Impact of COVID-19 on posttraumatic stress disorder in ICU survivors: a prospective observational comparative cohort study.

BACKGROUND: Posttraumatic stress disorder (PTSD) after a stay in the intensive care unit (ICU) can affect one in five ICU survivors. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, admission to the ICU for COVID-19 was stressful due to the severity of this disease. This study assessed whether admission to the ICU for COVID-19 was associated with a higher prevalence of PTSD compared with other causes of ICU admission after adjustment for pre-ICU psychological factors. METHODS: This prospective observational comparative cohort study included 31 ICUs. Eligible patients were adult ICU survivors hospitalized during the first wave of COVID-19 pandemic in France, regardless of the reason for admission. The prevalence of presumptive diagnosis of PTSD at 6 months was assessed using the PTSD Checklist for DSM-5 (PCL-5). Sociodemographics, clinical data, history of childhood trauma (Childhood Trauma Questionnaire [CTQ]), and exposure to potentially traumatic events (Life Events Checklist for DSM-5 [LEC-5]) were assessed. RESULTS: Of the 778 ICU survivors included during the first wave of COVID-19 pandemic in France, 417 and 361 were assigned to the COVID-19 and non-COVID-19 cohorts, respectively. Fourteen (4.9%) and 11 (4.9%), respectively, presented with presumptive diagnosis of PTSD at 6 months (p = 0.976). After adjusting for age, sex, severity score at admission, use of invasive mechanical ventilation, ICU duration, CTQ and LEC-5, COVID-19 status was not associated with presumptive diagnosis of PTSD using the PCL-5. Only female sex was associated with presumptive diagnosis of PTSD. However, COVID-19 patients reported significantly more intrusion and avoidance symptoms than non-COVID patients (39% vs. 29%, p = 0.015 and 27% vs. 19%, p = 0.030), respectively. The median PCL-5 score was higher in the COVID-19 than non-COVID-19 cohort (9 [3, 20] vs. 4 [2, 16], p = 0.034). CONCLUSION: Admission to the ICU for COVID-19 was not associated with a higher prevalence of PTSD compared with admission for another cause during the first wave of the COVID-19 pandemic in France. However, intrusion and avoidance symptoms were more frequent in COVID-19 patients than in non-COVID-19 patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT03991611, registered on June 19, 2019.

Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study.

BACKGROUND: Transient diaphragm dysfunction is common during the first week after cardiac surgery; however, the precise incidence, risk factors, and outcomes of persistent diaphragm dysfunction are not well described. METHODS: In a single-centre prospective cohort study, we included all consecutive patients over 18 yr who underwent elective cardiac surgery. Diaphragm function was evaluated with ultrasound (M-mode) by recording the excursion of both hemidiaphragms at two different time points: preoperatively and after the seventh postoperative day in patients breathing without assistance. Significant diaphragm dysfunction after the seventh day of the index cardiac surgery was defined as a decrease in diaphragm excursion below the lower limit of normal: at rest, < 9 mm for women and < 10 mm for men; after a sniff test, < 16 mm for women and < 18 mm for men. RESULTS: Overall, 122 patients were included in the analysis. The median [interquartile range (IQR)] age was 69 [59-74] years and 96/122 (79%) were men. Ten (8%) patients had diaphragm dysfunction after the seventh postoperative day. We did not identify risk factors for persistent diaphragm dysfunction. Persistent diaphragm dysfunction was associated with a longer median [IQR] duration of noninvasive (8 [0-34] vs 0 [0-0] hr; difference in medians, 8 hr; 95% confidence interval [CI], 0 to 22; P < 0.001) and invasive mechanical ventilation (5 [3-257] vs 3[2-4] hr; difference in medians, 2 hr; 95% CI, 0.5 to 41; P = 0.008); a higher reintubation rate (4/10, 40% vs 1/112, 0.9%; relative risk, 45; 95% CI, 7.1 to 278; P < 0.0001), a higher incidence of pneumonia (4/10 [40%] vs 7/112 [6%]; relative risk, 6; 95% CI, 2 to 16; P < 0.001), and longer median [IQR] length of stay in the intensive care unit (8 [5-29] vs 4 [2-6] days; difference in medians, 4 days; 95% CI, 2 to 12; P = 0.002). CONCLUSION: The incidence of persistent diaphragm dysfunction was 8% in patients undergoing elective cardiac surgery and was associated with adverse respiratory outcomes. STUDY REGISTRATION: ClinicalTrials.gov (NCT04276844); prospectively registered 19 February 2020.

