SAPIEN 3 Sizing Considerations:

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1 SAPIEN 3 Sizing Considerations: Oversizing, Undersizing, or Volume reduction? John Webb MD St Paul s Hospital University of British Columbia Vancouver

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below Grant/Research Support Edwards Lifesciences, Abbott Vascular St Jude Medical Siemens Consulting Fees/Honoraria Edwards Lifesciences Abbott Vascular

3 Oversize or undersize? Oversize Larger sheath may be needed AV block Peri-aortic hematoma Annular rupture (including septum, AML) Undersize Paravalvular leak Malposition

4 3D CT annulus measurement is now standard Systolic image Sinus Annulus LVOT

5 Annular Rupture is not Random Univariate Predictors Odds Ratio (95%CI) P value LVOT calcification > moderate ( ) <0.001 Prosthesis area oversizing 20% 8.38 ( ) <0.001 Barbanti M et al. Circulation 2013

6 Oversize less if there is LVOT calcium No LVOT calcium LVOT calcium

7 Cross-sectional Area Increases Markedly When Transitioning to a Larger THV 23 mm 26 mm Diameter increases 13% Perimeter increases 13% Area increases 28%

8 What happens if you underfill the balloon by 5-10%? Very roughly Annular stretch will be reduced THV inflow size will be reduced slightly Little effect on symmetry, gradients Less risk of annular injury? Reduced durability?

9 Tunable valve strategy Select an oversized valve Underfill 5% to <10%: if oversizing >20% by area if high risk for rupture (eg. LVOT calcification, very elderly, XRT) If there is a leak, then add in removed contrast and post-dilate

10 Reality check: balloon sizing Choose a balloon with a diameter close to that of the planned THV Aortogram +/- TEE Does it look like it fills the root? Is the balloon stable? Is there a leak around the balloon? 25mm balloon fills the root 26mm Sapien XT with nominal filling

11 Adjustable Valve Sizing Strategy 1. Under expand 2. Oversize 3. Redilate if necessary

12 An adjustable valve sizing strategy NovaFlex balloon SAPIEN XT Nominal Volume Under fill ~ 10% 23 mm 17 ml 1.5 ml 26 mm 22 ml 2 ml 29 mm 33 ml 3 ml

13 Hemodynamics with SAPIEN XT remain excellent at 1 year Mean gradient (mmhg) Area (cm2) Post-implant 1 year P AR <mild 100% 97% Tan J, in press

14 SAPIEN 3 SAPIEN 3 Sizing 20 mm 23 mm 26 mm 29 mm

15 SAPIEN 3 LVOT calcium, oversizing >20% by area LVOT calcium Underfilled 9% Slightly underexpanded No leak

16 SAPIEN 3: Asymmetric expansion is not rare even with nominal inflation volume

17 SAPIEN 3 Nominal volume Under expanded Redilation resulted in full expansion

18 SAPIEN 3 29mm THV, underfilled 2ml (6%) Slightly asymmetric Still circular

19 However the SAPIEN 3 THV is different!! Sizing with 3D imaging is more accurate Positioning is more accurate External skirt effectively adds ~1mm of sealing

20 PV Leak According to Degree of Oversizing Patients with >mil d PVL (%) p= p= Sapien 3 Sapien XT p= Oversizing not needed with SAPIEN 3? 0 0 to 5% 5 to 10% > 10% MDCT area oversizing (%) J Leipsic. Multicenter review

21 Predictable deployment & sealing

22 Bicuspid, 0% oversizing, no leak

23 We may not need to oversize at all Declined for SAPIEN XT 2 years before Annulus 680mm 2 SAPIEN 3 29 = 649mm 2 Undersizing 5% Still no leak

24 SAPIEN 3 CE high/intermediate risk trial Echo AR at 30 Days P A R A V A L V U L A R A R ( N = ) None/Trace Mild Moderate Severe 100% 2.6% 5.1% 3.4% 80% 28.6% 15.4% 24.1% 60% 40% 68.8% 79.5% 72.4% 20% 0% TF TAA Overall N = 77 N = 39 N = 116

25 SAPIEN 3 CE intermediate risk trial Echo AR at 30 Days 100% 2.3% 80% 26.4% 60% 40% 71.3% 20% 0% 30 Days None/Trace Mild Moderate Severe N = 87

26 PARTNER II S3HR & S3 trials Echo AR at 30 days 0.1% No. of Echos 1504

27 Paravalvular AR at 30 Days and 1 Year SAPIEN 3 HRi trial A L L PAT I E N T S None/Trace Mild Moderate Severe 100% 80% 3.4% 2.0% 23.9% 14.0% 60% 40% 72.7% 84.0% 20% 0% 30 Days 1 Year N = 117 N = 100

28 New Sizing Recommendations Using 3D CT Area 23 mm 26 mm 26 mm mm 2 mm 2 mm

29 PAR Stratified by % Oversizing by Area from Blanke and Leipsic, PII S3i 100% 90% Severe 80% 70% 60% Moderate-Severe Moderate 50% % 44.2 Mild-Moderate 30% 20% 10% Mild None/Trace 0% Below -5% Between -5% to 0% Between 0% to 5% Between 5% to 10% Above 10% No annular rupture

30 PAR Moderate for Oversizing by Systolic Area and Perimeter Predictor for PAR AUC [95% CI] Optimal Cutoff Sensitivity Specificity p-value % Oversizing by Area 0.74 [0.66,0.82] < % Oversizing by Perimeter 0.75 [0.67,0.82] < from Blanke and Leipsic, PII S3i

31 End

32 TEE

33 Paravalvular regurgitation The valve is too small The valve is too high The valve is too low Calcific nodules

34 Aortic injury Nodule perforates sinus hematoma Peri-aortic

35 SAPIEN 3 trials Study n Post-dilation Annular rupture SAPIEN 3 CE HRi % 0.7% SAPIEN 3 CE i % O.0% PARTNER II HR % 0.3% PARTNER II i % 0.2%

36

37 PAR Stratified by % Oversizing by Perimeter from Blanke and Leipsic, PII S3i 100% 90% Severe 80% 70% Moderate-Severe 60% 43.7 Moderate 50% 40% 45.6 Mild-Moderate 30% 20% Mild 10% 25.1 None/Trace 0% Below -2.5% Between -2.5% to 0% Between 0% to 2.5% Between 2.5% to 5% Above 5% No annular rupture

38 AR according to valve type Amat-Santos et al. Laval-Vancouver matched cases, in press AJC 2014

39 The annulus is larger in systole. Slide Courtesy of J. Leipsic, MD

Jonathon Leipsic MD FRCPC FSCCT. Vice Chairman of Radiology University of British Columbia. Disclosures

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