Early extubation in extracorporeal life support patients: A propensity score-matched study.

BACKGROUND: Extubation strategy in extracorporeal life support patients remains unclear, and literature only reports studies with significant biases. OBJECTIVES: To explore the prognostic impact of an early ventilator-weaning strategy in assisted patients after controlling for confounding factors. METHODS: A 10-year retrospective study included 241 patients receiving extracorporeal life support for at least 48 h, corresponding to a total of 977 days spent on assistance. The a priori probability of extubation for each day of assistance was calculated according to daily biological examinations, drug doses, clinical observations, and admission data to pair each day containing an extubation with one on which the patient was not extubated. The primary outcome was survival at day 28. The secondary outcomes were survival at day 7, respiratory infections, and safety criteria. RESULTS: Two similar cohorts of 61 patients were generated. Survival at day 28 was better in patients extubated under assistance in univariate and multivariate (HR = 0.37 [0.2-0.68], p-value = 0.002) analyses. Patients who underwent failed early extubation did not have a different prognosis from those without early extubation. Successful early extubation was associated with a better outcome than a failed or no attempt at early extubation. Survival at day 7 and the rate of respiratory infections were better in early-extubated patients. Safety data did not differ between the two groups. CONCLUSIONS: Early extubation during assistance was associated with a superior outcome in our propensity-matched cohort study. The safety data were reassuring. However, due to the lack of prospective randomized studies, the causality remains uncertain.

A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory.

PURPOSE: The efficacy of noninvasive ventilation (NIV) during procedures that require sedation and analgesia has not been established. We evaluated whether NIV reduces the incidence of respiratory events. METHODS: In this randomized controlled trial, we included 195 patients with an American Society of Anesthesiologists Physical Status of III or IV during electrophysiology laboratory procedures. We compared NIV with face mask oxygen therapy for patients under sedation. The primary outcome was the incidence of respiratory events determined by a computer-driven blinded analysis and defined by hypoxemia (peripheral oxygen saturation < 90%) or apnea/hypopnea (absence of breathing for 20 sec on capnography). Secondary outcomes included hemodynamic variables, sedation, patient safety (composite scores of major or minor adverse events), and adverse outcomes at day 7. RESULTS: A respiratory event occurred in 89/98 (95%) patients in the NIV group and in 69/97 (73%) patients with face masks (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.13 to 1.47; P < 0.001). Hypoxemia occurred in 40 (42%) patients in the NIV group and in 33 (34%) patients with face masks (RR, 1.21; 95% CI, 0.84 to 1.74; P = 0.30). Apnea/hypopnea occurred in 83 patients (92%) in the NIV group vs 65 patients (70%) with face masks (RR, 1.32; 95% CI, 1.14 to 1.53; P < 0.001). Hemodynamic variables, sedation, major or minor safety events, and patient outcomes were not different between the groups. CONCLUSIONS: Respiratory events were more frequent among patients receiving NIV without any safety or outcome impairment. These results do not support the routine use of NIV intraoperatively. STUDY REGISTRATION: ClinicalTrials.gov (NCT02779998); registered 4 November 2015.