RéSUMé: CONTEXTE: Un dysfonctionnement transitoire du diaphragme est fréquent au cours de la première semaine après une chirurgie cardiaque. Toutefois, l'incidence précise, les facteurs de risque et les devenirs liés à un dysfonctionnement persistant du diaphragme ne sont pas bien décrits. MéTHODE: Dans une étude de cohorte prospective monocentrique, nous avons inclus tous les patients consécutifs de plus de 18 ans qui ont bénéficié d'une chirurgie cardiaque non urgente. La fonction du diaphragme a été évaluée à l'échographie (mode M) en enregistrant l'excursion des deux hémidiaphragmes à deux moments différents : avant l'opération et après le septième jour postopératoire chez les patients respirant sans assistance. Un dysfonctionnement significatif du diaphragme après le septième jour de la chirurgie cardiaque initiale a été défini comme une diminution de l'excursion diaphragmatique en dessous de la limite inférieure de la normale, soit : au repos, < 9 mm pour les femmes et < 10 mm pour les hommes; après un test de reniflement, < 16 mm pour les femmes et < 18 mm pour les hommes. RéSULTATS: Au total, 122 patients ont été inclus dans l'analyse. L'âge médian des patients (écart interquartile [ÉIQ]) était de 69 ans [59-74] ans et 96/122 (79 %) étaient des hommes. Dix (8 %) patients ont présenté un dysfonctionnement du diaphragme après le septième jour postopératoire. Nous n'avons pas identifié de facteurs de risque de dysfonctionnement persistant du diaphragme. Un dysfonctionnement persistant du diaphragme était associé à : une durée médiane [ÉIQ] de ventilation non invasive (8 [0­34] vs 0 [0­0] h; différence dans les médianes, 8 heures; intervalle de confiance [IC] à 95 %, 0 à 22; P < 0,001) et de ventilation mécanique invasive (5 [3­257] vs 3[2­4] h; différence dans les médianes, 2 heures; IC 95 %, 0,5 à 41; P = 0,008) plus longues, un taux de réintubation plus élevé (4/10, 40 % vs 1/112, 0,9 %; risque relatif, 45; IC 95 %, 7,1 à 278; P < 0,0001), une incidence plus élevée de pneumonie (4/10 [40 %] vs 7/112 [6 %]; risque relatif, 6; IC 95 %, de 2 à 16; P < 0,001), et une durée de séjour médiane [ÉIQ] plus longue à l'unité de soins intensifs (8 [5-29] vs 4 [2­6] jours; différence en médianes, 4 jours; IC 95 %, 2 à 12; P = 0,002). CONCLUSION: L'incidence de dysfonctionnement persistant du diaphragme était de 8 % chez les patients bénéficiant d'une chirurgie cardiaque non urgente et était associée à des issues respiratoires indésirables. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT04276844); enregistrée prospectivement le 19 février 2020.

Risk factors and complications associated with intra-operative or post-operative identification of a PFO in cardiac surgery patients: A cohort study.

Introduction: It is unknown whether patent foramen ovale (PFO) reopening in the peri-operative setting of cardiac surgery affects the risk for stroke and post-operative outcomes. Methods: We performed a single-center, retrospective study based on a prospectively collected database in a tertiary cardiac surgery center. Using logistic regression, we assessed risk factors of PFO finding around surgery and subsequent clinical complications. Results: Between January 2007 and July 2019, 11034 patients who underwent cardiac surgery in our center were included. A total of 233 patients (2.1%) presented a finding of PFO including 138 per-operative disclosures and 95 post-operative finding for hypoxemia. In the whole cohort, the mean age was 68.4 ± 11.5 years including 73.9% of men. Post-operative PFO finding was associated with more ischemic strokes compared with per-operative finding and control group [7(7.4%) vs. 3(2.2%) vs. 236(2.2), respectively; p = 0.003]. Moreover, patients with post-operative PFO reopening experienced a higher rate of pneumonia, reintubation, and longer length of stay in the ICU. Post-operative reopening of PFO, but not per-operative finding, was independently associated with ischemic strokes {adjusted odds-ratio = 3.5, 95% confidence interval (CI) [1.6-7.8]; p = 0.002}. Other variables associated with stroke incidence included age, mitral valve surgery, and ascending aorta surgery. Per- or post-operative PFO closure was associated with reduced adverse respiratory outcomes and a trend of the lower cerebral ischemic event. Conclusion: Patent foramen ovale finding incidence in peri-operative cardiac surgery care was rare (2%) but post-operative finding of PFO was associated with a increased risk of ischemic strokes, worsened respiratory outcomes, and prolonged hospitalization.

