5th International Meeting on Aortic Diseases

Indications of TAVILuc Pierard, MD, PhD, FESC, FACC

Chair, ESC Working Group on Valvular Heart Diseases

Professor of Medicine

Head, Department of Cardiology

University Hospital Sart Tilman, Liège, Belgium

5th International Meeting on Aortic Diseases

No DisclosureLuc Pierard, MD, PhD, FESC, FACC

Chair, ESC Working Group on Valvular Heart Diseases

Professor of Medicine

Head, Department of Cardiology

University Hospital Sart Tilman, Liège, Belgium

Indications for TAVIESC/EACTS 2012 (new in 2017)

Class Level

TAVI should only be undertaken with a multidisciplinary “heart team” including

cardiologists and cardiac surgeons and other specialists if necessary.I C

TAVI should only be performed in hospitals with cardiac surgery on-site. I C

TAVI is indicated in patients with severe symptomatic AS who are not suitable for

AVR as assessed by a “ heart team” and who are likely to gain improvement in their

quality of life and to have a life expectancy of more than 1 year after consideration

of their comorbidities.

I B

TAVI should be considered in high risk patients with severe symptomatic AS who

may still be suitable for surgery, but in whom TAVI is favoured by a “heart team”

based on the individual risk profile and anatomic suitability.IIa B

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 &

European Journal of Cardio-Thoracic Surgery 2012 -

doi:10.1093/ejcts/ezs455).

SAVR vs TAVI

ACC/AHA Guidelines 2014

The PARTNER 2A Trial

Leon et al N Engl J Med 2016;374:1609-20

Editorial and Correspondance

• Still a high-risk population (highest quintile of risk)

• Lower risk of AF and acute kidney injury

• Long-term effect of paravalvular AR?

• Effects of silent brain infarcts after TAVI?

• Antithrombotic therapy after stroke in SAVR group?

• Treatment of frequent concomitant MR?

Questions

• Is aortic stenosis severe?

• What is the surgical risk?

• Frailty?

• Size of the prosthesis?

• Access route?

Risk assessment (ACC/AHA 2014)

Scores

PARTNER RISK SCORE FRANCE 2 RISK SCORE

Higher creatinine Age ≥ 90 years

Oxygen dependant CLD BMI < 30 kg/m²

Lower mini-mental status Dialysis

Major arrhythmias (AF) Non transfemoral access

Lower mean gradient NYHA Class IV

Lower 6MWT distance ≥2 pulmonary oedema’s/yr

Pulmonary hypertension

Geriatric evaluation

• Define a « frailty index »

– Cognitive assessment and risk of delirium

– Nutritional status

– Functional assessment

• Gait speed > 1m/sec

Schoenenberger A.W et al. Eur Heart J. 2013;34(9):684-692.

The Current Management of AS

Otto CM, Prendergast B. N Engl J Med 2014;371:744-756.

Futility for TAVI?

• Reduced LVEF

• Low valve gradient, reduced stroke volume

• Significant mitral regurgitation

• Chronic kidney disease

• Pulmonary disease

• Pulmonary arterial hypertension

• Trends in aortic valve intervention in Germany 2007-2013• TAVI: 32,581, SAVR: 55,992 – TAVI cohort older and higher risk

• Falling mortality

• TAVI 13.2% to 5.4%

• SAVR 3.8% to 2.2%

• Reduction in

• Stroke

• Bleeding

• PPM requirement

• AKI

Reinohl J et al. N Engl J Med 2015;373:2438-2447.

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Current status of transcatheter valve therapy in Europe: results from an EAPCI survey

EuroIntervention June 2016 (on-line ahead of print)

2010

2011

2012

2013

2014

2015

2016

Published

Completion

Low Intermediate High Extreme

NOTION

PARTNER 3

US Evolut R LR

PARTNER 2A

SURTAVI

PARTNER 1A

Corevalve US HR

PARTNER 1B

Corevalve US ER

REPRISE 3

SAVR Risk

SALUS

PORTICO IDE

Medtronic CoreValve/Evolut R

Edwards Sapien/Sapien XT/Sapien 3

Boston Lotus

Direct Flow Medical Direct Flow

St. Jude Portico

PARTNER 2 S3i

UK TAVI

Any available TAVR system

2017

2018

2019

2016

REBOOT

CHOICE

TAVR UNLOAD

PARTNER 2 S3

Investigational devices

SOLVE-TAV

Recent and Ongoing TAVI Trials

Some Remaining Areas of Concern(and of particular relevance in younger, low risk patients)

• Durability and Leaflet Thickening

• Endocarditis

• Stroke

• Paravalvular Leak

• Permanent Pacemaker Requirements

• Non-Transfemoral Access

• Bicuspid Valves

Eurostat 2010

Percent of total population

We are all getting older…

Estimated Global TAVR Procedure Growth

SOURCE: Credit Suisse TAVI Comment –January 8, 2015. ASP assumption for 2024 and 2025 based on analyst model. Revenue split assumption in 2025 is 45% U.S., 35% EU, 10% Japan, 10% ROW

In the next 10 years, TAVR growth will increase X4!