The IMPACT Score: A New Score to Predict the Risk of Early Mortality in Cardiogenic Shock Patients Treated With Venoarterial Extracorporeal Membrane Oxygenation.

OBJECTIVES: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) requires considerable human and financial resources. Few studies have focused on early mortality (ie, occurring within 72 hours after VA-ECMO implantation). The objective of this study was to establish a prognosis score-the IMPACT score (prediction of early mortality associated with VA-ECMO using preimplantation characteristics)-by determining the risk factors associated with early mortality. DESIGN: This was a retrospective and observational study. SETTING: The study was conducted at a University hospital. PARTICIPANTS: This single-center retrospective study included 147 patients treated with VA-ECMO for cardiogenic shock between 2014 and 2021. METHODS: The primary outcome was early mortality (ie, occurring within 72 hours after VA-ECMO implantation). Multivariate logistic regression was performed using a bootstrapping methodology to identify factors independently associated with early mortality. To construct the score, identified variables had points (pts) assigned corresponding to their odds ratio. RESULTS: A total of 147 patients were included in the study. Early mortality (<72 hours) was 26% (38 patients). Four variables were established: cardiac arrest (2 pts), lactate levels (3 pts), platelet count <100 g/L (4 pts), and renal-replacement therapy (5 pts). The IMPACT score had an area under the receiver operating characteristic curve of 0.78 (95% CI 0.86-0.70) to predict early mortality. CONCLUSIONS: In the authors' experience, 26% of patients treated with VA-ECMO presented early mortality. The IMPACT score is a reliable predictor of early mortality and may assist with VA-ECMO initiation decision-making.

Red Blood Cell Transfusion Requirements Before and After Implementation of a Perioperative Patient Blood Management Program in Adult Patients Undergoing Cardiac Surgery. A Before and After Observational Study.

OBJECTIVES: Anemia and transfusion are common in cardiac surgery patients, and are associated with significant morbidity and mortality. Multiple perioperative interventions have been described to reduce blood transfusion, but are rarely combined altogether. The aim of this study was to compare the incidence of red blood cell (RBC) transfusion in adult patients undergoing cardiac surgery before and after the implementation of a perioperative patient blood management (PBM) program. DESIGN: Before-and-after observational study. SETTING: Single-center French university teaching hospital. PARTICIPANTS: Adult patients scheduled for cardiac surgery. INTERVENTIONS: Perioperative patient blood management program including pre-, intra-, and postoperative interventions aimed at identifying and correcting anemia, minimizing blood loss during surgery, and optimizing coagulation. MEASUREMENTS AND MAIN RESULTS: Four hundred thirty-four patients were included in the study from January 2021 to July 2022. The incidence of perioperative RBC transfusion (intraoperatively and during the first 2 postoperative days) was significantly reduced from 43% (90/213) in the pre-PBM period to 27% (60/221) in the post-PBM period (p < 0.001). The application of a PBM program was associated with a reduction in perioperative RBC transfusion by multivariate analysis (odds ratio 0.55, 95% CI 0.36-0.85, p = 0.007), and was associated with a reduction in the median number of RBC units transfused within transfused patients (p = 0.025). These effects persisted at day 30 after surgery (p = 0.029). CONCLUSION: A perioperative PBM program in adult patients undergoing cardiac surgery was associated with a significant reduction in perioperative RBC transfusion, which persisted at day 30.

Multiple trauma in pregnant women: injury assessment, fetal radiation exposure and mortality. A multicentre observational study.

