Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.

Aims: The number of transcatheter aortic valve implantation (TAVI) procedures is rapidly increasing. This has a major impact on health care resource planning. However, the annual numbers of TAVI candidates per country are unknown. The aim of this study was to estimate current and future number of annual TAVI candidates in 27 European countries, the USA and Canada. Methods and results: Systematic literature searches and meta-analyses were performed on aortic stenosis (AS) epidemiology and decision-making in severe symptomatic AS. The incidence rate of severe AS was determined. Findings were combined with population statistics and integrated into a model employing Monte Carlo simulations to predict the annual number of TAVI candidates. Various future scenarios and sensitivity analyses were explored. Data from 37 studies (n = 26 402) informed the model. The calculated incidence rate of severe AS was 4.4‰/year [95% confidence interval (95% CI) 3.0-6.1‰] in patients ≥65 years. AS-related symptoms were present in 68.3% (95% CI 60.8-75.9%) of patients with severe AS. Despite having severe symptomatic AS, 41.6% (95% CI 36.9-46.3%) did not undergo surgical aortic valve replacement. Of the non-operated patients, 61.7% (95% CI 42.0-81.7%) received TAVI. The model predicted 114 757 (95% CI 69 380-172 799) European and 58 556 (95% CI 35 631-87 738) Northern-American TAVI candidates annually. Conclusion: Currently, approximately 180 000 patients can be considered potential TAVI candidates in the European Union and in Northern-America annually. This number might increase up to 270 000 if indications for TAVI expand to low-risk patients. These findings have major implications for health care resource planning in the 29 individual countries.

Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial.

BACKGROUND: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained <$20 000 per quality-adjusted life-year in most bootstrap replicates. Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs. In patients with left main disease or a SYNTAX score ≤22, however, DES-PCI was economically dominant compared with CABG, although these findings were less certain. CONCLUSIONS: For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT00114972.

A systematic review and critical assessment of 11 discordant meta-analyses on reduced-function CYP2C19 genotype and risk of adverse clinical outcomes in clopidogrel users.

We systematically investigated how 11 overlapping meta-analyses on the association between CYP2C19 loss-of-function alleles and clinical efficacy of clopidogrel could yield contradictory outcomes. The results of the meta-analyses differed because more recent meta-analyses included more primary studies and some had not included conference abstracts. Conclusions differed because between-study heterogeneity and publication bias were handled differently across meta-analyses. All meta-analyses on the clinical end point observed significant heterogeneity and several reported evidence for publication bias, but only one out of eight statistically significant meta-analyses concluded that therefore the association was unproven and one other refrained from quantifying a pooled estimate because of heterogeneity. For the end point stent thrombosis, all meta-analyses reported statistically significant associations with CYP2C19 loss-of-function alleles with no statistically significant evidence for heterogeneity, but only three had investigated publication bias and also found evidence for it. One study therefore concluded that there was no evidence for an association, and one other doubted the association because of a high level of heterogeneity. In summary, meta-analyses on the association between CYP2C19 loss-of-function alleles and clinical efficacy of clopidogrel differed widely with regard to assessment and interpretation of heterogeneity and publication bias. The substantial heterogeneity and publication bias implies that personalized antiplatelet management based on genotyping is not supported by the currently available evidence.Genet Med advance online publication 19 June 2014.

Coronary artery bypass grafting: Part 2--optimizing outcomes and future prospects.

Since first introduced in the mid-1960s, coronary artery bypass grafting (CABG) has become the standard of care for patients with coronary artery disease. Surprisingly, the fundamental surgical technique itself did not change much over time. Nevertheless, outcomes after CABG have dramatically improved over the first 50 years. Randomized trials comparing percutaneous coronary intervention (PCI) to CABG have shown converging outcomes for select patient populations, providing more evidence for wider use of PCI. It is increasingly important to focus on the optimization of the short- and long-term outcomes of CABG and to reduce the level of invasiveness of this procedure. This review provides an overview on how new techniques and widespread consideration of evolving strategies have the potential to optimize outcomes after CABG. Such developments include off-pump CABG, clampless/anaortic CABG, minimally invasive CABG with or without extending to hybrid procedures, arterial revascularization, endoscopic vein harvesting, intraprocedural epiaortic scanning, graft flow assessment, and improved secondary prevention measures. In addition, this review represents a framework for future studies by summarizing the areas that need more rigorous clinical (randomized) evaluation.

