The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies.

Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk-based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano-specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.

A global analysis of bioeconomy visions in governmental bioeconomy strategies.

Against the background of climate change and scarce non-renewable resources, transforming the fossil-based toward a bio-based economy is considered crucial for sustainable development. Numerous countries have released governmental strategies outlining their bioeconomy visions. This study examines the bioeconomy visions presented in 78 policy documents from 50 countries worldwide, building on earlier vision typologies. Through qualitative content analysis, 227 distinct policy goals were identified and analyzed. Descriptive statistics were used to determine the salience of specific goals, overarching goal categories, and distinct bioeconomy visions: bioresource, biotechnology, and bioecology visions. The results reveal that goals and visions prioritize economic growth, while environmental considerations are less salient. The bioresource vision emerges as the globally dominant perspective, while the bioecology and biotechnology visions have lower salience. These findings deepen our comprehension of current bioeconomy policies and emphasize the need for critical research on bioeconomy visions and their implications for public policy.

Acute hemoptysis and pulmonary hemorrhage after judo as presentation of intralobar sequestration.

Intralobar sequestration (ILS) is a rare anomaly that is usually diagnosed with symptoms of cough, expectoration, or recurrent pneumonia in children. We experienced a case of an 11-year-old boy with massive hemoptysis after judo sports. He was admitted to hospital and intubated due to respiratory failure. His chest computed tomography (CT) scan which was performed without contrast agent revealed a large intrapulmonary hematoma or tumor, mimicking traumatic hemothorax. Due to blood loss and circulatory instability, emergency thoracotomy was performed and a massive intralobar hemorrhage due to a ruptured ILS artery was found. After lobectomy including resection of the ILS, the patient was stabilized and extubated. Aspergillus was detected in the resected lobe and postoperatively acute respiratory distress syndrome (ARDS) and invasive aspergillosis occurred and was treated specifically. However, the young patient was discharged home 3 weeks later. In young patients with hemoptysis and intrapulmonary hemorrhage after trauma, the possibility of ruptured ILS should be kept in mind. This report shows that ILS can have a dramatic course of disease, and for this reason a nonurgent resection should be considered in all patients when this diagnosis is made.

Early Detection of Lung Cancer Using Small RNAs.

INTRODUCTION: Lung cancer remains the deadliest cancer in the world, and lung cancer survival is heavily dependent on tumor stage at the time of detection. Low-dose computed tomography screening can reduce mortality; however, annual screening is limited by low adherence in the United States of America and still not broadly implemented in Europe. As a result, less than 10% of lung cancers are detected through existing programs. Thus, there is a great need for additional screening tests, such as a blood test, that could be deployed in the primary care setting. METHODS: We prospectively recruited 1384 individuals meeting the National Lung Screening Trial demographic eligibility criteria for lung cancer and collected stabilized whole blood to enable the pipetting-free collection of material, thus minimizing preanalytical noise. Ultra-deep small RNA sequencing (20 million reads per sample) was performed with the addition of a method to remove highly abundant erythroid RNAs, and thus open bandwidth for the detection of less abundant species originating from the plasma or the immune cellular compartment. We used 100 random data splits to train and evaluate an ensemble of logistic regression classifiers using small RNA expression of 943 individuals, discovered an 18-small RNA feature consensus signature (miLung), and validated this signature in an independent cohort (441 individuals). Blood cell sorting and tumor tissue sequencing were performed to deconvolve small RNAs into their source of origin. RESULTS: We generated diagnostic models and report a median receiver-operating characteristic area under the curve of 0.86 (95% confidence interval [CI]: 0.84-0.86) in the discovery cohort and generalized performance of 0.83 in the validation cohort. Diagnostic performance increased in a stage-dependent manner ranging from 0.73 (95% CI: 0.71-0.76) for stage I to 0.90 (95% CI: 0.89-0.90) for stage IV in the discovery cohort and from 0.76 to 0.86 in the validation cohort. We identified a tumor-shed, plasma-bound ribosomal RNA fragment of the L1 stalk as a dominant predictor of lung cancer. The fragment is decreased after surgery with curative intent. In additional experiments, results of dried blood spot collection and sequencing revealed that small RNA analysis could potentially be conducted through home sampling. CONCLUSIONS: These data suggest the potential of a small RNA-based blood test as a viable alternative to low-dose computed tomography screening for early detection of smoking-associated lung cancer.

