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..................................................................................................................... 3.3.1 Risk scores The Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score (http://riskcalc.sts.org/stswebriskcalc/calculate) and the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II; http://www.euroscore.org/calc.html) accurately discriminate high- and low-risk surgical patients and show good calibration to predict postoperative outcome after valvular surgery in the majority of the patients,49,50 while risk estimation may be less accurate in high-risk patients.51 The STS-PROM score is dynamic and changes over time. Of note, the risk scores have not been validated for isolated tricuspid surgical interventions.

In isolation, surgical scores have major limitations for practical use in patients undergoing transcatheter intervention because they do not include major risk factors such as frailty, as well as anatomical factors with impact on the procedure, either surgical or transcatheter [porcelain aorta, previous chest radiation, mitral annular calcification (MAC)]. New scores have been developed to estimate the risk in patients undergoing TAVI, with better accuracy and discrimination than the surgical risk scores, despite numerous limitations5254 (Supplementary Table 1). Experience with risk stratification is currently limited for other interventional procedures, such as mitral or tricuspid interventions.

3.3.2 Other factors Other factors should be taken into account: • Frailty, defined as a decrease of physiologic reserve and ability to maintain homeostasis leading to an increased vulnerability to stresses and conferring an increased risk of morbidity and mortality after both surgery and TAVI.55 The assessment of frailty should not rely on a subjective approach, such as the ‘eyeball test’, but rather on a combination of different objective estimates.5559 Several tools are available for assessing frailty (Supplementary Table 2,59 and Supplementary Table 3).60 • Malnutrition61 and cognitive dysfunction62 both predict poor prognosis. • Other major organ failures (Supplementary Table 4), in particular the combination of severe lung disease,63,64 postoperative pain from sternotomy or thoracotomy and prolonged time under anaesthesia in patients undergoing SAVR via full sternotomy, may contribute to pulmonary complications. There is a positive association between the impairment of renal function and increased mortality after valvular surgery and transcatheter procedures,65

especially when the glomerular filtration rate is <30 mL/min. Liver disease, is also an important prognostic factor.66 • Anatomical aspects affecting procedural performance such as porcelain aorta or severe MAC67 (see Table 6 in section 5.1.3, and Supplementary Figure 1). At the extreme of the risk spectrum, futility should be avoided. Therapeutic futility has been defined as a lack of medical efficacy, particularly when the physician judges that the therapy is unlikely to produce its intended clinical results, or lack of meaningful survival according to the personal values of the patient. Assessment of futility goes beyond survival and includes functional recovery. The futility of interventions has to be taken into consideration, particularly for transcatheter interventions.63

The high prevalence of comorbidity in the elderly makes assessment of the risk/benefit ratios of interventions more difficult, therefore the role of the Heart Team is essential in this specific population of patients (Supplementary Table 5).

3.4 Patient-related aspects

Patient-related life expectancy and expected quality of life should be considered. The patient and their family should be thoroughly informed and assisted in their decision on the best treatment option.13 A patient-centred approach would take patient-reported outcome measures and patient-reported experience measures into consideration and make these parameters part of the informed choice offered to patients.68,69 When benefit in symptom relief aligns with a patient’s goals, care is not futile. However, care is futile when no life prolongation or symptom relief is anticipated.70

3.5 Local resources

Even if it is desirable that Heart Valve Centres are able to perform a large spectrum of procedures, either surgical or catheter-based, specialization and thereby expertise in specific domains will vary and should be taken into account when deciding on the orientation of the patient in specific cases, such as complex surgical valve repair or transcatheter intervention. In addition, penetration of transcatheter interventions is heterogeneous worldwide and highly dependent on socioeconomic inequalities.15,71 Appropriate stewardship of economic resources is a fundamental responsibility of the Heart Team.

3.6 Management of associated conditions

3.6.1 Coronary artery disease Recommendations for the management of CAD associated with VHD are provided below and are detailed in specific sections (section 5 and section 6.2) of this guideline document, as well as in other dedicated guideline documents.45,46,72,73

Recommendations for management of CAD in patients with VHD.

Recommendations Classa Levelb

Diagnosis of CAD Coronary angiography is recommended before valve surgery in patients with severe VHD and

any of the following: • History of cardiovascular disease. • Suspected myocardial ischaemia.c

• LV systolic dysfunction. • In men >40 years of age and postmenopausal women. • One or more cardiovascular risk factors. I C

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