BACKGROUND: Fetal radiation exposure in pregnant women with trauma is a concern. The purpose of this study was to evaluate fetal radiation exposure with regard to the type of injury assessment performed. METHODS: It is a multicentre observational study. The cohort study included all pregnant women suspected of severe traumatic injury in the participating centres of a national trauma research network. The primary outcome was the cumulative radiation dose (mGy) received by the fetus with respect to the type of injury assessment initiated by the physician in charge of the pregnant patient. Secondary outcomes were maternal and fetal morbi-mortality, the incidence of haemorrhagic shock and the physicians' imaging assessment with consideration of their medical specialty. RESULTS: Fifty-four pregnant women were admitted for potential major trauma between September 2011 and December 2019 in the 21 participating centres. The median gestational age was 22 weeks [12-30]. 78% of women (n = 42) underwent WBCT. The remaining patients underwent radiographs, ultrasound or selective CT scans based on clinical examination. The median fetal radiation doses were 38 mGy [23-63] and 0 mGy [0-1]. Maternal mortality (6%) was lower than fetal mortality (17%). Two women (out of 3 maternal deaths) and 7 fetuses (out of 9 fetal deaths) died within the first 24 h following trauma. CONCLUSIONS: Immediate WBCT for initial injury assessment in pregnant women with trauma was associated with a fetal radiation dose below the 100 mGy threshold. Among the selected population with either a stable status with a moderate and nonthreatening injury pattern or isolated penetrating trauma, a selective strategy seemed safe in experienced centres.

Blunt Traumatic Aortic Injury Management, a French TraumaBase Analytic Cohort.

OBJECTIVE: Blunt traumatic aortic injury (BTAI) in severe trauma patients is rare but potentially lethal. The aim of this work was to perform a current epidemiological analysis of the clinical and surgical management of these patients in a European country. METHODS: This was a multicentre, retrospective study using prospectively collected data from the French National Trauma Registry and the National Uniform Hospital Discharge Database from 10 trauma centres in France. The primary endpoint was the prevalence of BTAI. The secondary endpoints focused chronologically on injury characteristics, management, and patient outcomes. RESULTS: 209 patients were included with a mean age of 43 ± 19 years and 168 (80%) were men. The calculated prevalence of BTAI at hospital admission was 1% (162/15 094) (BTAI admissions/all trauma). The time to diagnosis increased with the severity of aortic injury and the clinical severity of the patients (grade 1: 94 [74, 143] minutes to grade 4: 154 [112, 202] minutes, p = .020). This delay seemed to be associated with the intensity of the required resuscitation. Sixty seven patients (32%) received no surgical treatment. Among those treated, 130 (92%) received endovascular treatment, 14 (10%) open surgery (two were combined), and 123 (85%) were treated within the first 24 hours. Overall mortality was 20% and the attributed cause of death was haemorrhagic shock (69%). Mortality was increased according to aortic injury severity, from 6% for grade 1 to 65% for grade 4 (p < .001). Twenty-six (18.3%) patients treated by endovascular aortic repair had complications. CONCLUSION: BTAI prevalence at hospital admission was low but occurred in severe high velocity trauma patients and in those with a high clinical suspicion of severe haemorrhage. The association of shock with high grade aortic injury and increasing time to diagnosis suggests a need to optimise early resuscitation to minimise the time to treatment. Endovascular treatment has been established as the reference treatment, accounting for more than 90% of interventional treatment options for BTAI.

Clinical decision support for severe trauma patients: Machine learning based definition of a bundle of care for hemorrhagic shock and traumatic brain injury.

BACKGROUND: Deviation from guidelines is frequent in emergency situations, and this may lead to increased mortality. Probably because of time constraints, 55% is the greatest reported guidelines compliance rate in severe trauma patients. This study aimed to identify among all available recommendations a reasonable bundle of items that should be followed to optimize the outcome of hemorrhagic shocks (HSs) and severe traumatic brain injuries (TBIs). METHODS: We first estimated the compliance with French and European guidelines using the data from the French TraumaBase registry. Then, we used a machine learning procedure to reduce the number of recommendations into a minimal set of items to be followed to minimize 7-day mortality. We evaluated the bundles using an external validation cohort. RESULTS: This study included 5,924 trauma patients (1,414 HS and 4,955 TBI) between 2011 and August 2019 and studied compliance to 36 recommendation items. Overall compliance rate to recommendation items was 71.6% and 66.9% for HS and TBI, respectively. In HS, compliance was significantly associated with 7-day decreased mortality in univariate analysis but not in multivariate analysis (risk ratio [RR], 0.91; 95% confidence interval [CI], 0.90-1.17; p = 0.06). In TBI, compliance was significantly associated with decreased mortality in univariate and multivariate analysis (RR, 0.85; 95% CI, 0.75-0.92; p = 0.01). For HS, the bundle included 13 recommendation items. In the validation cohort, when this bundle was applied, patients were found to have a lower 7-day mortality rate (RR, 0.46; 95% CI, 0.27-0.63; p = 0.01). In TBI, the bundle included seven items. In the validation cohort, when this bundle was applied, patients had a lower 7-day mortality rate (RR, 0.55; 95% CI, 0.34-0.71; p = 0.02). DISCUSSION: Using a machine-learning procedure, we were able to identify a subset of recommendations that minimizes 7-day mortality following traumatic HS and TBI. These two bundles remain to be evaluated in a prospective manner. LEVEL OF EVIDENCE: Care Management, level II.

