New ESC/EACTS Guidelines for the management of Valvular Heart Disease (VHD)
C. Cook reviews the new ESC/EACTS Guidelines on VHD
The new joint ESC/EACTS guidelines for the management of valvular heart disease have been hotly anticipated, with extended indications for transcutaneous aortic valve implantation (TAVI) widely tipped to be the star of the show. In comparison to 2012, where data from two randomized control trials assessing TAVI were available, outcome data from nearly six thousand patients across six randomized trials were available to the 2017 guideline writing committee. Therefore, the major challenge for this guideline was to assimilate this data and make it applicable in realworld clinical practice. In that regard, this new document has evolved beyond simple ‘guidance’ and now introduces new ‘concepts of care’ for patients with valvular heart disease.
Concepts of care – Heart Valve Centres
One of the major innovations in the 2017 ESC/EACTS valvular guidelines is the Class 1 recommendation for care to be delivered in dedicated Heart Valve Centres (HVC). Requirements for HVC status include the availability of onsite mutli-disciplinary expertise with competencies in both surgical and interventional domains. Furthermore, specialist cardiac imaging modalities including echocardiography, cardiac CT and cardiac magnetic resonance imaging should be available. Lastly, robust internal audit processes are required, with specific guidance that mortality data, complication rates and valve durability data be made publically available. The guidelines do, however, stop short of recommending a minimum number of procedures for an institution to be considered a heart valve centre. Finally, in line with previous guidelines across the cardiology spectrum, emphasis is placed on the importance of Heart Team shared decision-making.
Aortic valve disease recommendations
As expected, clinical indications for TAVI receive a significant boost in the 2017 iteration of the guidelines. The major developments are that TAVI now enjoys a class 1B recommendation in patients who are at ‘increased surgical risk’ (defined as STS or EuroSCORE II ≥ 4% or logistic EuroSCORE ≥ 10% or other risk factors not included in these scores such as frailty – which should be objectively scored). Decisions regarding TAVI versus SAVR must be made by the Heart Team and incorporate individual patient characteristics. Specific mention is also made of TAVI being favoured in elderly patients suitable for transfemoral access. Aside from the upgraded recommendations for TAVI, the use of language in the guideline is important – patients are identified as those that are at ‘low surgical risk’ and those that are at ‘increased surgical risk’. Accordingly, the guidelines now view surgical risk as a spectrum influenced by individual patient characteristics not necessarily captured by surgical risk sores. This marks a departure from the previous categorical terminology of ‘intermediate risk’, ‘high risk’ and ‘extreme risk’. Lastly, a Class 1B recommendation is also provided for TAVI in patients who are not suitable for SAVR, but ‘low surgical risk’ patients (the only categorical definition of risk to remain in the TAVI guidelines) and those under 75 years of age remain the prevail of the surgeon.
Moving away from TAVI-specific recommendations, but remaining with the aortic valve, the guidelines acknowledge the clinical conundrum posed by patients with severe aortic valve disease and no symptoms. Within this patient group, updated recommendations further define the role of markedly elevated BNP levels and invasive evidence of pulmonary hypertension as factors more likely to lead to aortic valve intervention, whereas measurements of the mean aortic pressure gradient during exercise have been removed. Many will also be thankful for the new algorithm for the assessment of aortic stenosis severity that now includes specific mention of low-gradient aortic stenosis. Clearly defined pathways to distinguish pseudosevere from true severe aortic stenosis are provided.
Mitral and tricuspid valve recommendations
The major changes relating to mitral valve recommendations include the addition of measurements of left ventricular volumes to guide surgical intervention in asymptomatic severe mitral regurgitation (IIa, C). This should provide clinicians clearer quantitative thresholds to refer their patients to surgical colleagues. With regards to percutaneous mitral valve intervention, although a huge amount of research and development continues in this field, percutaneous edge-to-edge mitral valve repair receives limited guidance in patients with symptomatic severe primary mitral regurgitation who are judged inoperable or at high surgical risk by the Heart Team (IIb, C).
Sometimes referred to as ‘the forgotten valve’, the tricuspid valve receives a significant boost by means of a helpful algorithm to determine indications for surgery in tricuspid regurgitation. Although the first point in the decision tree relates to whether left sided valve surgery is required, the majority of the algorithm’s permutations result in surgical tricuspid valve repair being recommended. Accordingly, conservative treatment of severe tricuspid regurgitation is now the exception to the rule rather than the guiding principle.
To conclude this short summary of the new ESC/EACTS Guidelines for the management of valvular heart disease, a number of miscellaneous recommendations are worthy of mention. A treatment algorithm covering antithrombotic therapy in patients with mechanical valve prosthesis undergoing PCI is borrowed and adapted from the 2017 ESC Focused Update on Dual Antiplatelet Therapy. The recommendations are helpfully stratified according to whether the relative concerns over ischemic risks outweigh the bleeding risks or vice versa. This clinically orientated aid memoire helps summarise the length of therapy and combination of therapy to be offered in this important patient group. Of note, there is no role identified for the NOACs or more potent P2Y12 receptor antagonist antiplatelet medications, with recommendations restricted to the combined use of aspirin, clopidogrel and warfarin only. Although NOAC use continues to expand into many other cardiology domains, NOAC use in patients with mechanical heart valves is contraindicated (III, B) and the use of NOACs is not recommended in patients with atrial fibrillation and moderate to severe mitral stenosis (III, C).
Regarding the management of prosthetic valve dysfunction, complex structural intervention techniques receive indications. Transcatheter valve-in-valve implantation in the aortic position receives a IIa, C recommendation following shared decision-making by the Heart Team depending on the risk of reoperation and the type and size of prosthesis. Lastly, transcatheter paravalvular leak closure receives a IIb, C recommendation in patients with clinically significant regurgitation who are high-risk for surgery.