The headline study this week in the NEJM was the highly positive TRIC I HF trial of tricuspid valve interventions. Gosh there was a lot to see under the hood of this trial
Thank you for walking through all six, John! The crossover rule needing a heart failure hospitalization first is such an important catch, and I would have read right past it.
John- Most of your concerns about the trial (which have been raised by many in the last 6 weeks since its publication) are reasonable. There are no perfect trials and TRIC-I-HF is no exception.
However, it's quite naive to say that "if we can blind a PCI procedure, we can blind a tricuspid valve intervention". The challenges with blinding a TR intervention are much greater than with PCI given the size of the devices (they show up on any imaging procedure including chest x-rays, CT scans, and echocardiograms) and the risk of large bore access vs. 6F transradial access (which raises the stakes substantially).
Nonetheless, I agree with you that a placebo-controlled trial of TTVI would be ideal, and we are very close to starting to enroll patients in that trial in the UK-- hopefully, in the next few weeks.
I think it's a bit harsh to describe this comment as "naive'. In the sentence after the one you quote, he says, "Blinding would not fix everything in this case because the clip is obvious on an x-ray, but at least it would blind patients." And if only the patient is going to be blinded, a convincing sham procedure need not involve any actual access.
I disagree. You underestimate the ability of all of these imaging studies to "leak" over to unblinding the patient. In 2026, patients often seek care at institutions other than the one where they received their investigational care. Morevoer, as I'm sure you are aware, in the US, when an imaging study is done, the results become available to the patient almost instantaneously through the patient portal. And while one might be able to mask these results at the enrolling institution, this would require a rather Herculean effort. And the likelihood of extending this masking to all institutions where a patient might obtain care during follow-up is close to zero. So, as a person who has actually designed and participated in several placebo-controlled device trials in my life, I stand by my assertion.
Excellent article. It's always a good idea to be prepared to tap the brakes on highly reimbursed interventional procedures, especially in 80 year olds.
Thank you for walking through all six, John! The crossover rule needing a heart failure hospitalization first is such an important catch, and I would have read right past it.
John- Most of your concerns about the trial (which have been raised by many in the last 6 weeks since its publication) are reasonable. There are no perfect trials and TRIC-I-HF is no exception.
However, it's quite naive to say that "if we can blind a PCI procedure, we can blind a tricuspid valve intervention". The challenges with blinding a TR intervention are much greater than with PCI given the size of the devices (they show up on any imaging procedure including chest x-rays, CT scans, and echocardiograms) and the risk of large bore access vs. 6F transradial access (which raises the stakes substantially).
Nonetheless, I agree with you that a placebo-controlled trial of TTVI would be ideal, and we are very close to starting to enroll patients in that trial in the UK-- hopefully, in the next few weeks.
I think it's a bit harsh to describe this comment as "naive'. In the sentence after the one you quote, he says, "Blinding would not fix everything in this case because the clip is obvious on an x-ray, but at least it would blind patients." And if only the patient is going to be blinded, a convincing sham procedure need not involve any actual access.
I disagree. You underestimate the ability of all of these imaging studies to "leak" over to unblinding the patient. In 2026, patients often seek care at institutions other than the one where they received their investigational care. Morevoer, as I'm sure you are aware, in the US, when an imaging study is done, the results become available to the patient almost instantaneously through the patient portal. And while one might be able to mask these results at the enrolling institution, this would require a rather Herculean effort. And the likelihood of extending this masking to all institutions where a patient might obtain care during follow-up is close to zero. So, as a person who has actually designed and participated in several placebo-controlled device trials in my life, I stand by my assertion.
Excellent article. It's always a good idea to be prepared to tap the brakes on highly reimbursed interventional procedures, especially in 80 year olds.