From a cardiology perspective, it is important to understand the causes of tricuspid regurgitation (TR) more thoroughly. Tricuspid valve repair is suitable for primary valvular defects, such as Ebstein anomaly, rheumatic disease, or endocarditis. However, in cases of secondary TR caused by left-sided heart failure, repair may worsen the underlying condition and lead to further pulmonary congestion. Therefore, I strongly recommend optimizing medical therapy for left-sided heart failure as the first approach. If mitral regurgitation continues to be difficult to manage, transcatheter edge-to-edge repair of the mitral valve should be considered, provided the patient can tolerate the procedure. The hemodynamic benefits of this procedure often eliminate the need for concurrent tricuspid interventions. Essentially, this approach, guided by the underlying pathophysiology, helps minimize unnecessary tricuspid valve procedures while effectively addressing the primary causes of secondary TR.
From a cardiology perspective, it is important to understand the causes of tricuspid regurgitation (TR) more thoroughly. Tricuspid valve repair is suitable for primary valvular defects, such as Ebstein anomaly, rheumatic disease, or endocarditis. However, in cases of secondary TR caused by left-sided heart failure, repair may worsen the underlying condition and lead to further pulmonary congestion. Therefore, I strongly recommend optimizing medical therapy for left-sided heart failure as the first approach. If mitral regurgitation continues to be difficult to manage, transcatheter edge-to-edge repair of the mitral valve should be considered, provided the patient can tolerate the procedure. The hemodynamic benefits of this procedure often eliminate the need for concurrent tricuspid interventions. Essentially, this approach, guided by the underlying pathophysiology, helps minimize unnecessary tricuspid valve procedures while effectively addressing the primary causes of secondary TR.
Great read and appreciate the opinions and facts within. I work in structural heart disease and can attest to the excitement of tTEER and evoque. I’m particularly interested in the subtraction anxiety and faith healing aspects. Thanks for sharing!
My view of medical studies is that the vast majority are influenced by money. I am also Machiavellian enough to view the lack of proper controls as done purposely. After all, the medical device makers have to make a living, right!. And of course, the cardiologist doing the procedures must not starve. Heaven forbid if we don’t get a positive result in favor of doing more whether it’s truly beneficial or not. I wonder how many negative, no benefit studies are buried somewhere. I suspect it would be a big pile of papers.
..."It’s about hubris and the need for proper control arms in device trials."...should include proper controls for all drug and vaccine trials. A major malfunction in the world of medicine.
The push for “Evidence based Medicine “ has impacted the actual practice of medicine in a way that promotes premature adoption of the “latest study results.” Then add economic incentives and you get a rush of tricuspid valve fixes, PFO closures, AF fixes, CA calcification alarms, etc.
We who follow you, dr Cifu, dr Prasad, dr Foy, etc get critical appraisal, but a "Journal of Critical Appraisal" would fill the void that lenient editorials have left. Maybe once monthly a journal that dissects the most publicized studies, specially the ones that "get a pass" despite bias and overinterpretation. Souds utopian, but who knows... Until then we have to see that more colleagues find this Substack.
Despite having worked in an EBM splinter cell, my role was engineer, and I focused on technical details while others spent time on critical appraisals. I realized during the pandemic I should have spent time in our journal club.
Retired surgeon here. We are taught early on in training how to read and decipher papers. Along with having to do studies/ papers also to try and get published. Can't help but think the physicians doing that tricuspid valve study know better but did it anyway. Infuriating
I think most responsibility for this problem lies with the FDA. If the FDA allows a lower standard of evidence, the device companies will insist on designing pivotal trials to meet it. The concerns of physician PIs will not be able to overcome these economic forces.
Exactly. FDA sets the bar. Sponsors will only do enough to clear that bar. To expect otherwise would be to deny human nature ( and the incentive structure and economics involved).
The blame lies with the FDA, who for whatever reason decides in some cases to accept garbage. Hopefully the new management will put an end to this.
Best to avert your eyes from the Tri Fr study then…
https://jamanetwork.com/journals/jama/fullarticle/2827209
Same charmin-soft endpoints. Same lack of sham control. Rather than improving on trilluminate, they did little more than repeat it.
