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2 Potential conflicts of interest Speaker's name: Petros Dardas MEDTRONIC proctor for TAVI

3 Intermediate risk 83 FEMALE COAD SEVERE AS NYHA III Mean gradient 35 mmhg, AVA 0.45cm2, SVI 21ml/m2 Paradoxical low flow low gradient normal EF severe AS PA = 50 mm Hg NORMAL CORS EUROSCORE 14,7% EVOLUT R 23mm

4 Intermediate risk - PARTNER II

5 Intermediate risk - SURTAVI

6

7

8

9 Intermediate risk Pre echo Pre aogram

10 Intermediate risk Post echo Post Aogram

11

12 A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data, and expert opinion in the field of AS 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients

13 An Appropriate treatment is one in which the potential benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the potential negative consequences of the treatment strategy scoring the clinical scenarios from 1 through Rarely Appropriate care 4 6 May Be Appropriate care 7 9 Appropriate care

14 High or Extreme Risk: STS-PROM score of 30-day surgical mortality >8% ANATOMICAL FACTORS : porcelain aorta hostile chest (e.g., prior chest radiation) LIMA crossing the midline in a substernal location FUNCTIONAL FACTORS : frailty advanced liver disease oxygen-dependent chronic obstructive pulmonarydisease (COPD) end-stage renal disease (ESRD) severe pulmonary hypertension with right ventricular dysfunction neurocognitive impairment

15 Intermediate Risk: STS-PROM 3% - 8% 10% Low Risk: STS-PROM < 3%

16 Scenario 1 multiple comorbidities Severe symptomatic AS STS-PROM 8% 15% Health status seems to be influenced more by AS than by comorbidities Anticipated life expectancy >1 y TAVI A (8) SAVR M (5)

17 CASE 1 79 female MVR metallic 2001 Normal MVR EF 35% AS mean gradient 34mmHg, AVA 0.37cm2, SVI < 35ml/m2 Low flow-low EF severe AS Severe PHT > 70 mm Hg MDS, COAD EUROSCORE 54,11%

18

19 Outcomes with TAVR Compared to Medical Therapy and SAVR in Low Gradient, Low EF AS Inoperable patients TAVR vs. MM N = 42 (out of 971 patients in PARTNER A and B) Improved survival observed with TAVR High risk patients TAVR vs. SAVR N = 105 (out of 971 patients in PARTNER A and B) Similar survival observed with TAVR Herrmann et al. Circulation 2013;127:

20 Repositionability could be especially useful in some subsets Previous metallic valve prosthesis

21 PRE LOTUS INSERTION

22 FINAL

23 ECHO 1 MONTH LV IMPROVED LOTUS GRADIENT

24 ECHO 1 MONTH LOTUS LOTUS

25 Scenario 2 Anatomy PORCELAIN AORTA Severe symptomatic AS Porcelain aorta or hostile chest Otherwise high or intermediate surgical risk due to comorbidities No intervention R (2) TAVI A (8) SAVR R (3) Severe symptomatic AS Porcelain aorta or hostile chest Otherwise low surgical risk due to comorbidities No intervention R (1) TAVI A (8) SAVR M (4)

26 CASE 2 72 FEMALE CA L BREAST radical mastectomy radiation chemotherapy HOSTILE CHEST L LYMPHOEDEMA SOB NYHA III

27 ECHO: Severe AS - small volume SVI <35ml/m2 AVGRAD 50mmHg (max) -30mmHg (mean) AVA 0.55cm2 PARADOXICAL LOW FLOW NORMAL EF SEVERE AS CT PORCELAIN AO, SEVERE LVOT CALCIFICATION LHC NORMAL CORS

28 EUROSCORE 4.81% HOSTILE CHEST PORCELAIN AO TAVI EVOLUT R 26MM POST TAVI: CHB - PPM

29

30 Echo pre

31 AOGRAM DEPLOYMENT 1

32 DEPLOYMENT 1 TOO DEEP SEVERE AR DEPLOYMENT 2 HIGHER

33 FINAL RELEASE MODERATE AR INCOMPLETE APOSITION due to severe LVOT calcification SMALL BALLOON (20mm) POST DILATATION

34 FINAL RESULT AOGRAM MINIMAL AR FINAL RESULT ECHO MINIMAL AR

35 3 days later ECHO

36 Scenario 3 associated CAD Left main; SYNTAX <33 3-vessel disease; SYNTAX >22 High or intermediate surgical risk Left main; SYNTAX <33 3-vessel disease; SYNTAX > 22 Low surgical risk TAVI + PCI Α (7) SAVR + CABG A (8) TAVI + PCI R (2) SAVR + CABG A (9)

37 Scenario 3 associated CAD Left main; SYNTAX >33 High or intermediate surgical risk Left main; SYNTAX >33 Low surgical risk TAVI + PCI M (6) SAVR + CABG A (8) TAVI + PCI R (2) SAVR + CABG A (9)

