Same evidence different recommendations: a methodological assessment of transatlantic guidelines for the management of valvular heart disease.

OBJECTIVES: To identify methodological variations leading to varied recommendations between the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) valvular heart disease (VHD) Guidelines, and to suggest foundational steps towards standardizing guideline development. METHODS: An in-depth analysis was conducted to evaluate the methodologies used in developing the Transatlantic Guidelines for managing VHD. The evaluation was benchmarked against the standards proposed by the Institute of Medicine. RESULTS: Substantial discrepancies were noted in the methodologies utilized in development processes, including writing committee composition, evidence evaluation, conflict of interest management, and voting processes. Furthermore, despite their mutual differences, both methodologies also demonstrate notable deviations from the IOM standards in several essential areas, including literature review and evidence grading. These dual variances likely influenced divergent treatment recommendations. For example, the ESC/EACTS recommends transcatheter edge-to-edge repair (TEER) for patients ineligible for mitral valve surgery, while the ACC/AHA recommends TEER based on anatomy, regardless of surgical risk. ESC/EACTS guidelines recommend a mechanical aortic prosthesis for patients under 60, while ACC/AHA guidelines recommend it for patients under 50. Notably, the ACC/AHA and ESC/EACTS guidelines have differing age cut-offs for surgical over transcatheter aortic valve replacement (<65 and <75 years, respectively). CONCLUSIONS: Variations in methodologies for developing CPGs have resulted in different treatment recommendations that may significantly impact global practice patterns. Standardization of essential processes is vital to increase the uniformity and credibility of CPGs, ultimately improving healthcare quality, reducing variability and enhancing trust in modern medicine.

European Association of Cardio-Thoracic Surgery (EACTS) expert consensus statement on perioperative myocardial infarction after cardiac surgery.

Cardiac surgery may lead to myocardial damage and release of cardiac biomarkers through various mechanisms such as cardiac manipulation, systemic inflammation, myocardial hypoxia, cardioplegic arrest and ischaemia caused by coronary or graft occlusion. Defining perioperative myocardial infarction (PMI) after cardiac surgery presents challenges, and the association between the current PMI definitions and postoperative outcomes remains uncertain. To address these challenges, the European Association of Cardio-Thoracic Surgery (EACTS) facilitated collaboration among a multidisciplinary group to evaluate the existing evidence on the mechanisms, diagnosis and prognostic implications of PMI after cardiac surgery. The review found that the postoperative troponin value thresholds associated with an increased risk of mortality are markedly higher than those proposed by all the current definitions of PMI. Additionally, it was found that large postoperative increases in cardiac biomarkers are prognostically relevant even in absence of additional supportive signs of ischaemia. A new algorithm for PMI detection after cardiac surgery was also proposed, and a consensus was reached within the group that establishing a prognostically relevant definition of PMI is critically needed in the cardiovascular field and that PMI should be included in the primary composite outcome of coronary intervention trials.

Impact of left ventricular ejection fraction on 10-year mortality in the SYNTAX trial.

BACKGROUNDS: The impact of reduced left ventricular ejection fraction (LVEF) on very long-term prognosis following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) has been debated. The aim of this study was to investigate the impact of LVEF at baseline on 10-year mortality in the SYNTAX trial. METHODS: Patients (n = 1800) were categorized into three sub-groups: reduced (rEF ≤ 40 %), mildly reduced (mrEF 41-49 %), and preserved LVEF (pEF ≥ 50 %). The SYNTAX score 2020 (SS-2020) was applied in patients with LVEF<50 % and ≥ 50 %. RESULTS: Ten-year mortalities were 44.0 %, 31.8 %, and 22.6 % (P < 0.001) in patients with rEF (n = 168), mrEF (n = 179), and pEF (n = 1453). Although no significant differences were observed, the mortality with PCI was higher than with CABG in patients with rEF (52.9 % vs 39.6 %, P = 0.054) and mrEF (36.0 % vs. 28.6 %, P = 0.273), and comparable in pEF (23.9 % vs. 22.2 %, P = 0.275). Calibration and discrimination of the SS-2020 in patients with LVEF<50 % were poor, whilst they were reasonable in those with LVEF≥50 %. The proportion of patients eligible for PCI who had a predicted equipoise in mortality with CABG was estimated to be 57.5 % in patients with LVEF≥50 %. CABG was safer than PCI in 62.2 % of patients with LVEF<50 %. CONCLUSIONS: Reduced LVEF was associated with an increased risk of 10-year mortality in patients revascularized either surgically or percutaneously. Compared to PCI, CABG was safe revascularization in patients with LVEF≤40 %. In patients with LVEF≥50 % individualized 10-year all-cause mortality predicted by SS-2020 was helpful in decision-making whilst the predictivity in patients with LVEF<50 % was poor.

