Translational Pathways for Cardiovascular Devices – Session VI: The Methods for Left Ventricular Assist Devices Development – Francis Pagani Practice Quiz – ISCTR | International Society for Cardiovascular Translational Research

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Question 1 of 11

1. Question
Which of the following is correct regarding heart failure?
- It is estimated that 250,000 patients over 75years of age suffer from advanced heart failure NYHA class III/IV
- 1 year mortality is approximately 15% in patients with heart failure NYHA class III/IV
- In the US, the number of heart transplants exceeds 5,000 patients/year
- None
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Question 2 of 11

2. Question
Ventricular assist device implantations in patients with heart failure exceed 10,000 per year
- True
- False
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Question 3 of 11

3. Question
The ROADMAP trial showed no improvement in survival when comparing ventricular assist devices to medical therapy
- True
- False
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Question 4 of 11

4. Question
It took approximately 20 years to develop the HeartMate 3 LVAD
- True
- False
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Question 5 of 11

5. Question
Verification and validation studies of LVAD include:
- Accelerated life test but not real time life test
- Accelerated life test but not highly accelerated life tests
- Mechanical safety but not electrical safety
- Real time life test and highly accelerated life tests
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Question 6 of 11

6. Question
During LVAD development, when standard testing is not available custom testing is acceptable by the FDA
- True
- False
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Question 7 of 11

7. Question
LVAD placement can increase aortic insufficiency
- True
- False
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Question 8 of 11

8. Question
The animal model used to evaluate LVAD predicted the occurrence of von Willebrand disease
- True
- False
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Question 9 of 11

9. Question
Which of the following is correct?
- The REMATCH trial compared LVAD to medical therapy and established the indication for the destination therapy
- The ENDURANCE trial compared LVAD to medical therapy and established the indication for the destination therapy
- The HeartMate II trial compared HeartWare vs HeartMate II devices
- None of the above
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Question 10 of 11

10. Question
Introducing adaptive design to the clinical trial of LVAD helps in early commercialization
- True
- False
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Question 11 of 11

11. Question
Which of the following is correct regarding ventricular assist device complications?
- The risk of stroke in VAD patients is 3-fold higher than medical therapy
- The risk of device thrombosis has increased with new devices
- Infection has currently almost been eliminated with new devices
- Bleeding occurs in approximately 5% of patients
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