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Background The debate on the advantages and limitations of off-pump (OPCAB) on long-term outcomes has not still arrived to a conclusion. This study was designed to compare the impact of OPCAB vs on-pump coronary artery bypass grafting (CABG) on long-term mortality and major adverse cardiac events (MACEs). Methods The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002–2004 and 2007–2008. Data on isolated CABG were linked to 2 administrative datasets. Time-to-event methods were employed to analyze outcomes. Results The population consisted of 11021 patients who underwent isolated CABG (27.2% OPCAB) that were divided into development and validation datasets. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, nonetheless the adjustment did not confirm OPCAB as a risk factor for mortality (HR 0.94, 95% CI 0.85–1.03, p=0.19). OPCAB was associated to an increased risk of MACE at 10 years (adjusted HR 1.14, 95% CI 1.06–1.23, p=0.001). Inside the MACEs, OPCAB was significantly related to increased incidence of rehospitalization for percutaneous cardiac intervention (PCI), (adjusted HR 1.33, 95% CI 1.16–1.53, p Conclusions OPCAB did not affect long-term mortality but is associated with an increased long-term risk of repeat PCI. These findings may have important implications towards health resources allocation, particularly in a climate of cost containment of healthcare expenditures. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health

Background Contemporary scores for estimating perioperative death have been proposed to also predict also long-term death. The aim of the study was to evaluate the performance of the updated European System for Cardiac Operative Risk Evaluation II, The Society of Thoracic Surgeons Predicted Risk of Mortality score, and the Age, Creatinine, Left Ventricular Ejection Fraction score for predicting long-term mortality in a contemporary cohort of isolated aortic valve replacement (AVR). We also sought to develop for each score a simple algorithm based on predicted perioperative risk to predict long-term survival. Methods Complete data on 1,444 patients who underwent isolated AVR in a 7-year period were retrieved from three prospective institutional databases and linked with the Italian Tax Register Information System. Data were evaluated with performance analyses and time-to-event semiparametric regression. Results Survival was 83.0% ± 1.1% at 5 years and 67.8 ± 1.9% at 8 years. Discrimination and calibration of all three scores both worsened for prediction of death at 1 year and 5 years. Nonetheless, a significant relationship was found between long-term survival and quartiles of scores (p < 0.0001). The estimated perioperative risk by each model was used to develop an algorithm to predict long-term death. The hazard ratios for death were 1.1 (95% confidence interval, 1.07 to 1.12) for European System for Cardiac Operative Risk Evaluation II, 1.34 (95% CI, 1.28 to 1.40) for the Society of Thoracic Surgeons score, and 1.08 (95% CI, 1.06 to 1.10) for the Age, Creatinine, Left Ventricular Ejection Fraction score. Conclusions The predicted risk generated by European System for Cardiac Operative Risk Evaluation II, The Society of Thoracic Surgeons score, and Age, Creatinine, Left Ventricular Ejection Fraction scores cannot also be considered a direct estimate of the long-term risk for death. Nonetheless, the three scores can be used to derive an estimate of long-term risk of death in patients who undergo isolated AVR with the use of a simple algorithm.