Gunshot and stab wounds in France: descriptive study from a national trauma registry.

PURPOSE: Severe trauma is a major problem worldwide. In France, blunt trauma (BT) is predominant and few studies are available on penetrating trauma (PT). The purpose of this study was to perform a descriptive analysis of severe gunshot (GSW) and stab wounds (SW) in patients who were treated in French trauma centers. METHODS: Retrospective study on prospectively collected data in a national trauma registry. All adult (> 15 years) trauma patients primarily admitted in 1 of the 17 trauma centers members of the Traumabase between January 2015 to December 2018 were included. Data from patients who had a PT were compared with those who had suffered a BT over the same period. Due to the known differences between GSW and SW, sub-group analyses on data from GSW, SW and BT were also performed. RESULTS: 8128 patients were included. Twelve percent of the study group had a PT. The main mechanism of PT was SW (68.1%). Five hundred and eighty patients with PT (59.4%) required surgery within the first 24 h. Severe hemorrhage was more frequent in penetrating traumas (11.2% vs. 7.8% p < 0.001). Hospital mortality following PT was 8.9% vs 11% for blunt trauma (p = 0.047). Among PT the mortality after GSW was ten times higher than after SW (23.8% vs 2%). CONCLUSION: This work is the largest study to date that has specifically focused on GSW and SW in France, and will help improving knowledge in managing such patients in our country.

Automated weaning from mechanical ventilation: Results of a Bayesian network meta-analysis.

PURPOSE: Mechanical ventilation (MV) weaning is a crucial step. Automated weaning modes reduce MV duration but the question of the best automated mode remains unanswered. Our objective was to compare the major automated modes for MV weaning in critically ill and post-operative adult patients. MATERIAL AND METHODS: We conducted a network Bayesian meta-analysis to compare different automated modes. We searched MEDLINE, EMBASE and Cochrane central registry for randomized control trials comparing automated weaning modes either to another automated mode or to standard-of-care. The primary outcome was the duration of MV weaning extracted from the original trials. RESULTS: 663 articles were screened and 26 trials (2097patients) were included in the final analysis. All automated modes included in the study (ASV°, Intellivent ASV, Smartcare, Automode°, PAV° and MRV°) outperformed standard-of-care but no automated mode reduced the duration of mechanical ventilation weaning as compared to others in the network meta-analysis. CONCLUSION: Compared to standard weaning practice, all automated modes significantly reduced the duration of MV weaning in critically ill and post-operative adult patients. When cross-compared using a network meta-analysis, no specific mode was different in reducing the duration of MV weaning. The study was registered in PROSPERO (CRD42015024742).

Noninvasive continuous monitoring versus intermittent oscillometric measurements for the detection of hypotension during digestive endoscopy.

