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.
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