European multicenter study with the Soprano valve for aortic valve replacement: one-year clinical experience and hemodynamic data.

BACKGROUND AND AIM OF THE STUDY: During recent years, pericardial bioprostheses have gained widespread acceptance as cardiac valve substitutes. The study aim was to evaluate the early clinical and hemodynamic performance of the Sorin SopranoTM supra-annular aortic bioprosthesis, as used for aortic valve replacement (AVR). METHODS: Between January 2004 and August 2006, a total of 501 patients (55% males; mean age 75 +/- 6.4 years) was prospectively enrolled into the study, which involved 10 European institutions. The indications for AVR were aortic stenosis in 91% of patients, aortic incompetence in 8%, and redo surgery in 1%. Preoperatively, 62% of the patients were in NYHA class III, and 12% in class IV. The mean prosthesis size was 21.4 +/- 1.8 mm. A non-everting technique was used in 88% of patients. Concomitant procedures were performed in 52% of cases (mainly coronary artery bypass grafts; 41%). The mean cross-clamp and cardiopulmonary bypass times were 70 +/- 27.2 min and 99 +/- 39.7 min, respectively. Doppler echocardiography performed at one and 12 months after surgery was evaluated by an independent core laboratory. RESULTS: Postoperatively, there were 25 early deaths (5%) and 13 late deaths, with an overall survival at one year of 92.9% (95% CI: 90.2-94.8) and freedom from valve-related death of 98.6% (95% CI: 97.5-99.6). After 12 months, most patients (87%) were in NYHA classes I-II. Actuarial freedoms from thromboembolism, bleeding, endocarditis and paraprosthetic leak at one year were 97.1% (CI: 95.1-98.2), 98.9% (CI: 97.4-99.5), 99.1% (CI: 97.7-99.7), and 99.6% (CI: 98.3-99.9), respectively. No events of thrombosis and structural valve deterioration (SVD) were observed. Subsequent echocardiographic evaluation showed low mean (11.1 +/- 5.1 mmHg at one year) and peak (19.5 +/- 8.9 mmHg at one year) transvalvular gradients, and a significant reduction in left ventricular mass, from 211 +/- 78.5 g at one month to 185 +/- 64.7 g at 12 months (p <0.0001). CONCLUSION: After 12 months, the clinical outcome with the Soprano bioprosthesis, when used for AVR, was excellent. The bioprosthesis also showed good hemodynamic performance, with a significant reduction of left ventricular hypertrophy.

Delayed sternal closure (DSC) after cardiac surgery: outcome and prognostic markers.

