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Aims: The aortic valve (AV) neocuspidization (Ozaki procedure) is a novel surgical technique for AV disease that preserves the natural motion and cardiodynamics of the aortic root. In this study, we sought to evaluate, by 4D-flow magnetic resonance imaging, the aortic blood flow characteristics after AV neocuspidization in paediatric patients., Methods and Results: Aortic root and ascending aorta haemodynamics were evaluated in a population of patients treated with the Ozaki procedure; results were compared with those of a group of patients operated with the Ross technique. Cardiovascular magnetic resonance studies were performed at 1.5 T using a 4D flow-sensitive sequence acquired with retrospective electrocardiogram-gating and respiratory navigator. Post-processing of 4D-flow analysis was performed to calculate flow eccentricity and wall shear stress. Twenty children were included in this study, 10 after Ozaki and 10 after Ross procedure. Median age at surgery was 10.7 years (range 3.9-16.5 years). No significant differences were observed in wall shear stress values measured at the level of the proximal ascending aorta between the two groups. The analysis of flow patterns showed no clear association between eccentric flow and the procedure performed. The Ozaki group showed just a slightly increased transvalvular maximum velocity., Conclusion: Proximal aorta flow dynamics of children treated with the Ozaki and the Ross procedure are comparable. Similarly to the Ross, Ozaki technique restores a physiological laminar flow pattern in the short-term follow-up, with the advantage of not inducing a bivalvular disease, although further studies are warranted to evaluate its long-term results., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Triage is crucial for patient's management and estimation of the required intensive care unit (ICU) beds is fundamental for health systems during the COVID-19 pandemic. We assessed whether chest computed tomography (CT) of COVID-19 pneumonia has an incremental role in predicting patient's admission to ICU. We performed volumetric and texture analysis of the areas of the affected lung in CT of 115 outpatients with COVID-19 infection presenting to the emergency room with dyspnea and unresponsive hypoxyemia. Admission blood laboratory including lymphocyte count, serum lactate dehydrogenase, D-dimer and C-reactive protein and the ratio between the arterial partial pressure of oxygen and inspired oxygen were collected. By calculating the areas under the receiver-operating characteristic curves (AUC), we compared the performance of blood laboratory-arterial gas analyses features alone and combined with the CT features in two hybrid models (Hybrid radiological and Hybrid radiomics)for predicting ICU admission. Following a machine learning approach, 63 patients were allocated to the training and 52 to the validation set. Twenty-nine (25%) of patients were admitted to ICU. The Hybrid radiological model comprising the lung %consolidation performed significantly (p = 0.04) better in predicting ICU admission in the validation (AUC = 0.82; 95% confidence interval 0.73-0.97) set than the blood laboratory-arterial gas analyses features alone (AUC = 0.71; 95% confidence interval 0.56-0.86). A risk calculator for ICU admission was derived and is available at: https://github.com/cgplab/covidapp . The volume of the consolidated lung in CT of patients with COVID-19 pneumonia has a mild but significant incremental value in predicting ICU admission., (© 2021. The Author(s).)

Objectives: The aim of this study was to identify the predictors of death and of reintervention after mitral valve replacement (MVR) in children., Methods: A single-centre retrospective study was performed including 115 patients under the age of 18 undergoing MVR between 1982 and 2019. For all patients, the ratio of prosthetic valve size (diameter in mm) to weight (kg) at surgery was calculated and long-term result was assessed. The primary outcome was freedom from mitral valve (MV) re-replacement. The composite secondary outcome was freedom from death or transplant., Results: Fifty-four patients had a previous surgical attempt to MV repair. The median age at surgery was 5.5 years (interquartile range 1.21-9.87). Death/transplant-free survival was 77 ± 4% at 5 years and 72 ± 5% at 10 years. Univariate analysis showed a size/weight ratio higher than 2 and age <2 years as significant risk factors for death or transplant. Freedom from MV re-replacement at 5 and 10 years was 90 ± 3% and 72 ± 6%, respectively. Biological prosthesis implanted at first replacement (P = 0.007) and size/weight ratio higher than 2 (P = 0.048) were predictors of reoperation. Significant upsizing (P < 0.0001) of mitral prosthesis was observed at re-replacement., Conclusions: MVR is a viable strategy in children with unrepairable MV disease. Mortality can be predicted based on size/weight ratio and age <2 years. MV re-replacement can be performed with low morbidity and mortality and a larger-size prosthesis can often be placed at the time of redo., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

An alternative strategy for left ventricular (LV) venting during short-term mechanical circulatory support is use of Impella axial-flow pump. We present our transcarotid Impella 2.5 implantation technique using a polytetrafluoroethylene graft, in two children with acute heart failure treated primarily with venoarterial ECMO. The venoarterial extracorporeal membrane oxygenator and Impella support were maintained for 5 and 17 days, respectively. Transcarotid Impella implantation might be an alternative and feasible option in pediatrics patients affected by severe LV failure, as a bridge to decision or bridge to candidacy. Potentially, the Impella 2.5 device provides less invasive support for children with heart failure.