RéSUMé: OBJECTIF: L'efficacité de la ventilation non invasive (VNI) pendant les interventions nécessitant une sédation et une analgésie n'a pas été établie. Nous avons évalué si la VNI réduisait l'incidence des complications respiratoires. MéTHODE: Dans cette étude randomisée contrôlée, nous avons inclus 195 patient·es de statut physique III ou IV selon l'American Society of Anesthesiologists pendant des interventions en laboratoire d'électrophysiologie. Nous avons comparé la VNI à l'oxygénothérapie par masque facial pour les patient·es sous sédation. Le critère d'évaluation principal était l'incidence des complications respiratoires déterminée par une analyse en aveugle assistée par ordinateur et définie par une hypoxémie (saturation périphérique en oxygène < 90 %) ou une apnée/hypopnée (absence de respiration pendant 20 secondes à la capnographie). Les critères d'évaluation secondaires comprenaient les variables hémodynamiques, la sédation, la sécurité des patient·es (scores composites des événements indésirables majeurs ou mineurs) et les issues indésirables au jour 7. RéSULTATS: Un événement respiratoire est survenu chez 89/98 (95 %) patient·es du groupe VNI et chez 69/97 (73 %) patient·es ayant un masque facial (risque relatif [RR], 1,29; intervalle de confiance [IC] à 95 %, 1,13 à 1,47; P < 0,001). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21 ; IC à 95 %, 0,84 à 1,74; P = 0,30). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21; IC 95 %, 0,84 à 1,74; P = 0,30). Les variables hémodynamiques, la sédation, les événements de sécurité majeurs ou mineurs et les issues pour les patient·es n'étaient pas différents entre les groupes. CONCLUSION: Les complications respiratoires étaient plus fréquentes chez les patient·es recevant une VNI sans aucun impact sur la sécurité ou les issues. Ces résultats n'appuient pas l'utilisation systématique de la VNI en peropératoire. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT02779998); enregistrée le 4 novembre 2015.

A Multimodal Cardioprotection Strategy During Cardiac Surgery: The ProCCard Study.

OBJECTIVE: The ProCCard study tested whether combining several cardioprotective interventions would reduce the myocardial and other biological and clinical damage in patients undergoing cardiac surgery. DESIGN: Prospective, randomized, controlled trial. SETTING: Multicenter tertiary care hospitals. PARTICIPANTS: 210 patients scheduled to undergo aortic valve surgery. INTERVENTIONS: A control group (standard of care) was compared to a treated group combining five perioperative cardioprotective techniques: anesthesia with sevoflurane, remote ischemic preconditioning, close intraoperative blood glucose control, moderate respiratory acidosis (pH 7.30) just before aortic unclamping (concept of the "pH paradox"), and gentle reperfusion just after aortic unclamping. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the postoperative 72-h area under the curve (AUC) for high-sensitivity cardiac troponin I (hsTnI). Secondary endpoints were biological markers and clinical events occurring during the 30 postoperative days and the prespecified subgroup analyses. The linear relationship between the 72-h AUC for hsTnI and aortic clamping time, significant in both groups (p < 0.0001), was not modified by the treatment (p = 0.57). The rate of adverse events at 30 days was identical. A non-significant reduction of the 72-h AUC for hsTnI (-24%, p = 0.15) was observed when sevoflurane was administered during cardiopulmonary bypass (46% of patients in the treated group). The incidence of postoperative renal failure was not reduced (p = 0.104). CONCLUSION: This multimodal cardioprotection has not demonstrated any biological or clinical benefit during cardiac surgery. The cardio- and reno-protective effects of sevoflurane and remote ischemic preconditioning therefore remain to be demonstrated in this context.

Diaphragm Thickening During Venoarterial Extracorporeal Membrane Oxygenation Weaning: An Observational Prospective Study.

OBJECTIVES: The respiratory workload, according to the diaphragm thickening fraction (TF) during sweep gas flow (SGF), decrease during weaning from venoarterial extracorporeal membrane oxygenation (VA ECMO) was evaluated for the present study. DESIGN: Prospective observational study. SETTING: Monocentric. PARTICIPANTS: Patients were included if they were suitable for a first VA ECMO weaning trial and were breathing spontaneously. INTERVENTIONS: SGF was set for 15 minutes when the TF was measured at 4 L/min, 2 L/min, and 1 L/min, with a 10-minute return to baseline between each step. Mechanical ventilation, when required, was set to pressure-support ventilation mode with 7 cmH2O (pressure support) and a positive end-expiratory pressure of 0 cmH2O. Diaphragm ultrasound was used to assess the TF at the end of each step. Demographics, left ventricular ejection fraction (LVEF), and outcome were collected. MEASUREMENTS AND MAIN RESULTS: Fifteen patients were included. Ten patients were extubated, and five were ventilated. TF values were 6.3% [0-10] at 4 L/min, 13.3% [10-26] at 2 L/min, and 26.7% [22-44] at 1 L/min (analysis of variance: p < 0.001 between 4 L/min and 2 L/min and p = 0.03 between 2 L/min and 1 L/min). TF did not differ whether patients were or were not ventilated or whether they were or were not weaned successfully from ECMO. TF was correlated with LVEF at 1 L/min SGF (Pearson R 0.67 [0.21-0.88]; p = 0.009) and at 2 L/min (R 0.7 [0.27-0.89]; p = 0.005) but not at 4 L/min. SGF mitigated the relationship between LVEF and TF (analysis of covariance: p < 0.005). CONCLUSIONS: Diaphragm TF was related to the SGF of the venoarterial ECMO settings and LVEF at the time of weaning.

