Κωνσταντίνος Τούτουζας

Αν. Καθηγητής Καρδιολογίας

Α’ Πανεπιστημιακή Καρδιολογική Κλινική

Ιπποκράτειο Νοσοκομείο Αθηνών

• Introduction

• Specific groups

• Clinical risk stratification

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

Iung et al.,Eur Heart J., 2003 Jul;24(13):1231-43

Inflammatory CD3 infiltrates in AVS Association of inflammatory and

neovascularization factors with temperature

differences

Toutouzas K et al, JACC, 2008

Dr Paul Dudley White

1931

Homograft – 1962

Porcine valve – 1965

Pericardial tissue valve – 1969

1960 20021970 2004

First CoreValve Transcatheter AVR by

Retrograde Approach

Laborde, Lal, Grube – July 12, 2004

First PVT Transcatheter AVR

by Antegrade Approach

Alain Cribier - 2002

Mechanical heart valve – 1962

Surgery

Transvascular

2006 2008 2014

First CoreValve PERCUTANEOUS AVR

by Retrograde Approach – Oct 12, 2006

Serruys, DeJaegere, Laborde

First Edwards/PVT Transapical

Beating Heart AVR

Webb, Lichtenstein – Nov 29, 2005

20012000

First PVT animal

implantation

A. Cribier

First Corevalve

animal implantation

JC. Laborde

Hippokration Hospital,

1stCoreValve implanted

>100.000 TAVI Valves implanted

worldwide

1st Lotus Valve

implanted at

Hippokration Hospital

Nishimura et al., Circulation, 2014

K. Toutouzas, K. Stathogiannis, G. Latsios, A. Synetos, C. Stefanadis,

2012, Recent Pat Cardiovasc Drug Discov

TAVI 2002-2014

COMPANY NAME SIZES ROUTE CHARACTERISTICS CE MARK

Boston Scientific Lotus Valve 23, 25, 27mm TF Repositionable Yes(2013)

Direct Flow Medical Direct Flow Medical 23, 25, 27, 29mm TF Repositionable Yes(2014)

Edwards Lifesciences Sapien 3 23, 26, 29mm TF, TA 14F sheath (23, 26mm) Yes (2014)

Edwards Lifesciences Centera 23, 26, 29mm TF, SC Repositionable No

Jena Valve Technology Jena Valve 23, 25, 27mm TA Repositionable/

Aortic Insufficiency

(CE mark, 2013)

Yes(2011)

Medtronic Engager 23, 26mm TA Yes(2013)

St Jude Medical Portico 23, 25mm TF Repositionable Yes(2013)

Symetis Acurate TF/

AcurateTAo

S, M, L TF, TAo No

K. Toutouzas, et al., in press

TAVI 2002-2014

EU: 10 Valves

USA: 2 Valves

J. Am. Coll. Cardiol. 2012;59;1200-1254

• Introduction

• Specific groups

• Clinical risk stratification

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

Horizontal Aorta

John.. Latsios.. Grube., JACC Inter, 2010

N= 100 with CoreValve

Severe Calcium

Treating bioprosthetic failure by transcatheter valve-in-

valve implantation has been shown to be feasible.

Currentevidenceis limited, therefore it cannot be considered as a

valid alternative to surgery except in inoperable or high-risk

patients as assessed by a ‘Heart Team’.

A. Vahanian et al, Eur Heart J. 2012 Oct; 33(20):2569-619

• Female 83yo

• Severe AoS, AVA= 0.4 cm2, peakG= 83mm Hg,

meanG=53mmHg

• LVEF: 50%

• PASP=50mmHg

• Euroscore= 24.4%

TAo-TAVI

Left Iliac Artery Diameter:3,8mm Right Iliac Artery Diameter:4,2mm

TAo-TAVI

Right Subclavian Artery Diameter: 5,1 mmLeft Subclavian Artery Diameter: 3,3 mm

TAo-TAVI

TAo-TAVI

TAo-TAVI

TAo-TAVI

• Introduction

• Specific groups

• Clinical risk stratification

Increased surgical risk

Impaired LV function, gradient and stroke volumes

Concomitant valve disease

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

• STS- Society of Thoracic Surgeons

• LES -EuroSCORE (logistic)

• EuroSCORE (additive)

• Ambler (UK)

• NNE-Northern New England

• New York State

• Providence Health System

• VA Risk Score

• ACEF Score

• Australian-AVR-Score

• STS Upgrade v2.73

• 2011 EuroSCORE II

Characteristic

TAVR

(n=348)