Objectives: Management of resternotomy is often a difficult challenge in patients with congenital diseases who have undergone multiple sternotomies. Our goal was to report our single-centre experience with carotid cannulation using a graft interposed during redo sternotomy in complex cardiac reintervention procedures., Methods: We performed a retrospective review of all patients who had undergone complex redo sternotomies between January 2019 and May 2020 utilizing a cervical cannulation technique with a Gore-Tex graft interposed on the carotid artery. We classified our population study on the basis of the primary diagnosis and the type of surgery. The primary outcomes of our analysis were the evaluation of the safety of the procedure in terms of survival and freedom from neurological events., Results: We analysed 22 patients who had undergone previous complex operations. The median age and weight at the time of reintervention were 130.35 (range 0.46-435) months and 31.5 (range 2.2-85) kg, respectively. Composite graft carotid cannulation provided adequate arterial flow in all patients with a median arterial flow of 3.5 l/min/m2 (range 0.6-6). One major cardiac injury occurred during sternotomy when emergency cardiopulmonary bypass (CPB) was initiated. Moreover, during their hospital stays, all patients had an uneventful recovery without neurological or vascular complications and no cervical wound infections., Conclusions: Carotid cannulation using interposition of a side graft on the common carotid artery for arterial inflow is a reliable and safe method for initiation of CPB in complex redo surgeries in patients with congenital disease. Complications directly associated with this type of cannulation are uncommon and allow surgical re-entry with overall low risks., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Early reports from Asia suggested that increased serum levels of the muscular enzyme creatine-(phospho)-kinase (CK/CPK) could be associated with a more severe prognosis in COVID-19. The aim of this single-center retrospective cohort study of 331 consecutive COVID-19 patients who were hospitalized during Italy's "first wave" was to verify this relationship, and to evaluate the role of possible confounding factors (age, body mass index, gender, and comorbidities). We subdivided our cohort in two groups, based on "severe" ( n = 99) or "mild" ( n = 232) outcomes. "Severe" disease is defined here as death and/or mechanical invasive ventilation, in contrast to "mild" patients, who were discharged alive with no need for invasive ventilation; this latter group could also include those patients who were treated with non-invasive ventilation. The CK levels at admission were higher in those subjects who later experienced more severe outcomes (median, 126; range, 10-1672 U/L, versus median, 82; range, 12-1499 U/L, p = 0.01), and hyperCKemia >200 U/L was associated with a worse prognosis. Regression analysis confirmed that increased CK acted as an independent predictor for a "severe" outcome. HyperCKemia was generally transient, returning to normal during hospitalization in the majority of both "severe" and "mild" patients. Although the direct infection of voluntary muscle is unproven, transient muscular dysfunction is common during the course of COVID-19. The influence of this novel coronavirus on voluntary muscle really needs to be clarified.

Introduction: Clinical practice guidelines need rigorous and transparent methods for summarizing the evidence, rate its certainty and moving from evidence to recommendations. We describe an intervention to support local efforts to provide optimal and safer care bridging the gap between researchers and local busy clinicians., Methods: A group of methodologists provided a wide range of research services to the medical community of a local non-teaching general hospital in Italy. Methodological support encompassed synthesis of evidence, rating of uncertainty and moving from evidence to recommendations. Local professionals were asked to judge GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology and its impact on patients' safety, professional liability, and guideline reliability. The research team then reflected on the barriers of implementing GRADE in local settings., Results: Seven clinical recommendations about frequent complex medical conditions were produced. Few local clinicians completed the project. All clinicians found the GRADE methodology a guarantee for defending excellent standards of care. However, we identified a diffuse sense of inability to improve clinical behaviours as negative effects of general poor working conditions, in particular the strained health care workforce., Discussion: Current financial constraints may be impeding the ability of clinicians in improving their clinical practice through adaptation and use of evidence. A successful integration of evidence-based guidelines cannot be separated from an activate promotion by the institutional management.

Evolving reconstructive techniques have progressively become the preferred approach for treatment of pediatric mitral valve regurgitation. We present our experience in a cohort of patients undergoing surgical correction for severe mitral regurgitation. Fifty-five patients (age 1 month-18 years; median 5 years) were included in the present analysis. Different surgical techniques were used (posterior leaflet augmentation in 25, isolated cleft closure in 12, Alfieri-type procedure in 10, annuloplasty in 5, with artificial chordae in 2, and quadrangular resection with chordal transposition in 1). Follow-up time ranged from 1 to 192 months (median 38[IQR 12-54] months). Operative and follow-up mortality was 0%. Reintervention in the whole population occurred in 31% of patients. However, when first surgery was performed under 2 years of age (no = 17), reintervention reached nearly 50%. The degree of residual mitral regurgitation at follow-up remained stable after surgery, while a significant increase in mean transmitral gradient was observed over time (paired t test = 0.03). In multivariable Cox-regression analysis, post-surgical transmitral gradient was the only independent predictor for reintervention (p = 0.017; HR 2.4; 95%CI 1.2-5.1), after correcting for differences in age at surgery, type of reintervention, mitral annulus dimension, and BSA at the first surgery. ROC curve demonstrated that a post-surgical transmitral mean gradient value > 5 mmHg, was predictive for reintervention (AUC = 0.89; Youden index = 0.44). Our study suggests that the use of conservative technique strategy achieves satisfactory functional results in infants and children with severe MR, although the rate of reoperation in younger patients remains substantial. Post-operative moderate mitral stenosis was the strongest predictor for reoperation.