BACKGROUND: Hemodynamic monitoring during digestive endoscopy is usually minimal and involves intermittent brachial pressure measurements. New continuous noninvasive devices to acquire instantaneous arterial blood pressure may be more sensitive to detect procedural hypotension. PURPOSE: To compare the ability of noninvasive continuous monitoring with that of intermittent oscillometric measurements to detect hypotension during digestive endoscopy. METHODS: In this observational prospective study, patients scheduled for gastrointestinal endoscopy and colonoscopy under sedation were monitored using intermittent pressure measurements and a noninvasive continuous technique (ClearSight™, Edwards). Stroke volume was estimated from the arterial pressure waveform. Mean arterial pressure and stroke volume values were recorded at T1 (prior to anesthetic induction), T2 (after anesthetic induction), T3 (gastric insufflation), T4 (end of gastroscopy), T5 (colonic insufflation). Hypotension was defined as mean arterial pressure < 65 mmHg. RESULTS: Twenty patients (53±17 years) were included. Six patients (30%) had a hypotension detected using intermittent pressure measurements versus twelve patients (60%) using noninvasive continuous monitoring (p = 0.06). Mean arterial pressure decreased during the procedure with respect to T1 (p < 0.05), but the continuous method provided an earlier warning than the intermittent method (T3 vs T4). Nine patients (45%) had at least a 25% reduction in stroke volume, with respect to baseline. CONCLUSION: Noninvasive continuous monitoring was more sensitive than intermittent measurements to detect hypotension. Estimation of stroke volume revealed profound reductions in systemic flow. Noninvasive continuous monitoring in high-risk patients undergoing digestive endoscopy under sedation could help in detecting hypoperfusion earlier than the usual intermittent blood pressure measurements.

Accuracy of a multiparametric score based on pulse wave analysis for prediction of fluid responsiveness: ancillary analysis of an observational study.

PURPOSE: The pressure recording analytical method (PRAM) monitor is a non-invasive pulse contour cardiac output (CO) device that cannot be considered interchangeable with the gold standard for CO estimation. It, however, generates additional hemodynamic indices that need to be evaluated. Our objective was to investigate the performance of a multiparametric predictive score based on a combination of several parameters generated by the PRAM monitor to predict fluid responsiveness. METHODS: Secondary analysis of a prospective observational study from April 2016 to December 2017 in two French teaching hospitals. We included critically ill patients who were monitored by esophageal Doppler monitoring and an invasive arterial line, and received a 250-500 mL crystalloid fluid challenge. The main outcome measure was the predictive score discrimination evaluated by the area under the receiver operating characteristics curve. RESULTS: The three baseline PRAM-derived parameters associated with fluid responsiveness in univariate analysis were pulse pressure variation, cardiac cycle efficiency, and arterial elastance (P < 0.01, P = 0.03, and P < 0.01, respectively). The median [interquartile range] predictive score, calculated after discretization of these parameters according to their optimal threshold value was 3 [2-3] in fluid responders and 1 [1-2] in fluid non-responders, respectively (P < 0.001). The area under the curve of the predictive score was 0.807 (95% confidence interval, 0.662 to 0.909; P < 0.001). CONCLUSION: A multiparametric score combining three parameters generated by the PRAM monitor can predict fluid responsiveness with good positive and negative predictive values in intensive care unit patients.

RéSUMé: OBJECTIF: Le moniteur PRAM (pressure recording analytical method) est un dispositif non invasif de surveillance du débit cardiaque (DC) fondé sur la mesure de contour de l'onde de pouls qui ne peut être considéré comme interchangeable avec la référence de l'estimation du DC. Cependant, ce dispositif génère des indices hémodynamiques supplémentaires qui doivent être évalués. Notre objectif était d'examiner la performance d'un score prédictif multiparamétrique fondé sur une combinaison de plusieurs paramètres générés par le moniteur PRAM afin de prédire la réponse au remplissage volémique. MéTHODE: Analyse secondaire d'une étude observationnelle prospective entre avril 2016 et décembre 2017 dans deux hôpitaux universitaires français. Nous avons inclus des patients en état critique monitorés par un Doppler oesophagien et une ligne artérielle invasive, et ayant reçu un bolus de cristalloïdes de 250­500 mL. Le critère d'évaluation principal était la discrimination du score prédictif telle qu'évaluée par la surface sous la courbe de fonction d'efficacité de l'observateur (ROC). RéSULTATS: Les trois paramètres de base dérivés du PRAM associés à la réponse au remplissage dans l'analyse univariée étaient la variation de pression différentielle, l'efficacité du cycle cardiaque, et l'élastance artérielle (P < 0,01, P = 0,03, et P < 0,01, respectivement). Le score prédictif médian [écart interquartile], calculé après discrétisation de ces paramètres selon leur valeur seuil optimale, était de 3 [2­3] chez les répondeurs au remplissage et de 1 [1­2] chez les non-répondeurs, respectivement (P < 0,001). La surface sous la courbe du score prédictif était de 0,807 (intervalle de confiance 95 %, 0,662 à 0,909; P < 0,001). CONCLUSION: Un score multiparamétrique combinant trois paramètres générés par le moniteur PRAM peut prédire la réponse au remplissage volémique avec de bonnes valeurs prédictives positives et négatives chez les patients à l'unité de soins intensifs.

