Affiliation/Financial Relationship Grant/ Research Support: Major Stock Shareholder/Equity Interest: Royalty Income: Ownership/Founder: Salary:

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1 IMPLANTATION OF SAPIEN XT, TRANSFEMORAL TAPED CASE Gerald Yong MBBS (Hons) FRACP FSCAI Interventional Cardiologist Royal Perth Hospital Western Australia TAVI Summit 9 th Aug 2013

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 Affiliation/Financial Relationship Grant/ Research Support: Consulting Fees/Honoraria: Company Edwards Lifesciences (consultant & proctor) Major Stock Shareholder/Equity Interest: Royalty Income: Ownership/Founder: Salary: Intellectual Property Rights: Other Financial Benefit:

3 77yo male Background CABG 1983 & 2000 Hypertension Hyperlipdemia Symptomatic severe aortic stenosis CCF and syncope TTE Mean gradient 58mmHg; AVA 0.5cm 2 Normal LV function Logistic EuroScore 12%; STS PROM 4%

4 Despite low Logistic EuroScore, Heart Team felt appropriate for TAVR given two previous cardiac surgeries, including patent LIMA

5 Large Clib Calibre Peripheral lv Vessels

6 Annulus Measure TEE 25mm CT 26mm x 28mm CSA 560mm 2 Perimetry 86mm

7 Heavy calcified valve with minimal LVOT Calcium

8 Suitable for TF TAVR using Edwards SAPIEN XT valve

9 Choice of THV 29mm SAPIEN XT Represents 18% oversizing by CSA

10 Transfemoral Kit Nova-Flex NovaFlex Delivery System Edwards SAPIEN XT Valve RetroFlex Balloon Catheter Crimper E sheath Dilator Kit Atrion QL2530 Inflation Device

11 Edwards d SAPIEN XT Valve 23, 26, 29mm Valves Bovine Pericardial Tissue Carpentier-Edwards d ThermaFix Process* Leaflet Matching Technology

12 Contralateral t lv Vascular Access 7Fr sheath to left common femoral artery of contralateral side for 6Fr pigtail for aortography Pressure transducer to sheath immediately and maintain 7Fr sheath to left femoral vein of contralateral side for 6Fr pacing wire

13 Common Femoral Artery Puncture Antegrade angiography guidance

14 Preclosure for large vascular access Operator experience important My current regime: 1x Prostar for 18F sheath 3x Proglide for 22 / 24F sheath Contraindication severely calcified vessel

15 Preclosure Prostar

16 Large Sheath Insertion Over stiff wire Amplatz Extra-stiff or Lunderquist Apply traction to wire Pass smaller dilators Pass at least one dilator past aortic bifurcation or areas of smaller diameter Know position of ffi final sheath tip Do not force sheath

17 Insetion of Pacing Wire for Rapid Ventricular Pacing PACER ON Begin pacing, wait for 1:1 conduction PACER OFF When balloon completely deflated BALLOON UP sbp <50mmHg & pulse pressure <10mmHg for Balloon Inflation Recovery back to 100 mmhg

18 Insertion of Pigtail Catheter and Co-Planar View II projection for valve deployment 3 sinus lined up Reduces parallax error

19

20 Finding Co-Planar View LAO 10 Caud 10 LAO 10 Caud 15

21 Crossing Aortic Valve AL 1 catheter straight-wire LAO projection Identify aortic valve Calcification / movement on fluroscopy Controlled movement Clockwise rotation Watch tip movement

22 Insertion of Stiff Wire with Loop in LV Shape with fingers Ensure junction of stiff & soft parts of wire is in the loop Junction of stiff J & soft

23 Bll Balloon Aortic Vl Valvuloplasty l l

24 Veriry Oi Orientation ti of fthv

25 Insertion of NF Catheter Timing 15 minutes from final crimp to exit sheath 2 minutes from insertion i into sheath to exit sheath

26 Vl Valve Alignment

27 Vl Valve alignment Gross alignment Position in straight portion of descending aorta Press the button with left thumb Pull back balloon catheter slowly Release the button Continue to pull back balloon catheter until lock into valve alignment position NOTE. Advance guidewire while pulling Do not apply torque to catheter Consider unlocking tension once pass double marker

28 Vl Valve alignment Fine alignment Verify system locked in valve alignment position Use magnified perpendicular fluroscopic view Slowly rotate the Valve Alignment Wheel clockwise to center the valve between the Valve Alignment Markers Make sure there is no gap or overlap with the distal valve alignment marker NOTE. A gap between valve and distal marker may result in difficulty crossing An overlap of valve and distal marker cannot be reversed and may result and improper valve deployment

29 Crossing Arch LAO position Observe arch and wire position in LV Rotate flex wheel and fully flex by the time THV reach arch Don t push against resistance Don t let wire pull out!!!

30 Crossing Aortic Valve Check BP before crossing Ensure system fully flexed Be careful of nose-cone after crossing Nose cone extends 4cm from valve

31 KEEP NOVAFLEX KEEP NOVAFLEX AS CLOSE AS POSSIBLE TO THE VALVE / BALLOON

32 Vl Valve Deployment Rapid ventricular pacing Confirm capture & BP drop <10mmHg) Fully inflate for 3 sec Stop rapid pacing after full balloon deflation Remove balloon ASAP

33 Valve Positioning Concept Ideal Position Aortic Valve Leaflet Tips 50% 50% Anterior Mitral Valve Hingepoint Not always possible to satisfy all these

34 Using Leaflet Tip Ca to Help Positioning Predictable Inflation C Ca

35 Final AortoGram TEE Trace PVL AR Index 0.34

36 Rt Retract tnf and dbll balloon Fully unflex the Flex Catheter and retract into the descending aorta Lock the Flex Catheter into the Default Position Remove NF catheter Remove sheath and tie pre-closure sutures

37 Final lf Femoral lag

38 Progress Uncomplicated recovery D/C POD#1 (patient request) TTE Trace PVL