Preoperative Statin Treatment Is Not Associated with Reduced Postoperative Mortality or Morbidity in Patients Undergoing Isolated Valve Surgery.

INTRODUCTION: Previous studies have shown that statin use before coronary surgery decreases the mortality and morbidity. This benefit was not clearly detected in isolated valve surgery. The aim of this study was to assess the effect of preoperative statin therapy on postoperative complications and mortality in a large group of patients undergoing valve surgery. PATIENTS, MATERIALS, AND METHODS: The data of consecutive patients undergoing isolated valve replacement during an 8-year period were retrospectively reviewed from a prospective database. Mortality was compared between the patients who received preoperative statin (statin group [SG]) and those who did not receive statin (control group [CG]) after adjustment on EuroSCORE. Main postoperative complications and mortality were compared between the 2 groups by using a propensity score analysis. RESULTS: During the study period, 1115 patients were prospectively included, 796 in the CG group and 319 in the SG. The SG patients were significantly older, had more cardiovascular risk factors (hypertension, diabetes, and weight) than the CG patients, and benefited from more elective surgery or aortic valve replacement. No difference in mortality was found between the groups: 4.4% in the SG and 4.5% in the CG, P = .95. Multivariate analysis also revealed no effect of statin on mortality, according to the type of surgery (aortic valve surgery alone or any kind of valve surgery) (P = .93), or the elective or urgent nature of the surgery (P = .67). Statin did not predict mortality after stratification with the EuroSCORE or the Parsonnet score. No difference was found between the 2 groups for postoperative complications (24-hour bleeding, atrial fibrillation, renal failure, length of mechanical ventilation, or hospital stay) and mortality after adjustment with a propensity score. DISCUSSION: This study found no difference in mortality or morbidity associated with preoperative statin therapy after isolated valve surgery.

Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial.

Importance: Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function. Objective: To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled trial conducted in 13 French cardiac surgical centers. Patients with a left ventricular ejection fraction less than or equal to 40% and scheduled for isolated or combined coronary artery bypass grafting with cardiopulmonary bypass were enrolled from June 2013 until May 2015 and followed during 6 months (last follow-up, November 30, 2015). Interventions: Patients were assigned to a 24-hour infusion of levosimendan 0.1 µg/kg/min (n = 167) or placebo (n = 168) initiated after anesthetic induction. Main Outcomes and Measures: Composite end point reflecting low cardiac output syndrome with need for a catecholamine infusion 48 hours after study drug initiation, need for a left ventricular mechanical assist device or failure to wean from it at 96 hours after study drug initiation when the device was inserted preoperatively, or need for renal replacement therapy at any time postoperatively. It was hypothesized that levosimendan would reduce the incidence of this composite end point by 15% in comparison with placebo. Results: Among 336 randomized patients (mean age, 68 years; 16% women), 333 completed the trial. The primary end point occurred in 87 patients (52%) in the levosimendan group and 101 patients (61%) in the placebo group (absolute risk difference taking into account center effect, -7% [95% CI, -17% to 3%]; P = .15). Predefined subgroup analyses found no interaction with ejection fraction less than 30%, type of surgery, and preoperative use of ß-blockers, intra-aortic balloon pump, or catecholamines. The prevalence of hypotension (57% vs 48%), atrial fibrillation (50% vs 40%), and other adverse events did not significantly differ between levosimendan and placebo. Conclusions and Relevance: Among patients with low ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite end point of prolonged catecholamine infusion, use of left ventricular mechanical assist device, or renal replacement therapy. These findings do not support the use of levosimendan for this indication. Trial Registration: EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.

