Prognostic Relevance of the Lung Ultrasound Score: A Multioutcome Study in Infants with Respiratory Distress Syndrome.

OBJECTIVE: There is growing evidence for the usefulness of the lung ultrasound score (LUS) in neonatal intensive care. We evaluated whether the LUS is predictive of outcomes in infants with respiratory distress syndrome (RDS). STUDY DESIGN: Neonates less than 34 weeks of gestational age were eligible for this prospective, multicenter cohort study. The outcomes of interest were the need for mechanical ventilation (MV) at <72 hours of life, the need for surfactant (SF), successful weaning from continuous positive airway pressure (CPAP), extubation readiness, and bronchopulmonary dysplasia. Lung scans were taken at 0 to 6 hours of life (Day 1), on Days 2, 3, and 7, and before CPAP withdrawal or extubation. Sonograms were scored (range 0-16) by a blinded expert sonographer. The area under the receiver operating characteristic curve (AUC) was used to estimate the prediction accuracy of the LUS. RESULTS: A total of 647 scans were obtained from 155 newborns with a median gestational age of 32 weeks. On Day 1, a cutoff LUS of 6 had a sensitivity (Se) of 88% and a specificity (Sp) of 79% to predict the need for SF (AUC = 0.86), while a cutoff LUS of 7 predicted the need for MV at <72 hours of life (Se = 89%, Sp = 65%, AUC = 0.80). LUS acquired prior to weaning off CPAP was an excellent predictor of successful CPAP withdrawal, with a cutoff level of 1 (Se = 67%, Sp = 100%, AUC = 0.86). CONCLUSION: The LUS has significant predictive ability for important outcomes in neonatal RDS. KEY POINTS: · Lung ultrasound has significant prognostic abilities in neonatal RDS.. · Early sonograms (0-6 h of life) accurately predict the requirement for SF and ventilation.. · Weaning off CPAP is effective when the LUS (range 0-16) is less than or equal to 1..

Risk factors for long-term survival in patients with ypN+ M0 rectal cancer after radical anterior resection.

BACKGROUND: Regional lymph node metastases are the main adverse prognostic factor in patients with rectal cancer without distant metastases. There are discrepancies, however, regarding additional risk factors in the group of ypN + M0 patients. The purpose of the study was to assess clinical and pathological factors affecting long-term oncological outcomes in the group of ypN + M0 patients after radical rectal anterior resection. METHODS: 112 patients with ypN + M0 rectal cancer after neoadjuvant therapy and radical anterior resection were subject to a retrospective analysis. The effect of potential factors on survival was assessed with the use of Kaplan-Meier curves together with a log-rank test and multiple factor Cox proportional hazards model. RESULTS: In the multiple factor Cox analysis, adverse factors affecting disease-free survival (DFS) were: the use of angiotensin-converting enzyme inhibitors (ACEIs) (hazard ratio HR: 3.11, 95% CI 1.01-9.56, p = 0.047), presence of perineural invasion (HR: 7.27, 95% CI 2.74-19.3, p < 0.001) and occurrence of postoperative complications (HR: 6.79, 95% CI 2.09-22.11, p = 0.001), while a positive factor was the negative lymph node (NLN) count > 7 (HR: 0.33, 95% CI 0.12-0.88, p = 0.026). In the disease-specific survival (DSS) analysis, an adverse factor was the use of ACEIs (HR: 4.275, 95% CI 1.44-12.694, p = 0.009), while a positive effect was caused by NLN > 5 (HR: 0.22, 95% CI 0.082-0.586, p = 0.002). CONCLUSIONS: The use of ACEIs may have a negative effect on long-term treatment outcomes in patients with ypN + M0 rectal cancer. In this group of patients, the NLN count seems to be an important prognostic factor, as well.

Application of Density Measurements for Discrimination and Evaluation of Chemical Composition of Different Types of Mechanically Separated Meat (MSM).

At present, the problem of identifying and controlling different types of Mechanically Separated Meat (MSM) is a very important practical issue in the meat industry. To address this challenge, the authors propose a new, analytical method for the discrimination and characterization of MSM that uses density measurements. The method proposed by the authors, in contrast to the analytical methods existing so far, is rapid, non-destructive, relatively simple and can be computerized. The density measurements of meat samples were conducted with a modified pycnometric method. Statistically significant (p<0.01) differences were found in the evaluated mean values of density for all investigated types of meat. Subsequently, the density measurements were correlated with the physicochemical properties of meat samples. A high correlation coefficient was found between the density of meat samples and the content of protein, sodium and fat. The authors have proven that density measurements allow for rapid discrimination of various types of MSM, and can also be effectively used to determine the chemical composition of MSM samples, e.g., the content of protein, fat and sodium.