Takotsubo cardiomyopathy after cardiac surgery: A case-series and systematic review of literature.

Background: Takotsubo cardiomyopathy (TTC) is a rare entity after cardiac surgery. Aims: To describe patients' profile who developed postoperative TTC after cardiac surgery, management, and outcomes. Methods: We performed a systematic literature search to extract cases of TTC after adult cardiac surgery (from 1990 to 2021). Additionally, we extracted all cases of TTC in a prospective single-center cohort database of 10,000+ patients (from 2007 to 2019). We then combined all cases in a single cohort to describe its clinical features. Results: From 694 screened articles, we retained 71 individual cases published in 20 distinct articles (19 cases reports and 1 case-series). We combined these to 10 cases extracted from our cohort [among 10,682 patients (0.09%)]. Overall, we included 81 cases. Patients were aged 68 ± 10 years-old and 64/81 (79%) were women. Surgery procedures included mitral valve and/or tricuspid valve surgery in 70/81, 86%. TTC was diagnosed in the first days after surgery [median 4 (1-4) days]. Incidence of cardiogenic shock, defined as requirement of vasopressor and/or inotropic support was 24/29, 83% (data available on 29/81 patients). Refractory cardiogenic appeared in 5/81, 6% who required implantation of arterio-venous extra-corporeal membrane oxygenation, and 6/81, 7%, intra-aortic balloon pump. In-hospital mortality was 5/81, 6%. Conclusion: This systematic review, based on case reports and case series, showed that postoperative TTC appears as a rare complication after cardiac surgery and mainly occurred after mitral and/or tricuspid valve repair procedures. In this population, TTC is associated with high rate of cardiogenic shock.

Use of Almitrine and Inhaled Nitric Oxide in ARDS Due to COVID-19.

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is manifested by an acute respiratory distress syndrome (ARDS) with intense inflammation and endothelial dysfunction leading to particularly severe hypoxemia. We hypothesized that an impaired hypoxic pulmonary vasoconstriction aggravates hypoxemia. The objective of the study was to test the effect of two pulmonary vasoactive drugs on patient oxygenation. Methods: Observational, single-center, open-label study in one intensive care unit (ICU) of the Paris area, realized in April 2020. Eligible patients had coronavirus disease 2019 (COVID-19) and moderate to severe ARDS [arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) <200 mmHg] despite conventional protective ventilation. Exclusion criteria included pulmonary artery hypertension defined by a pulmonary artery systolic pressure (PAPs) >45 mmHg. The assessment of oxygenation was based on PaO2/FiO2 at (1) baseline, then after (2) 30 min of inhaled nitric oxide (iNO) 10 ppm alone, then (3) 30 min combination of iNO + almitrine infusion 8 µg/kg/min, then (4) 30 min of almitrine infusion alone. Results: Among 20 patients requiring mechanical ventilation during the study period, 12 met the inclusion criteria. Baseline PaO2/FiO2 was 146 ± 48 mmHg. When iNO was combined with almitrine, PaO2/FiO2 rose to 255 ± 90 mmHg (+80 ± 49%, p = 0.005), also after almitrine alone: 238 ± 98 mmHg (+67 ± 75%, p = 0.02), but not after iNO alone: 185 ± 73 mmHg (+30 ± 5%, p = 0.49). No adverse events related to almitrine infusion or iNO was observed. Conclusion: Combining iNO and infused almitrine improved the short-term oxygenation in patients with COVID-19-related ARDS. This combination may be of interest when first-line therapies fail to restore adequate oxygenation. These findings argue for an impaired pulmonary hypoxic vasoconstriction in these patients.