Automated drug dispensing systems in the intensive care unit: a financial analysis.

INTRODUCTION: To evaluate the economic impact of automated-drug dispensing systems (ADS) in surgical intensive care units (ICUs). A financial analysis was conducted in three adult ICUs of one university hospital, where ADS were implemented, one in each unit, to replace the traditional floor stock system. METHOD: Costs were estimated before and after implementation of the ADS on the basis of floor stock inventories, expired drugs, and time spent by nurses and pharmacy technicians on medication-related work activities. A financial analysis was conducted that included operating cash flows, investment cash flows, global cash flow and net present value. RESULTS: After ADS implementation, nurses spent less time on medication-related activities with an average of 14.7 hours saved per day/33 beds. Pharmacy technicians spent more time on floor-stock activities with an average of 3.5 additional hours per day across the three ICUs. The cost of drug storage was reduced by €44,298 and the cost of expired drugs was reduced by €14,772 per year across the three ICUs. Five years after the initial investment, the global cash flow was €148,229 and the net present value of the project was positive by €510,404. CONCLUSION: The financial modeling of the ADS implementation in three ICUs showed a high return on investment for the hospital. Medication-related costs and nursing time dedicated to medications are reduced with ADS.

Percutaneous drainage of postoperative pericardial effusion in cardiac surgery.

BACKGROUND AND AIM OF THE STUDY: Postoperative pericardial effusion is frequent and can be complicated by cardiac tamponade. Although the different drainage techniques are well described in the setting of medical effusion, there is not a standard postoperative effusion treatment. The aim of this work was to assess the feasibility and effectiveness of the percutaneous pericardial drainage. METHODS: This a retrospective study involving 197 patients from 1990 to 2008. Drainage was performed by subxiphoid puncture (91.9%) or left parasternal puncture (8.1%) between 3 and 690 days following a cardiac procedure via median sternotomy. Effusion thickness was at least 10 mm in the subcostal echocardiography view. RESULTS: No deaths directly related to the procedure were observed. Complete and enduring drainage was achieved in 158 patients (80.2%). The procedure failed for 22 patients (11.2%) because no fluid was drained in 14 cases (7.1%) and a right ventricular puncture in 8 cases (4.1%). Recurrence of the effusion, which occurred for 17 patients (8.6%), was more frequent if an effusion of more than 5 mm persisted after the first drainage (P = 0.024) and if the drainage was performed outside the operating room because of emergency (P = 0.046). Risk factors for mortality were recurrence of the effusion (P = 0.04) and drainage performed outside the operating room (P = 0.007). CONCLUSIONS: Percutaneous pericardial drainage is effective to treat postoperative pericardial effusion. When the effusion is thicker than 10 mm and accessible, it can be the initial strategy and surgical drainage can serve as an alternate strategy in case of failure and complications of this procedure.

Extracorporeal life support as a bridge to high-urgency heart transplantation.

Extracorporeal life support (ECLS) represents an effective, emergent therapy for patients with end-stage heart failure or cardiac arrest. However, ECLS is typically not used as a bridge to heart transplantation because of the limited duration of ECLS. In France, high-urgency priority heart transplantation remains a possibility for transplant patients who are on ECLS. In this article, we present our experience with high-urgency priority heart transplantation after ECLS. From July 2004 to December 2009, 242 patients underwent emergent ECLS. Heart transplantation was performed in eight of these patients. Time of ECLS was 6.3 ± 4.6 d. Before heart transplantation, all patients on ECLS had decreased organ dysfunctions and four were conscious. Despite frequent post-operative complications, no death occurred during the first year after transplantation. In our experience, ECLS is a valid method of supporting patients awaiting high-urgency heart transplantation and can be used as a short-term bridge to heart transplantation.

