Interventional procedure overview of caval valve implantation for tricuspid regurgitation
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Outcome measures
The main outcomes include NYHA functional class, health and quality of life status using KCCQ, 6WMD, and maximal oxygen uptake. The measures used are detailed in the following paragraphs.
NYHA functional class
The NYHA functional class is used to classify heart failure according to severity of symptoms and limitation of physical activity:
Class 1 - no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, breathlessness or palpitations.
Class 2 - slight limitation of physical activity. Comfortable at rest but ordinary physical activity results in undue breathlessness, fatigue or palpitations.
Class 3 - marked limitation of physical activity. Comfortable at rest but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.
Class 4 - unable to carry out any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is done, discomfort is increased.
KCCQ
The KCCQ is a 23-item self-administered questionnaire that measures the patient's perception of their health status, including heart failure symptoms, effect on physical and social function, and how their heart failure affects their quality of life within a 2-week recall period. Scores are scaled from 0 to 100, where higher scores represent better health status.
Maximal oxygen uptake (VO2max)
The product of peak cardiac output and maximal arteriovenous oxygen difference is referred to as maximal oxygen uptake. This is the amount of oxygen used by a subject when exercising as hard as possible. The primary endpoint was determined by quantifying maximal oxygen uptake by treadmill spiro-ergometry.
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