Clinical evidence of TAVR in intermediate risk

patients: Lessons from clinical trials

Andreas Baumbach, M.D.

Queen Mary University and Barts Heart Centre, London

Yale School of Medicine, New Haven, CT

@

Disclosures

• Speaker Fees: AZ, The Medicines Company, Abbott Vascular, KSH, Microport

• Advisory Boards: Abiomed, Abott Vascular, KSH, Microport, Medicines Company, Sinomed

• Institutional Research Support: Medtronic, Abbott Vascular

Trial Evidence

• Randomised controlled trials

– TAVI in inoperable patients

– TAVI in high risk patients

– TAVI in intermediate risk patients

• Registry data

• Upcoming trials and next questions

WHAT IS INTERMEDIATE RISK ?

Intermediate risk

Intermediate risk

• Patients who are operable

• Absence of severe comorbidities

• Risk score in the medium/low range

DATA

TAVI vs Medical Rx: Inoperable Patients

TAVI vs SAVR: High Risk Patients

European sentinel registry

TAVI 2002-2016: Devices with CE Mark Approval

SURTAVI

TAVR

SAVR

SURTAVI Trial: All Death or Disabling Stroke

0%

5%

10%

15%

20%

25%

30%

0 6 12 18 24

All-

Cau

se M

ort

alit

y o

r D

isab

ling

Stro

ke

Months Post-Procedure

796 674 555 407 241

864 755 612 456 272

24 Months

TAVR SAVR

12.6% 14.0%

N=1746

Reardon M. NEJM 2016

Rationale for TAVI in Low Risk Patients

Bonow et al. Lancet 2016

TAVI in Low Risk Patients: Ongoing Trials

To be continued