Preoperative fibrinogen level and postcardiac surgery morbidity and mortality rates.

Background: High preoperative fibrinogen levels are associated with reduced bleeding rates after cardiac surgery. Fibrinogen is directly involved in inflammatory processes and is a cardiovascular risk factors. Whether high fibrinogen levels before cardiac surgery are a risk factor for mortality or morbidity remains unclear. Aims: This study aimed to examine the association between preoperative fibrinogen levels and mortality and morbidity rates after cardiac surgery. Settings and Design: This is a single-center retrospective study. Material and Methods: Patients (n = 1628) were divided into high (HFGr) and normal (NFGr) fibrinogen level groups, based on the cutoff value of 3.3 g/L, derived from the receiver operating characteristic (ROC) curve analysis. The primary outcome was the 30-day mortality rate. The rates of postoperative complications, including postoperative bleeding and transfusion rates, were examined. Statistical Analysis: Between-group comparisons were performed with the Mann-Whitney U test and Chi-squared test, as suitable. Model discriminative power was examined with the area under the ROC curve. Results: The HFGr and NFGr included 1103 and 525 patients, respectively. Mortality rate was higher in the HFGr than in the NFGr (2.7% vs. 1.1%, P = 0.04). The 12-h bleeding volume (280 mL [195-400] vs. 305 mL [225-435], P = 0.0003) and 24-h bleeding volume values (400 mL [300-550] vs. 450 mL [340-620], P < 0.0001) were lower in the HFGr than in the NFGr. However, the rate of red blood cell transfusion during hospitalization was higher in the HFGr than in the NFGr (21.7% vs. 5.9%, P = 0.0103). Major complications were more frequent in the HFGr than in the NFGr. Conclusion: High fibrinogen levels were associated with reduced postoperative bleeding volume and increased mortality and morbidity rates.

Helpfulness of the liver disease scores in cardiac surgery for cirrhotic patients.

OBJECTIVES: Liver cirrhosis is a well-known risk factor of mortality after cardiac surgery, but not considered in the widely used EuroSCOREII (ESII). The objective was to analyse the performance of the ESII, the Child-Pugh-Turcotte (CPT) and the Model of End-stage Liver Disease (MELD) scores to predict hospital mortality in cardiac surgery for cirrhotic patients and to analyse the survival according to the preoperative cirrhosis status. METHODS: Preoperative and cirrhosis characteristics and postoperative outcomes were compared according to hospital mortality. The performance of the 3 scores was analysed by the area under the receiver-operating characteristics (AUC-ROC) by DeLong's method. The survival of the patients who were discharged was analysed by Kaplan-Meier curves according to the preoperative cirrhosis status. RESULTS: Seventy-four patients were included. Observed hospital mortality was 12%, the predictive mortality by ESII was 3.9% ± 5.2%, and AUC-ROC was 0.67 [0.44-0.90]. Only the MELD score was discriminant (AUC-ROC 0.75 [0.57-0.93]). The observed hospital mortality increased by threefold over the ESII (12% versus 3.9%, p < 0.001), except the patients with MELD < 10 for whom hospital mortality was similar as ESII (3% versus 2.6%, p = 0.89). Long-term survival was higher for the MELD < 10 patients. CONCLUSIONS: The ESII did not predict hospital mortality after a cardiac surgery in cirrhotic patients and the MELD score should be considered for decision of cardiac intervention in cirrhotic patients.

Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial.

