(39/827)0.48

[0.28-0.81]0.002

Favors TAVR Favors SAVR

1 Year Death or Disabling StrokeCombined P3 and Evolut LR

3 European Advisory Board 8Sept2020

Mack et al NEJM 2019; 380 (18), epublication

Popma et al NEJM 2019; 380 (18), epublication

ACC/AHA guidelines 2020

Limitations

Age

Screening= indications

Concomitant procedures

Bicuspid

HALT

Age

Screening process in the us

Why?

Impact pvl on LV remodelingnotion trial

Impact pacemaker on survival

WHAT ABOUT LBBB?

Impact of ppmON CARDIAC MORTALITY

The increase in death and stroke rate between year 1 and year 2 undermined the early benefits of Sapien 3 over surgery

The early benefits of the Sapien 3 valve over SAVR are lost as the rate of death and disabling stroke accelerates after 1 year.

Valve Thrombosis may be a factor for the increased rate of deaths and strokes in the trial.

Mean Transvalvular Gradients of Sapien 3 remain higher than those of surgery after 2 years.

TAVR Clinical Data Update – Medtronic Clinical Advisers | September 2020 | CONFIDENTIAL11

Heart team is not procedural team

In low risk population

fine patientselection

no acceptable PVL

No acceptable PPM

No acceptable pacemaker

Conclusions

Strong evidence for TAVI in low risk patients

Procedure are safe, easy and reproducible

Durability demonstrated in old low risk patients

PPM is a key factor

Heart team is mandatory: selection, indications◦ Bicuspid, concomittant coronary disease, combined procedures