The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years.

AIMS: Numerous studies have linked prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR) to adverse outcomes. Its correlation with long-term survival has been described but with contradicting results. This systematic review and meta-analysis of observational studies aims to determine the hazard of PPM after AVR. METHODS AND RESULTS: The Medline and EMBase databases were searched for English-language original publications. Two researchers independently screened studies and extracted data. Pooled estimates were obtained by random effects model. Subgroup analyses were performed to detect sources of heterogeneity. The search yielded 348 potentially relevant studies; 34 were included comprising 27 186 patients and 133 141 patient-years. Defined by the universally accredited indexed effective orifice area <0.85 cm(2)/m(2), 44.2% of patients were categorized as having PPM. In 34.2 and 9.8% of patients moderate (0.65-0.85 cm(2)/m(2)) and severe (<0.65 cm(2)/m(2)) PPM was present, respectively. Prosthesis-patient mismatch was associated with a statistically significant increase in all-cause mortality (HR = 1.34, 95% CI: 1.18-1.51), but only a trend to an increase in cardiac-related mortality (HR = 1.51, 95% CI: 0.88-2.60) was recognized. Analysis by severity of PPM demonstrated that both moderate and severe PPM increased all-cause mortality (HR = 1.19, 95% CI: 1.07-1.33 and HR = 1.84, 95% CI: 1.38-2.45) and cardiac-related mortality (HR = 1.32, 95% CI: 1.02-1.71 and HR = 6.46, 95% CI: 2.79-14.97). Further analyses showed a consistent effect over separate time intervals during follow-up. CONCLUSION: Prosthesis-patient mismatch is associated with an increase in all-cause and cardiac-related mortality over long-term follow-up. We recommend that current efforts to prevent PPM should receive more emphasis and a widespread acceptance to improve long-term survival after AVR.

Towards excellence in revascularization for left main coronary artery disease.

PURPOSE OF REVIEW: The aim of this article is to review the current revascularization strategies in patients presenting with unprotected left main coronary artery disease (LMCAD). RECENT FINDINGS: Coronary artery bypass grafting (CABG) is the current standard of treatment for patients with LMCAD. The development and refinement of techniques increased the number of percutaneous coronary interventions (PCI) in LMCAD patients. SUMMARY: Although several observational studies show comparable results of CABG and/or PCI in patients with LMCAD, there is currently no convincing randomized evidence that either one of the two is associated with better long-term survival. Recent meta-analyses of four small randomized trials revealed a similar rate of 1-year major adverse cardiovascular and cerebrovascular events, higher rates of target vessel revascularization and lower stroke rates for PCI. Pooling randomized patients studies stratified by lesion complexity strengthened the hypothesis that CABG is better in more complex LMCAD patients. However, the randomized comparisons are affected by methodological limitations and lack power to be conclusive. The ongoing Evaluation of XIENCE V Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is expected to provide a better answer on the optimal treatment strategy for LMCAD patients. In the meantime, risk models need to be improved and the most appropriate revascularization strategy for the individual LMCAD patient should be chosen using a multidisciplinary heart team that considers not only risk models but also other clinical and economic facets.

Long-term outlook for transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) revolutionized the treatment of severe symptomatic aortic stenosis (AS). TAVR is increasingly offered for lower-risk patients. The role and place of TAVR in the future treatment of AS is not clear yet. In this review, we discuss the long-term outlook for TAVR, its challenges and its relationship to conventional surgical aortic valve replacement.

Statistical primer: basics of survival analysis for the cardiothoracic surgeon.