BACKGROUND: Maintenance of an open sternotomy (OS) after a complicated cardiac operation is an adjunct in the treatment of the severely impaired heart. The purpose of this retrospective study was to evaluate the incidence, survival, and predictors of poor outcome for open chest management (OCM) with delayed sternal closure (DSC) at our department. METHODS: Prolonged open chest (OC) was used in 179 of 5122 cardiac surgery patients between 2004 and 2008 (3.5%). We wanted to determine indications, mortality, postoperative complications, and predictors of outcome. RESULTS: The incidence of OS was 3.5%, with 1.3% for isolated CABG, 2.4% for isolated valve, and 6.4% for combined procedures. Indications for OS were: hemodynamic compromise (110), intractable bleeding (19), arrhythmia (14), and cardiac edema or tamponade (36). 127 of the 179 patients with DSC (71%) survived. 52 patients died: 20 before DSC and 32 after this procedure. Mortality could be related to the indication for OS: With the indication "low cardiac output syndrome" (LCOS) the mortality was 34.5%, for bleeding it was 26.3%, for arrhythmias, 21.4%, and for tamponade on closure it was 16.7%. After DSC, deep sternal wound infection occurred in nine patients (5%), superficial infection in 4.7% of patients. There were 16 patients with postoperative stroke (8.9%) and 24 patients with need for dialysis (13.4%). Predictors of mortality by univariate analysis were VAD insertion, new onset of hemodialysis, reoperation for bleeding, mean length of duration of OS (survivors 3.4 days, nonsurvivors 6.5 days), and longer duration of high-dose inotropic therapy. CONCLUSION: This study shows that OCM with DSC is a beneficial, therapeutic option in patients with postoperative LCOS, significant hemorrhage or intractable arrhythmias. However, patients with reoperation for bleeding, need for VAD, and particularly a prolonged delay before sternal closure continued to have a poor outcome.

No evidence for increased intraoperative bleeding in aortic-valve stenosis: a comparative analysis of haemotherapy in 136 patients undergoing aortic-valve replacement.

OBJECTIVE: An association of aortic-valve stenosis and abnormal bleeding, particularly from gastrointestinal angiodysplasia, has been reported. In this setting, high-shear stress generated by the transvalvular gradient leads to a conformational change of plasmic von Willebrand factor, making this adhesive protein more susceptible for proteolytic cleavage. Consequently, highest-molecular weight multimers of the von Willebrand factor are degraded through a von Willebrand factor specific protease leading to impaired platelet-related haemostasis. METHODS AND RESULTS: To assess the role of aortic-valve stenosis as a factor predicting abnormal intraoperative bleeding in patients suffering from aortic-valve stenosis, we compared the number of intraoperatively administered blood components during aortic-valve replacement for aortic-valve stenosis (n = 50), aortic-valve insufficiency (n = 19) and combined aortic-valve defects (n = 67). As a result, the three subgroups did not differ significantly regarding the mean number of transfused red-blood cell units (0.94 +/- 1.36, 0.4 +/- 0.9, or 0.86 +/- 1.3, respectively) and plasma units (0.04 +/- 0.28, 0.21 +/- 0.71, or 0.15 +/- 0.61, respectively). None of the patients received platelet concentrates. A multivariate logistic regression model adjusted for age and gender did not show an influence of the presence and severity of aortic-valve stenosis on intraoperatively applied haemotherapy. CONCLUSION: Along with our findings, the presence or severity of aortic-valve stenosis does not predict an increased need for intraoperative transfusion of blood components. Thus, this cardiac defect does not seem to represent a major risk determinant for intraoperative bleeding despite the high prevalence of shear-stress induced von Willebrand factor abnormalities in this setting.

Impact of mitral valve repair in patients with mitral regurgitation undergoing coronary artery bypass grafting.

BACKGROUND: The benefit of concomitant mitral valve correction (replacement or reconstruction, MVR) and coronary artery bypass grafting (CABG) in patients with coronary artery disease and mitral regurgitation (MR) remains unclear. PATIENTS AND METHODS: 298 consecutive patients underwent CABG alone (n=196) or CABG+ MVR (n=102) between January 2003 and April 2008. Clinical data were collected and MR graded according to preoperative echocardiographic studies. Four severity grades of MR were determined and patients assigned accordingly. Echocardiographic follow-up was performed postoperatively to assess heart and valve function. Multivariate logistic regression analysis was performed for perioperative morbidity and mortality. RESULTS: Patients were comparable within the groups regarding age, gender, NYHA-class, ejection fraction and number of graft vessels. Perioperative mortality (10.8% vs. 5.1%, P < 0.05) and degree of MR were higher among CABG+MVR patients. Among patients with moderate to severe or severe MR, postoperative echocardiography showed an improvement of mitral regurgitation in 95% of CABG+MVR and in 64% of CABG only patients. In patients with mild or moderate MR, improvement rates of both groups were similar (74% and 69%, respectively). Postoperatively, ejection fraction increased in both groups (CABG+MVR: 31.3 +/- 8.5 to 36.4 +/- 11.2; CABG only: 29.9 +/- 6.1 to 33.3 +/- 8.1, P > 0.05). Significant predictors for peri-operative mortality were renal insufficiency, older age and NYHA class III/IV. CONCLUSIONS: For reduction of ischaemic MR, CABG+MVR is preferable in patients with moderate to severe or severe MR. Combined CABG+MVR procedures cannot be recommended for patients with a particular risk profile because of disproportionately high peri-operative mortality.

