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Their wordsThe endpoint that drove the results were open to bias in this open label trial. In the win ratio, the HF hospitalization endpoint did the work: 9,280 vs 2,871 wins. Death rates were close (4,366 vs 3,166), and 74% of pairs were tied on death. Hospitalization, of course, is a clinician decision. Since everyone knows the treatment assignment, it's easy to give an increase in oral diuretics to a patient with a device while admitting a patient without one.
Their wordsThe fourth issue was that the amount of TR reduction was modest. Only 70% of repair patients had moderate or less TR at 30 days, versus 30% of controls. That is less complete than reported in TRILUMINATE.
Their wordsBefore embracing the tricuspid valve repair approach, I feel we need more compelling data.
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