1. Patient Selection for TAVI:
The European Approach
Jean Fajadet, MD, FESC
President-elect of EAPCI
(European Association of Percutaneous Cardiovascular Interventions)
Clinique Pasteur, Toulouse, France

2. I do not have any potential conflict of interest
Potential conflicts of interest
Speaker’s name: Jean FAJADET
I do not have any potential conflict of interest

3. Growing TAVI Experience in Europe
SAVR
1.2%
6.5%
13%
20%
# of procedures
2007
2008
2009
2010

4. EuroInterv. 2008;4:

5. Patient selection for TAVI
Patients with
severe, calcified, pure or predominant aortic stenosis
severe symptoms
high surgical operative risk
or with contraindication for surgery
with life expectancy at least > 1 year

6. Patient selection for TAVI
3 major steps
To set–up Heart Team: crucial
To establish that procedure is needed
To evaluate the feasibility of the procedure

7. Patient selection for TAVI
1. The Heart Team:
Multidisciplinary team approach
- Clinical cardiologist
- Echocardiographist
- Interventional cardiologist
- Cardiac surgeon
- Anaesthesiologist
- Geriatrician

8. Patient selection for TAVI
Why the Heart Team is crucial for success
Patient selection requires multidisciplinary collaboration
Risk scores have limitations
Good clinical judgement is essential
Heart Team = unbiased patient information
Prevents self referral
10–20% of patients referred to TAVI are redirected to SAVR

9. Patient selection for TAVI
2. The need for the procedure must be established
. Demonstration of severe AS
. Identify symptoms related to AS
. CI or high risk for SAVR
. Life expectancy > 1 year

10. Patient selection for TAVI
Confirmation of the severity of AS:
TAVI should be performed only in patients with severe A.S.
Echocardiography:
Measurements of valve area and flow-dependent indices
AVA < 0.8 cm² or < 0.6 cm²/m²
Low-dose dobutamine echo. useful to differentiate severe and pseudo severe AS (in pts with low EF and mean gradient)

11. Patient selection for TAVI
Evaluation of symptoms:
TAVI should be proposed only in patients with severe symptoms that can definitively be attributed to valve disease.
for instance, very difficult interpretation of dyspnoea in overweight patient with COPD and AS

12. Patient selection for TAVI
Analysis of the risk of surgery
Assessment of cardiac and extracardiac factors:
. Scores (7 scores in literature)
EuroScore, STS Predicted Risk of Mortality score…
. Value of individual scores in this high risk population?
. Predictive value of these scores for morbidity and long-term results?

13. Patient selection for TAVI
Surgical risk scores are used to guide
but not to dictate patient selection

14. Patient selection for TAVI
Analysis of the risk of surgery
The risk of surgery is based on
- Clinical judgement,
- Global appraisal of the patient ,
- Risk factors not covered in scores (chest radiation, previous CABG with patent grafts, porcelain aorta, liver cirrhosis…)
- Scores (expected mortality >20% by EuroScore and >10% by STS score)
- Local environment (results in the given institution)

15. Patient selection for TAVI
Evaluation of life expectancy and quality of life:
The evaluation of life expectancy is most significantly influenced by comorbidities
Clinical evaluation
Frialty index
Do not perform TAVI if life expectancy is < 1 year

16. Evaluation of life Expectancy / QOL
Mid-term outcomes
4-year mortality
Demographics
Age
Gender
Comorbidities
Diabetes
Cancer
Lung disease
Heart failure
BMI
Smoker
Functional measures
Bathing, walking,
Managing finances,
Pushing/pulling heavy things
Cognitive status
Mood and motivation
Communication
Mobility
Balance
Bowel function
Bladder function
Nutrition
Social resources
(Jones et al J Am Geriatr Soc 2004; 52: )
(Lee. JAMA 2006;295:801-8) 16

17. (OR 1.04, 95% CI 1.00–1.08, P ¼ 0.032) in the multivariate analysis
Karnofsky index
Pre-procedural Karnofsky index emerged as the only independent predictor
(OR 1.04, 95% CI 1.00–1.08, P ¼ 0.032) in the multivariate analysis
European Heart Journal (2010) 31, 984–991