From a cardiology perspective, it is important to understand the causes of tricuspid regurgitation (TR) more thoroughly. Tricuspid valve repair is suitable for primary valvular defects, such as Ebstein anomaly, rheumatic disease, or endocarditis. However, in cases of secondary TR caused by left-sided heart failure, repair may worsen the underlying condition and lead to further pulmonary congestion. Therefore, I strongly recommend optimizing medical therapy for left-sided heart failure as the first approach. If mitral regurgitation continues to be difficult to manage, transcatheter edge-to-edge repair of the mitral valve should be considered, provided the patient can tolerate the procedure. The hemodynamic benefits of this procedure often eliminate the need for concurrent tricuspid interventions. Essentially, this approach, guided by the underlying pathophysiology, helps minimize unnecessary tricuspid valve procedures while effectively addressing the primary causes of secondary TR.
From a cardiology perspective, it is important to understand the causes of tricuspid regurgitation (TR) more thoroughly. Tricuspid valve repair is suitable for primary valvular defects, such as Ebstein anomaly, rheumatic disease, or endocarditis. However, in cases of secondary TR caused by left-sided heart failure, repair may worsen the underlying condition and lead to further pulmonary congestion. Therefore, I strongly recommend optimizing medical therapy for left-sided heart failure as the first approach. If mitral regurgitation continues to be difficult to manage, transcatheter edge-to-edge repair of the mitral valve should be considered, provided the patient can tolerate the procedure. The hemodynamic benefits of this procedure often eliminate the need for concurrent tricuspid interventions. Essentially, this approach, guided by the underlying pathophysiology, helps minimize unnecessary tricuspid valve procedures while effectively addressing the primary causes of secondary TR.
Great read and appreciate the opinions and facts within. I work in structural heart disease and can attest to the excitement of tTEER and evoque. I’m particularly interested in the subtraction anxiety and faith healing aspects. Thanks for sharing!
Excellent opinion on this, thanks for sharing!
My view of medical studies is that the vast majority are influenced by money. I am also Machiavellian enough to view the lack of proper controls as done purposely. After all, the medical device makers have to make a living, right!. And of course, the cardiologist doing the procedures must not starve. Heaven forbid if we don’t get a positive result in favor of doing more whether it’s truly beneficial or not. I wonder how many negative, no benefit studies are buried somewhere. I suspect it would be a big pile of papers.
Ben Hourani MD, MBA
..."It’s about hubris and the need for proper control arms in device trials."...should include proper controls for all drug and vaccine trials. A major malfunction in the world of medicine.
The push for “Evidence based Medicine “ has impacted the actual practice of medicine in a way that promotes premature adoption of the “latest study results.” Then add economic incentives and you get a rush of tricuspid valve fixes, PFO closures, AF fixes, CA calcification alarms, etc.
We who follow you, dr Cifu, dr Prasad, dr Foy, etc get critical appraisal, but a "Journal of Critical Appraisal" would fill the void that lenient editorials have left. Maybe once monthly a journal that dissects the most publicized studies, specially the ones that "get a pass" despite bias and overinterpretation. Souds utopian, but who knows... Until then we have to see that more colleagues find this Substack.
Heartily second this.
Despite having worked in an EBM splinter cell, my role was engineer, and I focused on technical details while others spent time on critical appraisals. I realized during the pandemic I should have spent time in our journal club.
Retired surgeon here. We are taught early on in training how to read and decipher papers. Along with having to do studies/ papers also to try and get published. Can't help but think the physicians doing that tricuspid valve study know better but did it anyway. Infuriating
I think most responsibility for this problem lies with the FDA. If the FDA allows a lower standard of evidence, the device companies will insist on designing pivotal trials to meet it. The concerns of physician PIs will not be able to overcome these economic forces.
Exactly. FDA sets the bar. Sponsors will only do enough to clear that bar. To expect otherwise would be to deny human nature ( and the incentive structure and economics involved).
The blame lies with the FDA, who for whatever reason decides in some cases to accept garbage. Hopefully the new management will put an end to this.
I wonder if there is language in the FDA principles docs about trial design/control arms?
peer review should highlight this, stuff also but I get that's thornier