1. CoreValve ® MSCT Scan Acquisition and Processing March 2013 Innovating for life. UC201305577 EE

2. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. The MSCT Sizing Process The sizing process includes three main parts, all of equal importance: –Proper image acquisition and post-processing –Reformatting of the aortic root and preparation for measurement –Aortic root measurements and device selection (covered earlier in presentation)

3. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. MSCT Scan Acquisition

4. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Multi-detector CT scanner (64-slice minimum) with ECG- gating capability. –The scans of the aortic root MUST be ECG-gated. Non-gated scans in areas with cardiac motion lead to measurement inaccuracy and therefore incomplete information for device selection. –Peripheral vessel image acquisition may be non-gated. Post-processing software capable of MPR and standard measurements (diameter, area, perimeter) –This is typically standard on most imaging system workstations –This is also available on many second party applications Equipment Required

5. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. 1.Chest topogram 2.ECG-gated contrast enhanced aortic root 3.Non ECG-gated contrast enhanced peripheral vessels Sub-millimeter slice thickness is required for scans 2 and 3 Scans Required

6. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. The scan protocol is similar to a CT coronary angiogram. The aim is to get adequate contrast in the region of interest (i.e., endo-luminal surface) for visualization of left heart, aorta, and peripheral access vessels (i.e., femorals and subclavians) when necessary. Temporal resolution should be optimized to reduce motion artifact. Spatial resolution should be as high as possible (goal is smallest isotropic voxel size for high-quality MPR). Scanning Procedures

7. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Administer medication per institution standard practice for CT scanning. Attach ECG electrodes for gating of scan. Verify quality of ECG tracing on scanner console. Prepare large intravenous line (18 or 20 gauge) for administration of contrast media. Instruct patient to lie still during scan, even if they experience warmth or tingling due to the injection of contrast. Instruct patient in practice of breath-hold at end- inspiration for 10-15 seconds (duration required will depend on specific scanner performance). Assess heart rate variability during breath-hold. If heart rate is >65 bpm or unstable, consider titration of beta-blockers. Step 1: Patient Preparation

8. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Acquire a chest topogram for use in planning the imaging protocol. Step 2: Topogram

9. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Intent: Assessment of aortic root and valve anatomy Coverage area –Suggested: Superior to aortic arch - inferior to cardiac apex –Minimum: 10 mm below aortic annulus – 70 mm above aortic annulus (includes the aortic root and direct aortic access) Retrospective or prospective ECG-gating may be used Reconstruct or trigger in systole Required detector collimation of 0.4 – 0.625 mm Required slice thickness of < 1 mm Recommended slice overlap of 0.4 mm Step 3: Contrast Enhanced Scan Parameters

10. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Minimum Coverage Area Recommended Coverage Area

11. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Prepare iodinated contrast injection apparatus. Set up scan parameters per the table on slide 17. Instruct patient to lie still during scan, even if they experience warmth or tingling due to the injection of contrast. Initiate contrast injection. When contrast reaches threshold at bolus-tracking location, instruct patient to hold breath at end-inspiration, then initiate main scan protocol. At completion of scan verify images are of adequate quality. Record amount of contrast given. Record heart rate average and range. Step 3: ECG-Gated, Contrast Enhanced Scan Execution

12. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Verify heart rate ECG triggers are at consistent place in cardiac cycle, edit if necessary. Additional editing/removal of arrhythmias may be performed. If retrospective gating is used: –Reconstruct the cleanest systolic phase from a signal-noise ratio and motion artifact perspective. –Automated “best-systolic” reconstruction can also be used. –< 1 mm slice thickness with small overlap Step 4: Post-processing of Aortic Root Images

13. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. ECG-Gated, Contrast Enhanced Scan Parameters

14. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Intent: Assessment of peripheral access vessels Standard radiology CT angiography protocol Non ECG-gated Delay time calculated using protocol for current scanner (i.e., bolus tracking) with peak of contrast concentration in the area of interest Suggested coverage areas: –Femoral access only screening: abdominal aorta above celiac artery and down to the femoral head –Subclavian access only screening: above the subclavian arteries and down to mid-thorax –Combined access screening: above the subclavian arteries and down to the femoral head Source data reconstructed using < 1 mm slice thickness with small overlap Step 5: Non-gated, Contrast-Enhanced Scan of the Peripheral Access Vessels

15. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. MSCT Scan Processing

16. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. The aortic annulus is not co-planar with the planes of the body (i.e., axial, sagittal, or coronal). Therefore, multi-planar reformatting of the CT images is required to create a double-oblique axial image for annulus measurements. This reformatting is critical; if the plane is not correctly aligned, it may be passing through the sinuses or the LVOT. This can lead to improper device selection. This reformatting is also used in assessing the measurements for the rest of the aortic root (sinus width, height and ascending aorta diameters). The following methods are similar to those reported in Schultz et al. EuroIntervention Supplement (2010) Volume 6 (Supplement G) G6- G13. Proper Aortic Annulus Measurements

17. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Example images in original orientation (axial, coronal and sagittal). Red curved arrow and line indicate adjustment of coronal and sagittal planes to align with aortic annular plane. Step 1: Multiplanar Reformat AxialCoronal Sagittal3D

18. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Step 2: Verify Aortic Annular Plane Example images of reformatted oblique coronal (upper left), oblique sagittal (lower left), double oblique (upper right) and 3D reconstruction (lower right). Yellow triangles indicate most basal attachment points of the aortic valve. Double Oblique Axial Oblique Coronal Oblique Sagittal 3D

19. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. The Aortic Annulus on MSCT Descending Aorta Aortic Annulus RVOT RA LA LAA

20. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Example of Incorrect Plane – Too Low Example images of reformatted oblique coronal (upper left), oblique sagittal (lower left), double oblique (upper right) and 3D reconstruction (lower right). The double oblique axial image is located approximately 10 mm into the LVOT. Double Oblique Axial Oblique Coronal Oblique Sagittal 3D

21. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Example of Incorrect Plane – Too High Oblique Coronal Double Oblique Axial Oblique Sagittal Example images of reformatted oblique coronal (upper left), oblique sagittal (lower left), double oblique (upper right) and 3D reconstruction lower right. The double oblique axial image is located a few mm into the aortic root and the leaflets are visible. Double Oblique Axial Oblique Coronal Oblique Sagittal 3D

22. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. Example of Incorrect Plane – Wrong Orientation Example images of reformatted oblique coronal (upper left), oblique sagittal (lower left), double oblique (upper right) and 3D reconstruction lower right. The double oblique axial image is located in the wrong orientation as the right coronary leaflet is visible while the others are not. Double Oblique Axial Oblique Coronal Oblique Sagittal 3D

23. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S. or Japan. Medtronic, Inc. 2013. All Rights Reserved. CoreValve ® is a registered trademark of Medtronic CV Luxembourg S.a.r.l. For more information and a complete list of adverse events, warning and contraindications reference CoreValve IFU.