Background Despite the well-known impact of female sex on outcome after surgical aortic valve replacement (sAVR), few studies investigated its role after transcatheter aortic valve replacement (TAVR). Methods After propensity-matching for age, baseline comorbidities, previous interventions, priority, frailty score, New York Heart Association class, left ventricular function and associated cardiac diseases, hospital mortality, and procedure-related morbidities of 388 women (194 TAVR versus 194 sAVR)—of 5,231 patients enrolled in 70 centers participating in this prospective multicenter national registry—were analyzed at a central management unit of the Italian National Institute of Health. Results Although hospital mortality was comparable (4.1% TAVR versus 3.1% sAVR; p = 0.177), women undergoing sAVR showed a higher rate of transfusion (63.9% versus 37.1% TAVR; p = 0.0001); higher number of transfusions per patient (3.6 ± 0.4 versus 2.3 ± 0.3 TAVR; p = 0.049); a higher incidence of low cardiac output state (5.7% versus 3.6% TAVR; p = 0.017) and acute renal failure (8.8% versus 4.1% TAVR; p = 0.01); and higher mean transprosthetic gradients (15.7 ± 12.6 mm Hg versus 11.9 ± 10.7 mm Hg TAVR; p = 0.004). In contrast, women undergoing TAVR experienced significant postprocedural aortic regurgitation (mild, 37.6% versus 7.7% sAVR; moderate-to-severe, 7.1% versus 1.5% sAVR; p = 0.0001) and a higher rate of stroke (7.7% versus 2.5% sAVR; p = 0.037), major vascular complications (9.3% versus 0.5% sAVR; p = 0.0001), pacemaker implantation (12.4% versus 6.2% sAVR; p = 0.004), need for emergent percutaneous coronary intervention (1.0% versus 0% sAVR; p = 0.007), and longer intermediate care unit length of stay (2.5 ± 4.4 days versus 1.4 ± 2.6 days sAVR; p = 0.008). Perioperative myocardial infarction and lengths of intensive care unit stay and hospitalization were comparable (not significant). Conclusions Women undergoing sAVR and TAVR experienced different periprocedural morbidities. These data strongly suggest the need to strictly individualize the indications.

Background: There is still a wide debate concerning the performance of commonly used risk prediction models in assessing the risk of patients undergoing isolated aortic valve surgery. This study was designed to compare the performances of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II and age, creatinine, and ejection fraction (ACEF) score with those of The Society of Thoracic Surgeons (STS) score and logistic EuroSCORE in patients undergoing isolated aortic valve surgery. Methods: Data on 1,758 consecutive patients who underwent isolated aortic valve replacement in a 6-year period were retrieved from 3 prospective institutional databases. Discriminatory power was assessed using the c-index. Calibration was evaluated with calibration curves and associated statistics. Results: In-hospital mortality rate was 1.4%. The discriminatory power was similar in all algorithms (area under the curve 0.80, 95% confidence interval [CI] 0.72 to 0.88 for logistic EuroSCORE; 0.81, 95% CI 0.73 to -0.88 for EuroSCORE II; 0.78, 95% CI 0.68 to 0.88 for ACEF; 0.85, 95% CI 0.78-0.93 for STS score) and not significantly different (p values > 0.05 for all tests). The EuroSCORE II had a better calibration, being the only score with nonsignificant associated statistics (unreliability test, Hosmer-Lemeshow test, and Spiegelhalter Z-test for calibration accuracy). Nonetheless, EuroSCORE II calibration plot highlighted a trend over under-prediction. Conclusions: The EuroSCORE II is a good predictor of perioperative mortality in isolated aortic valve surgery, with lower discrimination if compared with STS and a better calibration when compared with logistic EuroSCORE, ACEF, and STS scores. Its performance is optimal in the lowest tertile of patients, whereas it under-predicts mortality afterward. None of these algorithms seems suitable for risk estimation in mid and high-risk patients that are the ones who might benefit most from transcatheter procedures. © 2013 The Society of Thoracic Surgeons.

The comparison of hemodilution at the end of surgery is of limited use as it represents only a snapshot of a dynamic phenomenon. This study was undertaken to compare the perioperative hemoglobin curves of isolated coronary artery bypass grafting performed with minimized extracorporeal circulation, traditional cardiopulmonary bypass, and off-pump technique. The propensity score method was used to select three groups of patients, homogenous regarding preoperative and operative data, who underwent isolated coronary artery bypass grafting. A generalized linear mixed model was used for estimating differences in perioperative hemoglobin trends among groups. The three groups were each composed of 50 patients with no differences in demographic data, preoperative risk profile, preoperative hemoglobin, or type of surgery. There was no significant difference in major postoperative complications. The pattern of the hemodilution curves was similar in patients operated with mini-circuit and off-pump technique (P > 005). Mini-circuit led to a 3.1 ± 11.9% hemoglobin reduction, which was similar to the off-pump group (1.6 ± 8.9%, P = 0.99 at ANOVA) and significantly different from the standard extracorporeal circuit group (16.0 ± 10.3%, P < 0.001 at ANOVA). The generalized linear mixed model determined that the standard circuit was the only independent predictor for increased hemodilution. Its effect on hemodilution was time-dependent and the slope of the hemoglobin curve was more pronounced between systemic heparinization and the end of surgery. Perioperative hemoglobin trends of patients who underwent myocardial revascularization with mini-circuit were similar to those of off-pump surgery and significantly less pronounced than those of standard extracorporeal circulation.