Enhancing predictive accuracy of the cardiac risk score in open abdominal aortic surgery: the role of left ventricular wall motion abnormalities.

Background: Open abdominal aortic surgery carries many potential complications, with cardiac adverse events being the most significant concern. The Vascular Study Group Cardiac Risk Index (VSG-CRI) is a commonly used tool for predicting severe cardiac complications and guiding clinical decision-making. However, despite the potential prognostic significance of left ventricular wall motion abnormalities (LVWMAs) and reduced LV ejection fraction (LVEF) for adverse outcomes, the VSG-CRI model has not accounted for them. Hence, the main objective of this study was to analyze the added value of LV wall motion on the discriminatory power of the modified VSG-CRI in predicting major postoperative cardiac complications. Methods: A prospective study was conducted involving 271 patients who underwent elective abdominal aortic surgery between 2019 and 2021. VSG-CRI scores were calculated, and preoperative transthoracic echocardiography was conducted for all patients. Subsequently, a modified version of the VSG-CRI, accounting for reduced LVEF and LVWMAs, was developed and incorporated into the dataset. The postoperative incidence of the composite endpoint of major adverse cardiac events (MACEs), including myocardial infarction, clinically relevant arrhythmias treated with medicaments or by cardioversion, or congestive heart failure, was assessed at discharge from the index hospitalization, with adjudicators blinded to events. The predictive accuracy of both the original and modified VSG-CRI was assessed using C-Statistics. Results: In total, 61 patients (22.5%) experienced MACEs. Among these patients, a significantly higher proportion had preoperative LVWMAs compared to those without (62.3% vs. 32.9%, p < 0.001). Multivariable regression analysis revealed the VSG-CRI [odds ratio (OR) 1.46, 95% confidence interval (CI) 1.21-1.77; p < 0.001] and LVWMA (OR 2.76; 95% CI 1.46-5.23; p = 0.002) as independent predictors of MACEs. Additionally, the modified VSG-CRI model demonstrated superior predictability compared to the baseline VSG-CRI model, suggesting an improved predictive performance for anticipating MACEs following abdominal aortic surgery [area under the curve (AUC) 0.74; 95% CI 0.68-0.81 vs. AUC 0.70; 95% CI 0.63-0.77; respectively]. Conclusion: The findings of this study suggest that incorporating preoperative echocardiography can enhance the predictive accuracy of the VSG-CRI for predicting MACEs after open abdominal aortic surgery. Before its implementation in clinical settings, external validation is necessary to confirm the generalizability of this newly developed predictive model across different populations.

Optimal management of cardiac surgery patients using direct oral anticoagulants: recommendations for clinical practice.

OBJECTIVES: Literature is scarce on the management of patients using direct oral anticoagulants (DOACs) undergoing elective, urgent and emergency surgery. Therefore, we summarize the current evidence and provide literature-based recommendations for the management of patients on DOACs in the perioperative phase. METHODS: A general literature review was conducted on the pharmacology of DOACs and for recommendations on the management of cardiac surgical patients on DOACs. Additionally, we performed a systematic review for studies on the use of direct DOAC reversal agents in the emergency cardiac surgical setting. RESULTS: When surgery is elective, the DOAC cessation strategy is relatively straightforward and should be adapted to the renal function. The same approach applies to urgent cases, but additional DOAC activity drug level monitoring tests may be useful. In emergency cases, idarucizumab can be safely administered to patients on dabigatran in any of the perioperative phases. However, andexanet alfa, which is not registered for perioperative use, should not be administered in the preoperative phase to reverse the effect of factor Xa inhibitors, as it may induce temporary heparin resistance. Finally, the administration of (activated) prothrombin complex concentrate may be considered in all patients on DOACs, and such concentrates are generally readily available. CONCLUSIONS: DOACs offer several advantages over vitamin K antagonists, but care must be taken in patients undergoing cardiac surgery. Although elective and urgent cases can be managed relatively straightforwardly, the management of emergency cases requires particular attention.

