Κωνσταντίνος Τούτουζας. Αναπληρωτής Καθηγητής Καρδιολογίας Α Πανεπιστημιακή Καρδιολογική Κλινική Ιπποκράτειο Νοσοκομείο Αθηνών

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1 Κωνσταντίνος Τούτουζας Αναπληρωτής Καθηγητής Καρδιολογίας Α Πανεπιστημιακή Καρδιολογική Κλινική Ιπποκράτειο Νοσοκομείο Αθηνών

2 Dr Paul Dudley White 1931

3 Homograft 1962 First PVT animal implantation A. Cribier First Corevalve animal implantation JC. Laborde Mechanical heart valve 1962 Transvascular Porcine valve 1965 Pericardial tissue valve 1969 First Edwards/PVT Transapical Beating Heart AVR Webb, Lichtenstein Nov 29, 2005 Hippokration Hospital, 1 st CoreValve implanted Surgery First PVT Transcatheter AVR by Antegrade Approach Alain Cribier First CoreValve Transcatheter AVR by Retrograde Approach Laborde, Lal, Grube July 12, 2004 > TAVI Valves implanted worldwide First CoreValve PERCUTANEOUS AVR by Retrograde Approach Oct 12, 2006 Serruys, DeJaegere, Laborde

4 (X 1000) CAG: EU 14% US 27% US EU ~90K procedures by Multiple Industry Sources

5 Existing TAVI Devices TAVI Studies Future TAVI Devices

6 K. Toutouzas, K. Stathogiannis, G. Latsios, A. Synetos, C. Stefanadis, 2012, Recent Pat Cardiovasc Drug Discov

7 Existing TAVI Devices TAVI Studies Future TAVI Devices

8 TCT 2014 S. Yakubov

9 Genereux et al., JACC, 2012 Urena et al., Circulation, 2014

10 235 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 Α Καρδιολογική Κλινική Πανεπιστημίου Αθηνών 2014

11 Nishimura et al, 2014

12 Existing TAVI Devices TAVI Studies Future TAVI Devices

13 Stroke Bleeding Vascular complications Device positioning PVL

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15 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

16 CoreValve Evolut R 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

17 CoreValve Evolut R Longer landing zone for better sealing Toutouzas K et al, HJC Supplement, 2014

18 CoreValve Evolut R

19 CoreValve Evolut R Low profile Recapturable Repositionable Advanced valve performance CoreValve Evolut R CE Study (n= 60) CoreValve Evolut R US Study (n= 250)

20 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

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22 Sapien 3 Reduces further PVL Delivered through 14 Fr esheath Bovine pericardial tissue

23 Sapien 3 V. Thourani, TCT 2014

24 Sapien 3 V. Thourani, TCT 2014

25 Sapien 3 V. Thourani, TCT 2014

26 Sapien 3 V. Thourani, TCT 2014

27 Sapien 3 V. Thourani, TCT 2014

28 Sapien 3 V. Thourani, TCT 2014

29 Sapien 3 V. Thourani, TCT 2014

30 Self expanding Centera

31 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

32 Direct Flow Non-metallic frame Bovine pericardial tissue 18 Fr delivery and retrieval for all sizes Treatment range: mm

33 Direct Flow C. Davidson

34 Direct Flow

35 Direct Flow

36 Direct Flow C. Davidson

37 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

38 Lotus

39 Lotus I. Meredith

40 Lotus I. Meredith

41 Lotus I. Meredith

42 Lotus I. Meredith

43 Lotus

44 Lotus I. Meredith

45 Lotus I. Meredith

46 Lotus

47 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

48 Acurate H. Mollmann

49 Acurate H. Mollmann

50 Acurate H. Mollmann

51 Acurate

52 Medtronic CoreValve Evolut R Edwards Sapien 3 and Centera Direct Flow Medical BSC Lotus Symetis Acurate Valve Medical

53 Valve Medical

54 Valve Medical

55 Valve Medical

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58 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

59 Valve Medical

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64 Kappetein et al., EHJ, 2012

65 Intermediate-risk Patients 405 TAVI 405 SAVR Piazza et al, JACC, 2013

66 Intermediate-risk Patients Wenaweser et al, EHJ, 2013

67 Intermediate-risk Patients Piazza et al, JACC CV Interv, 2013

68 Intermediate-risk Patients Osnabrugge et al, Ann of Thor Surg, 2012

69 Intermediate-risk Patients

70 Intermediate-risk Patients

71 Intermediate-risk Patients Low procedural risk Optimal valve performance Optimal valve durability Experience with TAVI

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73 Roberts et al, AJC, 2012

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77 Dilated aortic root Big angulation 2 pig-tails used Roy et al, JACC, 2013

78 Seiffert et al, JACC Card Interv, 2013

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80 100 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

81 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

82 Pre-procedural Karnofsky index (functional performance status) as the only independent predictor of TAVI outcome. Eur Heart J Apr;31(8):

83 29 mm CoreValve TAVI (trans-femoral 18 F access)

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85 29 mm CoreValve implantation under light sedation/ local anesthesia End result 5 mmhg gradient no Aortic Regurgitation

86 Stable and mobile Improvement in dyspnea (NYHA I) Echocardiography: Aortic valve area 1.8 cm 2 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

87 Special Contributors: G. Latsios A. Synetos K. Toutouzas

88 SURGERY TF-TAVI Genereux et al, 2013, JACC

89 By SamirKapadia

90 Δεν υπήρχε διαφορά μεταξύ των δύο ομάδων Thourani VH ACC 2013

91 Kodali et al., NEJM, 2012

92 TAVR Patients had Lower Mortality N= 795 Adams DH et al. N Engl J Med 2014

93 Procedural Outcomes N= 795 Adams DH et al. N Engl J Med 2014

94 In patients with prohibited risk for SAVR, TAVI showed an one year all-causemortality of 26%, much lower than the optimal performance goal (43%) Popma J, et.al., JACC 2014

95 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

96 2,47% NYHA after TAVI 1,24% 30,86% 65,43% NYHA I NYHA II NYHA III NYHA IV Η TAVI είχε ως αποτέλεσμα σημαντική βελτίωση στη λειτουργική ικανότητα κατά NYHA στο 1 έτος παρακολούθησης. Α Καρδιολογική Κλινική Πανεπιστημίου Αθηνών 2014