Post-operative Right Ventricular Failure After Cardiac Surgery: A Cohort Study.

Introduction: Right ventricular failure (RVF) after cardiac surgery is an important risk factor for morbidity and mortality. Its diagnosis is challenging, and thus, its incidence and predictors are not well-established. We investigated the incidence, complications, and variables associated with clinically relevant post-operative RVF. Methods: We included all patients who underwent cardiac surgery with cardiopulmonary bypass between 2016 and 2019 in a cardiac surgery center with standardized diagnostic and therapeutic management of RVF. RVF was considered only if clinically relevant: associated with hemodynamic instability requiring catecholamine support and inhaled nitric oxide relayed by sildenafil. Results: Overall, 3,826 patients were included, of whom, 110 (2.9%) developed post-operative RVF. Mortality was not different among patients who developed post-operative RVF, compared with the rest of the cohort (1.8 vs. 0.7%, p = 0.17). Using a composite outcome that combined death, reintubation, stroke, and prolonged intensive care unit stay (more than 14 days) yielded an incidence of 6.6%, and RVF was associated with this composite outcome with an odds ratio of 3.6 (2.2-5.8), p < 0.001. In a multivariable model, pre-operative variables independently associated with post-operative RVF were pre-operative atrial fibrillation (AF) {adjusted odds ratio (adjOR) 3.22 [95% confidence interval (95%CI) = 1.94-5.36], p < 0.001}, left ventricle ejection fraction below 50% [adjOR = 2.55 (95%CI = 1.52-4.33), p < 0.001], systolic pulmonary artery pressure above 55 mmHg [adjOR = 8.64 (95%CI = 5.27-14.1); p < 0.001], mitral valve surgery [adjOR = 2.17 CI (95%CI = 1.28-3.66), p = 0.004], and tricuspid valve surgery [adjOR = 10.33 (95%CI = 6.14-17.4), p < 0.001]. In patients who developed post-operative RVF requiring treatment, 32 (29.1%) showed RV dysfunction before surgery. Conclusion: In this cohort study, 2.9% of patients developed clinically significant post-operative RVF. Moreover, RVF was associated with severe adverse outcomes, including death, strokes, reintubation, and prolonged intensive care unit stay.

Virtual reality vs. Kalinox® for management of pain in intensive care unit after cardiac surgery: a randomized study.

INTRODUCTION: The management of pain and anxiety remains a challenge in the intensive care unit. By distracting patients, virtual reality (VR) may have a role in painful procedures. We compared VR vs. an inhaled equimolar mixture of N2O and O2 (Kalinox®) for pain and anxiety management during the removal of chest drains after cardiac surgery. METHODS: Prospective, non-inferiority, open-label study. Patients were randomized, for Kalinox® or VR session during drain removal. The analgesia/nociception index (ANI) was monitored during the procedure for objective assessment of pain and anxiety. The primary endpoint was the ΔANI (ANImin - ANI0) during the procedure, based on ANIm (average on 4 min). We prespecified VR as non-inferior to Kalinox® with a margin of 3 points. Self-reported pain and anxiety were also analysed using numeric rate scale (NRS). RESULTS: 200 patients were included, 99 in the VR group and 101 in the Kalinox® group; 90 patients were analysed in both groups in per-protocol analysis. The median age was 68.0 years [60.0-74.8]. The ΔANI was - 15.1 ± 12.9 in the Kalinox® group and - 15.7 ± 11.6 in the VR group (NS). The mean difference was, therefore, - 0.6 [- 3.6 to 2.4], including the non-inferiority margin of 3. Patients in the VR group had a significantly higher pain NRS scale immediately after the drain removal, 5.0 [3.0-7.0] vs. 3.0 [2.0-6.0], p = 0.009, but no difference 10 min after. NRS of anxiety did not differ between the two groups. CONCLUSION: Based on the ANI, the current study showed that VR did not reach the statistical requirements for a proven non-inferiority vs. Kalinox® in managing pain and anxiety during chest drain removal. Moreover, VR was less effective based on NRS. More studies are needed to determine if VR might have a place in the overall approach to pain and anxiety in intensive care units. Trial registration NCT, NCT03956264. Registered 20 May 2019, https://clinicaltrials.gov/ct2/show/NCT03956264.

