Κωνσταντίνος Τούτουζας

Αναπληρωτής Καθηγητής Καρδιολογίας

Α’ Πανεπιστημιακή Καρδιολογική Κλινική

Ιπποκράτειο Νοσοκομείο Αθηνών

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,

1st CoreValve implanted

>100.000 TAVI Valves implanted

worldwide

37

32

27

2016

11

520.7

47

40

3531

27

14

19

24

0

10

20

30

40

50

60

2010 2011 2012 2013 2014 2015 2016 2017 2018

US EU

Multiple Industry Sources - 2013

(X 1000)

~90K procedures

by 2018

52

CAG: EU 14%

US 27%

• Existing TAVI Devices

• TAVI Studies

• Future TAVI Devices

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

2012, Recent Pat Cardiovasc Drug Discov

• Existing TAVI Devices

• TAVI Studies

• Future TAVI Devices

TCT 2014

S. Yakubov

Genereux et al., JACC, 2012

Urena et al., Circulation, 2014

Α΄ Καρδιολογική Κλινική Πανεπιστημίου Αθηνών 2014

• 235 ασθενείς (213 μέσω Μηριαίας; 22 μέσω Υποκλειδίου)

• Επιτυχής τοποθέτηση σε όλους

• Μέσο Κ.Ε. 58±3%

• Μέση Κλίση Πίεσης 8mmHg

• Μέση Νοσηλεία 5±1 ημέρες

• FU έως 28 μήνες

Nishimura et al, 2014

• Existing TAVI Devices

• TAVI Studies

• Future TAVI Devices

• Stroke

• Bleeding

• Vascular complications

• Device positioning

• PVL

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

• Tailored height and fit

• Optimized radial force

• Coaptation in non-circular anatomy

• Anti-mineralization treatment:

Reduces early and late valvular

calcification

Toutouzas K et al, HJC Supplement, 2014

CoreValve Evolut R

Longer landing zone for better sealing

Toutouzas K et al, HJC Supplement, 2014

CoreValve Evolut R

CoreValve Evolut R

• Low profile

• Recapturable

• Repositionable

• Advanced valve performance

• CoreValve Evolut R CE Study (n= 60)

• CoreValve Evolut R US Study (n= 250)

CoreValve Evolut R

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

• Reduces further PVL

• Delivered through 14 Fr eSheath

• Bovine pericardial tissue

Sapien 3

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Sapien 3

V. Thourani, TCT 2014

Self expanding

Centera

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

• Non-metallic frame

• Bovine pericardial tissue

• 18 Fr delivery and retrieval for all sizes

• Treatment range: 19-26 mm

Direct Flow

C. Davidson

Direct Flow

Direct Flow

Direct Flow

C. Davidson

Direct Flow

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

Lotus

I. Meredith

Lotus

I. Meredith

Lotus

I. Meredith

Lotus

I. Meredith

Lotus

Lotus

I. Meredith

Lotus

I. Meredith

Lotus

Lotus

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

Acurate

H. Mollmann

Acurate

H. Mollmann

Acurate

H. Mollmann

Acurate

• Medtronic CoreValve Evolut R

• Edwards Sapien 3 and Centera

• Direct Flow Medical

• BSC Lotus

• Symetis Acurate

• Valve Medical

Valve Medical

Valve Medical

Valve Medical

• TAVI proved its safety and efficacy in the

mid-term

• Long-term results (>5 years) are eagerly awaited

• The newer generation valves show a great promise in safety

and applicability

• The trend of TAVI towards intermediate-risk patients is the

next big thing

Valve Medical

Kappetein et al., EHJ, 2012

Intermediate-risk Patients

405 TAVI

405 SAVR

Piazza et al, JACC, 2013

Wenaweser et al, EHJ, 2013

Intermediate-risk Patients

Piazza et al, JACC CV Interv, 2013

Intermediate-risk Patients

Osnabrugge et al, Ann of Thor Surg, 2012

Intermediate-risk Patients

Intermediate-risk Patients

Intermediate-risk Patients

• Low procedural risk

• Optimal valve performance

• Optimal valve durability

• Experience with TAVI

Intermediate-risk Patients

Roberts et al, AJC, 2012

Dilated aortic root Big angulation 2 pig-tails used

Roy et al,

JACC, 2013

Seiffert et al, JACC Card Interv, 2013

• 100 year old male patient, mobile

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

• Med Hx: hypertension on amloride/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 and

– gait speed test

• Karnofsky index 80-90

Pre-procedural Karnofsky index (functional performance status) as the only

independent predictor of TAVI outcome.

Eur Heart J. 2010 Apr;31(8):984-91.

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

Special Contributors:

• G. Latsios

• A. Synetos

• K. Toutouzas

Genereux et al, 2013, JACC

SURGERY TF-TAVI

By SamirKapadia

Δεν υπήρχε διαφορά μεταξύ των δύο ομάδων

Thourani VH ACC 2013

Kodali et al., NEJM, 2012

Adams DH et al. N Engl J Med 2014

N= 795

TAVR Patients had Lower Mortality

Procedural OutcomesN= 795

Adams DH et al. N Engl J Med 2014

In patients with prohibited risk for SAVR, TAVI showed an one year all-cause-

mortality of 26%, much lower than the optimal performance goal (43%)

Popma J, et.al., JACC 2014

Α΄ Καρδιολογική Κλινική Πανεπιστημίου Αθηνών 2014

89%

Η επιβίωση των ασθενών που υποβλήθηκαν σε διαδερμική αντικατάσταση αορτικής βαλβίδας (Core Valve) στην κλινική μας ανήλθε στο 89% στα 3,5 έτη παρακολούθησης.

Α΄ Καρδιολογική Κλινική Πανεπιστημίου Αθηνών 2014

65,43%

30,86%

1,24%2,47% NYHA after TAVI

NYHA I

NYHA II

NYHA III

NYHA IV

Η TAVI είχε ως αποτέλεσμα σημαντική βελτίωση στη λειτουργική ικανότητα κατά NYHA στο 1 έτος παρακολούθησης.