Association of Early, High Plasma-to-Red Blood Cell Transfusion Ratio With Mortality in Adults With Severe Bleeding After Trauma.

Importance: Optimal transfusion management is crucial when treating patients with trauma. However, the association of an early, high transfusion ratio of fresh frozen plasma (FFP) to packed red blood cells (PRBC) with survival remains uncertain. Objective: To study the association of an early, high FFP-to-PRBC ratio with all-cause 30-day mortality in patients with severe bleeding after trauma. Design, Setting, and Participants: This cohort study analyzes the data included in a multicenter national French trauma registry, Traumabase, from January 2012 to July 2017. Traumabase is a prospective, active, multicenter adult trauma registry that includes all consecutive patients with trauma treated at 15 trauma centers in France. Overall, 897 patients with severe bleeding after trauma were identified using the following criteria: (1) received 4 or more units of PRBC during the first 6 hours or (2) died from hemorrhagic shock before receiving 4 units of PRBC. Exposures: Eligible patients were divided into a high-ratio group, defined as an FFP-to-PRBC ratio more than 1:1.5, and a low-ratio group, defined as an FFP-to-PRBC ratio of 1:1.5 or less. The ratio was calculated using the cumulative units of FFP and PRBC received during the first 6 hours of management. Main Outcomes and Measures: A Cox regression model was used to analyze 30-day survival with the transfusion ratio as a time-dependent variable to account for survivorship bias. Results: Of the 12 217 patients included in the registry, 897 (7.3%) were analyzed (median [interquartile range] age, 38 (29-54) years; 639 [71.2%] men). The median (interquartile range) injury severity score was 34 (22-48), and the overall 30-day mortality rate was 33.6% (301 patients). A total of 506 patients (56.4%) underwent transfusion with a high ratio and 391 (43.6%) with a low ratio. A high transfusion ratio was associated with a significant reduction in 30-day mortality (hazard ratio, 0.74; 95% CI, 0.58-0.94; P = .01). When only analyzing patients who had complete data, a high transfusion ratio continued to be associated with a reduction in 30-day mortality (hazard ratio, 0.57; 95% CI, 0.33-0.97; P = .04). Conclusions and Relevance: In this analysis of the Traumabase registry, an early FFP-to-PRBC ratio of more than 1:1.5 was associated with increased 30-day survival among patients with severe bleeding after trauma. This result supports the use of early, high FFP-to-PRBC transfusion ratios in patients with severe trauma.

Intraoperative management of brain-dead organ donors by anesthesiologists during an organ procurement procedure: results from a French survey.

BACKGROUND: This study aimed at describing usual anesthetic practices for brain-dead donors (BDD) during an organ procurement (OP) procedure and to assess the knowledge and self-confidence of French anesthesiologists with this practice. METHODS: An electronic and anonymous survey with closed-questions about anesthetic management of BDD was distributed to French anesthesiologists via the mailing list of the French Society of Anesthesiology and Intensive Care Medicine. RESULTS: Four hundred fifty-eight responses were analyzed. Respondents were mainly attending physicians with more than 10 years of clinical experience. 78% of them declared being cognizant of guidelines regarding management of BDD. Advanced hemodynamic monitoring and endocrine substitution were rarely considered by respondents (31 and 35% of respondents, respectively). 98% of the respondents used crystalloids for fluid resuscitation. During the procedure, use of neuromuscular blockers, opioids and sedative agents were considered by respectively 84, 61 and 27% of the respondents. A very high level of agreement (10 [8-10], on a ten-points Likert-style scale) was reported concerning the expected impact of intraoperative anesthetic management on the primary function of grafts. CONCLUSIONS: Declared anesthetic practice appeared in accordance with guidelines concerning organ donor management in the ICU. Further studies are needed to evaluate the specific impact of intraoperative management during this procedure and thus the need for specific anesthetic guidelines.