Action needed for the EU Common Agricultural Policy to address sustainability challenges.

Making agriculture sustainable is a global challenge. In the European Union (EU), the Common Agricultural Policy (CAP) is failing with respect to biodiversity, climate, soil, land degradation as well as socio-economic challenges.The European Commission's proposal for a CAP post-2020 provides a scope for enhanced sustainability. However, it also allows Member States to choose low-ambition implementation pathways. It therefore remains essential to address citizens' demands for sustainable agriculture and rectify systemic weaknesses in the CAP, using the full breadth of available scientific evidence and knowledge.Concerned about current attempts to dilute the environmental ambition of the future CAP, and the lack of concrete proposals for improving the CAP in the draft of the European Green Deal, we call on the European Parliament, Council and Commission to adopt 10 urgent action points for delivering sustainable food production, biodiversity conservation and climate mitigation.Knowledge is available to help moving towards evidence-based, sustainable European agriculture that can benefit people, nature and their joint futures.The statements made in this article have the broad support of the scientific community, as expressed by above 3,600 signatories to the preprint version of this manuscript. The list can be found here (https://doi.org/10.5281/zenodo.3685632).

The use of autologous platelet gel (APG) for high-risk patients in cardiac surgery -- is it beneficial?

BACKGROUND: Wound healing in cardiac surgery has become a major problem due to the impaired risk profile of many patients. The aim of this study was to prove the influence of autologous platelet gel (APG) on wound healing in a special group of high-risk patients undergoing coronary surgery. PATIENTS AND METHODS: We performed a prospective, double-blind study in 44 patients with a special risk constellation relating to wound complications (obesity, diabetes, smoker, New York Heart Association (NYHA) III-IV and peripheral vascular disease). The study group was treated with APG, prepared using the Magellan platelet separator, the control group underwent conventional wound treatment. RESULTS: The incidence of major and minor wound complications at the thoracotomy, as well as in the area of saphenous vein harvesting, was not pronounced in either of the groups. Blood loss and pain sensations did not differ significantly either. Stay in the intensive care unit (ICU) and the in-hospital mortality were also comparable. The duration of the entire operation and the time until removing the chest-tubes were prolonged in the study group. CONCLUSION: Despite promising results in other fields of surgery, APG shows no beneficial effect in high-risk patients undergoing cardiac surgery. Probably, it depends on different types of microcirculation in atherosclerotic patients, which are quite different from those of other surgical areas. This factor may offset the existing beneficial platelet effects which could be observed, for example, in maxillo-facial surgery.

Oxygenation failure after cardiac surgery: early re-intubation versus treatment by nasal continuous positive airway pressure (NCPAP) or non-invasive positive pressure ventilation (NPPV).