Background Pediatric patients with atrioventricular valve disease have limited options for prosthetic valve replacement in sizes <15 mm. Based on successful experience with the stented bovine jugular vein graft (Melody valve) in the right ventricular outflow tract, the prosthesis has been modified for surgical valve replacement in pediatric patients with atrioventricular dysfunction with the intention of subsequent valve expansion in the catheterization laboratory as the child grows. Methods and Results A multicenter, retrospective cohort study was performed among patients who underwent atrioventricular valve replacement with Melody valve at 17 participating sites from North America and Europe, including 68 patients with either mitral (n=59) or tricuspid (n=9) replacement at a median age of 8 months (range, 3 days to 13 years). The median size at implantation was 14 mm (range, 9-24 mm). Immediately postoperatively, the valve was competent with low gradients in all patients. Fifteen patients died; 3 patients underwent transplantation. Nineteen patients required reoperation for adverse outcomes, including valve explantation (n=16), left ventricular outflow tract obstruction (n=1), permanent pacemaker implantation (n=1), and paravalvular leak repair (n=1). Twenty-five patients underwent 41 episodes of catheter-based balloon expansion, exhibiting a significant decrease in median gradient ( P<0.001) with no significant increase in grade of regurgitation. Twelve months after implantation, cumulative incidence analysis indicated that 55% of the patients would be expected to be free from death, heart transplantation, structural valve deterioration, or valve replacement. Conclusions The Melody valve is a feasible option for surgical atrioventricular valve replacement in patients with hypoplastic annuli. The prosthesis shows acceptable short-term function and is amenable to catheter-based enlargement as the child grows. However, patients remain at risk for mortality and structural valve deterioration, despite adequate early valvular function. Device design and implantation techniques must be refined to reduce complications and extend durability. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02505074.

Background: Patients with an open ventricular septal defect (VSD) after repair of pulmonary atresia (PA), VSD, and major aortopulmonary collaterals (MAPCAs) are the most vulnerable subgroup. We analyzed the impact of concomitant versus delayed VSD closure on survival and intermediate-term right ventricular (RV) function., Methods: Between October 1996 and February 2017, 96 patients underwent a pulmonary flow study-aided repair of PA/VSD/MAPCAs. For patients who underwent either concomitant or delayed intracardiac repair, echocardiographic RV systolic function was retrospectively calculated to assess (1) RV fractional area change (RVFAC) and (2) two-dimensional RV longitudinal strain (RVLS) of the free wall of the right ventricle. QLAB cardiac analysis software version 10.3 (Philips Medical Systems, Andover, MA) was used for analysis., Results: A total of 64 patients underwent concomitant VSD closure at the time of unifocalization, and 16 patients underwent delayed VSD closure at a median of 2.3 years (range: 3 days to 7.4 years). At a median follow-up of 8.1 years (range: 0.1 to 19.5 years) for the concomitant repair group versus 7.4 years (range: 0.01 to 15.3 years) for the delayed repair group, no differences in RVFAC and RVLS were observed (RVFAC: 41.0% ± 6.2% versus 41.2% ± 7.6%, p = 0.91; RVLS: -18.7 ± 4.3 versus -18.9 ± 4.0, p = 0.87)., Conclusions: Patients (83%) with PA/VSD/MAPCAs underwent complete repair at intermediate-term follow-up with preserved RV function. Delayed VSD closure was accomplished in 50% of the patients initially deemed unsuitable for repair. Delayed VSD closure did not affect survival and did not portend impaired RV systolic function., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Congenital heart diseases (CHDs) and cardiovascular abnormalities are one of the pillars of clinical diagnosis of 22q11.2 deletion syndrome (22q11.2DS) and still represent the main cause of mortality in the affected children. In the past 30 years, much progress has been made in describing the anatomical patterns of CHD, in improving their diagnosis, medical treatment, and surgical procedures for these conditions, as well as in understanding the underlying genetic and developmental mechanisms. However, further studies are still needed to better determine the true prevalence of CHDs in 22q11.2DS, including data from prenatal studies and on the adult population, to further clarify the genetic mechanisms behind the high variability of phenotypic expression of 22q11.2DS, and to fully understand the mechanism responsible for the increased postoperative morbidity and for the premature death of these patients. Moreover, the increased life expectancy of persons with 22q11.2DS allowed the expansion of the adult population that poses new challenges for clinicians such as acquired cardiovascular problems and complexity related to multisystemic comorbidity. In this review, we provide a comprehensive review of the existing literature about 22q11.2DS in order to summarize the knowledge gained in the past years of clinical experience and research, as well as to identify the remaining gaps in comprehension of this syndrome and the possible future research directions., (© 2018 Wiley Periodicals, Inc.)