AVR

(n=351)

n n

Age – years (Mean ± SD) 348 83.6 ± 6.8 349 84.5 ± 6.4

Male 201 57.8% 198 56.7%

NYHA Class III or IV 328 94.3% 328 94.0%

Previous CABG 148 42.5 152 43.6

Cerebrovascular disease 96 29.4 87 26.8

Peripheral vascular disease 149 43.2 142 41.6

STS Score (Mean ± SD) 347 11.8 ± 3.3 349 11.7 ± 3.5

Pooled Hazard Ratio [95% CI] p-value

Body Mass Index (lbs/in2) 0.96 [0.94, 0.98] 0.0002

Atrial Fibrillation 1.41 [1.11, 1.80] 0.0050

Mean Gradient (Baseline) 0.99 [0.98, 1.00] 0.0095

Liver Disease 2.38 [1.39, 4.09] 0.0016

STS Risk Score 1.04 [1.01, 1.07] 0.0194

ACC 2013

STS Score predicts mortality in TAVI population

Characteristic TAVRn = 179

Standard Rxn = 179

p value

Age – yr 83.1 ± 8.6 83.2 ± 8.3 0.95

Male sex (%) 45.8 46.9 0.92

STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14

NYHA

I or II (%)

III or IV (%)

7.8

92.2

6.1

93.9

0.68

0.68

CAD (%) 67.6 74.3 0.20

Prior MI (%) 18.6 26.4 0.10

Prior CABG (%) 37.4 45.6 0.17

Prior PCI (%) 30.5 24.8 0.31

Prior BAV (%) 16.2 24.4 0.09

CVD (%) 27.4 27.5 1.00

Makkar et al., NEJM, 2012

STS Score predicts mortality in TAVI population

NO difference with medical treatment

Gilard et al., NEJM, 2012

Gilard et al., NEJM, 2012

Euroscore predicts mortality in TAVI population

• STS score and log EuroSCORE have low c-indexes between 0.49 - 0.70.

• Although the 3 scores were not predictive for 30 day mortality theupdated

EuroSCORE II had better accuracy with area under curve of 0.70. TheSTS

score had the worse predictive value in short term mortality and there was no

difference in STS score between survivals and non-survivals 410±22 days.

Toutouzas K, Stefanadis C., Cardiology, 2013

Iung et al, Heart 2014

Relationship between the score value and predicted early

mortality after transcatheter aortic valve implantation

Development Cohort:

C-statistic (new Score)= 0.67

C-statistic (logistic

Euroscore)=0.59

• Introduction

• Specific groups

• Clinical risk stratification

Increased surgical risk

Impaired LV function, gradient and stroke volumes

Concomitant valve disease

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

1. Patients with low flow, low EF and low gradient should be considered for TAVI vs medical

therapy

2. TAVI has similar 2 year mortality compared to surgery

Herrmann H C et al. Circulation. 2013;127:2316-2326

MEDICAL vs TAVI

SURGICAL vs TAVI

Elmariah S et al. Circ CardiovascInterv. 2013;6:604-614

- EF in TAVI and SAVR did not predict the outcome

Elmariah S et al. Circ CardiovascInterv. 2013;6:604-614

Baseline Characteristics All (n=116)

Male Gender(%) 49 (42%)

Age (y) 80.11±7.27

Body surface area (m2) 1.35±0.19

Diabetes Mellitus 38 (32.7%)

Hypertension 69 (59.4%)

Dyslipidemia 48 (41.4%)

Smoking 12 (10.3%)

Ischemic Heart Disease 51 (43%)

M. Drakopoulou, K. Toutouzas, A. Synetos, G. Latsios, G.

Trantalis, A. Mastrokostopoulos, K. Stathogiannis,

D. Tousoulis, C. Stefanadis.

Parameter Low EF (n=22) High EF (n=94)

Low Svi(n=47) 13 (59.9%) 34 (36.2%)

High Svi (n=69) 9 (40.9%) 60 (63.8%)

ESC 2014

Parameter All (n=116) Low Svi (n=47) High Svi(n=69) P value

EjectionFraction (%) 51.43±9.26 49.68±10.85 52.62±7.85 0.09

Stroke volume index (ml/m2) 44.93±10.44 30.24±4.3 54.58±11.81 <0.01

LVOT diameter (cm) 1.85±0.20 1.81±0.21 1.93±0.18 0.002

AVA mean Gradient (mmHg) 50.38±14.79 46.37±15.57 53.11±13.69 0.01

AVA peak Gradient (mmHg) 83.19±23.14 77.96±24.11 86.86±21.87 <0.01

AVA(cm2) 0.59±0.14 0.53±0.14 0.63±0.12 0.001

Pulmonary systolic pressure

(mmHg)