2022 Joint ESC/EACTS review of the 2018 guideline recommendations on the revascularization of left main coronary artery disease in patients at low surgical risk and anatomy suitable for PCI or CABG.

In October 2021, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) jointly agreed to establish a Task Force (TF) to review recommendations of the 2018 ESC/EACTS Guidelines on myocardial revascularization as they apply to patients with left main (LM) disease with low-to-intermediate SYNTAX score (0-32). This followed the withdrawal of support by the EACTS in 2019 for the recommendations about the management of LM disease of the previous guideline. The TF was asked to review all new relevant data since the 2018 guidelines including updated aggregated data from the four randomized trials comparing percutaneous coronary intervention (PCI) with drug-eluting stents vs. coronary artery bypass grafting (CABG) in patients with LM disease. This document represents a summary of the work of the TF; suggested updated recommendations for the choice of revascularization modality in patients undergoing myocardial revascularization for LM disease are included. In stable patients with an indication for revascularization for LM disease, with coronary anatomy suitable for both procedures and a low predicted surgical mortality, the TF concludes that both treatment options are clinically reasonable based on patient preference, available expertise, and local operator volumes. The suggested recommendations for revascularization with CABG are Class I, Level of Evidence A. The recommendations for PCI are Class IIa, Level of Evidence A. The TF recognized several important gaps in knowledge related to revascularization in patients with LM disease and recognizes that aggregated data from the four randomized trials were still only large enough to exclude large differences in mortality.

2022 Joint ESC/EACTS review of the 2018 guideline recommendations on the revascularization of left main coronary artery disease in patients at low surgical risk and anatomy suitable for PCI or CABG.

Task Force structure and summary of clinical evidence of 2022 ESC/EACTS review of the 2018 guideline recommendations on the revascularization of left main coronary artery disease. CABG, coronary artery bypass grafting; PCI, percutaneous coronary intervention; LM, left main; SYNTAX, Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery. a'Event' refers to the composite of death, myocardial infarction (according to Universal Definition of Myocardial Infarction if available, otherwise protocol defined) or stroke. In October 2021, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) jointly agreed to establish a Task Force (TF) to review recommendations of the 2018 ESC/EACTS Guidelines on myocardial revascularization as they apply to patients with left main (LM) disease with low-to-intermediate SYNTAX score (0-32). This followed the withdrawal of support by the EACTS in 2019 for the recommendations about the management of LM disease of the previous guideline. The TF was asked to review all new relevant data since the 2018 guidelines including updated aggregated data from the four randomized trials comparing percutaneous coronary intervention (PCI) with drug-eluting stents vs. coronary artery bypass grafting (CABG) in patients with LM disease. This document represents a summary of the work of the TF; suggested updated recommendations for the choice of revascularization modality in patients undergoing myocardial revascularization for LM disease are included. In stable patients with an indication for revascularization for LM disease, with coronary anatomy suitable for both procedures and a low predicted surgical mortality, the TF concludes that both treatment options are clinically reasonable based on patient preference, available expertise, and local operator volumes. The suggested recommendations for revascularization with CABG are Class I, Level of Evidence A. The recommendations for PCI are Class IIa, Level of Evidence A. The TF recognized several important gaps in knowledge related to revascularization in patients with LM disease and recognizes that aggregated data from the four randomized trials were still only large enough to exclude large differences in mortality.

Lessons learned from the EACTS-MSTCVS quality fellowship: a call to action for continuous improvement of cardiothoracic surgery outcomes in Europe.

