THV PATIENT SCREENING FILE

Patient # ..

Center: _________________________

INSTRUCTIONS FOR USE 1/2

1. Please make a copy of this file for every patient

2. Provide as much data as possible (see slides)

3. Please incorporate the movies into the presentation as shown. (bring DICOM CDs with it)

4. Bring the data on a CD or USB stick to the training

5. To enter patient data (slide 5, 6, 7 and 8) go into edit mode PowerPoint.

6. To click the boxes (see slide 7) go into presentation mode

1. Please make a copy of this file for every patient

2. Provide as much data as possible (see slides)

3. Please incorporate the movies into the presentation as shown. (bring DICOM CDs with it)

4. Bring the data on a CD or USB stick to the training

5. To enter patient data (slide 5, 6, 7 and 8) go into edit mode PowerPoint.

6. To click the boxes (see slide 7) go into presentation mode

INSTRUCTIONS FOR USE 2/2Helpful tool for Windows users is the

“Snipping Tool”Where you can easily make pictures from your

screenVia START button->All Programs->Accessories

See example

Helpful tool for Windows users is the “Snipping Tool”

Where you can easily make pictures from your screen

Via START button->All Programs->AccessoriesSee example

CRITERIA

INDICATIONSINDICATIONS

1.Symptomatic Degenerative Aortic Stenonosis

2.AVA ≤ 0.8cm2

3.Logistic Euroscore > 20% or STS > 10%

www.euroscore.org/calc.html http://209.220.160.181/STSWebRiskCalc261

INDICATIONSINDICATIONS

1.Symptomatic Degenerative Aortic Stenonosis

2.AVA ≤ 0.8cm2

3.Logistic Euroscore > 20% or STS > 10%

www.euroscore.org/calc.html http://209.220.160.181/STSWebRiskCalc261

ANNULUS BY ANNULUS BY TEETEE

18 to 21mm -> 23mm SAPIEN

21+ to 24.5mm -> 26mm SAPIEN

ANNULUS BY ANNULUS BY TEETEE

18 to 21mm -> 23mm SAPIEN

21+ to 24.5mm -> 26mm SAPIEN

CRITERIA

1. Non-valvular aortic stenosis2. Congenital aortic stenosis, unicuspid or bicuspid aortic valve3. Non-calcified aortic stenosis4. Evidence of intracardiac mass, thrombus or vegetation5. Untreated clinically significant coronary artery disease requiring revascularization6. Active bacterial endocarditis or other active infections7. Myocardial infarction within 1 month8. Cerebrovascular accident (CVA)9. Patient unable to tolerate anticoagulation therapy10. Hypertrophic cardiomyopathy with or without obstruction (HOCM)11. Presence of mitral bioprosthesis12. Severe ventricular dysfunction with ejection fraction < 20%13. Severe deformities of the chest14. Severe coagulation problems15. Unstable angina during index procedure16. Recent pulmonary emboli Recent17. Significant atheroma of femoral and iliac vessels18. Severe tortuosities of the femoro -iliac vessels19. Severe calcifications or femoro -iliac vessels < 7mm20. Patients with bilateral iliofemoral bypasses

1. Non-valvular aortic stenosis2. Congenital aortic stenosis, unicuspid or bicuspid aortic valve3. Non-calcified aortic stenosis4. Evidence of intracardiac mass, thrombus or vegetation5. Untreated clinically significant coronary artery disease requiring revascularization6. Active bacterial endocarditis or other active infections7. Myocardial infarction within 1 month8. Cerebrovascular accident (CVA)9. Patient unable to tolerate anticoagulation therapy10. Hypertrophic cardiomyopathy with or without obstruction (HOCM)11. Presence of mitral bioprosthesis12. Severe ventricular dysfunction with ejection fraction < 20%13. Severe deformities of the chest14. Severe coagulation problems15. Unstable angina during index procedure16. Recent pulmonary emboli Recent17. Significant atheroma of femoral and iliac vessels18. Severe tortuosities of the femoro -iliac vessels19. Severe calcifications or femoro -iliac vessels < 7mm20. Patients with bilateral iliofemoral bypasses

CONTRA - INDICATIONSCONTRA - INDICATIONS

PATIENT DATA Echo Evaluation

Hospital Name Logisc EuroSCORE Logisc EuroSCORE / STS ScoreSTS Score Subject Initials_____________________________ __ % / __% __ __First/LastIf Euroscore < 20% and STS < 10%, COMMENTS:

Date of Screening: __/__/____ (dd/mm/yyyy)

Subject Gender Female MaleHeight:

Subject Age and birth date ___________________________ Weight:

ECHO FINDINGSECHO FINDINGSAnnulus Ø, TTE (mm) (18 to 24) Annulus Ø, TEE (mm) (18 to 24)AVA (cm2) (< 0.8 cm2) Mean gradient (mmHg)EF (>20%) Calcification degreeSeptal hyperthrophy Bicuspid/unicuspid aortic valve?