Background: Internal jugular vein cannulation has become increasingly widespread. Compared to the left internal jugular vein (LIJV), the right internal jugular vein (RIJV) is the preferred choice for the placement of central venous catheter (CVC) for hemodialysis, mostly due to the major technical difficulties and higher rate of complications of the LIJV approach. We aimed to investigate whether variability in the direction of the LIJV/brachiocephalic vein (BV) axis on the frontal plane could be a decisive factor in determining CVC dysfunctions., Methods: Retrospective cohort study. From our Register, a total of 1489 consecutive patients (age 69 ± 9 years, males 60%) in whom a CVC for hemodialysis was placed from January 2012 to June 2014 were selected., Results: LIJV cannulation, compared with RIJV, was associated with a higher rate of catheter dysfunction during an observational period of 2 weeks after catheter placement (16 vs.12%; p = 0.005). This complication was strongly correlated with the amplitude of the angle between the LIJV and the ipsilateral BV axis on the frontal plane; an angle ≤ 110° was associated with a higher rate of catheter dysfunction (78 vs.16%; p < 0.001)., Conclusions: The anatomical clarification presented in our study provides useful data that could explain the dysfunction rate of CVC inserted in the LIJV. Clinicians who insert high-flow catheters (such as hemodialysis catheters) should be aware of LIJV/BV axis variability and of the possible risks of CVC dysfunction when the angle between the LIJV and ipsilateral BV is ≤ 110°.

Background: The purpose of this study was to identify predictors of postoperative respiratory failure after surgical tracheoplasty for congenital tracheal stenosis., Methods: Between February 2011 and April 2017, 16 infants underwent congenital tracheal stenosis repair. Preoperative computed tomography evaluation of the trachea and mainstem bronchi was performed. The primary outcome was midterm freedom from postoperative respiratory failure defined as persistent need for mechanical ventilation or surgical tracheobronchial reoperation. Bronchial mismatch, defined as [1 - (smaller bronchus diameter / larger bronchus diameter)] × 100, was analyzed in relation to the primary outcome., Results: Median age was 106 days (range, 1 to 406) and median weight was 5.3 kg (range, 2.6 to 8 kg). Four patients were neonates (25%) and 6 had genetic abnormalities (37.5%). There were no early nor late deaths. Median ventilation time was 5.5 days (range, 3 to 45). Mean follow-up time was 2.2 years (range, 0.1 to 4.5). Four patients with bronchial mismatch greater than 20% had postoperative respiratory failure (p = 0.002). Two of them underwent tracheostomy and were discharged with ventilation home care support. One underwent successful reoperation consisting of bilateral bronchial plasty with autologous cartilage rib grafts, and the other underwent successful right bronchial and tracheal reconstruction. One patient with bilateral bronchial hypoplasia underwent slide tracheoplasty associated with preemptive bilateral bronchial plasty and made a full recovery., Conclusions: Surgical treatment of congenital tracheal stenosis in neonates and infants portends a good outcome. Bronchial mismatch greater than 20% can identify a subset of patients at increased risk for surgical reintervention and chronic respiratory failure. Slide tracheoplasty with preemptive bronchial reconstruction may prevent postoperative respiratory failure., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Acute failure of the Fontan circulation is rare but remains associated with high morbidity and mortality rates. Little is known about the long-term outcome of patients who underwent Fontan takedown to an intermediate palliative circulation and their potential candidacy for redo Fontan completion., Methods: Patients followed up at a single institution who underwent takedown of a Fontan circulation to an intermediate palliative circulation within 2 months of extracardiac Fontan completion were reviewed., Results: Between October 1990 and December 2015, 18 patients underwent Fontan takedown to a superior cavopulmonary connection (with or without an additional shunt) at a median age of 3.3 years (range, 1.8 to 8.0) and median weight of 13.8 kg (range, 8.0 to 27.0 kg). Takedown was required during the Fontan procedure itself in 2 patients, and within the first 2 postoperative months in 16 patients (median time to takedown, 3 days). Seventeen patients survived the post-takedown period and 3 ultimately underwent successful redo Fontan. Four patients required heart transplantation, with 2 deaths. In patients with extended intermediate palliation, median arterial oxygen saturation was 84% (range, 76% to 92%) at a median follow-up of 6.3 years (range, 0.7 to 25.9)., Conclusions: Takedown to a superior cavopulmonary connection is an effective treatment option and, in some patients, acts as a bridge to subsequent redo Fontan completion or heart transplantation. An extended intermediate palliative circulation is tolerated for several years with reasonable oxygen saturation levels at rest. In our experience, an early takedown strategy to a superior cavopulmonary connection is the treatment of choice for acute Fontan failure., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Introduction: The study evaluated the Heparin Bioactive Surface (HBS) Viabahn Stent (W.L. Gore & Associates, Flagstaff, Arizona) efficacy in the maintenance or re-establishment of hemodialysis., Materials and Methods: Fifty HBS Viabahn stents deployed in 37 consecutive patients with hemodialysis dysfunction from January 2008 to May 2016 were evaluated in a single-institution retrospective review. Outcomes were stent patency intended as primary circuit patency (PP), assisted primary patency (APP), target lesion primary patency (TLPP) and secondary patency (SP). Moreover, the risk factor analysis for hemodialysis dysfunction that required reintervention was performed. A subgroup analysis was conducted to assess patency of Viabahn stent to treat peripheral venous long segment obstruction (LSO)., Results: Overall Kaplan-Meyer PPs were 60% at 12 months and 42% at 24 months. Overall TLPP estimated rates were 68% and 49% at 12 and 24 months, respectively. The corresponding SP rates were 85% and 78% at the same period. Estimated PP rates at 12 and 24 months for stent placement after peripheral venous long segment recanalization procedure were 53% and 31%, respectively. Corresponding SP rates were 82% and 68%, respectively. The APP rates were 79% at 12 months and 61% at 24 months. Female sex, access age and thrombosis were associated with reduced primary patency., Conclusions: Considering the high rates of PP, TLPP, APP and SP, Viabahn stents have been proven effective in maintaining or re-establishing the hemodialysis access. Moreover, stent placement after recanalization of LSO of venous out-flow represented a valid approach to rescue a dysfunctional fistula that would otherwise be abandoned.