The Michigan Society of Thoracic and Cardiovascular Surgeons (MSTCVS), a pioneer in initiating and nurturing quality improvement strategies in statewide cardiothoracic surgery, has been running the Quality Collaborative (MSTCVS-QC) program since 2001. This initiative has significantly grown over the years, facilitating at least 4 in-person meetings annually. It actively engages cardiac and general thoracic surgeons, data managers and researchers from all 32 non-federally funded cardiothoracic surgery sites across Michigan. Broadening its influence on joint learning and clinical outcomes, the MSTCVS-QC formed a strategic partnership with Blue Cross Blue Shield of Michigan, the state's largest private insurer, to further promote its initiatives. The MSTCVS-QC, operating from a dedicated QC centre employs an STS-associated database with additional aspects for data collection and analysis. The QC centre also organizes audits, facilitates collaborative meetings, disseminates surgical outcomes and champions the development and implementation of quality improvement initiatives related to cardiothoracic surgery in Michigan. Recognizing the MSTCVS-QC's successful efforts in advancing quality improvement, the European Association for Cardiothoracic Surgery (EACTS) introduced a fellowship program in 2018, facilitated through the EACTS Francis Fontan Fund (FFF). This program allows early-career academic physicians to spend 4-6 months with the MSTCVS-QC team in Ann Arbor. This article chronicles the evolution and functionality of the MSTCVS-QC, enriched by the experiences of the inaugural 4 EACTS/FFF fellows. Our objective is to emphasize the critical importance of fostering a culture of quality improvement and patient safety in the field of cardiothoracic surgery with open discussion of audited, high-quality data points. This principle, while implemented locally, has implications and value extending far beyond Europe, resonating globally.

Mastering the Best Practices: A Comprehensive Look at the European Guidelines for Cardiopulmonary Bypass in Adult Cardiac Surgery.

The successful outcome of a cardiac surgery procedure is significantly dependent on the management of cardiopulmonary bypass (CPB). Even if a cardiac operation is technically well-conducted, a patient may suffer CPB-related complications that could result in severe comorbidities, reduced quality of life, or even death. However, the role of clinical perfusionists in perioperative patient care, which is critical, is often overlooked. Therefore, the European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Cardiothoracic Anaesthesiology (EACTA), and the European Board of Cardiovascular Perfusion (EBCP) have agreed to develop joint clinical practice guidelines (CPGs) for CPB due to its significant impact on patient care and significant variations in practice patterns between countries. The European guidelines, based on the EACTS standardized framework for the development of CPGs, cover the entire spectrum of CPB management in adult cardiac surgery. This includes training and education of clinical perfusionists, machine hardware, disposables, preparation for initiation of CPB, a complete set of procedures during CPB to help maintain end-organ function and anticoagulation, weaning from CPB, and the gaps in evidence and future research directions. This comprehensive coverage ensures that all aspects of CPB management are addressed, providing clinicians with a standardized approach to CPB management based on the latest evidence and best practices. To ensure better integration of these evidence-based recommendations into daily practice, this review aims to provide a general understanding of guideline development and an overview of essential treatment recommendations for CPB management.

Impact of on-pump and off-pump coronary artery bypass grafting on 10-year mortality versus percutaneous coronary intervention.

OBJECTIVES: The very long-term mortality of off-pump and on-pump coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in a randomized complex coronary artery disease population is unknown. This study aims to investigate the impact of on-pump and off-pump CABG versus PCI on 10-year all-cause mortality. METHODS: The SYNTAX trial randomized 1800 patients with three-vessel and/or left main coronary artery disease to PCI or CABG and assessed their survival at 10 years. In this sub-study, the hazard of mortality over 10 years was compared according to the technique of revascularization: on-pump CABG (n = 725), off-pump CABG (n = 128) and PCI (n = 903). RESULTS: There was substantial inter-site variation in the use of off-pump CABG despite baseline characteristics being largely homogeneous among the 3 groups. The crude rate of mortality was significantly lower following on-pump CABG versus PCI [25.6% vs 28.4%, hazard ratio (HR) 0.79, 95% confidence interval (CI) 0.65-0.96], while it was comparable between off-pump CABG and PCI (28.5% vs 28.4%, HR 0.98, 95% CI 0.69-1.40). After adjusting for the 9 variables included in the SYNTAX score II 2020, 10-year mortality remained significantly lower with on-pump CABG than PCI (HR 0.75 against PCI, P = 0.009). CONCLUSIONS: In the SYNTAXES trial, 10-year mortality adjusted for major confounders was significantly lower following on-pump CABG compared to PCI. There was no evidence for unadjusted difference between off-pump CABG and PCI, although the unadjusted estimated HR had a wide CI. Site heterogeneity in the technique used in bypass surgery has had measurable effects on treatment performance.

Comparative study of male and female patients undergoing surgical aortic valve replacement.