Monitoring haemodynamic response to fluid-challenge in ICU: comparison of pressure recording analytical method and oesophageal Doppler: A prospective observational study.

BACKGROUND: The ability of the pressure recording analytical method (PRAM) in tracking change in cardiac output (ΔCO) after a fluid challenge in ICU needs to be evaluated with the most contemporary comparison methods recommended by experts. OBJECTIVE: Our objective was to report the trending ability of PRAM in tracking ΔCO after a fluid challenge in ICU and to compare this with oesophageal Doppler monitoring (ODM). DESIGN: Prospective, observational study. SETTING: Hôpital Lariboisière and Hôpital Européen George Pompidou, Paris, France, from April 2016 to December 2017. PATIENTS: Critically ill patients admitted to ICU with monitoring of CO monitored by ODM and invasive arterial pressure. INTERVENTION: ΔCO after fluid challenge was simultaneously registered with ODM and PRAM connected to the arterial line. MAIN OUTCOME MEASURE: Polar statistics (mean angular bias, radial limits of agreement and polar concordance rate) and clinical concordance evaluation (error grid and clinical concordance rate). Predictors of bias were determined. RESULTS: Sixty-eight fluid challenge were administered in 49 patients. At the time of fluid challenge, almost all were mechanically ventilated (99%), with 85% receiving norepinephrine. Admission diagnosis was septic shock in 70% of patients. Patients had a Sequential Organ Failure Assessment score of 10 [7 to 12] and a median Simplified Acute Physiology Score II of 61 [49 to 69]. Relative ΔCO bias was 7.8° (6.3°) with radial limits of agreement of ±41.7°, polar concordance rate 80% and clinical concordance rate 74%. ΔCO bias was associated with baseline bias (P = 0.007). Baseline bias was associated with radial location of the arterial line (P = 0.03). CONCLUSION: When compared with ODM, PRAM has insufficient performance to track ΔCO induced by fluid challenge in ICU patients. Baseline bias is an independent predictor of trending bias. TRIAL REGISTRATION: IRB 00010254-2016-033.

Effectiveness of a High-Fidelity Simulation-Based Training Program in Managing Cardiac Arrhythmias in Children: A Randomized Pilot Study.

OBJECTIVES: Pediatric cardiac arrest is a rare event. Its management requires technical (TSs) and nontechnical skills (NTSs). We assessed the effectiveness of a simulation-based training to improve these skills in managing life-threatening pediatric cardiac arrhythmias. METHODS: Four teams, each composed of 1 pediatric resident, 1 emergency medicine resident, and 2 pediatric nurses, were randomly assigned to the experimental group (EG) participating in 5 video-recorded simulation sessions with debriefing or to the control group (CG) assessed 2 times with video-recorded simulation sessions without debriefing at a 2-week interval. Questionnaires assessed self-reported changes in self-efficacy, stress, and satisfaction about skills. Blinded evaluators assessed changes in leaders' TSs and NTSs during the simulations and the time to initiate cardiopulmonary resuscitation. RESULTS: After training, stress decreased and satisfaction about skills increased in the EG, whereas it remained the same in the CG (P = 0.014 and P < 0.001, respectively). There was no significant change in self-efficacy. Analyses of video-recorded skills showed significant improvements in TSs and NTSs of the EG leaders after training, but not of the CG leaders (P = 0.026, P = 0.038, respectively). The comparison of the evolution of the 2 groups concerning time to initiate cardiopulmonary resuscitation was not significantly different between the first and last simulation sessions. CONCLUSIONS: A simulation-based training with debriefing had positive effects on stress and satisfaction about skills of pediatric residents and nurses and on observed TSs and NTSs of the leaders during simulation sessions. A future study should assess the effectiveness of this training in a larger sample and its impact on skills during actual emergencies.

Outcomes after extracorporeal membrane oxygenation for the treatment of high-risk pulmonary embolism: a multicentre series of 52 cases.