Background: The purpose of this study was to evaluate the accuracy of the pulmonary flow study in (1) predicting the feasibility of concomitant intracardiac repair after one-stage unifocalization; and in (2) predicting long-term survival and the onset of right ventricular dysfunction after surgery., Methods: Between October 1996 and July 2015, a flow study was obtained in 95 patients undergoing complete one-stage unifocalization for pulmonary atresia with ventricular septal defect and major aortopulmonary collaterals. The ability to achieve 100% flow (approximately 2.5 L · min -1 · m -2 ) into the pulmonary bed at a mean pressure of 30 mm Hg or less was utilized as an indicator for acceptability of ventricular septal defect closure., Results: Overall survival was 78% ± 6% at 15 years. Sixty-four patients underwent successful one-stage intracardiac repair. The flow study accurately predicted suitability for VSD closure (area under the curve = 0.855). After one-stage ventricular septal defect closure, no difference in survival was observed after stratification according to flow study pressures (25 mm Hg or less versus greater than 25 mm Hg, log rank p = 0.20). At a median follow-up of 7 years, no association was found between flow study pressure and the onset of right ventricular dysfunction (p = 0.21). Overall, the inability to achieve final intracardiac repair was a strong predictor of death (hazard ratio 9.14, 95% confidence interval: 1.98 to 42.07, p < 0.0001)., Conclusions: Suitability for ventricular septal defect closure is reliably defined by the flow study with a cutoff of 30 mm Hg. Flow study pressure values do not affect long-term outcomes. The ability to obtain intracardiac repair (in either one or more stages) is the strongest predictor of survival., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

We present the surgical implantation in mitral position of the Edwards Sapien 3 valve for prosthetic valve endocarditis in a severely ill child after multiple valve replacements. The procedure was safely performed and provided adequate hemodynamic results in the short term. This report highlights the excellent potential of Sapien 3 valve for the treatment of mitral valve disease in children with a mitral valve annulus of appropriate size. Of note, the use of the Sapien 3 valve should be considered when a bioprosthesis is required at the time of valve re-replacement., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Primary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48., Methods: Patients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm)., Results: In June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm., Conclusion: Switching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy.

Objectives: We sought to determine differences in baseline characteristics and clinical outcomes in a consecutive series of patients undergoing arterial switch operation (ASO), assessing the effect of coronary anatomy on postoperative mortality, both overall and adjusted for surgical era., Methods: From January 2000 to May 2015, 283 consecutive patients underwent ASO for transposition of the great arteries. A total of 103 patients (36.4%) had an associated ventricular septal defect and 23 (8.1%) had an aortic arch obstruction. Coronary anomalies were present in 119 (42%) patients., Results: Overall survival was 93.0 ± 1% at 15 years (19 events). Intraoperative revision of the coronary anastomosis was required in 8 patients (2.8%) due to inability to wean from cardiopulmonary bypass (CPB) or post-CPB myocardial ischaemia. Surgical revision was neither related to the underlying coronary anatomy ( χ 2  =   0.681, P  = 0.4091) nor to the surgical era ( χ 2  =   0.682, P  = 0.4090). Univariable analysis suggested decreased mortality rate for infants who underwent surgery during 2008 or later ( P  = 0.01). In multivariable analysis, intraoperative coronary button revision was the only predictor of mortality [ P  < 0.001, hazard ratio (HR) 12.01, 95% confidence interval (CI) 3.85-37.49], whereas surgical era (before 2008) failed to achieve statistical significance ( P  = 0.057, HR 2.19, 95% CI 0.96-12.04)., Conclusions: In the recent era, unusual coronary patterns do not affect survival following ASO, whereas intraoperative coronary button revision is a predictor of mortality. Preventive strategies aimed towards intraoperative detection of impaired coronary perfusion are useful tools that might be considered for all patients in order to improve outcomes., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: To determine the value of surgery for infective endocarditis (IE) in patients on hemodialysis by comparing the nature and invasiveness of endocarditis in hemodialysis and nonhemodialysis patients and their hospital and long-term outcomes, and identifying risk factors for time-related mortality after surgery., Methods: From January 1997 to January 2013, 144 patients on chronic hemodialysis and 1233 nonhemodialysis patients underwent valve surgery for IE at our institution. Propensity matching identified 99 well-matched hemodialysis and nonhemodialysis patient pairs for comparison of outcomes., Results: Staphylococcus aureus infection was more common in hemodialysis patients than in nonhemodialysis patients (42% vs 21%; P < .0001), but invasive disease was similar in the 2 groups (47%; P = .3). Hospital mortality was 13% and 5-year survival was 20% for hemodialysis patients, 20% below that expected in a general hemodialysis population but 15% above that of hemodialysis patients treated nonsurgically for IE. For matched patients, hospital mortality was 13% for hemodialysis patients versus 5.1% for nonhemodialysis patients (P = .05), and survival at 1 and 5 years was 56% versus 83% and 24% versus 59%, respectively (P < .004). Use of an arteriovenous graft for dialysis access (P = .01) and preoperative placement of a pacemaker (P < .0001) were risk factors for late mortality in hemodialysis patients. For matched patients, freedom from reoperation was similar in the hemodialysis and nonhemodialysis groups (P > .9)., Conclusions: Intermediate-term survival after surgery for IE in hemodialysis patients is substantially worse than that in nonhemodialysis patients, but only slightly worse than that in the general hemodialysis population and substantially better than that in hemodialysis patients with IE treated nonsurgically, supporting continued surgical intervention for IE., (Copyright © 2017. Published by Elsevier Inc.)