AORTOGRAMAORTOGRAMCalcified bulky leaflets? Distance coronary ostia – annulus (≥10mm)Horizontal aorta? Define optimum view (3 leaflets aligned)Porcelain aorta?

CORONAR ANGIOGRAMCORONAR ANGIOGRAMCoronary diseases?Comments:

ECGECGConduction irregularitiesPace MakerAV Block/ RBBB/LBBBComments

Add text in Edit modeClick boxes in Presentation mode

PATIENT DATA Echo EvaluationPATIENT ’S HISTORY , SYMPTOMS, NYHA CLASS

ADDITIONAL COMMENTS HELPFUL FOR PATIENT EVALUATION

Add text in Edit mode

PATIENT DATA Peripheral Sizing

CT Scan (section 5 mm max) Angiogram

RIGHT VESSEL SIZERight Common Femoral Vessel Size > 7.5 mm (Smallest Diameter) YES

NORight External Iliac Vessel Size > 8 mm (Smallest Diameter) YES NORight Common Iliac Vessel Size > 8 mm (Smallest Diameter) YES NOTortuosity None Mild Moderate SevereDegree of Calcification None Mild Moderate Severe

LEFT VESSEL SIZERight Common Femoral Vessel Size > 7.5 mm (Smallest Diameter) YES NORight External Iliac Vessel Size > 8 mm (Smallest Diameter) YES NORight Common Iliac Vessel Size > 8 mm (Smallest Diameter) YES NOTortuosity None Mild Moderate SevereDegree of Calcification None Mild Moderate Severe

ABDOMINAL AND THORACIC AORTAAortic Calcification No Yes Aortic Tortuosity No YesEDWARDS RECOMMENDATIONS

Edwards Valve Size: 23mm 26mmEdwards Sheath Access Site: Right

Left

Add text in Edit modeClick boxes in presentation mode

PATIENT DATA

INVESTIGATOR SIGNATUREPrint Name Date __ __ / __ __ / __ __ __ __(dd/mm/yyyy)Email address:

CASE APPROVED BY SCREENER Yes NoScreener Comments/Explanations

SCREENERS SIGNATUREPrint Name Date __ __ / __ __ / __ __ __ __(dd/mm/yyyy)

Add text in Edit modeClick boxes in presentation mode

ECHO Pictures

PICTURE 1PICTURE 1

LONG AXIS LONG AXIS Measurement Nr1Measurement Nr1

+ value+ value

PICTURE 1PICTURE 1

LONG AXIS LONG AXIS Measurement Nr1Measurement Nr1

+ value+ value

PICTURE 2PICTURE 2

LONG AXIS LONG AXIS Measurement Nr2Measurement Nr2

+ value+ value

PICTURE 2PICTURE 2

LONG AXIS LONG AXIS Measurement Nr2Measurement Nr2

+ value+ valuePICTURE 3PICTURE 3

LONG AXIS LONG AXIS Measurement Nr3Measurement Nr3

+ value+ value

PICTURE 3PICTURE 3

LONG AXIS LONG AXIS Measurement Nr3Measurement Nr3

+ value+ value

Show annulus measurements-hinge point to hinge point-Include diameter sinuses3 different measurements

Show annulus measurements-hinge point to hinge point-Include diameter sinuses3 different measurements

PICTURE 4PICTURE 4

SHORTSHORT AXIS view AXIS view(Calcium distribution)(Calcium distribution)

PICTURE 4PICTURE 4

SHORTSHORT AXIS view AXIS view(Calcium distribution)(Calcium distribution)

ECHO Movie

EchoEcho

AVI file AVI file MovieMovie

EchoEcho

AVI file AVI file MovieMovieShow Echo Movie:

•Long Axis view•4 Chamber view•Short axis view (calcium distribution)

•Ventricular contraction•Mitral Valve apparatus

Show Echo Movie:

•Long Axis view•4 Chamber view•Short axis view (calcium distribution)