Survival analysis incorporates various statistical methods specific to data on time until an event of interest. While the event is often death, giving rise to the phrase 'survival analysis', the event might also be, for example, a reoperation. As such, it is sometimes referred to as 'time-to-event analysis'. Censoring sets survival analysis apart from other analyses: at the end of the follow-up period, not all subjects have experienced the event of interest, and some subjects may drop out of the study prior to completion. Survival data for a group of subjects is usually visualized by the Kaplan-Meier estimator, representing the probability of a subject remaining free of the event during follow-up. There are several methods to compare survival between the study groups, for example, treatment arms, including the log-rank test and the Cox proportional hazards model. The log-rank test is an unadjusted non-parametric method, whereas the Cox proportional hazards model allows comparison while adjusting for multiple covariates. A principal assumption of the Cox proportional hazards model is that the relative hazard stays constant over time-the so-called proportionality. Specific methods exist for comparison of survival with the general population. This article describes the fundamental concepts every cardiothoracic surgeon should be aware of when analysing survival data and are illustrated with a clinical example.

Statistical primer: a cost-effectiveness analysis.

Cost-effectiveness analyses (CEAs) of new treatment strategies are increasingly reported. This can be a part of a clinical trial or as a separate study. Governments and healthcare payers frequently require a CEA to decide whether a new treatment strategy will be reimbursed. CEA is a framework to assess the effectiveness and costs of a new treatment strategy (e.g. a drug or intervention) when compared with a reference strategy. Effectiveness is often measured in life-years or quality-adjusted life-years, whereas costs consist of direct costs (the costs of the treatment), induced costs (downstream costs and cost offsets) and indirect costs. In this statistical primer, the rationale for assessing the economic consequences of new therapies is explained, followed by the fundamental concepts of CEAs, the different types of CEAs and an introduction to interpretation of CEAs. Finally, a real-world example of a CEA is discussed, comparing cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk.

Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease.

BACKGROUND: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, patients with 3-vessel or left main coronary artery disease (CAD) had improved long-term outcomes with coronary artery bypass graft (CABG) surgery compared with percutaneous coronary intervention (PCI) with drug-eluting stents (DES), improvements driven mainly by differences in myocardial infarction and repeat revascularization. OBJECTIVES: This study compared the long-term quality-of-life benefits of DES-PCI versus CABG for patients with 3-vessel or left main CAD. METHODS: Between 2005 and 2007, the SYNTAX trial randomized 1,800 patients with 3-vessel or left main CAD to either CABG or DES-PCI. Health status was assessed at baseline and at 1, 6, 12, 36, and 60 months by using the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey. RESULTS: At 5-year follow-up, CABG was superior to DES-PCI on several SAQ domains including angina frequency and physical function, as well as the role physical and role emotional scales of the 36-Item Short Form Health Survey. Subgroup analysis demonstrated a significant interaction between angiographic complexity (as assessed by the SYNTAX score) and angina relief (mean difference in the SAQ angina frequency score for CABG vs. PCI of -0.9, 3.3, and 3.9 points for low, intermediate, and high SYNTAX score patients, respectively; p = 0.048 for interaction). CONCLUSIONS: Among patients with 3-vessel or left main CAD, both CABG and DES-PCI were associated with substantial and sustained quality-of-life benefits over 5 years of follow-up. In general, CABG resulted in greater angina relief, although the absolute treatment benefit was small. Angina relief at 5 years was enhanced with CABG among patients with high SYNTAX scores, a finding reinforcing the recommendation that CABG should be strongly preferred for such patients. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972).

Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective.