Diaphragm Dysfunction After Cardiac Surgery: Reappraisal.

OBJECTIVES: The aim of this study was to re-investigate the incidence, risk factors, and outcomes of postoperative diaphragmatic dysfunction (DD) with actual cardiac surgery procedures. DESIGN: Single-center, retrospective, observational study based on a prospectively collected database. SETTING: Tertiary care cardiac surgery center. PARTICIPANTS: Patients who underwent cardiac surgery between January 2016 and September 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The DD group included patients with clinically perceptible diaphragmatic paralysis, which was confirmed by chest ultrasound (amplitude of the diaphragm movement in time-motion mode at rest, after a sniff test). The primary endpoint was the incidence of DD. Among 3,577 patients included, the authors found 272 cases of DD (7.6%). Individuals with DD had more arterial hypertension (64.3% v 52.6%; p < 0.0001), higher body mass index (BMI) (28 [25-30] kg/m2v 26 [24-29] kg/m2; p < 0.0002), and higher incidence of coronary bypass grafting (CABG) (58.8% v 46.6%; p = 0.0001). DD was associated with more postoperative pneumonia (23.9% v 8.7%; p < 0.0001), reintubation (8.8% v 2.9%; p < 0.0001), tracheotomy (3.3% v 0.3%; p < 0.0001), noninvasive ventilation (45.6% v 5.4%; p < 0.0001), duration of mechanical ventilation (five [four-11] hours v four [three-six] hours; p < 0.0001), and intensive care unit and hospital stays (14 [11-17] days v 13 [11-16] days; p < 0.0001). In multivariate analysis, DD was associated with CABG (odds ratio [OR] 1.9 [1.5-2.6]; p = 0.0001), arterial hypertension (OR 1.4 [1.1-1.9]; p = 0.008), and BMI (OR per point 1.04 [1.01-1.07] kg/m2; p = 0.003). CONCLUSIONS: The incidence of symptomatic DD after cardiac surgery was 7.6%, leading to respiratory complications and increased ICU stay. CABG was the principal factor associated with DD.

Performance of EuroSCORE II and Society of Thoracic Surgeons risk scores in elderly patients undergoing aortic valve replacement surgery.

BACKGROUND: In cardiac surgery, risk is estimated with models such as EuroSCORE II and the Society of Thoracic Surgeons (STS) score. Performance of these scores may vary across various patient age ranges. AIM: To assess the effect of patient age on performance of the EuroSCORE II and STS scores, regarding postoperative mortality after surgical aortic valve replacement. METHODS: In a prospective cohort of patients, we assessed risk stratification of EuroSCORE II and STS scores for discrimination of in-hospital mortality with the area under the receiver operating characteristic curve (AUROC) and calibration with the Hosmer-Lemeshow test. Two groups of patients were compared: elderly (aged>75years) and younger patients. RESULTS: Of 1229 patients included, 635 (51.7%) were elderly. Mean EuroSCORE II score was 3.7±4.4% and mean STS score was 2.1±1.5%. Overall in-hospital mortality was 4.8% and was higher in the elderly compared with younger patients (6.6% vs. 2.8%; log-rank P=0.014). AUROC for the EuroSCORE II score was lower in elderly than in younger patients (0.731 vs. 0.784; P=0.025). Similarly, AUROC for the STS score was lower in elderly versus younger patients (0.738 vs. 0.768; P=0.017). In elderly patients, EuroSCORE II and STS scores were not adequately calibrated and significantly underestimated mortality. Age was independently associated with mortality, regardless of EuroSCORE II or STS score. CONCLUSIONS: In this cohort, EuroSCORE II and STS scores did not perform as well in elderly patients as in younger patients. Elderly patients may be at increased postoperative risk, regardless of risk score.

Low Tidal Volume Mechanical Ventilation Against No Ventilation During Cardiopulmonary Bypass in Heart Surgery (MECANO): A Randomized Controlled Trial.

