My 95 yo dad was admitted with hypertension , CHF and Cr 2.3. He had neg enzymes and normal EF . I sat at his bedside for 7 days watching the cardiologist , Hospitalist and nephrologist argue in sequence about whether to keep his valsartan in place or stop it. He had slow afib (60-70) and was placed on eliquis and lasix drip. 15 pounds lighter he was discharged on demadex, no valsartan , nitrates and nifidepine. His Cr peaked at 2.8 and came back to baseline at 2.3. Farxiga added by CHF doc 4 days after Dc and he now has NO edema, BP 150/70, HR 70's and feels better. Here is a study question - you think his care was altered by his cardiologist son staying at his bedside out of state and then transporting him back (another comment on how that happened -clue not cheap ) for a consult with CHF cardiologist 4 days after DC??
Have you seen this? Now, american cardiology associations put in their "Quality Measures" interventions such as "SGLT2i in HFpEF". HF trials found their key to the distorted Eden of drugs trials - a primary outcome combining "HF events / hospitalizations" with "CV death" (CV death doesn't improve, total events don't improve...but HF events kind of improve et voilà, positive trial)
This new HF treatment path of "treat them all with all you can" is worrisome and potentially harmful to patients (and, in this case, also to doctors who want the best for their patients).
The conclusion I reached was that more frequent doctor visits led to more medications being prescribed at higher doses with no significant benefit. Well I suppose substituting outpatient visits for hospitalization is probably a significant benefit. In view of the high cost of medication, I wouldn't agree that there was no monetary incentive. There was no post to the article but Dr. Cifu did link to the summary and under the word "funding" it said Roche diagnostics. The summary also listed figures for side effects. The incidences were 41% for the intensive group and 29% for usual care---a larger difference than that of the primary endpoint. But they hastened to add that serious adverse events were even at 16% and 17% and fatal adverse events (I guess they mean mortality) 5% and 6%. Stating in the conclusion that the intensive regimen reduced the 180 day mortality was certainly an overstatement. Word selection is also a subtle indicator of bias in many of these studies. The treatment group is commonly referred to as "aggressive", "intensive", or "modern", while the more conservative approach is "usual care" , suggesting that it is inferior or outmoded.
I do not subscribe to Lancet nor have I read this paper. Unless the researchers were able to take into account the effect of the additional care the treatment group received when they analyzed their data and made their conclusion, I believe that the ultimate error was made by the Lancet reviewers and editor. JM, AC, and VP: If no letter to the editor with this error you describe has been published, can one of you or a colleague write a letter to the editor about the errors made in the study? Unfortunately, I think a letter to the editor published in Lancet would be more impactful than this Sensible Medicine article. More medical journalist and cardiologists read Lancet than Sensible Medicine.
"Unfortunately, I think a letter to the editor published in Lancet would be more impactful than this Sensible Medicine article."
I'd actually argue this point. An average article on SM is read more people than almost all journal articles. LTE are read by almost no one. It is absurdly hard to get a LTE published, and impossible well after the article appears.
SM is not searchable on pubmed or linked to the article, these certainly disadvantages we have here. Publication on SM doesn't count for much on the CV.
I write this because we hope to make this a great forum to question the interpretation of articles
I commend you and your colleagues for educating us. However, I bet FDA's biostatisticians put more credence in the Lancet article than your article in SM. Sigh.
I think when you nailed it when you said the post discharge INTENSITY OF CARE was a significant factor. The main “profit” in this situation is reduced hospital readmission. A good CHF clinic can be run by an RN or NP under the supervision of a cardiologist. Experience and Exposure is what is needed and good oversight/teaching.
CHF is not rocket science.
Francis Weld Peabody, MD
In The Journal (88:877, 1927), Francis Weld Peabody, MD, of the Thorndike Memorial Laboratory in the Boston City Hospital, wrote on "The Care of the Patient." The final sentence reads: "One of the essential qualities of the clinician is an interest in humanity, for the secret of the care of the patient is in caring for ...
He meant emotional caring but I the US we are facing a crisis in access to any kind of care especially primary care.
I’m less pessimistic than you about this trial and its actual utility in clinical practice.
The “guidelines” (which are with every passing day progressively becoming more full of bunk) promote ‘4 pillars for everyone as soon as yesterday’ in the absence of evidence. This trial actually (indirectly) suggests that, “IF” you can get pts quickly titrated on all 4 drugs, it does in fact provide a benefit (even if driven primarily, though not entirely, by HHF reductions). That’s more than could be said before this study (and more than could be said for the basis of the guidelines themselves). That’s a useful thing to have some confirmation for.
And it to me actually serves as a brake for the mindless enthusiasm for “all 4 drugs ASAP for everyone and even in the water supply”….cuz if you can’t replicate the conditions of this trial (which most in Canada and North America cannot)….then such promotion remains in the absence of evidence. I also focus on the fact that the average age was 63. It tells me that, in young HFrEF pts for whom I have the good fortune to be able to provide this degree of intensive follow up, this rapid uptitration of “4 pillars” stuff is worth trying; but for most people, there is no evidence to compel me to deviate from the progressive titration style of yore.
I agree it “makes sense” that intensive follow up care “should help”. But this actually proves it. That someone went out to prove a motherhood statement to be correct should be celebrated.
Slightly off topic. In the US one big barrier to getting heart failure patients on SGLT2is is cost. The other meds are relatively inexpensive and I can get people on them. I've even failed to get insurance coverage for an SGLT2i when a patient has both HFrEF and diabetes.
One of the main reasons trials differ from real life is the relative ease of getting the pharmaceutical agents.
