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THV PATIENT SCREENING FILE Patient # .. Center:  _________________________
INSTRUCTIONS FOR USE 1/2 Please make a copy of this file for every patient Provide as much data as possible  (see slides) Please incorporate the movies into the presentation as shown.  (bring DICOM CDs with it)  Bring the data on a CD or USB stick to the training To enter patient data  (slide 5, 6, 7 and 8)   go into edit mode PowerPoint. To click the boxes  (see slide 7)  go into presentation mode
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
CRITERIA INDICATIONS Symptomatic Degenerative Aortic Stenonosis AVA  0.8cm2 Logistic Euroscore > 20%  or STS > 10% www.euroscore.org/calc.html    http://209.220.160.181/STSWebRiskCalc261 ANNULUS BY  TEE 18 to 21mm  -> 23mm SAPIEN 21+ to 24.5mm  -> 26mm SAPIEN
CRITERIA Non-valvular aortic stenosis Congenital aortic stenosis, unicuspid or bicuspid aortic valve Non-calcified aortic stenosis Evidence of intracardiac mass, thrombus or vegetation Untreated clinically significant coronary artery disease requiring revascularization Active bacterial endocarditis or other active infections Myocardial infarction within 1 month Cerebrovascular accident (CVA) Patient unable to tolerate anticoagulation therapy Hypertrophic cardiomyopathy with or without obstruction (HOCM) Presence of mitral bioprosthesis Severe ventricular dysfunction with ejection fraction < 20% Severe deformities of the chest Severe coagulation problems Unstable angina during index procedure Recent pulmonary emboli Recent Significant atheroma of femoral and iliac vessels Severe tortuosities of the femoro -iliac vessels Severe calcifications or femoro -iliac vessels < 7mm Patients with bilateral iliofemoral bypasses CONTRA - INDICATIONS
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 , TTE (mm) (18 to 24) Annulus , 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
PATIENT DATA  Echo Evaluation Add text in Edit mode PATIENT S HISTORY , SYMPTOMS, NYHA CLASS ADDITIONAL COMMENTS HELPFUL FOR PATIENT EVALUATION
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
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)
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)
ECHO  Movie Echo AVI file  Movie Show Echo Movie: Long Axis view 4 Chamber view Short axis view  (calcium distribution) Ventricular contraction Mitral Valve apparatus
AORTOGRAM  Picture PICTURE Aortic Root Shot To recognize distance  ostia to bottom cusps
ANGIOGRAM  Peripheral Include here the  Peripheral Angiogram AVI file  Movie
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
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)
CORONARY Angiogram Include here the  Coronary Angiogram Full coverage standard Coronary Angiogram AVI file Movie
OUR SUGGESTIONS This Patient will be suitable for TransFemoral or TransApical Comments:  ___________________________________________________ Suggested Valve Size: ___ mm
EXAMPLES IMAGING =>Echo 22mm 23mm ECHO 3x Long Axis Views Measurements  (not realistic measurements!) 23mm ECHO  Short Axis View
EXAMPLES IMAGING => Aortogram AORTOGRAM Provides Info on: Angulation Left Main to bottom cusps Diameter Sinusses Porcelain Aorta
EXAMPLES IMAGING => Aortogram peripherals ANGIOGRAM PERIPHERALS Provides Info on: Tortuosity
EXAMPLES IMAGING => CT Angio BIFURCATION OSTIA TO BOTTOM CUSPS SMALLEST DIAMETERS 3D 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 CDs 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!

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Thv patient screening template

  • 1. THV PATIENT SCREENING FILE Patient # .. Center: _________________________
  • 2. INSTRUCTIONS FOR USE 1/2 Please make a copy of this file for every patient Provide as much data as possible (see slides) Please incorporate the movies into the presentation as shown. (bring DICOM CDs with it) Bring the data on a CD or USB stick to the training To enter patient data (slide 5, 6, 7 and 8) go into edit mode PowerPoint. To click the boxes (see slide 7) go into presentation mode
  • 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
  • 4. CRITERIA INDICATIONS Symptomatic Degenerative Aortic Stenonosis AVA 0.8cm2 Logistic Euroscore > 20% or STS > 10% www.euroscore.org/calc.html http://209.220.160.181/STSWebRiskCalc261 ANNULUS BY TEE 18 to 21mm -> 23mm SAPIEN 21+ to 24.5mm -> 26mm SAPIEN
  • 5. CRITERIA Non-valvular aortic stenosis Congenital aortic stenosis, unicuspid or bicuspid aortic valve Non-calcified aortic stenosis Evidence of intracardiac mass, thrombus or vegetation Untreated clinically significant coronary artery disease requiring revascularization Active bacterial endocarditis or other active infections Myocardial infarction within 1 month Cerebrovascular accident (CVA) Patient unable to tolerate anticoagulation therapy Hypertrophic cardiomyopathy with or without obstruction (HOCM) Presence of mitral bioprosthesis Severe ventricular dysfunction with ejection fraction < 20% Severe deformities of the chest Severe coagulation problems Unstable angina during index procedure Recent pulmonary emboli Recent Significant atheroma of femoral and iliac vessels Severe tortuosities of the femoro -iliac vessels Severe calcifications or femoro -iliac vessels < 7mm Patients with bilateral iliofemoral bypasses CONTRA - INDICATIONS
  • 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 , TTE (mm) (18 to 24) Annulus , 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)
  • 11. ECHO Movie Echo AVI file Movie Show Echo Movie: Long Axis view 4 Chamber view Short axis view (calcium distribution) Ventricular contraction Mitral Valve apparatus
  • 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
  • 17. OUR SUGGESTIONS This Patient will be suitable for TransFemoral or TransApical Comments: ___________________________________________________ Suggested Valve Size: ___ mm
  • 18. EXAMPLES IMAGING =>Echo 22mm 23mm ECHO 3x Long Axis Views Measurements (not realistic measurements!) 23mm ECHO Short Axis View
  • 19. EXAMPLES IMAGING => Aortogram AORTOGRAM Provides Info on: Angulation Left Main to bottom cusps Diameter Sinusses Porcelain Aorta
  • 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 CDs with all the files in DICOM format as he/she can re-measure (If you have questions please contact your local Clinical Specialist)