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Objectives: The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management., Methods: Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated., Results: The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml., Conclusions: This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time., Clinical Trial Registration Number: NCT02088554, NCT02701283, NCT01586910 and NCT01531374., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Preamble: The finalized document was endorsed by the EACTS Council and STS Executive Committee before being simultaneously published in the European Journal of Cardio-thoracic Surgery (EJCTS) and The Annals of Thoracic Surgery (The Annals) and the Journal of Thoracic and Cardiovascular Surgery (JTCVS)., (This article has been co-published with permission in the European Journal of Cardio-Thoracic Surgery, The Annals of Thoracic Surgery, and the Journal of Thoracic and Cardiovascular Surgery. All rights reserved. © 2023 European Association for Cardio-Thoracic Surgery, The Society of Thoracic Surgeons, and the American Association for Thoracic Surgery. The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Any of the three citations can be used when citing this article.)

Objectives: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement., Methods: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated., Results: A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery., Conclusions: The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Aims: Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM., Methods and Results: In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi ≤0.85 cm2/m2, and severe PPM was defined as EOAi ≤0.65 cm2/m2. The reference values obtained from the training set ranged from 1.27 cm2 for size 19 mm up to 1.81 cm2 for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%., Conclusion: The use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease., Methods: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years., Results: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG., Conclusions: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial., Methods and Results: By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis., Conclusion: In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores., Methods: Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG., Results: COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P < 0.0001), death (17.1% vs 7.5%, P = 0.0005) and myocardial infarction (18.3% vs 7.3%, P < 0.0001), but not stroke (3.3% vs 2.9%, P = 0.84). There were no statistically significant interactions in the relative risks of PCI versus CABG for the primary composite end point in patients with and without COPD at 30 days [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.12-1.21 vs HR 0.55, 95% CI 0.29-1.06; Pinteraction = 0.61] or at 3 years (HR 0.85, 95% CI 0.46-1.56 vs HR 1.28, 95% CI 0.84-1.94; Pinteraction = 0.27)., Conclusions: In the EXCEL trial, COPD was independently associated with poor prognosis after left main coronary artery disease revascularization. The relative risks of PCI versus CABG at 30 days and 3 years were consistent in patients with and without COPD., Clinical Trial Registration Number: http://www.clinicaltrials.gov; NCT01205776., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Observational data suggest that the use of a single internal thoracic artery (SITA) may result in inferior outcomes compared with bilateral internal thoracic artery (BITA) use for coronary artery bypass grafting (CABG)-a finding not yet supported by randomized trial outcomes. However, the optimal number of internal thoracic artery grafts in patients with left main coronary artery disease has not been investigated., Methods: The EXCEL trial randomized 1905 patients with left main coronary artery disease to percutaneous coronary intervention with everolimus-eluting stents versus CABG. Among the 905 patients undergoing CABG, 688 (76.0%) received SITA and 217 (24.0%) received BITA. Differences in clinical event rates were estimated using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox regression was used to adjust for differences in baseline covariates., Results: Compared to SITA, patients treated with BITA were younger (66.1 ± 9.5 vs 64.5 ± 9.3 years, P = 0.020), were less likely female (24.3% vs 14.3%, P = 0.002) and diabetic (28.8% vs 15.2%, P < 0.001), and had a lower prevalence of peripheral vessel disease (10.2% vs 5.5%, P = 0.040). The unadjusted 3-year composite primary endpoint of death, stroke or myocardial infarction (MI) occurred in 15.6% of SITA vs 11.6% of BITA patients (P = 0.17). The SITA group tended to have a higher 3-year rate of all-cause death compared with the BITA group (6.7% vs 3.3%; P = 0.070). Stroke, MI and ischaemia-driven revascularization outcomes were not significantly different between groups. After adjusting for baseline differences, neither the composite of death, stroke or MI [hazard ratio (HR) 1.12, 95% confidence interval (CI) 0.71-1.78; P = 0.62] nor mortality (HR 1.36, 95% CI 0.60-3.12; P = 0.46) was significantly higher with SITA. The rehospitalization rate after 3 years was higher in the SITA group (35.8% vs 26.0%, P = 0.008), a difference which was no longer present after multivariable adjustment (HR 1.27, 95% CI 0.93-1.74; P = 0.13). Sternal wound dehiscence within 30 days did not occur more often in the BITA group compared to the SITA group (1.8% vs 2.2%, P > 0.99)., Conclusions: In the EXCEL trial, there were no clinical differences at 3 years between SITA or BITA revascularization in patients with left main coronary artery