Response to Latest British Society of Echocardiography recommendations for left ventricular ejection fraction categorisation: potential implications and relevance to contemporary heart failure management

in Echo Research and Practice
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  • 1 East Suffolk and North Essex NHS Foundation Trust, Colchester, UK
  • 2 West Suffolk NHS Foundation Trust, Bury St Edmunds, UK
  • 3 Royal United Hospitals Bath NHS Foundation Trust, Bath, UK
  • 4 Liverpool John Moores University, Research Institute for Sports and Exercise Science, Liverpool, UK
  • 5 North West Anglia NHS Foundation Trust, Peterborough, UK
  • 6 Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK

Correspondence should be addressed to A Harkness: allan.harkness@esneft.nhs.uk

We thank Dr Kanagala and Professor Squire for their keen interest in our paper (1) and their insight into the challenge of grading left ventricular ejection fraction (LVEF) (2). We must emphasise that our paper’s remit was not to be a clinical guide on heart failure nor on its treatment.

The cut-off for what is regarded as a severely impaired LVEF has changed over the last half-century and vary from society to society (3). Previous BSE guidelines recommended that severe LVEF was ≤35%, therefore, the BSE has chosen to remain consistent with reporting standards used throughout the UK. Every BSE accredited sonographer and department has issued a report stating severe LVEF was ≤35% for almost a decade. We have also been consistent in recommending measuring (and reporting) the LVEF as accurately as possible.

The American Society of Echocardiography and European Association of Cardiovascular Imaging have also remained consistent in their definition of severe LVEF as <30% in their 2015 chamber definitions paper (4), unchanged from their 2005 paper (5). This is despite the ACCF/AHA defining HFrEF as ≤ 40% in 2013 (6). Our paper outlines why we chose to adhere to ≤ 35%.

In the 2012 European Society of Cardiology (ESC) paper on heart failure (7), the authors pointed out that ‘The major trials in patients with HF and a reduced EF (HF-REF), or ”systolic HF”, mainly enrolled patients with an EF ≤ 35%, and it is only in these patients that effective therapies have been demonstrated to date‘. In 2016, the ESC brought in the term ‘Heart Failure with mid-range Ejection Fraction’ (HFmrEF) and almost (but not quite) aligned with the ACCF/AHA by defining HFrEF as an LVEF < 40% (8).

Since 2012, the cut-off LVEF used in trials of heart failure medications has varied; it is this value that then determines a drug’s license. None of the imaging or clinical American, European or British society guideline provides a cut-off for severe LVEF or HFrEF that universally determines prescribing across all drug classes. The numerical value of the ejection fraction is essential to determine if a particular drug is indicated, which is why we insist on it being quoted; the only exception being cases where image quality is so poor it would be inaccurate to do so. We also recommend that when management plans are determined by LVEF, but routine trans-thoracic echo images are of poor quality, contrast echocardiography or alternative modalities are considered.

For this reason, we must disagree with Dr Kanagala and Professor Squire in claiming that the MRAs and the ARNIs have ’a well established and evidence-based extended survival benefit’ across the entire HFrEF population. We would urge readers to refer to the British National Formulary and the NICE guidelines as well as the landmark trial papers for the actual LVEF and specific clinical criteria required for prescribing within license (9, 10, 11, 12, 13, 14, 15).

Similarly, we also disagree with Dr Kanagala and Professor Squire that there is a clear benefit for device therapy in patients with HFrEF when defined as an LVEF ≤ 40%. The NICE guidelines (16) and thus clinical commissioning groups insist on an LVEF ≤35%. The results of a study of patients who had a conventional indication for pacing (17) does not open up the utility of complex device therapy to all the heart failure patients with an LVEF up to 50% but rather highlights the potential detriment of the conventional RV pacing on heart function in this group.

We note Dr Kanagala and Professor Squire’s criticism that we have simplified the relationship between prognosis and LVEF. However, we stated that ‘a lower ejection fraction is associated with a poorer prognosis’ only in the context of considering and rejecting the use of 30% or lower as a useful cut-off for severe LVEF as opposed to 35%.

Reducing systolic dysfunction categories from three groups to two will not adversely affect future heart failure research nor will it overwhelm community heart failure services. The BSE has not changed its severe cut-off from its previous guidelines used throughout the UK for almost a decade and we do not define HFrEF in our paper. We have merely removed the arbitrary ‘mild’ and ‘moderate’ terms and replaced them with the quoting of an ejection fraction. This emphasis on quoting LVEF% for this group was also highlighted in our poster to accompany the paper.

