Table 9.
All-Cause Mortality | Cardiovascular Mortality and Noncardiovascular Mortality |
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Cardiovascular mortality | Death classified and adjudicated as 1 of the mutually exclusive categories below: |
Cardiac mortality—death related to: | |
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Vascular mortality—death caused by noncardiac vascular causes classified and adjudicated as one category below | |
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Valve-related mortalitya—death presumed to be related to | |
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Cardiohepatic: hepatic failure related to tricuspid valve dysfunction | |
Cardiorenal: renal failure related to tricuspid valve dysfunction | |
Noncardiovascular mortality | Death clearly related to a noncardiovascular cause such as respiratory failure not related to heart failure (eg, pneumonia), noncardiac renal failure, noncardiac liver failure, infection (eg, urosepsis), cancer, trauma, and suicide |
aRelatedness to device therapy should be adjudicated for each endpoint.
bTiming with respect to device therapy to be classified as per Table 8.