BACKGROUND: Sex does have an effect on disease perception and outcomes after cardiac surgery. OBJECTIVES: The aim of this study was to quantify the differences in cardiovascular risk profiles within an age-matched cohort and assess the long-term survival differences in males and females who underwent surgical aortic valve replacement (SAVR) with or without concomitant coronary artery bypass surgery. METHODS: All-comers patients who underwent SAVR with or without coronary artery bypass surgery were included. Characteristics, clinical features and survival up to 30 years were compared between female and male patients. Propensity matching and age matching using propensity scores were used to compare both groups. RESULTS: During the total study period between 1987 and 2017, there were 3462 patients {mean age 66.8 [standard deviation (SD): 11.1] years, 37.1% female} who underwent SAVR with or without coronary artery bypass surgery at our institution. In general, female patients were older than male patients (69.1 (SD : 10.3) versus 65.5 (SD : 11.3), respectively). In the age-matched cohort, female patients were less likely to have multiple comorbidities and undergo concomitant coronary artery bypass surgery. Twenty-year survival following the index procedure was higher in age-matched female patients (27.1%) compared to male patients (24.4%) in the overall cohort (P = 0.018). CONCLUSIONS: Substantial sex differences in cardiovascular risk profile exist. However, when SAVR with or without coronary artery bypass surgery is performed, extended long-term mortality is comparable between males and females. More research regarding sex-dimorphic mechanisms of aortic stenosis and coronary atherosclerosis would promote more awareness in terms of sex-specific risk factors after cardiac surgery and contribute to more guided personalized surgery in the future.

Impact of periprocedural major adverse events on 10-year mortality after revascularisation.

BACKGROUND: The long-term prognostic impact of a composite of periprocedural major adverse events (PMAE) following revascularisation for patients with complex coronary artery disease (CAD) has not yet been established. AIMS: This study aimed to assess the impact on 10-year mortality of non-fatal PMAE following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Other objectives were to evaluate 1) whether PMAE affect mortality predicted by the SYNTAX score II 2020 (SSII-2020) and 2) whether optimal medical therapy (OMT) positively affects the prognosis of patients with non-fatal PMAE. METHODS: The association between 10-year mortality and non-fatal PMAE occurring within 30 days of PCI or CABG in patients with three-vessel disease and/or left main disease enrolled in the SYNTAXES study was investigated. RESULTS: The main findings are that non-fatal PMAE occurred less frequently following PCI than CABG (11.2% vs 28.2%; p<0.001) and that non-fatal PMAE were an independent predictor of all-cause mortality in the first year post-procedure, but not at 5 or 10 years, in both treatment modalities. PMAE substantially alter the individual predictions of 10-year mortality by the SSII-2020. In patients with non-fatal PMAE, OMT may provide survival benefits during the first year post-procedure as well as in the long term. CONCLUSIONS: In patients with complex CAD, non-fatal PMAE were more common following CABG than PCI, but their prognostic impact was similar, being significant in the first year and then diminishing out to 10 years. Patients with non-fatal PMAE may therefore require more careful follow-up and additional preventive treatment in the first year post-procedure.

ESC/EACTS vs. ACC/AHA guidelines for the management of severe aortic stenosis.

Aortic stenosis (AS) is a serious and complex condition, for which optimal management continues to evolve rapidly. An understanding of current clinical practice guidelines is critical to effective patient care and shared decision-making. This state of the art review of the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines and 2020 American College of Cardiology/American Heart Association Guidelines compares their recommendations for AS based on the evidence to date. The European and American guidelines were generally congruent with the exception of three key distinctions. First, the European guidelines recommend intervening at a left ventricular ejection fraction of 55%, compared with 60% over serial imaging by the American guidelines for asymptomatic patients. Second, the European guidelines recommend a threshold of ≥65 years for surgical bioprosthesis, whereas the American guidelines employ multiple age categories, providing latitude for patient factors and preferences. Third, the guidelines endorse different age cut-offs for transcatheter vs. surgical aortic valve replacement, despite limited evidence. This review also discusses trends indicating a decreasing proportion of mechanical valve replacements. Finally, the review identifies gaps in the literature for areas including transcatheter aortic valve implantation in asymptomatic patients, the appropriateness of Ross procedures, concomitant coronary revascularization with aortic valve replacement, and bicuspid AS. To summarize, this state of the art review compares the latest European and American guidelines on the management of AS to highlight three areas of divergence: timing of intervention, valve selection, and surgical vs. transcatheter aortic valve replacement criteria.