18. Patient selection for TAVI
3. Evaluation of the procedure feasibility

19. Anatomical characteristics of the cardiovascular system from « skin to heart »
Aortic arch
Ascending aorta & aortic root
Coronary arteries
Left ventricle
Aorta
Ilio-femoral vessels

20. Patient selection for TAVI
. Assessment of coronary anatomy:
Coronary angiography: CAD ?, need for revascularisation?
. Measurement of aortic annulus:
for correct sizing
to minimize risk of prosthesis migration and paravalvular leakage
TEE >TTE, MSCT, MRI, Aortography
. Evaluation of anatomy of iliac and femoral arteries:
size, tortuosities and calcifications
MSCT, Angio, MRI

21. Conventional angiography
Ascending aorta angiogram (Graduated pig-tail)
Abdominal Aorta and Ilio-femoral angiogram 21

22. MSCT : Example of tortuosities of iliac arteries unfavorable for TAVI

23. MSCT : Example of calcifications of iliac arteries
No CI for for TAVI via femoral access

25. Example of calcified stenosis of right iliac artery
TAVI could be performed via left femoral access

27. MSCT
Left ventricle MDCT view: Double oblique transverse Outflow tract (5): mm Aortic valve Valve calcification (6) (score 1-4): Relative distance of coronary ostia to aortic valve annular plane MDCT view: Sagital Left main ostium (7): mm Right coronary ostium (8): mm 27

28. MSCT for evaluation of
- aortic annulus
- aortic calcifications
- and distance between annulus and coronary artery ostium

29. Transthoracic & transoesophagal echocardiography
22 mm 29

30. Valve selection: size of aortic annulus
≥18 or ≤ 25 mm for Edwards Sapien™ - XT™
≥20 or ≤ 27 mm for Medtronic CoreValve™
40/43 mm
15-16 mm
53/55 mm
22/24 mm
23-26 mm
23/26 mm
26/29 mm

31. Patient selection for TAVI General contraindications
. Size of aortic annulus <18mm or >25mm for balloon expandable device <20mm or >27mm for self expandable device
. Bicuspid valves: risk of incomplete deployment
. Asymetric heavy valvular calcification: compression of coronary arteries, paravalvular leak
. Size of aortic root: >45mm for self expandable device
. Apical LV thrombus

32. Patient selection for TAVI
Contraindications of transfemoral approach
- Iliac arteries:
severe calcifications, tortuosities, small diameter, previous bypass
- Aorta:
AAA, severe angulation, severe atheroma of the arch, coarctation, transverse ascending aorta
Contraindications of transapical approach
Previous surgery of LV using a patch
Calcified pericardium
Severe respiratory insufficiency
Non-reachable LV apex

33. Treatment options for AS:
“Low
Risk”
“High
Risk”
Too Sick to
Benefit from
any intervention
SAVR
TAVI
MEDICAL
TREATMENT

34. Indications for TAVI 2010 TAVI Surgery TAVI Surgery FUTURE? No TAVI
# Patients
Risk
TAVI
Surgery
No TAVI
2010
# Patients
Risk
TAVI
Surgery
No TAVI
FUTURE?
Risk

35. Future indications of TAVI
Patients with intermediate risk for SAVR
We must randomise
SurTAVI trial

37. Comparison of Risk Scores
75 year-old male and EF 55%
Low Risk 60 50
Range:
1.0 to 4.3% 40 30
Estimated operative mortality (%) 20 10
3.4
4.3
2.6
1.0
1.0
1.3
1.8
STS
online (2.61)
Jin
PHS
Nowicki
NNE
Rankin
STS
Logistic
EuroSCORE
online
Hannan
NY State
Kudavalli
Multicenter

38. Comparison of Risk Scores
85 year old female, EF 30%, renal dysfunction and pulmonary hypertension
High Risk
59.8 60 50
Range:
4.3 to 59.8% 40
27.4 30
Estimated operative mortality (%) 20
15.4
8.5 10
6.6
7.2
4.3
Logistic
EuroSCORE
online
Nowicki
NNE
Jin
PHS
Rankin
STS
Hannan
NY State
STS
online 2.61
Kudavalli
Multicenter

39. Logistic EuroSCORE mean ± SD
Illustration of the gradual decline in Log EuroSCORE in current practice. Also of note: the wide standard deviations 39