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

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

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

EuroInterv. 2008;4:193-199

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

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

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

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

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

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)

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

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?

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

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)

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

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: 1929-33) (Lee. JAMA 2006;295:801-8) 16

(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

Patient selection for TAVI 3. Evaluation of the procedure feasibility

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

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

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

MSCT : Example of tortuosities of iliac arteries unfavorable for TAVI

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

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

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

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

Transthoracic & transoesophagal echocardiography 22 mm 29

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

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

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

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

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

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

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

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

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