42.93±14.79 42.87±12.57 42.97±10.61 0.96

M. Drakopoulou, K. Toutouzas, A. Synetos, G. Latsios, G.

Trantalis, A. Mastrokostopoulos, K. Stathogiannis,

D. Tousoulis, C. Stefanadis.

ESC 2014

M. Drakopoulou, K. Toutouzas, A. Synetos, G. Latsios, G.

Trantalis, A. Mastrokostopoulos, K. Stathogiannis,

D. Tousoulis, C. Stefanadis.

SVi was the only independent predictor of 2-year mortality

(OR:0.95, 95%, CI:0.917-0.998, p=0.039)

0

10

20

30

40

50

60

70

No Yes

Sv

i(m

l/m

2)

No Yes

Cumulative mortality

p=0.03

0

10

20

30

40

50

60

70

No Yes

EF

(%

)

No Yes

Cumulative mortality

p=0.31

ESC 2014

• Introduction

• Specific groups

• Clinical risk stratification

Increased surgical risk

Impaired LV function, gradient and stroke volumes

Concomitant valve disease

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

Toggweiler et al., JACC, 2012

N= 451 with Edwards

Barbanti et al., Circulation, 2013

N= 518

TAVI SURGERY

Barbanti et al., Cath and Card Int, 2014

None/mild Mod/Sev P

All-cause 20% 38.4% 0.001

Cardiac 4.6% 13% 0.004

N= 79

• Introduction

• Specific groups

• Clinical risk stratification

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

MGA:

Cognition

Nutrition

Mobility

Daily activity

Stortecky et al., JACC Inter, 2012

Buellesfeld.. Latsios.. Grube et al., EHJ, 2010

• 100 year old male patient, mobile

• Severe symptomatic (NYHA III-IV) aortic valve stenosis

• Med Hx: hypertension on amiloride/furosemide

• Echocardiography:

– EF 30%, estimated pulmonary pressure 50 mmHg

– aortic valve area 0.5 cm2, mean gradient 45 mmHg, peak gradient 105 mmHg

• No significant coronary artery disease

• EuroSCORE: 41%

• Katz ADLS: 6/6

• Groningen Frailty Indicator: 1/15

• Fried Frailty Index: 1/5

• Passed :

– eye ball test

– grip strength test

– gait speed test

• Karnofsky index: 80-90

29 mm CoreValve TAVI (trans-femoral 18 F access)

• 29 mm CoreValve implantation

• under light sedation/ local anesthesia

• End result

• 5 mmHg gradient

• no Aortic Regurgitation

• Stable and mobile

• Improvement in dyspnea (NYHA I)

• Echocardiography:

– Aortic valve area 1.8 cm2 with trivial paravalvular

regurgitation

– mean gradient 9 mmHg, peak gradient 18 mmHg,

– EF 30%.

• 2 year follow up

• Same clinical and echo condition

• Walks, writes memoirs (!)

• 102 years old 5 meter gait speed test

• Introduction

• Specific groups

• Clinical risk stratification

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

Lindman et al., JACC Card Inter, 2014

• Introduction

• Specific groups

• Clinical risk stratification

• Geriatric risk stratification

• Benefit of TAVI

• Future perspectives

Kappetein et al., EHJ, 2012

Intermediate-risk Patients

Intermediate-risk Patients

405 TAVI

405 SAVR

Piazza et al, JACC, 2013

Wenaweser et al, EHJ, 2013

Intermediate-risk Patients

Osnabrugge et al, Ann of Thor Surg, 2012

Intermediate-risk Patients

Intermediate-risk Patients

Intermediate-risk Patients

• Female, 89 yo

• NYHA III

• Euroscore: 24.4%

• AVA: 0.64cm2

• MG: 48mmHg

• Vmax: 4.33m/s

• PASP~ 40mmHg

NO AORTIC REGURGITATION

• Low procedural risk

• Optimal valve performance

• Optimal valve durability

• Experience with TAVI

Intermediate-risk Patients

Bicuspid AV

Bicuspid AV

Dilated aortic root Big angulation 2 pig-tails used

Roy et al,

JACC, 2013

Pure AR

Seiffert et al, JACC Card Interv, 2013

Pure AR

Martinez-Clarck et al, JACC Card Interv, 2014

Banai et al, JACC Card Interv, 2014

Mitral Valve

The First “In-Air” Holographic Display and

Interface System

3D Acquisition

Modalities

Special Contributors:

• G. Latsios

• A. Synetos

• K. Toutouzas

• TAVI has increased the capacity for treating AoS

patients

• Proper evaluation by a Heart Team is necessary

• No therapy is universally beneficial

• When TAVI is futile, supporting care must go on

• The best of medical care is still ahead!

Α’ Καρδιολογική Κλινική

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