Persistent left fifth aortic arch is a rare anomaly often associated with aortic coarctation. We report the case of a newborn presenting with signs of duct-dependent aortic coarctation. Echocardiography showed an interrupted fourth aortic arch, persistent left fifth aortic arch associated with aortic coarctation, and a restrictive arterial duct. Arch repair was accomplished using the fifth aortic arch as an in situ flap to enlarge the hypoplastic fourth aortic arch associated with coarctectomy and extended end-to-end anastomosis. We believe that this newly reported surgical approach is safe and effective and allows for adequate enlargement of the entire fourth aortic arch., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Pemetrexed (PEM) is a new-generation multitargeted antifolate agent with a demonstrated broad-spectrum activity in several types of human cancers, including non-small cell lung cancer (NSCLC) and mesothelioma. Major side effects include dose-limiting hematologic toxicities. PEM nephrotoxicity is well known; however, its frequency is considered to be low., Case Presentation: Here we report two cases of acute kidney injury (AKI) related to PEM administration (500 mg/m2) in patients with NSCLC. The first patient required hemodialysis treatment and was submitted to renal biopsy which showed acute tubular damage and interstitial edema without acute tubular necrosis. No other potential nephrotoxic agents were identified. The second patient developed AKI, not proven by biopsy and did not require renal replacement therapy. Both patients, on regular supplementation with folic acid and vitamin B12, concomitantly developed myelosuppression and even several months after PEM withdrawal, showed only a modest improvement of renal function., Conclusions: PEM is an antifolate antineoplastic agent with a broad-spectrum activity in locally advanced or metastatic NSCLC. It has been shown that PEM allows longer survival. The risk of acute or chronic kidney disease may be one of the prices to be paid for this success.

Recurrent prosthetic valve endocarditis, especially when characterized by annular abscess and aortic root destruction, remains a surgical challenge. A radical and aggressive surgical treatment is required preventing recurrent infection. Homograft implants are still thought to be the best surgical option, but they are not always available and their use in younger patient remains controversial. We propose an additional anatomical surgical technique, which consists in the implantation of a composite graft in the left ventricular outflow tract, well below the native aortic annulus, and then the direct reimplantation of coronary ostia., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Lactose intolerance syndrome can be efficiently tackled consuming low lactose products. Lactase is the key tool to manufacture low lactose milk (LLM): its addition during milk processing can be done "in batch", i.e. before thermal treatment, or directly "in pack" after sterilization. In this paper data on sensory properties, Maillard Reaction products (MRPs) and free amino acids formation were obtained on six commercial Italian LLMs over six months storage. They showed that the side proteolytic activity of lactase caused the release of amino acids with a significant higher MRPs and off-flavors formation in four out of five samples produced by adding the enzyme in the pack after thermal treatment. We concluded that the in pack addition of lactase after milk sterilization can have negative sensorial and nutritional consequences mainly related to the enzyme side proteolytic activity especially for prolonged storage time., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Intrapartum antibiotic prophylaxis (IAP) reduces both the vertical transmission of Streptococcus agalactiae or Group B Streptococcus (GBS) and the early onset of neonatal sepsis. However, existing guidelines do not recommend that antimicrobial susceptibility testing (AST) be routinely performed. Penicillin or ampicillin are indicated as first-choice antibiotics, cefazolin being an alternative in the case of history of mild allergic reactions, and vancomycin or clindamycin an alternative in the event of severe reactions. We performed a cross-sectional analysis to identify the presence of any bacterial resistance towards the antibiotics most frequently used for IAP in pregnant women with GBS positive vaginal-rectal swabs, in the Pistoia area of central Italy. Of the 255 tested samples, 65 (25.5%) were positive for GBS. Sensitivity to glycopeptides was over 90%, but lower to ampicillin and penicillin (87.10% and 87.93% respectively). Resistance towards clindamycin and erythromycin was as high as 43.75% and 32.20%. All tested GBS proved susceptible to moxifloxacin, linezolid and tigecycline. Our observed prevalence is aligned or slightly higher than data reported in other series. The less than full effectiveness and low percentages of ampicillin and penicillin sensitivity observed give cause for concern. We confirmed the increase in clindamycin and erythromycin resistance. Glycopeptides can be used as second-line antibiotics, but the complete AST of GBS should always be performed before IAP. Given that gentamicin is used synergically with penicillin when treating chorioamnionitis, it needs to be always included in the AST. This is the first study on the GBS sensitivity profile in Tuscany. Further investigation on a larger scale is required prior to implementing any changes in the current guidelines.