INTRODUCTION: Incidence of delirium after cardiac surgery remains high and delirium has a significant burden on short-term and long-term outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Preserving the circadian rhythm with overnight infusion of low-dose dexmedetomidine has been shown to lower the occurrence of delirium in older patients after non-cardiac surgery. However, these results remain controversial. The aim of this study was to demonstrate the usefulness of sleep induction by overnight infusion of dexmedetomidine to prevent delirium after cardiac surgery. METHODS AND ANALYSIS: Dexmedetomidine after Cardiac Surgery for Prevention of Delirium is an investigator-initiated, randomised, placebo-controlled, parallel, multicentre, double-blinded trial. Nine centres in France will participate in the study. Patients aged 65 years or older and undergoing cardiac surgery will be enrolled in the study. The intervention starts on day 0 (the day of surgery) until intensive care unit (ICU) discharge; the treatment is administered from 20:00 to 08:00 on the next day. Infusion rate is modified by the treating nurse or the clinician with an objective of Richmond Agitation and Sedation Scale score from -1 to +1. The primary outcome is delirium occurrence evaluated with confusion assessment method for the ICU two times per day during 7 days following surgery. Secondary outcomes include incidence of agitation related events, self-evaluated quality of sleep, cognitive evaluation 3 months after surgery and quality of life 3 months after surgery. The sample size is 348. ETHICS AND DISSEMINATION: The study was approved for all participating centers by the French Central Ethics Committee (Comité de Protection des Personnes Ile de France VI, registration number 2018-000850-22). The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03477344.

Prognostic value of signs of life throughout cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest.

PURPOSE: Prognostication of refractory out-of-hospital cardiac arrest (OHCA) is essential for selecting the population that may benefit from extracorporeal cardiopulmonary resuscitation (ECPR). We aimed to examine the prognostic value of signs of life before or throughout conventional CPR for individuals undergoing ECPR for refractory OHCA. METHODS: Pooling the original data from three cohort studies, we estimated the prevalence of signs of life, for individuals with refractory OHCA resuscitated with ECPR. We performed multivariable logistic regression to examine the independent associations between the occurrence of signs of life and 30-day survival with a CPC score ≤ 2. RESULTS: The analytical sample consisted of 434 ECPR recipients. The prevalence of any sign of life was 61%, including pupillary light reaction (48%), gasping (32%), or increased level of consciousness (13%). Thirty-day survival with favorable neurological outcome was 15% (63/434). In multivariable analysis, the adjusted odds ratios of 30-day survival with favorable neurological outcome were 7.35 (95% confidence interval [CI], 2.71-19.97), 5.86 (95% CI, 2.28-15.06), 4.79 (95% CI, 2.16-10.63), and 1.75 (95% CI, 0.95-3.21) for any sign of life, pupillary light reaction, increased level of consciousness, and gasping, respectively. CONCLUSION: The assessment of signs of life before or throughout CPR substantially improves the accuracy of a multivariable prognostic model in predicting 30-day survival with favorable neurological outcome. The lack of any sign of life might obviate the provision of ECPR for patients without shockable cardiac rhythm.

Comparison of the additive, logistic european system for cardiac operative risk (EuroSCORE) with the EuroSCORE 2 to predict mortality in high-risk cardiac surgery.

Background: The aim of this study was to compare the new EuroSCORE (ES) 2 prediction model in high-risk patients with the 2 other oldest additive ES (aES) and logistic ES (lES). Methods: Consecutive adult patients undergoing all cardiac surgery except heart transplantation and left ventricular assist device were included. The 3 risk scores were collected before surgery. We defined 4 high-risk groups of patients, patients ≥80 years, combined cardiac surgery, surgery of the thoracic aorta, and emergency cardiac surgery, and 2 low-risk groups, valve surgery and coronary artery bypass surgery. The predicted value of each score has been assessed by the area under the receiver operating characteristics curve (AUC). Results: The study had included 3301 patients. Thirty-day mortality was 3.9% (95% confidence interval (CI), 3.3 - 4.6%). The AUC of ES2 was 0.81 (0.77 - 0.84), 0.82 (0.78 - 0.85), 0.70 (0.64 - 0.76), 0.79 (0.74 - 0.83), 0.85 (0.83 - 0.87), and 0.88 (0.86 - 0.90) for octogenarians, thoracic aortic surgery, combined surgery, emergency surgery, coronary surgery, and valve surgery, respectively. These ES2 AUC values were higher than those obtained with the aES for octogenarians, and with the lES for octogenarians and valve surgery. The ES2 calibration was better than the aES and lES calibration for the whole population, and low-risk groups. The ES2 calibration was superior to aES and lES in high-risk groups, except for octogenarians and thoracic aortic surgery compared to lES. Conclusion: In high-risk cardiac surgery patients, ES2 only marginally improve the predicted 30-day mortality in comparison to other ES.