BACKGROUND: Due to an increasing incidence of respiratory failure after cardiac surgery we wanted to study whether nasal continuous positive airway pressure (NCPAP) may improve pulmonary oxygen transfer and may avoid reintubation after coronary operations. Additionally, we compared this protocol to non-invasive positive pressure ventilation (NPPV). METHODS: For a period of 2 years we analyzed all patients that were extubated within 12 hours after coronary surgery, and in whom oxygen transfer (PaO2/FIO2) deteriorated without hypercapnia so that all these patients met predefined criteria for reintubation: group A=immediate reintubation (n=88), group B=NCPAP-treatment (n=173), group C=NPPV (n=18). RESULTS: 25.4% of group B- and 22.2% of group C-patients were also intubated after a period of NCPAP or NPPV. All other patients of groups B and C could be weaned from these devices (B = 34.3 +/- 5.9 hours; C = 26.4 +/- 4.4 h; p < 0.05) and were well oxygenated by face mask at ambient pressure (Ratio PaO2/FIO2: B, 138 +/- 13; C, 140 +/- 13). In group A we found a higher mortality (7.95%) compared to group B (4.04%) and group C (5.55%). NCPAP-patients suffered more frequently from an impaired sternal wound healing (A = 4.5%, B = 8.6%; p < 0.05). CONCLUSIONS: We conclude that reintubation after cardiac operations should be avoided since NCPAP and NPPV are safe and effective to improve arterial oxygenation in most patients with non hypercapnic respiratory failure.

Is size-reducing ascending aortoplasty with external reinforcement an option in modern aortic surgery?

OBJECTIVE: Enlargement of the ascending aorta is often combined with valvular, coronary, or other cardiac diseases. Reduction aortoplasty can be an optional therapy; however, indications regarding the diameter of aorta, the history of dilatation (poststenosis, bicuspid aortic valve), or the intraoperative management (wall excision, reduction suture, external reinforcement) are not established. METHODS: In a retrospective study between 1997 and 2005, we investigated 531 patients operated for aneurysm or ectasia of the ascending aorta (diameter: 45-76mm). Of these, in 50 patients, size-reducing ascending aortoplasty was performed. External reinforcement with a non-coated dacron prosthesis was added in order to stabilize the aortic wall. RESULTS: Aortoplasty was associated with aortic valve replacement in 47 cases (35 mechanical vs 12 biological), subvalvular myectomy in 29 cases, and CABG in 13 cases. The procedure was performed with low hospital mortality (2%) and a low postoperative morbidity. Computertomographic and echocardiographic diameters were significantly smaller after reduction (55.8+/-9mm down to 40.51+/-6.2mm (CT), p<0.002; 54.1+/-6.7mm preoperatively down to 38.7+/-7.1mm (echocardiography), p<0.002), with stable performance in long-term follow-up (mean follow-up time: 70 months). CONCLUSIONS: As demonstrated in this study, size reduction of the ascending aorta using aortoplasty with external reinforcement is a safe procedure with excellent long-term results. It is a therapeutic option in modern aortic surgery in patients with poststenotic dilatation of the aorta without impairment of the sinotubular junction of the aortic valve and root.

Gene expression in acute Stanford type A dissection: a comparative microarray study.

BACKGROUND: We compared gene expression profiles in acutely dissected aorta with those in normal control aorta. MATERIALS AND METHODS: Ascending aorta specimen from patients with an acute Stanford A-dissection were taken during surgery and compared with those from normal ascending aorta from multiorgan donors using the BD Atlas Human1.2 Array I, BD Atlas Human Cardiovascular Array and the Affymetrix HG-U133A GeneChip. For analysis only genes with strong signals of more than 70 percent of the mean signal of all spots on the array were accepted as being expressed. Quantitative real-time polymerase chain reaction (RT-PCR) was used to confirm regulation of expression of a subset of 24 genes known to be involved in aortic structure and function. RESULTS: According to our definition expression profiling of aorta tissue specimens revealed an expression of 19.1% to 23.5% of the genes listed on the arrays. Of those 15.7% to 28.9% were differently expressed in dissected and control aorta specimens. Several genes that encode for extracellular matrix components such as collagen IV alpha2 and -alpha5, collagen VI alpha3, collagen XIV alpha1, collagen XVIII alpha1 and elastin were down-regulated in aortic dissection, whereas levels of matrix metalloproteinases-11, -14 and -19 were increased. Some genes coding for cell to cell adhesion, cell to matrix signaling (e.g., polycystin1 and -2), cytoskeleton, as well as several myofibrillar genes (e.g., alpha-actinin, tropomyosin, gelsolin) were found to be down-regulated. Not surprisingly, some genes associated with chronic inflammation such as interleukin -2, -6 and -8, were up-regulated in dissection. CONCLUSION: Our results demonstrate the complexity of the dissecting process on a molecular level. Genes coding for the integrity and strength of the aortic wall were down-regulated whereas components of inflammatory response were up-regulated. Altered patterns of gene expression indicate a pre-existing structural failure, which is probably a consequence of insufficient remodeling of the aortic wall resulting in further aortic dissection.