38 CASE 3 - Concomitant CAD PTCA-TAVI markedly oval annulus 84 male Previous CVA x 2 Moderate CRF NYHA III ECHO: Severe AS, mean gradient 48mmHg, peak gradient 87mmHg, AVA 0.42cm2 LHC: Severe LMS - LAD - Im - RCA disease SYNTAX 24 EUROSCORE 25.27%

39 ECHO PRE

40 CT Annulus diameter : 30,5 x 19,4 mm mean 25,9 mm LVOT diameter : 31 x 17.5 mm

41 PTCA LMS LAD - IM PRE POST

42 PTCA RCA PRE POST

43 TAVI EVOLUT R 29 mm PRE POSITION 1

44 TAVI EVOLUT R 29 mm POSITION 1 POSITION 1

45 TAVI EVOLUT R 29 mm REPOSITION lower REPOSITION lower

46 TAVI EVOLUT R 29 mm FINAL INITIALLY incomplete apposition moderate residual AR ECHO

47 TAVI EVOLUT R 29 mm 10 mins later complete aposition

48 ECHO FINAL 4 days later

49 Scenario 4 associated Mitral valve Severe symptomatic AS Severe primary/secondary MR High surgical risk disease Severe symptomatic AS Severe primary/secondary MR Intermediate Low surgical risk TAVI + Mitral clip M (6) SAVR + MVR A (7) TAVI + Mitral clip R (2) SAVR + MVR A (9)

50 CASE 4 80 years old 2000: CABG x 3: LIMA-LAD, RIMA-IM, RADIAL- CX/OM SEVERE SOB NYHA III

51 ECHO LVH INFEROSEPTAL HYPOKINESIS EF 40% SEVERE AS PG max=73mmhg, Pg mean = 44 mmhg, AVA = 0.64 SEVERE MR type I/IIIb SEVERE PHT (70 mmhg)

52 LHC PATENT GRAFTS NO SEVERE STENOSES RCA

53 PLAN EUROSCORE 35.6% TAVI EVOLUT R 29mm? MITRAL CLIP

54 SEVERE AS

55 SEVERE AS

56 LHC Patent LIMA Patent RCA Patent SVG Cx

57 SEVERE FMR

58 SEVERE FMR

59 TAVI EVOLUT R 29mm

60 TAVI EVOLUT R 29mm

61 TAVI EVOLUT R 29mm

62 TAVI EVOLUT R 29mm FINAL RESULT

63 TAVI EVOLUT R 29 mm

64 TAVI EVOLUT R 29 mm

65 FMR still persisting

66 4 months later FMR still persisting NYHA II-III

67 4 months later FMR still persisting NYHA II-III 3 D TOE incomplete leaflet aposition TAVI very good result

68 RESHAPE TRIAL MITRAL CLIP 3 D incomplete coaptation 3 D COLOR severe MR

69 RESHAPE TRIAL MITRAL CLIP

70 RESHAPE TRIAL MITRAL CLIP

71 RESHAPE TRIAL MITRAL CLIP

72 RESHAPE TRIAL MITRAL CLIP 2 nd clip 2 nd clip

73 RESHAPE TRIAL MITRAL CLIP

74

75 3 MONTHS LATER patient NYHA I-II TAVI short axis TAVI short axis colour

76 3 MONTHS LATER patient NYHA I-II TAVI TAVI colour

77 3 MONTHS LATER patient NYHA I-II Mitral clip 2D Mitral clip 2D colour

78 Scenario 5 Failing Aortic Valve Bioprosthesis Severe symptomatic AS or AR Degenerative surgical bioprosthesis size > 23 mm High surgical risk Severe symptomatic AS or AR Degenerative surgical bioprosthesis size > 23 mm Intermediate surgical risk TAVI A (8) SAVR A (7) TAVI A (7) SAVR A (8)

79 Scenario 5 - Failing Aortic Valve Severe symptomatic AS or AR Degenerative surgical bioprosthesis size < 19 mm High surgical risk Bioprosthesis Severe symptomatic AS or AR Degenerative surgical bioprosthesis size < 19 mm Intermediate surgical risk TAVI M (5) SAVR A (8) TAVI R (3) SAVR A (8)

80 VIV - attractive treatment option Avoids redo operation Less trauma Faster recovery Easier Procedure Less/no contrast Near Perfect Implant zone Every patient with degenerated Surgical valve is NOT for VIV

81 Main Concerns with VIV Aortic SHV THV Malposition High Gradients Coronary Obstruction Native anatomy

82 CASE 5 valve in valve 84 MALE AVR bioprosthetic MITROFLOW 23 8 years ago Renal failure hemodialysis Severe heart failure NYHA IV Repeated episodes of pulmonary oedema

83 ECHO: severe transvalvular AR - moderate AVR stenosis moderate LV impairment LHC: moderate CAD EUROSCORE = 34.7

84

85

86 VALVE in VALVE CORE VALVE 23 mm

87

88

89

90

91 36 months later: NYHA II

92 In conclusion

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