Translational Pathways for Cardiovascular Devices – Session II: The Methods for Transcatheter Aortic Valve Development Practice Quiz – ISCTR | International Society for Cardiovascular Translational Research

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Question 1 of 9

1. Question
Which of the following is correct regarding aortic valve replacement?
- Mechanical valve durability is known and well defined
- Biological valve durability is known and well defined for patients with bicuspid valves
- Biological valve durability is known and well defined for older patients with tricuspid valves
- None of the above
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Question 2 of 9

2. Question
Which of the following is correct when comparing transcatheter aortic valves to bioprosthetic surgical valves?
- Tissues in both valves are identical
- Flow dynamics evaluation is the same for both TAVR and SAVR
- Host response is different between the two valves
- Surgical valves require anticoagulation
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Question 3 of 9

3. Question
Valve tissue validation requirements include all of the following except:
- Fixation chemistry, biomechanics uniaxial and biaxial
- Tensile and stress/strain and bending properties
- Crimping duration should vary
- All testing for valve performance should be conducted on devices that have not been crimped prior to testing
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Question 4 of 9

4. Question
Which of the following is correct regarding valve fatigue testing?
- 200 million cycles to simulate 10 years of valve implant duration
- 200 million cycles to simulate 5 years of valve implant duration
- Visual examination should be done every 50 million cycles or until failure
- Visual examination should be done every 100 million cycles or until failure
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Question 5 of 9

5. Question
In TAVR – valve hydrodynamic performance testing needs to account for which of the following?
- Annulus shape before deployment
- Variations in valve shape and leaflet motion.
- A fixed flow rate for all measures
- All of the above
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Question 6 of 9

6. Question
Delivery system testing includes all of the following, except?
- Tracking and recapturing
- Rotational alignment
- Shelf life
- Human factor testing
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Question 7 of 9

7. Question
Valve validation and verification testing occurs before design freeze
- True
- False
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Question 8 of 9

8. Question
Migration resistance should be tested in an animal model
- True
- False
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Question 9 of 9

9. Question
When evaluating TAVR in animal, the sheep animal model is almost identical to humans and provides all information needed to proceed to a first-in-human study
- True
- False
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