ΔΙΑΔΕΡΜΙΚΗ ΑΝΣΙΚΑΣΑΣΑΗ ΑΟΡΣΙΚΗ ΒΑΛΒΙΔΑ αντιμετώπιση επιπλοκών ΠΕΣΡΟ. ΔΑΡΔΑ, MD, FESC IICE 2012

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1 ΔΙΑΔΕΡΜΙΚΗ ΑΝΣΙΚΑΣΑΣΑΗ ΑΟΡΣΙΚΗ ΒΑΛΒΙΔΑ αντιμετώπιση επιπλοκών ΠΕΣΡΟ. ΔΑΡΔΑ, MD, FESC IICE 2012

2 TAVR Technologies Current Generation Devices ~ 50,000 patients treated thru 2011 in > 500 interventional centers around the world! Edwards Lifesciences Medtronic CoreValve

3 PARTNER Manuscripts in NEJM (October, 2010 May, 2012)

4 All Cause Mortality (ITT) Crossover Patients Censored All Cause Mortality (%) Standard Rx TAVR at 1 yr = 20.0% NNT = 5.0 pts HR [95% CI] = 0.56 [0.43, 0.73] p (log rank) < % 30.7% 68.0% 43.3% at 2 yr = 24.7% NNT = 4.0 pts Months Numbers at Risk TAVR Standard Rx

5 All-Cause Mortality (ITT) TAVR AVR HR [95% CI] = 0.88 [0.70, 1.12] p (log rank) = All-Cause Mortality 26.8% 24.3% 35.0% 33.9% Months Numbers at Risk TAVR AVR

6 TAVR Complications Strokes Vascular Events/Bleeding New Pacemakers Para-Valvular Regurgitation Others

7 CoreValve ADVANCE 30-day Outcomes

8 Para-valvular Regurgitation

9 PARTNER Grading Criteria for Paravalvular AR Circumference = 6 AR = = 0.45 Ratio = 8% Severity = Mild (< 10%) Circumference = 6 AR = = 1.0 Ratio = 17% Severity = Moderate (10 20%) (Trans AR also present) Circumference = 6 AR = = 1.7 Ratio = 28% Severity = Severe (> 20%) Images courtesy of Pamela Douglas, MD, FASE

10 Relation of AR to All-cause Mortality 2-year Results of PARTNER trial Cohort A Kodali SK. et al. NEJM 2012

11 Relation of AR to All-cause Mortality Corevalve ADVANCE Registry March 2012 data

12 Relation of AR to Cardiovascular Mortality Corevalve ADVANCE Registry March 2012 data

13 ΣΟ ΠΡΟΓΡΑΜΜΑ ΜΑ ΜΕ ΣΗΝ COREVALVE MEDTRONIC

14 Χαρακτηριςτικά ΜΣ Ηλικία Φύλo Θ Θ Θ Θ Α STS score 10,5 6,9 21,2 8 12,6 11,8 EuroScore 22,1 8, ,2 14,5 17,2 NYHA IV IV IV IV IV τεφ. Νόςοσ ΝΑΙ ΝΑΙ ΟΧΙ ΝΑΙ ΝΑΙ Προηγηθείςα Επαναγγείωςη Περιφ. Αγγειοπάθεια CABG CABG PCI ΟΧΙ ΟΧΙ ΟΧΙ ΟΧΙ ΟΧΙ ΧΑΠ ΝΑΙ ΝΑΙ ΟΧΙ ΟΧΙ ΟΧΙ ΧΝΑ ΝΑΙ ΟΧΙ ΟΧΙ ΟΧΙ ΝΑΙ

15 ECHO post Max PG Mean PG AR

16 CRS Italy: Valve-in-Valve Causes of PVL lower deployment 75.0% (N=18) higher deployment 25.0% (N=6)

17 CASE 1 79 male MI 2008 PTCA LMS LAD Multiple myeloma chronic chemotherapy

18 CASE 1 Recently worsening SOB NYHA III/IV ECHO: Moderate LV impairment EF 35% AVA 0.9 cm2 AVAI 0.5cm2/m2 severe AS (max gradient 43 mmhg mean gradient 24 mmhg) LOW FLOW LOW EF SEVERE AORTIC STENOSIS LHC: Patent stents EUROSCORE 15% - multiple comorbidities TAVI (transfemoral)

19

20 CASE 1

21 CASE 1

22 CASE 1 RFA pigtail in non-coronary sinus

23 CASE 1 wire crossing - ballooning

24 Target landing zone 4-6 mm below the aortic annulus

25 Release in a 3 steps sequence 1. Slow release before annular contact

26 Release in a 3 steps sequence 2. Fast release post annular contact and drop in BP

27 Release in 3 steps sequence 3. Slow release with distal end still attached to the catheter

28 CASE 1 core valve positioning 4mm above 0 level

29 CASE 1 gradual opening high position

30 CASE 1 valve withdrawal

31 CASE 1 valve repositioning lower position 4-6 mm

32 CASE 1 valve positioning

33 Target landing zone 4-6 mm below the aortic annulus 4-6 mm

34 CASE 1 final result no AR

35 TOE post TAVI

36 CASE 1 iliac angio

37 CASE 2 76 female IDDM CABG 2008 (LIMA, RIMA) PPM due to sinus arrest Chronic anemia Poor mobility

38 CASE 2 Gradually worsening SOB NYHA III Recent admission with severe LVF iv diuretics ECHO : Good LV, LVH Severe AS (peak gradient 105mmHg mean gradient 50 mmhg) AVA 0.5 cm2 Moderate PHT LHC : patent grafts EUROSCORE 19% - multiple comorbidities TAVI (transfemoral)

39 CASE 2 valve positioning

40 CASE 2 paravalvular leak low position

41 CASE 2 pulling the device

42 CASE 2 final result

43 CASE 2 post echo

44 Key Factors in PVL PVL Prosthesis Sizing Prosthesis Positioning Prosthesis Expansion Prosthesis Apposition Annulus/Prosthesis Delivery System Annulus Measur. Technique of Implant. Line-up Range of Implant. Circularity/full opening Stent frames material Calcium Calcium Annulus Shape Tricuspid/Bicuspid

45 Optimal MSCT Sizing Area Perimeter Elliptical Shape: Max dia. 28,5 mm; Min dia. 20 mm Area 4,71 cm2, Perimeter 7,9 cm

46 Post-Dilation after TAVR RESULTS: BPD in 59 pts (28%) leading to a reduction of 1 grade AR in 71% and residual AR < 2 in 54% Predictors for BPD: degree of valve Ca++ & TF approach; valve Ca++ volume best predicted need for and poor response to BPD Nombela-Franco LO et al. JACC Intv 2012;5:

47

48 Devices with Reduced Paravalvular AR Subannular Fixation Space Fillers

49 Take Home Message PVL after TAVI are not rare, but generally are Trivial or Mild Significant AR is a powerfull adverse prognostic indicator of short and long term mortality; Mild AR may be clinically significant Prosthesis Sizing has a crucial role in PVL genesis Measurement of annulus perimeter and area with MSCT is mandatory to prevent significant PVL ViV and Postdilatation are generally effective in PVL reduction Next Generation devices will help in PVL reduction

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