Aims: The role of extracorporeal membrane oxygenation (ECMO) remains ill defined in pulmonary embolism (PE). We investigated outcomes in patients with high-risk PE undergoing ECMO according to initial therapeutic strategy. Methods and results: From 01 January 2014 to 31 December 2015, 180 patients from 13 Departments in nine centres with high-risk PE were retrospectively included. Among those undergoing ECMO, we compared characteristics and outcomes according to adjunctive treatment strategy (systemic thrombolysis, surgical embolectomy, or no reperfusion therapy). Primary outcome was all-cause 30-day mortality. Secondary outcome was 90-day major bleeding. One hundred and twenty-eight patients were treated without ECMO; 52 (mean age 47.6 years) underwent ECMO. Overall 30-day mortality was 48.3% [95% confidence interval (CI) 41-56] (87/180); 43% (95% CI 34-52) (55/128) in those treated without ECMO vs. 61.5% (95% CI 52-78) (32/52) in those with ECMO (P = 0.008). In patients undergoing ECMO, 30-day mortality was 76.5% (95% CI 57-97) (13/17) for ECMO + fibrinolysis, 29.4% (95% CI 51-89) (5/17) for ECMO + surgical embolectomy, and 77.7% (95% CI 59-97) (14/18) for ECMO alone (P = 0.004). Among patients with ECMO, 20 (38.5%, 95% CI 25-52) had a major bleeding event in-hospital; without significant difference across groups. Conclusion: In patients with high-risk PE, those with ECMO have a more severe presentation and worse prognosis. Extracorporeal membrane oxygenation in patients with failed fibrinolysis and in those with no reperfusion seems to be associated with particularly unfavourable prognosis compared with ECMO performed in addition to surgical embolectomy. Our findings suggest that ECMO does not appear justified as a stand-alone treatment strategy in PE patients, but shows promise as a complement to surgical embolectomy.

The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE).

BACKGROUND: During high-risk abdominal surgery the use of a multi-faceted lung protective ventilation strategy composed of low tidal volumes, positive end-expiratory pressure (PEEP) and recruitment manoeuvres, has been shown to improve clinical outcomes. It has been speculated, however, that mechanical ventilation using PEEP might increase intraoperative bleeding during liver resection. OBJECTIVE: To study the impact of mechanical ventilation with PEEP on bleeding during hepatectomy. DESIGN: Post-hoc analysis of a randomised controlled trial. SETTING: Seven French university teaching hospitals from January 2011 to August 2012. PARTICIPANTS: Patients scheduled for liver resection surgery. INTERVENTION: In the Intraoperative Protective Ventilation trial, patients scheduled for major abdominal surgery were randomly assigned to mechanical ventilation using low tidal volume, PEEP between 6 and 8  cmH2O and recruitment manoeuvres (lung protective ventilation strategy) or higher tidal volume, zero PEEP and no recruitment manoeuvres (non-protective ventilation strategy). MAIN OUTCOME AND MEASURE: The primary endpoint was intraoperative blood loss volume. RESULTS: A total of 79 (19.8%) patients underwent liver resections (41 in the lung protective and 38 in the non-protective group). The median (interquartile range) amount of intraoperative blood loss was 500 (200 to 800)  ml and 275 (125 to 800)  ml in the non-protective and lung protective ventilation groups, respectively (P = 0.47). Fourteen (35.0%) and eight (21.5%) patients were transfused in the non-protective and lung protective groups, respectively (P = 0.17), without a statistically significant difference in the median (interquartile range) number of red blood cells units transfused [2.5 (2 to 4) units and 3 (2 to 6) units in the two groups, respectively; P = 0.54]. CONCLUSION: During hepatic surgery, mechanical ventilation using PEEP within a multi-faceted lung protective strategy was not associated with increased bleeding compared with non-protective ventilation using zero PEEP. TRIAL REGISTRATION: The current study was not registered. The original Intraoperative Protective Ventilation study was registered on clinicaltrials.gov; number NCT01282996.

Determinants of Transcutaneous Ear Lobe CO2 Tension (PtCO2) at 37°C During On-Pump Cardiac Surgery.