Objective: Magnesium (Mg2+) is cardioprotective and has been routinely used to supplement cardioplegic solutions during coronary artery bypass graft (CABG) surgery. However, there is no consensus about the Mg2+ concentration that should be used. The aim of this study was to compare the effects of intermittent antegrade warm-blood cardioplegia supplemented with either low- or high-concentration Mg2+. Methods: This study was a randomised controlled trial carried out in two cardiac surgery centres, Bristol, UK and Cuneo, Italy. Patients undergoing isolated CABG with cardiopulmonary bypass were eligible. Patients were randomised to receive warm-blood cardioplegia supplemented with 5 or 16 mmol l−1 Mg2+. The primary outcome was postoperative atrial fibrillation. Secondary outcomes were serum biochemical markers (troponin I, Mg2+, potassium, lactate and creatinine) and time-to-plegia arrest. Intra-operative and postoperative clinical outcomes were also recorded. Results: Data from two centres for 691 patients (342 low and 349 high Mg2+) were analysed. Baseline characteristics were similar for both groups. There was no significant difference in the frequency of postoperative atrial fibrillation in the high (32.8%) and low (32.0%) groups (risk ratio 1.03, 95% confidence interval, CI, 0.82–1.28). However, compared with the low group, troponin I release was 28% less (95% CI 55–94%, p = 0.02) in the high-Mg2+ group. The 30-day mortality was 0.72% (n = 5); all deaths occurred in the high-Mg2+ group but there was no significant difference between the groups (p = 0.06). Frequencies of other major complications were similar in the two groups. Conclusions: Warm-blood cardioplegia supplemented with 16 mmol l−1 Mg2+, compared with 5 mmol l−1 Mg2+, does not reduce the frequency of postoperative atrial fibrillation in patients undergoing CABG but may reduce cardiac injury. (This trial was registered as ISRCTN95530505.)

We read with interest the comments by Dr. Spadaccio and colleagues regarding the results of the OBSERVANT (Italian Observational Multicenter Registry) study, and we thank them for giving us the opportunity to clarify some of the issues raised in their letter. First, we would like to emphasize that

Introduction: Permanent pacemaker (PPM) implantation represents a potential event after cardiac surgery. However, comprehensive investigation of robust patient cohorts in this respect is unavailable. Hypothesis: A multicenter retrospective study was undertaken to assess in-hospital and long-term postoperative outcome of a large patient population undergoing PPM soon after cardiac surgery procedures. Methods: Among 94.693 patients submitted to cardiac surgery procedures in 16 centers from 2000 to 2013, there were 1.156 patients (1.2 %) with PPM implantation during hospitalization postoperatively. Preoperative, in-hospital, and follow-up data were collected with a common dataset and analyzed. Follow-up was performed by direct visit, and PPM dependency was assessed by electrocardiogram and pacemaker check during periodic examinations. The identification of potential predictors of PPM dependency at follow-up was evaluated with a multivariate logistic regression. Results: Patient mean age was 69 years (range 17-92 years) and 53.4% were male. Preoperative electrocardiogram showed first degree atrio/ventricular block in 11.0% of patients, left bundle branch block in 11.1%, right bundle branch block in 11.0%, and atrial fibrillation in 22.8%, respectively. Most of the patients had had isolated aortic valve replacement (25.8%). Pacemakers were implanted after a median of 11 days after surgery. At follow-up, 43.6% of the patients did not show a PPM dependency with restoration of sinus rhythm. The multivariate logistic regression demonstrated that only preoperative right bundle branch block (p-value 0.031) and mitral valve repair (p-value 0.032) were independent risk factor for PPM dependency at follow-up. Conclusions: More than 40% of patients with PPM implantation shortly after cardiac surgery show recovery of sinus rhythm at follow-up. Wide variability of strategies and PM implant timing are currently applied in routine practice. Refinement of current guidelines in this setting based also on predictors of permanent conduction defects postoperatively are warranted.