The Use of Unique, Environmental Lactic Acid Bacteria Strains in the Traditional Production of Organic Cheeses from Unpasteurized Cow's Milk.

The aim of this study was to use local LAB cultures for the production of organic acid-rennet cheeses from unpasteurized cow's milk. Under industrial conditions, three types of cheese were produced, i.e., traditionally with acid whey (AW), with starter culture L. brevis B1, or with starter culture L. plantarum Os2. Strains were previously isolated from traditional Polish cheeses. Chemical composition, physico-chemical, microbiological, and sensory studies during 2 months of storage were carried out. As a result of this research, it was found that the basic composition was typical for semi-hard, partially skimmed cheeses. Mainly saturated fatty acids were detected. The cheeses were rich in omega-3, -6, and -9 fatty acids and conjugated linoleic acid (CLA), and were characterized by good lipid quality indices (LQI). All of the cheeses were characterized by a high number of lactic acid bacteria, with Enterobacteriaceae, yeast, molds, and staphylococci contaminants, which is typical microbiota for unpasteurized milk products. Water activity, pH, and total acidity were typical. A lower oxidation-reduction potential (ORP) of cheeses with the addition of strains and stability of the products during storage were observed. The B1 and Os2 cheeses were lighter, less yellow, had a more intense milk and creamy aroma, were softer, moister, and more elastic than AW cheese. The research results indicate the possibility of using environmental LAB strains in the production of high-quality acid-rennet cheeses, but special attention should be paid to the production process due to the microbiological quality of the cheeses.

Community Heroes and Sleeping Members: Interdependency of the Tenets of Energy Justice.

Energy justice literature generally treats its three tenets, distributional justice, procedural justice and recognition justice, as separate and independent issues. These are seen as separate dimensions by which criteria can be formulated for a just state of affairs. And a just state of affairs regarding energy should fulfill all criteria. However, we show, using empirical research on six European energy communities that the tenets of energy justice are interdependent and negotiated in practice. We show this interdependency using three core concerns of justice-risk, effort and power-which we identified through our empirical work. Our findings reveal that community members are often willing to take risks and put in effort, if they are compensated with more power within the community. Similarly, members are willing to compromise power if no effort or risk-taking is required from them. This demonstrates the interdependency of the tenets "procedural justice" and "distributional justice" within energy communities. We reflect on the need for energy justice theory and policymakers to recognize the significance of this interdependency.

Modified lung ultrasound score predicts ventilation requirements in neonatal respiratory distress syndrome.

BACKGROUND: We propose a modified lung ultrasound (LUS) score in neonates with respiratory distress syndrome (RDS), which includes posterior instead of lateral lung fields, and a 5-grade rating scale instead of a 4-grade rating scale. The purpose of this study was to evaluate the reproducibility of the rating scale and its correlation with blood oxygenation and to assess the ability of early post-birth scans to predict the mode of respiratory support on day of life 3 (DOL 3). As a secondary objective, the weight of posterior scans in the overall LUS score was assessed. METHODS: We analyzed 619 serial lung scans performed in 70 preterm infants < 32 weeks gestation and birth weight < 1500 g. Assessments were performed within 24 h of birth (LUS0) and on days 2, 3, 5, 7, 10, 14, 21 and 28. LUS scores were correlated with oxygen saturation over fraction of inspired oxygen (S/F) and mode of respiratory support. Interrater agreement was determined with the intraclass correlation coefficient (ICC) and Cronbach's alpha. Probabilities of the need for various respiratory support modes on DOL 3 were assessed with ordinal logistic regression. Least square (ls) means of the posterior and anterior pulmonary field scores were compared. RESULTS: The LUS score correlated significantly with S/F (Spearman rho = -0.635; p < 0.0001) and had excellent interrater agreement (ICC = 0.94, 95% CI 0.93-0.95; Cronbach's alpha = 0.99). Significant predictors of ventilation requirements on DOL 3 were LUS0 (p < 0.016) and birth weight (BW) (p < 0.001). In the ROC analysis, LUS0 had high reliability in prognosing invasive ventilation on DOL 3 (AUC = 0.845 (95% DeLong CI: 0.738-0.951; p < 0.001)). Invasive ventilation was the most likely mode of respiratory support for LUS0 scores: ≥7 (in infants with BW 900 g), ≥ 10 (in infants with BW 1050 g) and ≥ 15 (in infants with BW 1280 g). Posterior fields exhibited significantly higher average scores than anterior fields. Respective ls means (confidence levels) were 4.0 (3.8-4.1) vs. 2.2 (2.0-2.4); p < 0.001. CONCLUSIONS: Post-birth LUS predicts ventilation requirements on DOL 3. Scores of posterior pulmonary fields have a predominant weight in the overall LUS score.

Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology.

The new European Union (EU) law governing the regulatory approval of medical devices that entered into force in May 2017 will now take effect from 26 May 2021. Here, we consider how it will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals. Clinical evidence for any high-risk device must be reported by the manufacturer in a Summary of Safety and Clinical Performance (SSCP) that will be publicly available in the European Union Database on Medical Devices (Eudamed) maintained by the European Commission; this will facilitate evidence-based choices of which devices to recommend. Hospitals must record all device implantations, and each high-risk device will be trackable by Unique Device Identification (UDI). Important new roles are envisaged for clinicians, scientists, and engineers in EU Expert Panels-in particular to scrutinize clinical data submitted by manufacturers for certain high-risk devices and the evaluations of that data made by notified bodies. They will advise manufacturers on the design of their clinical studies and recommend to regulators when new technical specifications or guidance are needed. Physicians should support post-market surveillance by reporting adverse events and by contributing to comprehensive medical device registries. A second law on In Vitro Diagnostic Medical Devices will take effect from 2022. We encourage all healthcare professionals to contribute proactively to these new systems, in order to enhance the efficacy and safety of high-risk devices and to promote equitable access to effective innovations. The European Society of Cardiology will continue to advise EU regulators on appropriate clinical evaluation of high-risk devices.

Effects of Lacticaseibacillus rhamnosus LOCK900 on Development of Volatile Compounds and Sensory Quality of Dry Fermented Sausages.

Traditional dry fermented meat products are highly appreciated by consumers. A probiotic starter culture increases their attractiveness through sensory qualities and a potential health-promoting effect. The ability to scale the laboratory solution to industrial conditions is an additional scientific and practical value of a new way of using probiotics in the meat industry. The aim was to evaluate the influence of the probiotic starter culture Lacticaseibacillus rhamnosus LOCK900 on the development of volatile organic compounds and the sensory quality of dry fermented pork sausages during fermentation and refrigeration storage. The microbiological and sensory characteristic (QDA method) and volatile compound (gas chromatography coupled with mass spectrometry: GC-MS) were evaluated. The number of LOCK900 cells during 12 weeks of storage remained above 6 log CFU g-1, making this product a functional food. The addition of probiotic LOCK900 increased the levels of acidic volatile compounds, aldehydes, and esters, which, combined with the additives and spices used, had a positive effect on the sensory properties of ripening sausages. The sausages with LOCK900 were characterised by positive sensory features, and their overall quality remained high during storage and did not differ from that of the control sausages.

The need for transparency of clinical evidence for medical devices in Europe.

To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed-with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property-and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible.

The usefulness of cardiac CT in the diagnosis of perivalvular complications in patients with infective endocarditis.