Mucormycosis in intensive care unit: surgery is a major prognostic factor in patients with hematological malignancy.

BACKGROUND: Mucormycosis is an invasive fungal infection, with an increasing incidence especially in patients with hematological malignancies. Its prognosis is poor because of its high invasive power and its intrinsic low susceptibility to antifungal agents. We aimed to describe the epidemiology of mucormycosis in intensive care units (ICU) and evaluate the outcomes. We performed a retrospective multi-center study in 16 French ICUs between 2008 and 2017. We compared the patients who survived in ICU and the patients who did not to identify factors associated with ICU survival. Then, we focused on the subgroup of patients with hematological malignancies. RESULTS: Mucormycosis was diagnosed in 74 patients during the study period. Among them, 60 patients (81%) were immunocompromised: 41 had hematological malignancies, 9 were solid organ transplant recipients, 31 received long-term steroids, 11 had diabetes, 24 had malnutrition. Only 21 patients survived to ICU stay (28.4%) with a median survival of 22 days (Q1-Q3 = 9-106) and a survival rate at day 28 and day 90, respectively, of 35.1% and 26.4%. Survivors were significantly younger (p = 0.001), with less frequently hematological malignancies (p = 0.02), and less malnutrition (p = 0.05). Median survival in patients with hematological malignancies (n = 41) was 15 days (Q1-Q3 = 5-23.5 days). In this subgroup, curative surgery was a major factor associated with survival in multivariate analysis (odds ratio = 0.71, [0.45-0.97], p < 0.001). CONCLUSION: Overall prognosis of mucormycosis in ICU remains poor, especially in patients with hematological malignancies. In this subgroup of patients, a therapeutic strategy including curative surgery was the main factor associated with survival.

First-line capecitabine monotherapy for slowly progressing metastatic breast cancer: do we need aggressive treatment?

BACKGROUND: Primary treatment goals in less aggressive metastatic breast cancer (MBC) are prolonged survival, good quality of life and control of the disease and its symptoms. High activity, oral administration and no alopecia make capecitabine monotherapy attractive in slowly evolving disease. METHODS: We retrospectively analysed 226 patients who had received single-agent capecitabine as 1st-line chemotherapy at our institution. RESULTS: The median interval between breast cancer diagnosis and MBC was 52 months (range 0-479); 76% had received endocrine therapy for MBC, 58% had visceral involvement and 30% had 3 or more metastatic sites. The median starting dose was 1,000 mg/m(2) twice daily. Disease was improved in 56% of the patients (median duration: 13.2 months) and stabilised in 20%. Median time to treatment failure was 8.8 months (95% CI: 7.1-10.5); median overall survival from initiating capecitabine was 23.6 months (95% CI: 19.7-27.4). Prior adjuvant chemotherapy, endocrine therapy for MBC, visceral disease, hormone receptor status and initial capecitabine dose did not influence time to treatment failure. Among 161 patients <75 years, 90% received further chemotherapy. CONCLUSION: Based on these findings, 1st-line capecitabine should be considered in slowly progressing disease, offering an active, well-tolerated oral treatment with minimal toxicity and no alopecia. More toxic treatments may be reserved for more aggressive disease.

Immediate prehospital hypothermia protocol in comatose survivors of out-of-hospital cardiac arrest.

