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Latin American guideline shows the way
  1. David E Newby,
  2. Nicholas L Mills
  1. BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
  1. Correspondence to Professor David E Newby, BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh EH16 4SB, UK; d.e.newby{at}ed.ac.uk

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Guidelines are increasingly being used and quoted in everyday clinical practice. They are often promoted as a binary decision tool and increasingly form the basis of quality improvement programmes in the belief that following guidelines will improve patient care. To choose not to follow guideline recommendations can therefore lead to criticisms and questions regarding the adequacy and quality of care. However, rigorous application and strict implement of guidelines can lead to poor quality care for many patients. Clinical decision-making is rarely simplistic and binary. Shared decision-making with the patient is all important and should be at the centre of our practice. Furthermore, recommendations are only as good as the guideline. Some societies continue to believe that expert opinion has primacy and should dictate guideline content and its recommendations. This methodology is often performed in the absence of systematic or structured clinical evidence synthesis and evaluation. Many observers have increasingly challenged this approach which is becoming outdated.1 2 Expert opinion-based guidelines urgently need to change and to evolve to make themselves more credible, reliable and professional.

Lamelas and colleagues present a clinical practice guideline focused on the use and selection of surgical aortic valve replacement or transcatheter aortic valve implantation.3 This was endorsed by the South American cardiology societies: Sociedad Latino Americana de Cardiologia Intervencionista and the Sociedad Interamericana de Cardiologia. Interestingly, the authors also included representation from McMaster University in Canada presumably providing methodological support for the development of the guideline. We commend and applaud the authors and the guideline development group for setting an example that many other guideline development groups would do well to follow. This guideline is notable for several reasons. First, the bedrock of any guideline is the evidence base. In many international guidelines, the evidence is blandly quoted without standardised, structured or systematic evaluation. For example, in the 2020 European Society of Cardiology guideline for the management of non-ST segment elevation acute coronary syndrome,4 all patients with non-ST segment elevation myocardial infarction were recommended for immediate (within 24 hours) invasive coronary angiography. This was given a class 1A recommendation because the evidence was obtained from a meta-analysis of prior trials. However, this meta-analysis5 concluded that there was no impact on mortality from immediate early invasive coronary angiography. Analysis of subgroups at high risk hinted at mortality differences that the authors of the paper described as ‘exploratory and hypothesis generating’ and which needed further external validation and confirmation. Importantly, there was no significant heterogeneity by these risk subgroups and therefore no robust evidence to support its application. Despite these findings, a strong class 1A recommendation was made to implement this management strategy even though there was no conclusive evidence of a mortality benefit for its implementation. It is therefore refreshing to see Lamelas and colleagues evaluate the evidence for aortic valve intervention in a rigorous and impartial way with the support of their Canadian colleagues. The guideline team and roles were clearly defined, including balanced representation from interventional cardiologists and cardiac surgeons. The evidence tables give open and transparent assessments of the overall evidence and how they were evaluated and rated. They also give a guide as to the risks, benefits and potential biases as well as the importance of uncertainty and variability of the considered evidence. This is open, transparent and rigorous.

The guideline provides a conditional recommendation for transcatheter aortic valve implant over surgical aortic valve replacement in elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis. Their recommendation recognises patient preference: where most would want a transcatheter valve, some may prefer a surgical valve. The involvement of public and patient groups in the Latin American guideline is extremely welcome. Again, something that other major international guidelines could learn from. For the choice between surgical aortic valve replacement or transcatheter aortic valve implantation, there are clearly important issues for the patient and the financial costs for society. Transcatheter aortic valve implantation avoids the need for sternotomy, cardiopulmonary bypass and invasive ventilation. For the patient, recovery periods are shortened, and the morbidity associated with open aortic valve replacement surgery is avoided. However, there is a trade-off with vascular access problems, paravalvular leak and need for pacemaker implantation. The balance of benefits and risks is clearly something that the patient is best placed to evaluate and to provide input into the acceptability and preference of treatment selection. The importance of this is brought out well by the guideline and importantly, the guideline group included patients in their decision-making and recommendations as well as providing input to the acceptability of the procedures. The procedural selection is clearly a joint decision and choice made between the patient and the physician. Guidelines need a strong patient voice in their processes.

Many cardiologists and clinicians like binary decision-making points. These are clear, auditable and easy to apply. However, for many clinical situations, management strategies are much more nuanced and need to account for the patient and societal perspective. The guideline by Lamelas and colleagues also provides a structure for decision-making, highlighting factors and reasons to select surgical aortic valve replacement or transcatheter aortic valve implantation. This includes, in addition to procedural considerations, the value that the patient places on valve durability, pacemaker risk and lower procedural morbidity to ensure a rapid recovery, which do not feature in the European or North American guidelines for the management of valvular heart disease.6 7 This detail helps provide a framework for decision-making that will prove invaluable for both patients and clinicians in their discussions regarding the relative merits of each approach.

For many guidelines, there is the cycle of guideline development with new guidelines often announced at major societal meetings and published in societal journals. The impact of relaunching guidelines and providing updates is important to ensure practice remains contemporary and is line with up-to-date evidence and practice. However, this cycle of guideline development is inefficient, and changes to recommendations sometimes can reflect composition and biases of members in the guideline committees. Having a structure and framework to assess evidence is helpful as this can be used to include new evidence more efficiently and to assess rapidly the impact on existing guideline recommendations. This can be achieved in ‘living documents’ that can be updated in real time and not wait for the next planned iteration of the guideline. It also begs the question of the value of publishing guidelines in societal journals.

There is much to admire and to commend in this focused Latin American guideline to address a problem that many observers across the world are grappling with. The South American societies are leading by example and the professionalisation and inclusivity of the approach provide lessons for other societies and guideline committees. The methodologies of many bodies, such as the National Institute for Health and Care Excellence,8 are gaining greater traction for the evaluation of evidence to inform clinical decisions. Such rigour is now the standard from which guidelines should and must be developed. The inclusion of experts in the methods of systematic evidence evaluation as well as putting the patient at the centre of any recommendations is now mandatory.

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Footnotes

  • Contributors Both authors contributed to the drafting and revision of the manuscript.

  • Funding The authors are supported by the British Heart Foundation (CH/09/002, RG/16/10/32375, FS/16/14/32023, RE/18/5/34216) and Wellcome Trust (WT103782AIA).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Commissioned; internally peer reviewed.

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