•Ventricular contraction•Mitral Valve apparatus

AORTOGRAM Picture

PICTUREPICTURE

Aortic Root ShotAortic Root Shot

To recognize distance To recognize distance ostia to bottom cuspsostia to bottom cusps

PICTUREPICTURE

Aortic Root ShotAortic Root Shot

To recognize distance To recognize distance ostia to bottom cuspsostia to bottom cusps

ANGIOGRAM Peripheral

Include here the Include here the Peripheral AngiogramPeripheral Angiogram

AVI file AVI file MovieMovie

Include here the Include here the Peripheral AngiogramPeripheral Angiogram

AVI file AVI file MovieMovie

CT Angio Heart & Peripherals

Place PICTUREPlace PICTURE

Aortic Root Aortic Root distance from, Corononary Ostia to distance from, Corononary Ostia to

bottom cusp bottom cusp

Place PICTUREPlace PICTURE

Aortic Root Aortic Root distance from, Corononary Ostia to distance from, Corononary Ostia to

bottom cusp bottom cusp

Place PICTUREPlace PICTURE

Aortic bifurcationAortic bifurcation(CT-slice)(CT-slice)

Place PICTUREPlace PICTURE

Aortic bifurcationAortic bifurcation(CT-slice)(CT-slice)

Both for TA & TFBoth for TA & TF

CT Angio Heart & Peripherals

Place PICTUREPlace PICTURELeftLeft Side Side

Smallest lumen from Aortic Smallest lumen from Aortic bifurcation to common bifurcation to common

femoralfemoral

Place PICTUREPlace PICTURELeftLeft Side Side

Smallest lumen from Aortic Smallest lumen from Aortic bifurcation to common bifurcation to common

femoralfemoral

Place PICTUREPlace PICTURERight Right SideSide

Smallest lumen from Aortic Smallest lumen from Aortic bifurcation to common bifurcation to common

femoralfemoral

Place PICTUREPlace PICTURERight Right SideSide

Smallest lumen from Aortic Smallest lumen from Aortic bifurcation to common bifurcation to common

femoralfemoralIf availableIf available

3D Reconstruction3D ReconstructionTotal Aorta and Total Aorta and

peripheralsperipheralspicturespictures

If availableIf available3D Reconstruction3D Reconstruction

Total Aorta and Total Aorta and peripheralsperipherals

picturespictures

Please keep Please keep DICOMDICOM CT- CT-Angio CD Angio CD availableavailable

SPECIFIC FOR TransFemoral CASESSPECIFIC FOR TransFemoral CASES

Make sure you can recognize calcium differentiating from lumina (greyscaling)

Make sure you can recognize calcium differentiating from lumina (greyscaling)

CORONARY Angiogram

Include here the Include here the Coronary AngiogramCoronary Angiogram

Full coverage standard Coronary Full coverage standard Coronary AngiogramAngiogram

AVI file MovieAVI file Movie

Include here the Include here the Coronary AngiogramCoronary Angiogram

Full coverage standard Coronary Full coverage standard Coronary AngiogramAngiogram

AVI file MovieAVI file Movie

OUR SUGGESTIONS

This Patient will be suitable for

TransFemoralor

TransApical

Comments: ___________________________________________________

Suggested Valve Size: ___ mm

This Patient will be suitable for

TransFemoralor

TransApical

Comments: ___________________________________________________

Suggested Valve Size: ___ mm

EXAMPLES IMAGING=>Echo

22mm

23mm

ECHO 3xLong Axis Views Measurements (not realistic measurements!)

ECHO 3xLong Axis Views Measurements (not realistic measurements!)

23mm

ECHO Short Axis ViewECHO Short Axis View

EXAMPLES IMAGING => Aortogram

AORTOGRAMAORTOGRAM

Provides Info on:•Angulation•Left Main to bottom cusps•Diameter Sinusses•Porcelain Aorta

Provides Info on:•Angulation•Left Main to bottom cusps•Diameter Sinusses•Porcelain Aorta

EXAMPLES IMAGING => Aortogram peripherals

ANGIOGRAMPERIPHERALSANGIOGRAM

PERIPHERALS

Provides Info on:Tortuosity

Provides Info on:Tortuosity

EXAMPLES IMAGING => CT Angio

BIFURCATIONBIFURCATION

OSTIA TO BOTTOM CUSPSOSTIA TO BOTTOM CUSPSSMALLEST DIAMETERSSMALLEST DIAMETERS

3D RECONSTRUCTION3D RECONSTRUCTION

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)

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)

Thank you!