Prediction of atrial fibrillation after coronary artery bypass grafting: the role of chemoreflex-sensitivity and P wave signal averaged ECG.

Atrial fibrillation (AF) after coronary artery bypass grafting (CABG) results in a prolonged hospital stay associated with higher costs. In our study P wave triggered P wave signal averaged ECG and chemoreflex-sensitivity (CHRS) was performed on 101 consecutive patients with sinus rhythm before CABG in order to evaluate the utility of these methods to predict AF. A CHRS below 3.0 ms/mm Hg was predefined as a pathological CHRS. Postoperative AF was observed in 37 (37%) of 101 patients. Patients with AF were older (68.4+/-6.9 vs. 63.8+/-9.4 years, p<0.01), had a longer filtered P-wave duration (FPD) (133.6+/-10.2 vs. 123.6+/-14.9 ms, p<0.0001), a lower root mean square voltage of the last 20 ms of the P wave (RMS 20) (2.86+/-0.88 vs. 5.10+/-2.73 microV, p<0.0001) and a significantly lower CHRS (3.32+/-1.83 vs. 4.17+/-2.19 ms/mm Hg, p<0.05). A cut-off point (COP) of FPD> or =124 ms and RMS 20< or =3.7 microV achieved a specificity of 75%, a sensitivity of 78%, a negative predictive value of 86%, a positive predictive value of 64% and an accuracy of 76% for prediction of AF. The predictive power was lower for a pathological CHRS which achieved a specificity of 63%, a sensitivity of 60%, a negative predictive value of 73%, a positive predictive value of 48% and an accuracy of 61%. A stepwise logistic regression analysis of all preoperative variables identified COP (odds ratio 8.21; 95% CI, 2.02-33.37, p<0.003) as independent predictor. Patients with postoperative AF stayed longer in the intensive care unit (2.9+/-1.7 vs. 1.3+/-0.5 days, p<0.0001) and in hospital (13.5+/-4.3 vs. 11.4+/-1.1 days, p<0.0004). The results of our study show that the risk for AF after CABG could preoperatively be predicted with P wave signal averaged ECG and an analysis of CHRS. The predictive power of the COP could be used for a preoperative risk stratification and a corresponding prophylactic therapy in order to reduce costs.

Abdominal complications following open-heart surgery: a report of 12 cases and review of the literature.