disease., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: The incidence, indications, and risk factors for cardiac implantable electronic device (CIED) implantation after cardiac surgery in an era with an aging population are not well described. There are limited data about the survival of these patients compared with a non-device group. We aimed to evaluate the incidence, indications, and risk factors for postoperative CIED implantation. We also assessed survival of these patients compared with a non-device group., Methods: We included all patients without prior CIED implantation who underwent cardiac surgery at our institution from 1996 to 2008. Characteristics associated with CIED implantation were identified by multivariable logistic regression. A propensity model was constructed to compare survival., Results: A total of 39 546 patients were included in the study of which 1608 patients (4.1%) underwent postoperative CIED implantation. Conduction disease accounted for most devices, but 371 patients underwent CIED implantation for secondary prevention of ventricular arrhythmias. Risk factors associated with implantation included older age, valvular disease, atrial fibrillation, and prior surgery. The propensity-adjusted risk of early death (within 1 year) was significantly less in the device group (hazard ratio [HR] 0.38; 95% confidence interval [CI] 0.22-0.65; P = 0.0004). However, the propensity-adjusted risk of late death was significantly greater in the device group (HR 1.3; 95% CI 1.2-1.5; P = <0.0001)., Conclusion: Despite an aging population, the incidence of CIED implantation after cardiac surgery remains low and varies by the type of operation. Follow-up suggests increased early survival but decreased late survival in patients who undergo CIED implantation compared with a non-device group., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: This investigation was undertaken to analyse the association between body mass index (BMI) and morbidity after coronary artery bypass graft (CABG) operations., Methods: The setting was a cardiovascular intensive care unit (ICU) of a tertiary medical referral centre. This was a retrospective review; patients were classified according to their BMI into five groups: underweight <18.5 kg/m(2); normal weight 18.5-24.9 kg/m(2); overweight 25-29.9 kg/m(2); Class I obesity 3034.9 kg/m(2); and Class II/III obesity >35 kg/m(2). We included patients who underwent isolated CABG between January 3, 2006 and March 8, 2011. After including only the initial operation or admission in patients with more than one operation or hospital admission and excluding patients with any missing variable, 3470 patients remained in the analyses. The primary outcomes analysed were hospital mortality and pulmonary and infection morbidities. We secondarily assessed the association between BMI category and each of the three outcomes., Results: Respective mortality, and pulmonary and infection morbidity occurrence rates were: 8.7, 13.0 and 13.0% for the underweight; 2.4, 8.0 and 4.8% for the overweight; 1.8, 10.9 and 5.6% for the Class I obesity group; and 2.7, 11.1 and 5.7% for the Class II/III obesity group, vs 2.3, 7.0 and 6.2% for the normal weight group. Class I and II/III obesity patients were more likely to have pulmonary morbidity compared with the normal weight group, after adjusting for the potential confounding variables., Conclusions: Class I and Class II/III obesity (BMI ≥30 kg/m(2)) was associated with increased pulmonary morbidity after CABG operations. There was no difference in mortality or infection morbidity in any BMI group compared with the normal group., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: Treatment of ischaemic mitral regurgitation (IMR) remains controversial. While IMR is associated with worse outcomes, randomized controlled trials (RCTs) and observational studies provided conflicting evidence regarding the benefit of mitral valve replacement (MVR) or repair (MVr) in addition to coronary artery bypass grafting (CABG). We conducted a meta-analysis incorporating data from published RCTs and observational studies comparing CABG vs. CABG + MVR/MVr., Methods and Results: We searched PubMed, MEDLINE, Embase, Ovid, and Cochrane for RCTs and observational studies comparing CABG (Group 1) vs. CABG + MVR/MVr (Group 2). Outcome was 30-day and 1-year mortality after surgical intervention. Mantel-Haenszel odds ratio (OR) was calculated using random-effects meta-analysis for the outcome. Heterogeneity was assessed by I2 statistics. Four RCTs and 11 observational studies met the inclusion criteria (5781 patients, 507 in RCTs, 5274 in observational studies). Group 1 vs. 2 weighted mean left ventricular ejection fraction in RCTs and combined RCTs/observational studies was 41.5 ± 12.3 vs. 40.3 ± 10.4% ( P -value = 0.24) and 45.5 ± 7.2 vs. 38 ± 10% ( P -value < 0.001), respectively. In RCTs, there was no difference in 30-day [OR: 0.95, 95% confidence interval (95% CI): 0.30-3.08, P = 0.94] or 1-year (OR: 0.90, 95% CI: 0.43-1.87, P = 0.78) mortality, respectively. For combined RCTs/observational studies, there was no difference in mortality at 30 days (OR: 0.67, 95% CI: 0.43-1.04, P = 0.08) or at 1 year (OR: 0.90, 95% CI: 0.7-1.15, P = 0.39)., Conclusion: In a meta-analysis of RCTs and observational studies of IMR patients, the addition of MVR/MVr to CABG did not improve survival.

Aims: To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial., Methods and Results: Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (<33). After completion of patient recruitment in EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction)., Conclusion: The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)