The scenarios that Dr Kanagala and Professor Squire describe where they envisage that our guidelines would cause patient harm do not stand scrutiny when a report contains a numeric LVEF%. We make no recommendation that would lead to patients with impaired LVEF being offered inappropriate therapy, nor would they be denied treatment, let alone have it withdrawn if their LVEF has improved. In fact, we concur with the ESC clinical guidelines that patients with impaired LVEF should be considered for therapy whilst accepting that, for many patient groups, further research is required. By quoting the LVEF, those specific patients who may benefit from a particular therapy in certain circumstances can be selected by the clinician.

Measurement and reporting of LVEF are recommended in our BSE normal reference interval guideline and are the key take home message we would like to put to Dr Kanagala and Professor Squire. Most of the treatments mentioned in their letter require an ejection fraction to be measured to ensure prudent, safe, and evidence-based care. While categorisation of systolic dysfunction has useful but limited benefits (mainly to non-specialists), we agree that the numerical reporting of ejection fraction is important for all prescribing clinicians and especially heart failure specialists (3). It is recommended as standard practice by the BSE.

Declaration of interest

The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the article.

Funding

This article did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.

References

  • 1

    Harkness A, , Ring L, , Augustine DX, , Oxborough D, , Robinson S, , Sharma V & Education Committee of the British Society of Echocardiography. Normal reference intervals for cardiac dimensions and function for use in echocardiographic practice: a guideline from the British Society of Echocardiography. Echo Research and Practice 2020 7 G1–G18. (https://doi.org/10.1530/ERP-19-0050)

    • Search Google Scholar
    • Export Citation
  • 2

    Kanagala P, & Squire IBLatest British Society of Echocardiography recommendations for left ventricular ejection fraction categorisation: potential implications and relevance to contemporary heart failure management. Echo Research and Practice 2020 7 L1L4. (https://doi.org/10.1530/ERP-20-0029)

    • Search Google Scholar
    • Export Citation
  • 3

    Hudson S, & Pettit S. What is ‘normal’ left ventricular ejection fraction ? Heart 2020 106 14451446. (https://doi.org/10.1136/heartjnl-2020-317604)

    • Search Google Scholar
    • Export Citation
  • 4

    Lang RM, , Badano LP, , Mor-Avi V, , Afilalo J, , Armstrong A, , Ernande L, , Flachskampf FA, , Foster E, , Goldstein SA, , Kuznetsova T, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J ournal of the Am erican Soc iety of Echocardiogr aphy 2015 28 1 .e1439.e14. (https://doi.org/10.1016/j.echo.2014.10.003)

    • Search Google Scholar
    • Export Citation
  • 5

    Lang RM, , Bierig M, , Devereux RB, , Flachskampf FA, , Foster E, , Pellikka PA, , Picard MH, , Roman MJ, , Seward J, , Shanewise JS, et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J ournal of the Am erican Soc iety of Echocardiogr aphy 2005 18 14401463. (https://doi.org/10.1016/j.echo.2005.10.005)

    • Search Google Scholar
    • Export Citation
  • 6

    Yancy CW, , Jessup M, , Bozkurt B, , Butler J, , Casey DE, , Drazner MH, , Fonarow GC, , Geraci SA, , Horwich T, , Januzzi JL, et al. 2013 ACCF/AHA guideline for the management of heart failure. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology 2013 62 e147e239.

    • Search Google Scholar
    • Export Citation
  • 7

    McMurray JJ, , Adamopoulos S, , Anker SD, , Auricchio A, , Böhm M, , Dickstein K, , Falk V, , Filippatos G, , Fonseca C, , Gomez-Sanchez MA, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. European Journal of Heart Failure 2012 14 803869. (https://doi.org/10.1093/eurjhf/hfs105)

    • Search Google Scholar
    • Export Citation
  • 8

    Ponikowski P, , Voors AA, , Anker SD, , Bueno H, , Cleland JG, , Coats AJ, , Falk V, , González-Juanatey JR, , Harjola VP, , Jankowska EA, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Journal of Heart Failure 2016 18 891975. (https://doi.org/10.1002/ejhf.592)