INTRODUCTION: Abdominal complications following open-heart surgery remain serious events as the mortality is reported to be tremendously high. The clinical presentation, the diagnostic strategy and the therapeutic management varies. We reviewed all records of those patients who developed abdominal complications with surgical consequences during the last five years, recorded a complete follow-up and compared the findings to a current view of the literature. PATIENTS AND METHODS: Altogether 5720 patients underwent open-heart surgery at our institution between 1/98 and 12/02. Out of these 12 (10 men, 2 women) developed severe gastrointestinal complications with surgical consequences. The mean age was 73.17 +/- 8.1 I1 years. Seven patients underwent isolated coronary artery bypass grafting (CABG), two patients combined aortic valve replacement (AVR) and CABG, one isolated AVR, one mitral valve replacement (MVR) and yet another one combined MVR and CABG. The clinical records of all these patients were examined and a complete follow-up was recorded. RESULTS: The duration of the entire cardiac operation was a mean of 212.67 +/- 36.97 min, perfusion time 103 +/- 29.32 min and myocardial ischaemic time 52.25 +/- 24.56 min. Length of ICU-stay was between I and 5 days after cardiac surgery. Concerning gastrointestinal complications nine patients suffered from ischaemic intestinal disease, two from gastrointestinal ulcer bleeding and one from a preoperatively unknown bowel tumour with subsequent ileus. Four patients died in the immediate postoperative course, one patient within two years and seven patients show a satisfactory status at follow-up. CONCLUSIONS: A review from the literature shows an enormous mortality from abdominal complications following open-heart surgery. This was also found in our series. As many of these patients have a history of abdominal disease more attention should be paid to such anamnestic hints in the preparation before cardiac surgery. Hence we recommend early diagnostic measures and explorative laparotomy in doubtful situations in patients with positive anamnesis.

Percutaneous extracorporeal life support in patients with circulatory failure: results of the German Lifebridge Registry.

OBJECTIVES: Mortality rates remain high in patients with cardiogenic shock or acute refractory circulatory failure. Extracorporeal life support (ECLS) has been recently introduced into clinical practice for treatment of refractory hypotension in selected patients in combination with rapid restoration of gas exchange. The aim of this study was to evaluate the procedural performance and safety of the automated Lifebridge ECLS system (Zoll Lifebridge GmbH). METHODS: A total of five tertiary cardiovascular centers located in Germany contributed data to this registry (n = 54 patients). Data were collected using a standardized case report form to record clinical characteristics, demographic, procedural, and follow-up data. Patients were included if they were in circulatory crisis (caused by cardiogenic shock or ongoing resuscitation) in an acute setting or in an elective setting during high-risk percutaneous intervention. RESULTS: The Lifebridge device was successfully used in all patients. During elective use, no complications occurred besides 1 minor vascular injury. All elective patients were successfully weaned from the device and alive at the primary endpoint after 30 days. In the emergency setting, 85% of the patients were successfully weaned from the device and 49% of the patients were alive after 30 days. Relevant bleeding resulting in transfusion of red blood cells occurred in 5% of patients. CONCLUSION: In this observational study, we report data from the real-world use of a novel automated ECLS system. Elective use of Lifebridge was feasible and safe without major side effects. In the emergency setting, mortality rates were high; however, stabilization of the selected patients was safe and feasible.

Cardiopulmonary bypass: Evidence or experience based?

OBJECTIVE: Evidence-based medicine is emerging as a new paradigm for medical practice. The purpose of this study was to evaluate the amount and quality of scientific evidence supporting principles that are currently applied for cardiopulmonary bypass performance. METHODS: A survey of all German departments of cardiac surgery regarding cardiopulmonary bypass performance disclosed major differences. Consequently, for 48 major principles of cardiopulmonary bypass performance, relevant Medical Subject Headings were identified, and a literature search of the Medline database was performed. Two sequentially applied sets of inclusion-exclusion criteria were selected to assess the best available evidence. RESULTS: Thirty-three thousand articles relating to the subject were identified. Among these, 1500 fulfilled the first set of inclusion criteria: meta-analysis of (randomized) controlled clinical trials and in vitro and animal studies. Rigorous methodological criteria were then applied to further select remaining publications. Ultimately, 225 articles referring to major cardiopulmonary bypass principles were identified as providing the best available evidence. These were graded according to their methodological rigor (susceptibility to bias). The scientific evidence on the investigated cardiopulmonary bypass principles did not prove to be of a high enough level to allow general recommendations to be made. CONCLUSIONS: The scientific data concerning the effectiveness and safety of key principles of cardiopulmonary bypass are insufficient in both amount and quality of scientific evidence to serve as a basis for practical, evidence-based guidelines.