Background: We hypothesized that factors associated with an institution's residual risk unaccounted for by population-based models may be identifiable and used to enhance the value of population-based risk scores for quality improvement., Methods: From January 2000 to January 2010, 4,971 patients underwent aortic valve replacement (AVR), either isolated (n = 2,660) or with concomitant coronary artery bypass grafting (AVR+CABG; n = 2,311). Operative mortality and major morbidity and mortality predicted by The Society of Thoracic Surgeons (STS) risk models were compared with observed values. After adjusting for patients' STS score, additional and refined risk factors were sought to explain residual risk. Differences between STS model coefficients (risk-factor strength) and those specific to our institution were calculated., Results: Observed operative mortality was less than predicted for AVR (1.6% [42 of 2,660] vs 2.8%, p < 0.0001) and AVR+CABG (2.6% [59 of 2,311] vs 4.9%, p < 0.0001). Observed major morbidity and mortality was also lower than predicted for isolated AVR (14.6% [389 of 2,660] vs 17.5%, p < 0.0001) and AVR+CABG (20.0% [462 of 2,311] vs 25.8%, p < 0.0001). Shorter height, higher bilirubin, and lower albumin were identified as additional institution-specific risk factors, and body surface area, creatinine, glomerular filtration rate, blood urea nitrogen, and heart failure across all levels of functional class were identified as refined risk-factor variables associated with residual risk. In many instances, risk-factor strength differed substantially from that of STS models., Conclusions: Scores derived from population-based models can be enhanced for institutional level use by adjusting for institution-specific additional and refined risk factors. Identifying these and measuring differences in institution-specific versus population-based risk-factor strength can identify areas to target for quality improvement initiatives., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Neonates with hypoplastic left heart syndrome and high-risk factors for an open Norwood procedure may benefit from a hybrid stage I procedure. The presence of a giant patent ductus arteriosus prevents safe deployment of the ductus arteriosus stent. We describe a new technique that involves banding the patent ductus arteriosus, therefore allowing stent implantation during hybrid stage I palliation., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Primary repair of pulmonary atresia (PA) with ventricular septal defect (VSD) and major aortopulmonary collaterals based on single-stage unifocalization was first reported in 1995. From a midline approach, all collaterals are extensively dissected, translocated in front of the oesophagus and/or the trachea, when required, and directly anastomosed to each other or to the native pulmonary arteries, whenever present, without interposition of prosthetic material. The need for concomitant VSD closure is assessed intraoperatively with a pulmonary flow study according to a standardized protocol. Pulmonary blood supply is established by valved conduit interposition in all patients, regardless of the suitability for VSD closure. Palliation with systemic-pulmonary shunt is reserved for selected cases. Between 1994 and 2015, 94 patients with a median age of 1.09 years (range 0.03-19) underwent single-stage unifocalization at our institution. In 78 (82.1%) of them, an intraoperative pulmonary flow study was utilized to assess acceptability for concomitant VSD closure, which was accomplished in 69 cases (73%). Intraoperatively, following VSD closure, the mean right ventricle-to-aortic pressure ratio was 0.49 ± 0.14. The overall mortality rate was 11.2% (n = 10), with an 82% survival at 12.5 years. At a median follow-up interval of 5.8 years, the right ventricle-to-aortic pressure ratio did not differ significantly from the early postoperative phase. The surgical results of primary repair of PA with VSD and major aortopulmonary collaterals based on single-stage unifocalization and an intraoperative pulmonary flow study are satisfactory and durable, despite the need for repeated percutaneous or surgical reinterventions., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Low superior vena cava (SVC) blood flow has recently been identified as a marker for bidirectional superior cavopulmonary connection (SCPC) failure and death. Prior innominate vein occlusion is considered a significant anatomic risk factor for SCPC failure. We therefore evaluated the outcomes of infants who underwent SCPC with known upper-body venous obstruction., Methods: Between February 1995 and June 2014, SCPC was carried out in 8 patients who had either a single SVC with known prior occlusion of the innominate vein (n = 6) or bilateral SVCs without a bridging vein with occlusion of one SVC (n = 2). The cause of the occlusion was an indwelling catheter in 5 patients. These patients were compared with 8 patients with normal upper-body venous drainage who underwent SCPC. Patients were evaluated for preoperative risk factors (including SVC size, pulmonary artery size, Nakata index, pulmonary vascular resistance), operative factors, and clinical outcomes to determine the impact of prior upper-body venous occlusion on SCPC failure or death., Results: There were no significant differences in preoperative risk factors between the two groups, except for a significantly lower Nakata index in the study group with a trend toward smaller pulmonary artery branch size. There were no SCPC takedowns or mortalities. There was no significant difference in postoperative length of stay (median of 7 days [range, 5 to 32 days] versus 5 days [range, 4 to 32 days]; p = 0.17. Study patients had a lower mean systemic oxygen saturation at discharge, 81% versus 85% (p = 0.05). In the study group, at a median follow-up of 42 months, 3 patients underwent successful Fontan completion and 5 are still awaiting Fontan completion., Conclusions: Although patients with prior upper-body venous obstruction may have lower systemic oxygen saturations at hospital discharge, they do not demonstrate an increased SCPC failure or mortality rate. Innominate vein occlusion or its equivalent in patients with bilateral SVCs should not preclude the performance of SCPC. Physiologic rather than anatomic evaluation of preoperative systemic venous return may be more useful to predict outcome after SCPC., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Pemetrexed (Alimta(®)) (PEM) is an antifolate antineoplastic agent effective in several tumor types, such as non-small-cell lung cancer (NSCLC) and mesothelioma, among others. It is almost exclusively excreted by the kidney and an eGFR lower 45 mL/min is a contraindication for its use: above this level PEM administration is considered safe and dose adjustment is not required. Although there are some reported cases of PEM-induced renal injury, its incidence and the negative effects on patients' outcome has not been systematically evaluated., Methods: We report a retrospective evaluation on the incidence of PEM-induced renal injury in patients affected by NSCLC. Between June 2010 and March 2012 a total of 38 NSCLC patients were treated at our hospital. In 29 of them other possible cause of renal injury were excluded and thus they were eligible to be analysed., Results: Although by protocol all of them had eGFR >45 mL/min at baseline, six patients (average eGFR 56.2 ± 11.5 mL/min/1.73 m(2)) developed AKI (21 %). In these six patients PEM-induced myelosuppression was more severe and hospitalization was longer. Kidney function completely recovered in four patients whereas in the other two deterioration of renal function was irreversible. The number of patients with baseline eGFR <60 mL/min/1.73 m(2) was higher (4/6) in the group that developed AKI as compared to those who did not (6/23) (p < 0.05)., Conclusions: There is no clear cut eGFR above which PEM may be used without potential risks of renal toxicity. If PEM has to be used, all the coexisting risk factors for AKI should be possibly corrected.