    • Search Google Scholar
    • Export Citation
  • 9

    Pitt B, , Remme W, , Zannad F, , Neaton J, , Martinez F, , Roniker B, , Bittman R, , Hurley S, , Kleiman J, , Gatlin M, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N ew Engl and J ournal of Med icine 2003 348 13091321. (https://doi.org/10.1056/NEJMoa030207)

    • Search Google Scholar
    • Export Citation
  • 10

    Pitt B, , Zannad F, , Remme WJ, , Cody R, , Castaigne A, , Perez A, , Palensky J, & Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N ew Engl and J ournal of Med icine 1999 341 709717. (https://doi.org/10.1056/NEJM199909023411001)

    • Search Google Scholar
    • Export Citation
  • 11

    Desai AS, , Lewis EF, , Li R, , Solomon SD, , Assmann SF, , Boineau R, , Clausell N, , Diaz R, , Fleg JL, , Gordeev I, et al. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am erican Heart J ournal 2011 162 966 .e10972.e10. (https://doi.org/10.1016/j.ahj.2011.09.007)

    • Search Google Scholar
    • Export Citation
  • 12

    Solomon SD, , Claggett B, , Lewis EF, , Desai A, , Anand I, , Sweitzer NK, , O'Meara E, , Shah SJ, , McKinlay S, , Fleg JL, et al. Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. European Heart Journal 2016 37 455462. (https://doi.org/10.1093/eurheartj/ehv464)

    • Search Google Scholar
    • Export Citation
  • 13

    National Institute for Health and Clinical Excellence. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. London, UK: NICE, 2012. (available at: (https://www.nice.org.uk/guidance/ta388)

    • Search Google Scholar
    • Export Citation
  • 14

    National Institute for Health and Clinical Excellence. Chronic heart failure in adults: diagnosis and management. London, UK: NICE, 2018. (available at: (https://www.nice.org.uk/guidance/ng106)

    • Search Google Scholar
    • Export Citation
  • 15

    McMurray JJV, , Packer M, , Desai AS, , Gong J, , Lefkowitz MP, , Rizkala AR, , Rouleau JL, , Shi VC, , Solomon SD, , Swedberg K, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. New England Journal of Medicine 2014 371 9931004. (https://doi.org/10.1056/NEJMoa1409077)

    • Search Google Scholar
    • Export Citation
  • 16

    National Institute for Health and Clinical Excellence. Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. London, UK: NICE, 2014. (available at: (https://www.nice.org.uk/guidance/ta314)

    • Search Google Scholar
    • Export Citation
  • 17

    Curtis AB, , Worley SJ, , Adamson PB, , Chung ES, , Niazi I, , Sherfesee L, , Shinn T, , St. John Sutton MS & Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. New England Journal of Medicine 2013 368 15851593. (https://doi.org/10.1056/NEJMoa1210356)

    • Search Google Scholar
    • Export Citation

 

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  • 1

    Harkness A, , Ring L, , Augustine DX, , Oxborough D, , Robinson S, , Sharma V & Education Committee of the British Society of Echocardiography. Normal reference intervals for cardiac dimensions and function for use in echocardiographic practice: a guideline from the British Society of Echocardiography. Echo Research and Practice 2020 7 G1–G18. (https://doi.org/10.1530/ERP-19-0050)

    • Search Google Scholar
    • Export Citation
  • 2

    Kanagala P, & Squire IBLatest British Society of Echocardiography recommendations for left ventricular ejection fraction categorisation: potential implications and relevance to contemporary heart failure management. Echo Research and Practice 2020 7 L1L4. (https://doi.org/10.1530/ERP-20-0029)

    • Search Google Scholar
    • Export Citation
  • 3

    Hudson S, & Pettit S. What is ‘normal’ left ventricular ejection fraction ? Heart 2020 106 14451446. (https://doi.org/10.1136/heartjnl-2020-317604)

    • Search Google Scholar
    • Export Citation
  • 4

    Lang RM, , Badano LP, , Mor-Avi V, , Afilalo J, , Armstrong A, , Ernande L, , Flachskampf FA, , Foster E, , Goldstein SA, , Kuznetsova T, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J ournal of the Am erican Soc iety of Echocardiogr aphy 2015 28 1 .e1439.e14. (https://doi.org/10.1016/j.echo.2014.10.003)

