Even as new guidelines for the treatment of heart failure were rolled out by the European Society of Cardiology, new research presented at their virtual congress hinted that the team of experts who developed the extensive document will be revising the work.
The guidelines, also published online in the , state that no treatment has been shown to reduce mortality and morbidity in patients with heart failure with preserved ejection fraction to date, but the first Hot Line session of the meeting undermined that statement with positive results from the EMPEROR-Preserved study, which showed that treatment with empagliflozin (Jardiance) robustly reduced the risk of hospitalizations for these patients.
"Every guideline we write is out of date a few days after it's published. I'm, of course, exaggerating a little bit, but guidelines are dynamic documents. They represent what we know at the time that they're written and then new information comes out and they have to be updated, and that takes time," Milton Packer, MD, of Baylor University Medical Center in Dallas, told ֱ.
"It's a process, and we all understand that process; there is no real concept of finality here. We do the best we can with the data we have. And so these guidelines coming won't represent the results of the EMPEROR-Preserved trial, but the next one will," Packer added.
Carlos Aguiar, MD, of Hospital Santa Cruz in Lisbon, concurred, noting, "We also know that these new indications do need to go through the regulatory authorities, so it does take some time for the whole process to be concluded."
"We do need to wait for those approvals also from the regulatory agencies in their reviews for physicians to be able to implement this in clinical practice," he told ֱ.
However, the 2021 guideline writers did tweak the comprehensive algorithm for the treatment of heart failure. The highlights include:
- Right heart catheterization should be considered in patients in whom heart failure is thought to be due to constrictive pericarditis, restrictive cardiomyopathy, congenital heart disease, and high-output states. It may be considered in selected patients with heart failure with preserved left ventricular ejection fraction (LVEF) to confirm the diagnosis.
- In patients with chronic heart failure with reduced LVEF, dapagliflozin (Farxiga) or empagliflozin are recommended to reduce the risk of hospitalizations and death. This is a Class I recommendation, meaning it is based on evidence gleaned from randomized clinical trials.
- Vericiguat (Verquvo) may be considered in patients with New York Heart Association (NYHA) class II to IV heart failure after worsening with treatment with an angiotensin inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist, to reduce the risk of cardiovascular mortality or heart failure hospitalization.
- For treatment of heart failure with midrange LVEF -- a change in term from "mildly reduced" ejection fraction -- the guidelines suggest a number of treatments to reduce death and hospitalizations, but none have strong clinical trial evidence (Class IIb). These treatments include angiotensin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and the combination agent sacubitril/valsartan (Entresto).
- For patients with heart failure with preserved ejection fraction, the current guidelines recommend (Class I evidence) screening for and treatment of etiologies, as well as cardiovascular and non-cardiovascular comorbidities.
- After hospitalization for heart failure, the guidelines recommend (Class I evidence) that patients be carefully evaluated to exclude persistent signs of congestion before discharge and to optimize oral treatment, and that evidence-based oral medical treatment be administered before discharge. An early follow-up visit is recommended at 1 to 2 weeks after discharge to assess signs of congestion and drug tolerance, and to start and/or uptitrate evidence-based therapy.
- The SGLT2 inhibitors canagliflozin (Invokana), dapagliflozin, empagliflozin, ertugliflozin (Steglatro), and sotagliflozin are recommended in patients with heart failure and type 2 diabetes at risk of cardiovascular events to reduce hospitalizations for heart failure, major cardiovascular events, end-stage renal dysfunction, and cardiovascular death. The SGLT2 inhibitors dapagliflozin, empagliflozin, and sotagliflozin are recommended in patients with type 2 diabetes and heart failure with reduced ejection fraction (Class I evidence). The DPP-4 inhibitor saxagliptin (Onglyza) is not recommended in patients with heart failure (Class III evidence).
Disclosures
Packer disclosed relationships with AbbVie, Amarin Pharma, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Casana, CSL Behring, Cytokinetics, Eli Lilly and Company, Johnson & Johnson, Moderna, Novartis, ParatusRX, Pfizer, Relypsa, Salamandra, Teva, and Theravance Biopharma.
Aguiar disclosed relationships with Bayer, Bristol Myers Squibb, Daiichi Sankyo, and Pfizer.
Primary Source
European Heart Journal
McDonagh TA, et al "2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) with the special contribution of the Heart Failure Association (HFA) of the ESC" Eur Heart J 2021; DOI: 10.1093/eurheartj/ehab368.