EuroSCORE algorithms were developed to predict perioperative mortality in cardiac surgery. This study was designed to evaluate the reliability of EuroSCORE algorithms and to analyze the predicting role of the scoring system's factors on patients that undergo isolate AVR. 339 patients underwent aortic valve replacement. Data collection was prospective and the logistic and additive EuroSCORE algorithms were calculated according to published guidelines. The observed-over-expected mortality ratio was 0.096. In the ROC curve analysis, the asymptotic significance was greater than 0.05. On multivariate analysis, only critical preoperative state remained significant independent predictor of in-hospital mortality (Odds Ratio 1.6, CI 1.2–2.1). These outcomes suggest that EuroSCORE models may fail in predicting hospital mortality in subsets of cardiac surgery patients and dedicated risk models for isolate aortic valvular surgery may be useful to provide more precise estimates of hospital mortality.

Aortic stenosis (AS) is common in patients with end-stage renal disease and the rate of progression is faster than in patients without end-stage renal disease. While aortic valve replacement (AVR) is the gold-standard approach for patients with symptomatic severe AS, surgical AVR (SAVR) carries

OBJECTIVES: Age, creatinine, ejection fraction (ACEF) score is a simplified algorithm for prediction of mortality after elective cardiac surgery. Although mainly conceived for elective cardiac surgery, no information is available on its performance in non-elective surgery and on comparison with the new EuroSCORE II. This study was undertaken to compare the performance of ACEF score and EuroSCORE II within classes of urgency. METHODS: Complete data on 13 871 consecutive patients who underwent major cardiac surgery in a 6-year period were retrieved from three prospective institutional databases. Discriminatory power was assessed using the c-index and h with Delong, bootstrap and Venkatraman methods. Calibration was evaluated with calibration curves and associated statistics. RESULTS: The in-hospital mortality rate was 2.5%. The discriminatory power of ACEF score within elective and non-elective surgery was similar (area under the curve (AUC) 0.71, 95% confidence interval (CI) 0.67-0.74 and AUC 0.68, 95% CI 0.62-0.73, respectively) but significantly lower than that of EuroSCORE II (AUC 0.80, 95% CI 0.77-0.83 for elective surgery; AUC 0.82, 95% CI 0.78-0.85 for non-elective surgery). The calibration patterns were different in the two subgroups, but the summary statistics underscored a miscalibration in both of them (U-statistic and Spiegelhalter Z-test P-values

Aims The European System for Cardiac Operation Risk Evaluation (EuroSCORE) is widely used for predicting in-hospital mortality after cardiac surgery. A new score (EuroSCORE II) has been recently developed to update the previously released versions. This study was undertaken to validate EuroSCORE II, to compare its performance with the original EuroSCOREs and to evaluate the effects of the removal of those factors that were included in the score even if they were statistically non-significant.Methods and resultsData on 12 325 consecutive patients who underwent major cardiac surgery in a 6-year period were retrieved from three prospective institutional databases. Discriminatory power was assessed using the c-index and comparison among the scores' performances was performed with Delong, bootstrap, and Venkatraman methods. Calibration was evaluated with calibration curves and associated statistics.The in-hospital mortality rate was 2.2%. The discriminatory power was high and similar in all algorithms (area under the curve 0.82, 95% CI: 0.79-0.84 for additive EuroSCORE; 0.82, 95% CI: 0.79-0.84 for logistic EuroSCORE; 0.82, 95% CI: 0.80-0.85 for EuroSCORE II). The EuroSCORE II had a fair calibration till 30%-predicted values and over-predicted beyond. The removal of non-significant factors from EuroSCORE II did not affect performance, being both the calibration and discrimination comparable. Conclusion This validation study demonstrated that EuroSCORE II is a good predictor of perioperative mortality. It showed an optimal calibration until 30%-predicted mortality. Nonetheless, it does not seem to significantly improve the performance of older versions in the higher tertiles of risk. Moreover, it could be simplified, as the removal from the algorithm of non-significant factors does not alter its performance. © 2012 The Author.