    • Search Google Scholar
    • Export Citation
  • 5

    Lang RM, , Bierig M, , Devereux RB, , Flachskampf FA, , Foster E, , Pellikka PA, , Picard MH, , Roman MJ, , Seward J, , Shanewise JS, et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J ournal of the Am erican Soc iety of Echocardiogr aphy 2005 18 14401463. (https://doi.org/10.1016/j.echo.2005.10.005)

    • Search Google Scholar
    • Export Citation
  • 6

    Yancy CW, , Jessup M, , Bozkurt B, , Butler J, , Casey DE, , Drazner MH, , Fonarow GC, , Geraci SA, , Horwich T, , Januzzi JL, et al. 2013 ACCF/AHA guideline for the management of heart failure. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology 2013 62 e147e239.

    • Search Google Scholar
    • Export Citation
  • 7

    McMurray JJ, , Adamopoulos S, , Anker SD, , Auricchio A, , Böhm M, , Dickstein K, , Falk V, , Filippatos G, , Fonseca C, , Gomez-Sanchez MA, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. European Journal of Heart Failure 2012 14 803869. (https://doi.org/10.1093/eurjhf/hfs105)

    • Search Google Scholar
    • Export Citation
  • 8

    Ponikowski P, , Voors AA, , Anker SD, , Bueno H, , Cleland JG, , Coats AJ, , Falk V, , González-Juanatey JR, , Harjola VP, , Jankowska EA, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Journal of Heart Failure 2016 18 891975. (https://doi.org/10.1002/ejhf.592)

    • Search Google Scholar
    • Export Citation
  • 9

    Pitt B, , Remme W, , Zannad F, , Neaton J, , Martinez F, , Roniker B, , Bittman R, , Hurley S, , Kleiman J, , Gatlin M, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N ew Engl and J ournal of Med icine 2003 348 13091321. (https://doi.org/10.1056/NEJMoa030207)

    • Search Google Scholar
    • Export Citation
  • 10

    Pitt B, , Zannad F, , Remme WJ, , Cody R, , Castaigne A, , Perez A, , Palensky J, & Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N ew Engl and J ournal of Med icine 1999 341 709717. (https://doi.org/10.1056/NEJM199909023411001)

    • Search Google Scholar
    • Export Citation
  • 11

    Desai AS, , Lewis EF, , Li R, , Solomon SD, , Assmann SF, , Boineau R, , Clausell N, , Diaz R, , Fleg JL, , Gordeev I, et al. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am erican Heart J ournal 2011 162 966 .e10972.e10. (https://doi.org/10.1016/j.ahj.2011.09.007)

    • Search Google Scholar
    • Export Citation
  • 12

    Solomon SD, , Claggett B, , Lewis EF, , Desai A, , Anand I, , Sweitzer NK, , O'Meara E, , Shah SJ, , McKinlay S, , Fleg JL, et al. Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. European Heart Journal 2016 37 455462. (https://doi.org/10.1093/eurheartj/ehv464)

    • Search Google Scholar
    • Export Citation
  • 13

    National Institute for Health and Clinical Excellence. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. London, UK: NICE, 2012. (available at: (https://www.nice.org.uk/guidance/ta388)

    • Search Google Scholar
    • Export Citation
  • 14

    National Institute for Health and Clinical Excellence. Chronic heart failure in adults: diagnosis and management. London, UK: NICE, 2018. (available at: (https://www.nice.org.uk/guidance/ng106)

    • Search Google Scholar
    • Export Citation
  • 15

    McMurray JJV, , Packer M, , Desai AS, , Gong J, , Lefkowitz MP, , Rizkala AR, , Rouleau JL, , Shi VC, , Solomon SD, , Swedberg K, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. New England Journal of Medicine 2014 371 9931004. (https://doi.org/10.1056/NEJMoa1409077)

    • Search Google Scholar
    • Export Citation
  • 16

    National Institute for Health and Clinical Excellence. Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. London, UK: NICE, 2014. (available at: (https://www.nice.org.uk/guidance/ta314)

    • Search Google Scholar
    • Export Citation
  • 17

    Curtis AB, , Worley SJ, , Adamson PB, , Chung ES, , Niazi I, , Sherfesee L, , Shinn T, , St. John Sutton MS & Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. New England Journal of Medicine 2013 368 15851593. (https://doi.org/10.1056/NEJMoa1210356)

    • Search Google Scholar
    • Export Citation