This document provides instructions for collecting and presenting patient screening data for transcatheter aortic valve implantation (TAVI). It includes sections on indications and contraindications, guidelines for collecting echo, angiogram, CT, and other imaging data, templates for presenting this data, and examples of how to incorporate imaging files and measurements. The overall goal is to thoroughly evaluate and document each patient's eligibility for the TAVI procedure.

1. THV PATIENT SCREENING FILE Patient # .. Center: _________________________

3. INSTRUCTIONS FOR USE 2/2 Helpful tool for Windows users is the “Snipping Tool” Where you can easily make pictures from your screen Via START button->All Programs->Accessories See example

6. PATIENT DATA Echo Evaluation Add text in Edit mode Click boxes in Presentation mode Hospital Name Logisc EuroSCORE / STS Score Subject Initials _____________________________ __ % / __% __ __First/Last If Euroscore < 20% and STS < 10%, COMMENTS: Date of Screening: __/__/____ (dd/mm/yyyy) Subject Gender Female Male Height: Subject Age and birth date ___________________________ Weight: ECHO FINDINGS Annulus Ø, TTE (mm) (18 to 24) Annulus Ø, TEE (mm) (18 to 24) AVA (cm 2 ) (< 0.8 cm 2 ) Mean gradient (mmHg) EF (>20%) Calcification degree Septal hyperthrophy Bicuspid/unicuspid aortic valve? AORTOGRAM Calcified bulky leaflets? Distance coronary ostia – annulus (≥10mm) Horizontal aorta? Define optimum view (3 leaflets aligned) Porcelain aorta? CORONAR ANGIOGRAM Coronary diseases? Comments: ECG Conduction irregularities Pace Maker AV Block/ RBBB/LBBB Comments

7. PATIENT DATA Echo Evaluation Add text in Edit mode PATIENT ’S HISTORY , SYMPTOMS, NYHA CLASS ADDITIONAL COMMENTS HELPFUL FOR PATIENT EVALUATION

8. PATIENT DATA Peripheral Sizing Add text in Edit mode Click boxes in presentation mode CT Scan (section 5 mm max) Angiogram RIGHT VESSEL SIZE Right Common Femoral Vessel Size > 7.5 mm (Smallest Diameter) YES NO Right External Iliac Vessel Size > 8 mm (Smallest Diameter) YES NO Right Common Iliac Vessel Size > 8 mm (Smallest Diameter) YES NO Tortuosity None Mild Moderate Severe Degree of Calcification None Mild Moderate Severe LEFT VESSEL SIZE Right Common Femoral Vessel Size > 7.5 mm (Smallest Diameter) YES NO Right External Iliac Vessel Size > 8 mm (Smallest Diameter) YES NO Right Common Iliac Vessel Size > 8 mm (Smallest Diameter) YES NO Tortuosity None Mild Moderate Severe Degree of Calcification None Mild Moderate Severe ABDOMINAL AND THORACIC AORTA Aortic Calcification No Yes Aortic Tortuosity No Yes EDWARDS RECOMMENDATIONS Edwards Valve Size: 23mm 26mm Edwards Sheath Access Site: Right Left

9. PATIENT DATA Add text in Edit mode Click boxes in presentation mode INVESTIGATOR SIGNATURE Print Name Date __ __ / __ __ / __ __ __ __(dd/mm/yyyy) Email address: CASE APPROVED BY SCREENER Yes No Screener Comments/Explanations SCREENERS SIGNATURE Print Name Date __ __ / __ __ / __ __ __ __(dd/mm/yyyy)

10. ECHO Pictures PICTURE 1 LONG AXIS Measurement Nr1 + value PICTURE 2 LONG AXIS Measurement Nr2 + value PICTURE 3 LONG AXIS Measurement Nr3 + value Show annulus measurements -hinge point to hinge point- Include diameter sinuses 3 different measurements PICTURE 4 SHORT AXIS view (Calcium distribution)

12. AORTOGRAM Picture PICTURE Aortic Root Shot To recognize distance ostia to bottom cusps

13. ANGIOGRAM Peripheral Include here the Peripheral Angiogram AVI file Movie

14. CT Angio Heart & Peripherals Place PICTURE Aortic Root distance from, Corononary Ostia to bottom cusp Place PICTURE Aortic bifurcation (CT-slice) Both for TA & TF

15. CT Angio Heart & Peripherals Place PICTURE Left Side Smallest lumen from Aortic bifurcation to common femoral Place PICTURE Right Side Smallest lumen from Aortic bifurcation to common femoral If available 3D Reconstruction Total Aorta and peripherals pictures Please keep DICOM CT-Angio CD available SPECIFIC FOR TransFemoral CASES Make sure you can recognize calcium differentiating from lumina (greyscaling)

16. CORONARY Angiogram Include here the Coronary Angiogram Full coverage standard Coronary Angiogram AVI file Movie

18. EXAMPLES IMAGING =>Echo 22mm 23mm ECHO 3x Long Axis Views Measurements (not realistic measurements!) 23mm ECHO Short Axis View

20. EXAMPLES IMAGING => Aortogram peripherals ANGIOGRAM PERIPHERALS Provides Info on: Tortuosity

21. EXAMPLES IMAGING => CT Angio BIFURCATION OSTIA TO BOTTOM CUSPS SMALLEST DIAMETERS 3D RECONSTRUCTION

22. GENERAL INFO For coming to the training please bring the Powerpoint Presentations. Make sure you provide as much data as possible If sending data to the proctor (who will attend the implants) also include the CD’s with all the files in DICOM format as he/she can re-measure (If you have questions please contact your local Clinical Specialist)

23. Thank you!