the right choice for low risk aortic stenosispatients tavi
TRANSCRIPT
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