AIMS: Recent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective. We, therefore, used individual patient-level data from the SYNTAX trial to evaluate the cost-effectiveness of PCI versus CABG from a European (Dutch) perspective. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with three-vessel or left main coronary artery disease were randomised to either CABG (n=897) or PCI with drug-eluting stents (DES; n=903). Costs were estimated for all patients based on observed healthcare resource usage over 5 years of follow-up. Health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on Dutch life-tables was used to extrapolate the 5-year in-trial data to a lifetime horizon. Although initial procedural costs were lower for CABG, total initial hospitalisation costs per patient were higher (€17 506 vs €14 037, p<0.001). PCI was more costly during the next 5 years of follow-up, due to more frequent hospitalisations, repeat revascularisation procedures and higher medication costs. Nevertheless, total 5-year costs remained €2465/patient higher with CABG. When the in-trial results were extrapolated to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with gains in both life expectancy and quality-adjusted life expectancy. The incremental cost-effectiveness ratio (ICER) (€5390/quality-adjusted life year (QALY) gained) was favourable and remained <€80 000/QALY in >90% of the bootstrap replicates. Outcomes were similar when incorporating the prognostic impact of non-fatal myocardial infarction and stroke, as well as across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. However, DES-PCI was economically dominant compared with CABG in patients with a SYNTAX Score ≤22 or in those with left main disease. In patients for whom the SYNTAX Score II favoured PCI based on lower predicted 4-year mortality, PCI was also economically dominant, whereas in those patients for whom the SYNTAX Score II favoured surgery, CABG was highly economically attractive (ICER range, €2967 to €3737/QALY gained). CONCLUSIONS: For the broad population with three-vessel or left main disease who are candidates for either CABG or PCI, we found that CABG is a clinically and economically attractive revascularisation strategy compared with DES-PCI from a Dutch healthcare perspective. The cost-effectiveness of CABG versus PCI differed according to several anatomic factors, however. The newly developed SYNTAX Score II provides enhanced prognostic discrimination in this population, and may be a useful tool to guide resource allocation as well. TRIAL REGISTRATION NUMBER: Clinical trial unique identifier: NCT00114972 (http://www.clinical-trials.gov).

Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial.

OBJECTIVES: The purpose of this study was to characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome. BACKGROUND: For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival. METHODS: Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12, and the EuroQol-5D. The overall summary scale of the KCCQ (range 0 to 100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as death, a KCCQ overall summary score (OS) <45, or a decline in KCCQ-OS of 10 points at 6-month follow-up. RESULTS: A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval [CI]: 20.3 to 27.5 points) at 1 month, 27.4 points (95% CI: 24.2 to 30.6 points) at 6 months, 27.4 points (95% CI: 24.1 to 30.8 points) at 12 months, along with substantial increases in Short Form-12 scores and EuroQol-5D utilities (all p < 0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior coronary artery bypass grafting, oxygen dependency, very high predicted mortality with surgical aortic valve replacement, and low serum albumin. CONCLUSIONS: Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for whom TAVR is beneficial. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Patient selection for TAVI in 2014: is there a justification for treating low- or intermediate-risk patients? The surgeon's view.

The introduction of transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of patients with symptomatic severe aortic valve stenosis (AS). In extreme and high-risk patients, randomised studies have shown the benefit of this new therapy. However, there are still a lot of unknowns, and the question has arisen whether it is justified to expand the indication of TAVI to other patient groups, especially intermediate-or even low-risk patients.

Role of percutaneous coronary intervention in the treatment of left main coronary artery disease.

Revascularization with coronary artery bypass graft surgery is the choice of therapy in patients with left main (LM) coronary artery stenosis. During the last decade, the introduction of drug-eluting stents, together with antiplatelet and antithrombotic treatments, has improved the outcome of percutaneous coronary interventions (PCIs) by reducing the number of repeat revascularizations and the risk of stent thrombosis. Many institutions inside and outside the United States have adopted stent treatment of unprotected LM coronary artery disease as a more routine strategy. However, coronary bypass surgery has improved as well by using more arterial grafts, better perioperative care, and optimizing medical treatment postoperatively. The advances in stent technique may reduce the gap between coronary surgery and PCIs further, but the results of the Evaluation of Xience Prime versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization study, randomizing patients with LM coronary artery disease between coronary bypass grafting and PCIs, will be needed to test whether PCIs is noninferior to coronary bypass surgery.

Cost, quality, and value in coronary artery bypass grafting.