OBJECTIVE: There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients undergoing cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB. DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital. PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: A total of 41 patients were included (520 observations). There was a statistically significant association between PaCO2 and PtCO2 (beta = 0.493 [0.154-0.832], p = 0.043), mostly when PaCO2 was outside the normal range. When PaCO2 was normal, PtCO2 was inversely correlated with mean arterial pressure (after adjustment for PaCO2 and body temperature: Beta -0.245, SE = 0.037, p<0.001) but not with CPB flow rate (p = 0.11). CONCLUSION: The factors that influence PtCO2 during CPB cardiac surgery are PaCO2, body temperature, and mean arterial pressure. When PaCO2 is normal, a PtCO2 elevation might be explained by insufficient mean arterial pressure. Whether low PtCO2 values during CPB should trigger the administration of vasoconstrictors remains to be evaluated.

Animal studies with the Carmat bioprosthetic total artificial heart.

OBJECTIVES: The Carmat bioprosthetic total artificial heart (TAH) contains bioprosthetic blood-contacting surfaces, and is designed for orthotopic cardiac replacement. In preparation for clinical studies, we evaluated the TAH performance and its effects on end-organ function in an animal model. METHODS: Twelve female Charolais calves, 2-3 months of age and weighing 102-122 kg, were implanted with the TAH through a mid-sternotomy to ensure an adequate anatomic fit. The intended support duration was 4-10 days. Haematological values, creatinine, bilirubin and lactate levels were measured and mean arterial and central venous pressure, central venous oxygen saturation and TAH parameters were monitored. RESULTS: The calves were placed in a cage immediately postoperatively, and extubated on postoperative day 1 in most cases. Average support duration was 3 days, with 4 of 12 calves supported for 4, 4, 8 and 10 days. The initial procedures were used to refine surgical techniques and postoperative care. Pump output ranged from 7.3 to 10 l/min. Haemodynamic parameters and blood analysis were within acceptable ranges. No device failures occurred. No anticoagulation was used in the postoperative phase. The calves were euthanized in case of discomfort compromising the animal well-being, such as respiratory dysfunction, severe blood loss and cerebral dysfunction. Device explant analysis showed no thrombus formation inside the blood cavities. Histological examination of kidneys showed isolated micro-infarction in 2/12 animals; brain histology revealed no thromboembolic depositions. CONCLUSION: The Carmat bioprosthetic TAH implanted in calves up to 10 days provided adequate blood flow to organs and tissues. Low levels of haemolysis and no visible evidence of thromboembolic depositions in major organs and device cavities, without the use of anticoagulation, may indicate early-phase haemocompatibility of the TAH.

A trial of intraoperative low-tidal-volume ventilation in abdominal surgery.

BACKGROUND: Lung-protective ventilation with the use of low tidal volumes and positive end-expiratory pressure is considered best practice in the care of many critically ill patients. However, its role in anesthetized patients undergoing major surgery is not known. METHODS: In this multicenter, double-blind, parallel-group trial, we randomly assigned 400 adults at intermediate to high risk of pulmonary complications after major abdominal surgery to either nonprotective mechanical ventilation or a strategy of lung-protective ventilation. The primary outcome was a composite of major pulmonary and extrapulmonary complications occurring within the first 7 days after surgery. RESULTS: The two intervention groups had similar characteristics at baseline. In the intention-to-treat analysis, the primary outcome occurred in 21 of 200 patients (10.5%) assigned to lung-protective ventilation, as compared with 55 of 200 (27.5%) assigned to nonprotective ventilation (relative risk, 0.40; 95% confidence interval [CI], 0.24 to 0.68; P=0.001). Over the 7-day postoperative period, 10 patients (5.0%) assigned to lung-protective ventilation required noninvasive ventilation or intubation for acute respiratory failure, as compared with 34 (17.0%) assigned to nonprotective ventilation (relative risk, 0.29; 95% CI, 0.14 to 0.61; P=0.001). The length of the hospital stay was shorter among patients receiving lung-protective ventilation than among those receiving nonprotective ventilation (mean difference, -2.45 days; 95% CI, -4.17 to -0.72; P=0.006). CONCLUSIONS: As compared with a practice of nonprotective mechanical ventilation, the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization. (IMPROVE ClinicalTrials.gov number, NCT01282996.).