An 88-year-old man was admitted to our department for the evaluation of an asymptomatic pulsating haematoma of the left thoracic wall. He had undergone uneventful transcatheter aortic valve implantation (TAVI) with transapical access 5 months earlier. At 3-month follow-up the echocardiography did

Background The aim of the study is to design a specific Intensive Care Unit length-of-stay risk model based on the preoperative factors and surgeries utilizing modeling strategies for time-to-event data in a prospective observational clinical study. Methods From January 2004 to April 2011 data on 3861 consecutive heart surgery patients were prospectively collected. ICU length of stay was analyzed as a time-to-event variable in a competing risk framework with death as competing risk. Results The median ICU-LOS was one day. All factors considered but gender was included in the multivariable modeling. In the final model, factors that mostly affected time-to-discharge from ICU were critical preoperative state (Relative Risk 0.41; 95% Confidence Interval: 0.29–0.58), emergency (0.41; 0.32–0.53), poor left ventricular dysfunction (0.50; 0.44–0.57) and serum creatinine>200μmol/L (0.54; 0.46–0.65). Most of the predictors had a time-dependent effect that decreased in the first fifteen days and was constant thereafter. After the plateau, the risk profile was changed as most of the factors were no longer significant, Conversely, the time-to-ICU death model included only two variables, critical perioperative state and serum creatinine>200μmol/L, with a constant RR of 9.1 and 3.37 respectively. Conclusions ICU-LOS can be predicted by preoperative data and type of surgeries. The derived ICU-LOS prediction model is dynamic and most predictors have an effect that decreases with time. The algorithm can preoperatively predict ICU-LOS curves and could have a major role in the decision making-behavior of clinicians, resources' allocation and maximization of care for high-risk patients.

We read with great interest the article by De Cocker and colleagues [1]. It deals with one of the hot topics in cardiac surgery, as the prediction of postoperative intensive care unit length of stay (ICU-LOS) can be a useful tool for quality control and for the planning of perioperative resources, reducing costs, and improving the standard of care. In our opinion, the novel issue of the article is the evaluation of ICU-LOS as a time-to-event variable. Previous studies have focused on ICU risk modeling but their common limitation was the dichotomizing of the continuous data nature of ICU-LOS [2]. To our knowledge, it is the first time that regression models for time-to-event data are employed for the prediction of ICU-LOS. Nonetheless, the article raises some methodological questions. The authors evaluated the predictors of time-to-ICU discharge and considered deaths in ICU as censored. This choice leads to an overestimation of the probability of the event in the naive Kaplan–Meier estimator, as the assumption of independence of the censoring distribution is violated [3]. ICU-LOS represents a classic example of time-to-event variable in a competing risk setting, where an individual can experience more than one type of event, named discharge and death, and the occurrence of one type of event hinders the occurrence of the other [4]. When competing risks are present, Kaplan–Meier estimates cannot be interpreted as probabilities and their complements can be interpreted as the probability of an event of representing an ideal world when the other types of events do not exist. A different approach based on the cumulative incidence function (CIF) is suggested. Consequently, the effects of covariates should be modeled not on the crude hazard rates but directly on the CIF, with methods that are alternative to the Cox analysis [5]. Moreover, by its nature, the Cox model estimates the effect of the covariate on the time-to-event but does not make any assumption on the baseline hazard. In our opinion, the goal of this model should be to simultaneously characterize both the basic underlying distribution of time-to-event and the distribution changes as a function of the covariates, namely error and systematic components, respectively. The baseline distribution reflects the ICU-discharge protocol employed in the ICU and can have high variations. No ICU discharge criteria were reported but a high percentage of the study population (43%) had an ICU-LOS >2 days. This large quote does not seem to be representative of the modern cardiac ICU and does not reflect the fast-track protocol that is nowadays employed in several cardiac ICUs. Hence, a more detailed analysis of the baseline ICU-LOS should be considered. In conclusion, if the methods utilized in this study were addressed in a rather refined fashion by focusing on competing risks and fully parametric algorithms, the results of this study could have had a far wider utility. Nevertheless, by the token that this study has pioneered the correct methodology for the analysis of ICU-LOS after cardiac surgery, it certainly is a valuable addition to the literature.