OBJECTIVES: The aim of the study was to compare the usefulness of cardiac CT to transthoracic (TTE) and transesophageal (TEE) echocardiography in the diagnosis of infective endocarditis (IE) and perivalvular complications using surgical inspection as the gold standard. MATERIAL AND METHODS: Fifty-three consecutive patients (42 men, mean age 58.3 ± 12.5) with IE requiring surgical procedures were enrolled in the study. All patients underwent preoperative TTE, TEE, and CT. The presence of vegetations, perivalvular abscess/pseudoaneurysm, leaflet perforation, inflammatory infiltration, and prosthesis dehiscence was assessed. RESULTS: We analyzed 71 affected valves (58 native, 13 prosthetic). Intraoperative assessment revealed 11 abscesses/pseudoaneurysms. Sensitivity and specificity of echocardiography (TTE + TEE) and CT were 63%, 90% and 81%, 90%, respectively. The combination of CT and echocardiography allowed diagnosing all abscesses/pseudoaneurysms. Inflammatory infiltration was found intraoperatively in 15 patients. Sensitivity and specificity of TEE and CT were 53%, 94% and 46%, 100%, respectively. Intraoperative assessment revealed leaflet perforation in 16 patients. Sensitivity and specificity of TEE and CT were 75%, 79% and 43%, 89%. The sensitivity of the combination of TTE + TEE + CT was 81%. Perivalvular leakage was found in eight patients with a prosthetic valve. Sensitivity and specificity of echocardiography and CT were 100%, 100% and 88%, 100%, respectively. TEE showed higher sensitivity (97%) than CT (89%) in the diagnosis of vegetations. CONCLUSIONS: The combination of TTE, TEE, and CT increased the sensitivity for the detection of valvular and perivalvular complications of IE. KEY POINTS: • CT is a useful modality in the diagnosis of IE and its local complications in addition to echocardiography. • For the detection of abscesses and pseudoaneurysms, CT is superior to echocardiography. Combining these two modalities can increase the sensitivity of diagnosing abscess/pseudoaneurysm up to 100%. • Adding CT to TEE increases the sensitivity for detection of inflammatory infiltrate. CT is not superior to echocardiography in diagnosing vegetations, valvular leaflet perforations, and perivalvular leaks, but it can be a useful tool when echocardiography is indeterminate.

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Caseous calcification of the mitral annulus - the complementary role of computed tomography and transthoracic echocardiogram.

PURPOSE: Caseous calcification is a relatively uncommon variant of calcification of the mitral annulus. The purpose of the study was to assess characteristic radiological features of caseous calcification of the mitral annulus (CCMA) using computed tomography (CT) and compare the usefulness of CT and transthoracic echocardiogram (TTE) in a diagnosis of CCMA. MATERIAL AND METHODS: Seventeen patients with CCMA, who underwent TTE and CT, were analysed. The following features of CCMA were evaluated: location, size, attenuation, enhancement after contrast administration, and margins. RESULTS: In all cases TTE visualised an echo-dense structure with an irregular appearance involving the mitral valve annulus. In five cases the acoustic shadowing artefact was visible, and in four cases the mass contained central areas of echolucency. Eleven patients had valve disease.On CT CCMA appeared as a round mass in one case, in 10 cases as an oval mass, and in six patients it had a semilunar shape.In all cases on unenhanced CT, CCMA appeared as a hyperdense mass. On enhanced CT, CCMA in 10 cases (58.8%) had a hypodense centre, and in 7seven (41.2%) it had a hyperdense centre without enhancement after contrast administration. A hyperdense rim was observed in all cases except one patient. CONCLUSIONS: In cases of the atypical appearance of CCMA on TTE, CT can lead to a definitive diagnosis. The combination of unenhanced CT and after IV contrast administration scans allows for recognition and distinction of CCMA from other pathologies, while TTE allows for assessment of additional valve dysfunction.

Transapical Beating-Heart Mitral Valve Repair With an Expanded Polytetrafluoroethylene Cordal Implantation Device: Initial Clinical Experience.

BACKGROUND: Degenerative mitral valve (MV) disease is a common cause of severe mitral regurgitation (MR) and accounts for the majority of MV operations. Conventional MV surgery requires cardiopulmonary bypass, aortic cross-clamping, cardioplegia, and a thoracotomy or sternotomy and, therefore, is associated with significant disability, risks, and unpredictable rates of MV repair. Transesophageal echocardiography-guided beating-heart MV repair with expanded polytetrafluoroethylene cordal insertion has the potential to significantly reduce surgical morbidity. We report the first-in-human clinical experience with a novel preformed expanded polytetrafluoroethylene knot implantation device (Harpoon TSD-5) designed to treat degenerative MR. METHODS: Through a small left thoracotomy, the device was inserted into the heart and guided by transesophageal echocardiography to the ventricular surface of the prolapsed leaflet. Multiple expanded polytetrafluoroethylene cords were anchored in the leaflet and then adjusted to the correct length to restore MV leaflet coaptation and secured at the epicardium. RESULTS: Eleven patients with posterior leaflet prolapse and severe MR, with mean±SD age of 65±13 years and mean ejection fraction of 69±7%, were treated with 100% procedural success. Immediate postprocedural mean MR grade was trace. At 1 month, the mean MR grade was mild with significant decreases in end-diastolic volume (139 to 107 mL; P=0.03) and left atrial volume (118 to 85 mL; P=0.04). CONCLUSIONS: A novel device used for beating-heart image-guided MV repair demonstrates a significant reduction in MR with favorable left ventricular and left atrial reverse remodeling. This approach has the potential to decrease invasiveness and surgical morbidity. Further follow-up is necessary to assess long-term efficacy. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02432196.

