@CMichaelGibson That’s more than I will make!!
@CMichaelGibson In all seriousness, I am convinced that there is real benefit based on our published work in the TRILUMINATE trial. But I’ve also been really impressed with the power of a placebo-controlled trial to resolve all doubt. That would be the goal of a placebo controlled trial in TR.
@djc795 @CMichaelGibson What findings in an open label trial would be convincing that the QOL findings are not just due to placebo? For TR, concerning to me that improved QOL from a presumed hemodynamic benefit doesn’t also improve 6 min walk. For another analogous RV disease - PAH they track very well.
@yreddyhf @CMichaelGibson I disagree that TR and PAH are analogous diseases and pt populations. The demographics differences alone are so profound that any attempt to compare across conditions is problematic. Moreover, in the full randomized cohort of TRILUMINATE, 6MWD did improve with T-TEER.
@yreddyhf @CMichaelGibson And while I agree that the only way to completely rule out a placebo effect is to conduct a placebo-controlled trial, you can read our paper to see the evidence that supports a true, biologic benefit of T-TEER in the TRILUMINATE trial. jacc.org/doi/abs/10.101…
@djc795 @CMichaelGibson I’ve definitely seen your paper, just curious why you believe that the QOL effects cannot all be explained by placebo alone especially if patients know their TR is improved.
@yreddyhf @CMichaelGibson According to the trial investigators I have spoken with, most patients were not aware of how much their TR improved at the time they completed their KCCQs. But you are certainly entitled to your opinion.
@djc795 @yreddyhf @CMichaelGibson If true then TR⬇️of equal magnitude (there were pts in control arm that had 1 or 2-grade⬇️in TR) should translate into KCCQ improvement of equal/similar magnitude? If there is a gradient in KCCQ⬆️despite similar TR⬇️then it suggests patient awareness & possible placebo effect.
@kaulcsmc @yreddyhf @CMichaelGibson (1) I never said there was no placebo effect- just that there was a true biologic effect; and (2) The analysis I was referring to was performed entirely in device patients to examine the biologic effect among pts who all knew they got the device.
@djc795 @yreddyhf @CMichaelGibson I get that. All I am saying is that if TR is reduced to a similar degree in both device & control pts, but KCCQ only improves in device pts, then that is highly suggestive of placebo/expectation effect.
@djc795 @yreddyhf @CMichaelGibson I am also struggling to explain why 26% in control arm had KCCQ improvement >15, yet only 8% had mod. or less TR at f/u c/w 50% with KCCQ improvement >15 & 88% with mod. or less TR in device arm. Is that c/w a strong correlation of KCCQ ⬆️with TR ⬇️?
@kaulcsmc @yreddyhf @CMichaelGibson In addition to any treatment effect, there are 3 additional effects that occur with treatment: (1) placebo effect; (2) Hawthorne Effect and (3) regression to the mean. Both 2 and 3 occur in the control group, too. And all 3 occur in a sham group.