Background and aim of the study: The aim of this study was to evaluate the early and mid-term off-pump coronary artery bypass surgery (OPCAB) results in a single surgical unit, assessing the impact of completeness of revascularization. Methods: Three hundred and twelve patients underwent OPCAB between August 2000 and January 2005. In-hospital data were collected prospectively for all patients un- dergoing OPCAB. Complete revascularization (CR) was derived by comparing significantly stenotic vessels at cardiac catheterization with surgically grafted coronary vessels. Grafting of all the significantly stenotic coronary vessels was considered CR. In-hospital outcomes were compared between patients with CR and incomplete revascularization (IR). A multivariate analysis based on the Cox proportional hazards regression model was performed. Results: Patients receiving IR (105 patients, 43.7%) presented a worse preoperative risk profile then those having CR (mean Euroscore 6.8 ± 2.9 vs. 4.3 ± 2.8, p < 0.0001). IR was not asso- ciated with a higher incidence of early adverse events. Five-year freedom from death and major adverse cardiac events (MACE) were 0.88 (0.02 SE) and 0.86 (0.03 SE), respectively. Complete revascularization was protective for mid-term unstable angina recurrence (heart rate (HR) = 0.24, 95% confidence interval (CI) 0.10 to 0.58), acute myocardial infarction (HR = 0.25, 95% CI 0.09 to 0.73), all-cause repeat revascularization (HR = 0.35, 95% CI 0.13 to 0.90), and MACE (HR = 0.2, 95% CI 0.1 to 0.5). Conclusion: Our study suggests that, although incomplete revascularization may not result in increased short-term morbidity and mortal

The design of automotive control systems is becoming increasingly complex as the level of performance required by car manufactures grows continuously and the constraints on cost and development time imposed by the market become tighter. A successful design, without costly and time consuming re-design cycles, can be achieved only by using an efficient design methodology that allows for component re-use and evaluation of platform requirements at the early stages of the design flow. In this paper, we illustrate the application of an integrated control-implementation design methodology, recently proposed by our group, to the development of the top few layers of abstraction in the design flow of an engine control system for motorcycles.

✓ Seven patients with “isolated” traumatic intracerebellar hematomas due to closed head injuries are presented. Computerized tomography parameters useful in the correct management of these hematomas include: location (hemisphere or midline), size, and appearance of the posterior fossa cisterns (intact or obliterated). Three patients with hemispheric hematomas were treated conservatively and recovered. One patient with a midline hematoma was managed conservatively and died. Three hematomas (one hemispheric and two midline) were operated on. The immediate results of surgery were good, but two patients died later due to medical complications. The results of this study support the concept that large hematomas (3 cm or greater) generally need surgery and that hemispheric hematomas of limited size (less than 3 cm) may be treated conservatively. The clinical course and prognosis of midline hematomas is grave, and evacuation of accessible hematomas should be considered early in the course of the disease.

Objective: The study was designed to validate euroSCORE II and ACEF (age, creatinine, and ejection fraction) scores in patients undergoing isolated or associated mitral valve surgery and compare them with logistic euroSCORE and Society of Thoracic Surgeons scores. Methods: Data on 3441 consecutive patients undergoing isolated or associated mitral valve surgery in a 6-year period were retrieved from 3 prospective institutional databases. Discriminatory power was assessed with the C index. Calibration was evaluated with calibration curves and associated statistics. Results: In-hospital mortality was 3.4%. Discriminatory power was uniformly good (for euroSCORE II: area under curve, 0.79; 95% confidence interval, 0.74-0.84; for logistic euroSCORE: area under the curve, 0.78; 95% confidence interval, 0.74-0.83; for ACEF: area under the curve, 0.73; 95% confidence interval, 0.69-0.79) but significantly higher in euroSCORE models (P