Red Cell Distribution Width as a Prognostic Marker in Patients Undergoing Valve Surgery.

BACKGROUND: Numerous studies have shown that elevated red cell distribution width (RDW) is associated with poor outcomes in patients with cardiovascular diseases such as acute myocardial infarction, stroke, and chronic heart failure. The prognostic utility of RDW in patients with valvular disease undergoing heart valve surgery is unknown. METHODS: A prospective study was conducted on a group of consecutive patients with hemodynamically significant valvular heart disease that underwent elective valvular surgery. The preoperative complete blood count, data on risk factors, course of operations and the postoperative period were assessed. The primary and secondary endpoints were 30-day mortality and any major adverse event within 30 days. The data were analyzed with Kaplan-Meier survival curves, regression analyses, and receiver operator characteristic (ROC) curves. RESULTS: The study group included 500 consecutive patients who underwent replacement or repair of the valve/valves. Sixteen patients died during the follow up period. On multivariate analysis, creatinine (p = 0.04), red blood cell (RBC) count (p = 0.005) and RDW (p = 0.02) were each associated with an increased risk of death. The composite endpoint occurred in 208 patients. On multivariate analysis, chronic kidney disease (p = 0.003), raised pulmonary blood pressure (p = 0.02) and RDW (p = 0.001) remained independent predictors of the secondary endpoint. The preoperative RDW in patients with valvular disease undergoing valve surgery, combined with EuroSCORE II, predicted 30-day mortality significantly better than did EuroSCORE II alone. CONCLUSIONS: An elevated RDW is associated with a worse outcome following valve surgery. The predictive ability of the RDW, when assessed by the area under the ROC curve, improved the predictive ability of the EuroSCORE II calculator.

Triple Percutaneous Mitral Balloon Valvuloplasty for Patients with Recurrent Mitral Valve Stenosis: Long-Term Observations.

BACKGROUND: A third percutaneous mitral balloon valvuloplasty (PMBV) may provide a means of treating symptomatic patients with re-restenosis after successful initial and second valvuloplasties, though data related to the long-term safety and efficacy of a third PMBV are lacking. The study aim was to determine the immediate and long-term clinical outcome in patients who underwent a third PMBV to treat recurrent mitral stenosis. METHODS: Among a total of 1,849 patients who underwent PMBV at the authors' institution, seven females (mean age 38.5 ± 12.2 years at the first procedure) required repeat second and third PMBVs. The mean interval between the first and second valvuloplasties was 6.4 ± 2.5 years, and between the first and third valvuloplasties was 12.5 ± 6.5 years. All procedures were performed using the Inoue balloon system. RESULTS: Second and third PMBVs resulted in a significant increase in mitral valve area (MVA), from 1.1 ± 0.1 cm2 to 1.6 ± 0.2 cm2, and from 1.0 ± 0.2 cm2 to 1.6 ± 0.4 cm2, respectively. However, as mitral degeneration progressed, four patients required mitral valve replacement (MVR) at 9.2 ± 5.8 years (range: 6-18 years) after the third PMBV. The preoperative MVA of these patients was 0.97 ± 0.1 cm2. One patient died due to surgical complications, while the fifth and sixth patients remain under clinical observation. If patients have a fourth recurrence of mitral stenosis they are no longer considered to be suitable candidates for re-PMBV. The seventh patient died at the age of 84 years. CONCLUSIONS: A repeat, third PMBV is a safe and feasible procedure in selected patients with recurrent stenosis after successful first and second valvuloplasties. Although the third procedure provides good immediate results, the long-term outcome is not satisfactory. Nonetheless, a third PMBV would allow MVR surgery to be postponed for a few years.