Perventricular ventricular septal defect (VSD) closure has been adopted as a therapeutic option for selected patients with muscular VSDs. This technique may combine some of the advantages of surgical and interventional techniques. Complication rates have been low: only one case of procedure-related left ventricular (LV) pseudoaneurysm has been documented. We report the surgical repair for a LV pseudoaneurysm after perventricular VSD device closure., (© 2013 Wiley Periodicals, Inc.)

Apart from the BENCHMRK study, there are no large observational experiences describing the long-term efficacy and safety of rescue regimens for human immunodeficiency virus type 1 (HIV-1) infection. Antiretroviral-experienced patients with detectable viraemia starting a raltegravir (RAL)-based regimen between March 2007 and June 2009 were consecutively enrolled and followed for ≥4 years. Data were censored at Week 206 for homogeneity. Of 333 patients, 258 (77.5%) were still on RAL-based therapy at Week 206, and 241 had undetectable HIV-1 RNA (73% in intention-to-treat analysis). Of the 75 subjects who discontinued RAL therapy, 36 were lost to follow-up, 15 changed their regimen due to virological failure, 2 simplified their regimen stopping RAL, 9 stopped all antiretrovirals and 13 died. Overall, 100 subjects (30.0%) had at least one detectable viraemia, but only 32 (9.6%) had true viral failure. Seventeen patients continued their failing regimen. 'Blips' were experienced by 53 patients (15.9%), whilst 15 (4.5%) had confirmed viral rebound due to adherence issues and were re-suppressed upon treatment re-introduction. In a multivariate analysis of predictors of interruption or failure, each baseline HIV-1 RNA log10 increase was associated with an adjusted hazard ratio for failure of 1.6; having more than 13 previous treatment courses also emerged as a predictor. Overall, adverse events were rare (n=64), with 13 deaths. Tumours were mainly early events, often fatal (7/15), mainly non-Hodgkin's lymphomas (8), followed by hepatocarcinoma (2). RAL proved effective and well tolerated in this cohort, and few patients experienced viral failure after 4 years., (Copyright © 2013 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.)

Objectives: We investigated whether oxidative stress and the arginine/nitric oxide pathway differ in control subjects and in adult patients who are candidates for the three most common cardiac surgical operations: coronary bypass surgery, aortic valve replacement for calcific non-rheumatic aortic stenosis or mitral valve repair for degenerative mitral insufficiency., Methods: In this prospective observational study, we studied 165 consecutive patients undergoing surgery from January to June 2011 (coronary bypass surgery, n = 63; aortic valve replacement for calcific non-rheumatic aortic stenosis, n = 51; mitral valve repair for degenerative mitral insufficiency, n = 51). Thirty-three healthy subjects with cardiovascular risk factors similar to surgery patients were also studied (Controls). Oxidative stress (the ratio of reduced and oxidized glutathione and urinary isoprostane), antioxidants (alpha- and gamma tocopherol) and factors involved in nitric oxide synthesis (arginine, symmetric and asymmetric dimethylarginine) were measured before surgery. Analysis of variance general linear models and principal component analysis were used for statistical analysis., Results: Surgical patients had increased levels of oxidative stress and decreased levels of antioxidants. Increased levels of nitric oxide inhibitor asymmetric dimethylarginine were detected in surgical candidates, suggesting arginine/nitric oxide pathway impairment. Concerning the differences among surgical procedures, higher oxidative stress and a major imbalance of the ratio between substrate and inhibitors of nitric oxide synthesis were evidenced in patients who were candidates for mitral valve repair with respect to coronary bypass surgery patients and patients with calcific non-rheumatic aortic stenosis., Conclusions: Patients undergoing cardiac surgery have increased oxidative stress and a trend towards an impaired arginine/nitric oxide pathway with respect to Controls. Patients affected by mitral valve regurgitation show more pronounced perturbations in these pathways. The clinical implications of these findings need to be investigated.