Therapeutic hypothermia (TH) improves the outcomes of cardiac arrest (CA) survivors. The aim of this study was to evaluate retrospectively the efficacy and safety of an immediate prehospital cooling procedure implemented just after the return of spontaneous circulation with a prehospital setting. During 30 months, the case records of comatose survivors of out-of-hospital CA presumably due to a cardiac disease were studied. A routine protocol of immediate postresuscitation cooling had been tested by an emergency team, which consisted of an infusion of large-volume, ice-cold intravenous saline. We decided to assess the efficacy and tolerance of this procedure. A total of 99 patients were studied; 22 were treated with prehospital TH, and 77 consecutive patients treated with prehospital standard resuscitation served as controls. For all patients, TH was maintained for 12 to 24 hours. The demographic, clinical, and biological characteristics of the patients were similar in the 2 groups. The rate of patients with a body temperature of less than 35 degrees C upon admission was 41% in the cooling group and 18% in the control group. Rapid infusion of fluid was not associated with pulmonary edema. After 1 year of follow-up, 6 (27%) of 22 patients in the cooling group and 30 (39%) of 77 patients in the control group had a good outcome. Our preliminary observation suggests that in comatose survivors of CA, prehospital TH with infusion of large-volume, ice-cold intravenous saline is feasible and can be used safely by mobile emergency and intensive care units.

Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study.

BACKGROUND: Diaphragm paresis is common after cardiac surgery and may delay the weaning from the ventilator. Our objective was to evaluate diaphragm thickening during weaning and secondly the muscle thickness as a marker of myotrauma. METHODS: Patients undergoing elective cardiac surgery were prospectively included. Ultrasonic index of right hemidiaphragm thickening fraction (TF) was measured as a surrogate criterion of work of breathing. A TF < 20% was defined as a low diaphragm thickening. Measurements of TF were performed during three periods to study diaphragm thickening evolution defined by the difference between two consecutive time line point: preoperative (D - 1), during a spontaneous breathing trial (SBT) in the intensive care unit and postoperative (D + 1). We studied three patterns of diaphragm thickness at end expiration evolution from D - 1 to D + 1: > 10% decrease, stability and > 10% increase. Demographical data, length of surgery, type of surgery, ICU length of stay (LOS) and extubation failure were collected. RESULTS: Of the 100 consecutively included patients, 75 patients had a low diaphragm thickening during SBT. Compared to TF values at D - 1 (36% ± 18), TF was reduced during SBT (17% ± 14) and D + 1 (12% ± 11) (P < 0.0001). Thickness and TF did not change according to the type of surgery or cooling method. TF at SBT was correlated to the length of surgery (both r = - 0.4; P < 0.0001). Diaphragm thickness as continuous variable did not change over time. Twenty-eight patients (42%) had a > 10% decrease thickness, 19 patients (29%) stability and 19 patients (28%) in > 10% increase, and this thickness evolution pattern was associated with: a longer LOS 3 days [2-5] versus 2 days [2-4] and 2 days [2], respectively (ANOVA P = 0.046), and diaphragm thickening evolution (ANOVA P = 0.02). Two patients experience extubation failure. CONCLUSION: These findings indicate that diaphragm thickening is frequently decreased after elective cardiac surgery without impact on respiratory outcome, whereas an altered thickness pattern was associated with a longer length of stay in the ICU. Contractile activity influenced thickness evolution. Trial registry number ClinicalTrial.gov ID NCT02208479.

Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial.

BACKGROUND: Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single aspect of cardioprotection have shown conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass. METHODS: This study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. In the study, 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treatment group (105 patients in each group). In the control group, patients receive total intravenous anesthesia with propofol and liberal intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 60 min, is greater than 180 mg/dl), as a standard of care. The treatment group receives a bundle of care combining five techniques of cardioprotection: (1) remote ischemic preconditioning applied before aortic cross-clamping; (2) maintenance of anesthesia with sevoflurane; (3) tight intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 30 min, is greater than 140 mg/dl); (4) moderate respiratory acidosis (pH 7.30) at the end of cardiopulmonary bypass; and (5) a gentle reperfusion protocol following aortic unclamping. The primary outcome is myocardial damage measured by postoperative 72-h area under the curve of high-sensitivity cardiac troponin I. DISCUSSION: The ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardioprotective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03230136 . Registered on July 26, 2017. Last updated on April 17, 2019.