PS -he now lives 6 miles away vs 1000
My 95 yo dad was admitted with hypertension , CHF and Cr 2.3. He had neg enzymes and normal EF . I sat at his bedside for 7 days watching the cardiologist , Hospitalist and nephrologist argue in sequence about whether to keep his valsartan in place or stop it. He had slow afib (60-70) and was placed on eliquis and lasix drip. 15 pounds lighter he was discharged on demadex, no valsartan , nitrates and nifidepine. His Cr peaked at 2.8 and came back to baseline at 2.3. Farxiga added by CHF doc 4 days after Dc and he now has NO edema, BP 150/70, HR 70's and feels better. Here is a study question - you think his care was altered by his cardiologist son staying at his bedside out of state and then transporting him back (another comment on how that happened -clue not cheap ) for a consult with CHF cardiologist 4 days after DC??
2024 Update to the 2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure - https://www.sciencedirect.com/science/article/abs/pii/S0735109724072887?via%3Dihub
Have you seen this? Now, american cardiology associations put in their "Quality Measures" interventions such as "SGLT2i in HFpEF". HF trials found their key to the distorted Eden of drugs trials - a primary outcome combining "HF events / hospitalizations" with "CV death" (CV death doesn't improve, total events don't improve...but HF events kind of improve et voilà, positive trial)
This new HF treatment path of "treat them all with all you can" is worrisome and potentially harmful to patients (and, in this case, also to doctors who want the best for their patients).
The conclusion I reached was that more frequent doctor visits led to more medications being prescribed at higher doses with no significant benefit. Well I suppose substituting outpatient visits for hospitalization is probably a significant benefit. In view of the high cost of medication, I wouldn't agree that there was no monetary incentive. There was no post to the article but Dr. Cifu did link to the summary and under the word "funding" it said Roche diagnostics. The summary also listed figures for side effects. The incidences were 41% for the intensive group and 29% for usual care---a larger difference than that of the primary endpoint. But they hastened to add that serious adverse events were even at 16% and 17% and fatal adverse events (I guess they mean mortality) 5% and 6%. Stating in the conclusion that the intensive regimen reduced the 180 day mortality was certainly an overstatement. Word selection is also a subtle indicator of bias in many of these studies. The treatment group is commonly referred to as "aggressive", "intensive", or "modern", while the more conservative approach is "usual care" , suggesting that it is inferior or outmoded.
I do not subscribe to Lancet nor have I read this paper. Unless the researchers were able to take into account the effect of the additional care the treatment group received when they analyzed their data and made their conclusion, I believe that the ultimate error was made by the Lancet reviewers and editor. JM, AC, and VP: If no letter to the editor with this error you describe has been published, can one of you or a colleague write a letter to the editor about the errors made in the study? Unfortunately, I think a letter to the editor published in Lancet would be more impactful than this Sensible Medicine article. More medical journalist and cardiologists read Lancet than Sensible Medicine.
Thanks so much for you comment.
"Unfortunately, I think a letter to the editor published in Lancet would be more impactful than this Sensible Medicine article."
I'd actually argue this point. An average article on SM is read more people than almost all journal articles. LTE are read by almost no one. It is absurdly hard to get a LTE published, and impossible well after the article appears.
SM is not searchable on pubmed or linked to the article, these certainly disadvantages we have here. Publication on SM doesn't count for much on the CV.
I write this because we hope to make this a great forum to question the interpretation of articles
I commend you and your colleagues for educating us. However, I bet FDA's biostatisticians put more credence in the Lancet article than your article in SM. Sigh.
I think when you nailed it when you said the post discharge INTENSITY OF CARE was a significant factor. The main “profit” in this situation is reduced hospital readmission. A good CHF clinic can be run by an RN or NP under the supervision of a cardiologist. Experience and Exposure is what is needed and good oversight/teaching.
CHF is not rocket science.
Francis Weld Peabody, MD
In The Journal (88:877, 1927), Francis Weld Peabody, MD, of the Thorndike Memorial Laboratory in the Boston City Hospital, wrote on "The Care of the Patient." The final sentence reads: "One of the essential qualities of the clinician is an interest in humanity, for the secret of the care of the patient is in caring for ...
He meant emotional caring but I the US we are facing a crisis in access to any kind of care especially primary care.
I’m less pessimistic than you about this trial and its actual utility in clinical practice.
The “guidelines” (which are with every passing day progressively becoming more full of bunk) promote ‘4 pillars for everyone as soon as yesterday’ in the absence of evidence. This trial actually (indirectly) suggests that, “IF” you can get pts quickly titrated on all 4 drugs, it does in fact provide a benefit (even if driven primarily, though not entirely, by HHF reductions). That’s more than could be said before this study (and more than could be said for the basis of the guidelines themselves). That’s a useful thing to have some confirmation for.
And it to me actually serves as a brake for the mindless enthusiasm for “all 4 drugs ASAP for everyone and even in the water supply”….cuz if you can’t replicate the conditions of this trial (which most in Canada and North America cannot)….then such promotion remains in the absence of evidence. I also focus on the fact that the average age was 63. It tells me that, in young HFrEF pts for whom I have the good fortune to be able to provide this degree of intensive follow up, this rapid uptitration of “4 pillars” stuff is worth trying; but for most people, there is no evidence to compel me to deviate from the progressive titration style of yore.
I agree it “makes sense” that intensive follow up care “should help”. But this actually proves it. That someone went out to prove a motherhood statement to be correct should be celebrated.
Slightly off topic. In the US one big barrier to getting heart failure patients on SGLT2is is cost. The other meds are relatively inexpensive and I can get people on them. I've even failed to get insurance coverage for an SGLT2i when a patient has both HFrEF and diabetes.
One of the main reasons trials differ from real life is the relative ease of getting the pharmaceutical agents.