OBJECTIVE: Pay-for-performance measures, part of the Affordable Care Act, aim to reduce health care costs by linking value with Medicare payments, but until now the concept of value has not been applied to specific procedures. We sought to define value in coronary artery bypass grafting (CABG) and provide a framework to identify high-value centers. METHODS: In a multiinstitutional statewide database, clinical patient-level data from 42,839 patients undergoing CABG were matched with cost data. Hierarchical models adjusting for relevant preoperative patient characteristics and comorbidities were used to estimate center-specific risk-adjusted costs and risk-adjusted postoperative length of stay. Variation in value across centers was assessed by the correlation between risk-adjusted measures of quality (mortality, morbidity/mortality) and resource use (costs and length of stay). RESULTS: There were no significant correlations between risk-adjusted costs and risk-adjusted mortality (r = 0.20, P = .45) or morbidity/mortality (r = 0.15, P = .57) across centers. Risk-adjusted costs and length of stay were not significantly associated (r = 0.23, P = .37) because of cost accounting differences across centers. This may explain the lack of correlation between risk-adjusted quality and risk-adjusted cost measures. When risk-adjusted length of stay and morbidity/mortality were used for the framework, there was a strong positive correlation (r = 0.67, P = .003), indicating that higher risk-adjusted quality is associated with shorter risk-adjusted length of stay. CONCLUSIONS: Risk-adjusted length of stay and risk-adjusted combined morbidity/mortality are important outcome measures for assessing value in cardiac surgery. The proposed framework can be used to define value in CABG and identify high-value centers, thereby providing information for quality improvement and pay-for-performance initiatives.

Performance of EuroSCORE II in a large US database: implications for transcatheter aortic valve implantation.

OBJECTIVES: Validation studies of European system for cardiac operative risk evaluation II (EuroSCORE II) have been limited to European datasets. Therefore, the aims of this study were to assess the performance of EuroSCORE II in a large multicentre US database, and compare it with the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM). In addition, implications for patient selection for transcatheter aortic valve implantation (TAVI) were explored. METHODS: EuroSCORE II and the STS-PROM were calculated for 50 588 patients from a multi-institutional statewide database of all cardiac surgeries performed since 2003. Model performance was assessed using the area under the receiver operator curve (AUC), observed vs expected (O:E) ratios and calibration plots. Analyses were performed for isolated coronary artery bypass grafting (CABG) (n = 40 871), aortic valve replacement (AVR) (n = 4107), AVR + CABG (n = 3480), mitral valve (MV) replacement (n = 1071) and MV repair (n = 1059). RESULTS: The overall in-hospital mortality rate was 2.1%. EuroSCORE II was outperformed by the STS-PROM in the overall cohort with regard to discrimination (AUC = 0.77 vs 0.81, respectively; P < 0.001) and calibration (O:E = 0.68 vs 0.80, respectively). Discrimination for CABG was worse with EuroSCORE II (AUC = 0.77 vs STS-PROM: 0.81, P < 0.001). For other procedures discrimination was similar: AVR (AUC = 0.71 vs STS-PROM: 0.74, P = 0.40), AVR + CABG (AUC = 0.72 vs STS-PROM: 0.74, P = 0.47), MV repair (AUC = 0.82 vs STS-PROM: 0.86, P = 0.55) and MV replacement (AUC = 0.78 vs STS-PROM: 0.79, P = 0.69). Calibration of EuroSCORE II was worse for CABG (O:E = 0.68 vs STS-PROM: 0.80), similar in AVR + CABG (O:E = 0.76 vs STS-PROM: 0.70) and MV repair (O:E = 0.64 vs STS-PROM: 0.67), while EuroSCORE II may be more accurate in AVR (O:E = 0.96 vs STS-PROM: 0.76). Performance of both models improved when only recent cases (after 1 January 2008) were used. Ongoing TAVI trials aimed at patients with an estimated 4-10% risk of mortality are enrolling patients with mean estimated risks of 6.2% (EuroSCORE II) or 6.0% (STS-PROM), and an actual mortality rate of 4.6% (EuroSCORE II) or 4.8% (STS-PROM). CONCLUSIONS: In a large US multicentre database, the STS-PROM performs better than EuroSCORE II for CABG. However, EuroSCORE II is a reasonable alternative in low-risk CABG patients and in those undergoing other cardiac surgical procedures. Clinical trials and physicians that use these scores recruit and treat patients who are at a lower risk than anticipated. This potentially leads to overtreatment with an investigational device. Decision-making should not solely be based on risk scores, but should comprise multidisciplinary heart team discussions.