BACKGROUND: Postoperative pulmonary complications are common after cardiac surgery and have been related to lung collapse during cardiopulmonary bypass (CPB). No consensus exists regarding the effects of maintaining mechanical ventilation during CPB to decrease these complications. RESEARCH QUESTION: To determine whether maintaining low-tidal ventilation (3 mL/kg 5 times/min, with positive end expiratory pressure of 5 cm H2O) during CPB (ventilation strategy) was superior to a resting-lung strategy with no ventilation (no ventilation strategy) regarding postoperative pulmonary complications, including mortality. STUDY DESIGN AND METHODS: In a randomized controlled trial, patients undergoing cardiac surgery at a single center from May 2017 through August 2019 were randomized to the ventilation or no ventilation strategy during CPB (1:1 ratio). Apart from the CPB phase, perioperative ventilation procedures were standardized. RESULTS: The study included 1,501 patients (mean age, 68.8 ± 10.3 years; 1,152 (76.7%) men; mean EuroSCORE II, 2.3 ± 2.7). Seven hundred fifty-six patients were in the ventilation strategy group, and no differences existed in baseline characteristics and types of procedures between the two groups. An intention-to-treat analysis yielded no significant difference between the ventilation and no ventilation groups regarding incidence of the primary composite outcome combining death, early respiratory failure, ventilation support beyond day 2, and reintubation, with 112 of 756 patients (14.8%) in the ventilation group vs 133 of 745 patients (17.9%) in the no ventilation group (OR, 0.80; 95% CI, 0.61-1.05; P = .11). Strict per-protocol analyses of 1,338 patients (89.1%) with equally distributed preoperative characteristics yielded similar results (OR, 0.81; 95% CI, 0.60-1.09; P = .16). Post hoc analysis of the subgroup who underwent isolated coronary artery bypass graft procedures (n = 725) showed that the ventilation strategy was superior to the no ventilation strategy regarding the primary outcome (OR, 0.56; 95% CI, 0.37-0.84; P = .005). INTERPRETATION: Among patients undergoing cardiac surgery with CPB, continuation of low tidal volume ventilation was not superior to no ventilation during CPB with respect to postoperative complications, including death, early respiratory failure, ventilation support beyond day 2, and reintubation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03098524; URL: www.clinicaltrials.gov.

Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay.

BACKGROUND: The short-term and long-term consequences of the most frequent painful procedures performed in the ICU are unclear. This study aimed to identify the risk factors associated with pain-related discomfort perceived by critically ill patients during the whole ICU stay as self-reported by patients at the end of their ICU stay. METHODS: The study involved 34 ICUs. Adult patients who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Discomforts, including the pain-related discomfort, were assessed using the French 18-item questionnaire on discomfort in ICU patients, the "Inconforts des Patients de REAnimation" (IPREA). Patients scored each item from 0 (minimal discomfort) to 10 (maximal discomfort). Associations between patient characteristics at ICU admission, life support therapies and main potentially painful procedures performed during the ICU stay and pain-related discomfort scores assessed at the end of the ICU stay were analyzed. RESULTS: Patients with complete IPREA questionnaires (n = 2130) were included. The median pain-related discomfort score was 3 (IQR 0-5). From the univariate analysis, pain-related discomfort scores were negatively correlated with age and positively correlated with ICU stay duration; surgical patients reported significant higher pain-related discomfort scores than medical patients; chest drain insertion, chest drain removal, use of bladder catheter, central venous catheter (CVC) insertion, complex dressing change, and intra-hospital transport were associated with pain-related discomfort scores. From the multivariate analyses using generalized estimating equations models, only age, chest drain removal, use of a bladder catheter, CVC insertion, and intra-hospital transport were the main risk factors associated with pain-related discomfort scores. CONCLUSION: Patients who underwent chest drain removal, bladder catheter, CVC insertion, and intra-hospital transport during their ICU stay reported higher pain-related discomfort scores (with respect to the whole ICU stay and assessed at the end of their ICU stay) than patients who did not experience these events. This study may pave the way for further targeted studies aiming at investigating a causal link between these common procedures in the ICU and adult critically ill patients' perceptions of their ICU stay regarding recalled pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT02442934, retrospectively registered on May 13, 2015.

Effect of BNP on risk assessment in cardiac surgery patients, in addition to EuroScore II.

Patients' prognostication around cardiac surgery is key to better assess risk-benefit balance. Preoperative brain natriuretic peptide (BNP) biomarker has been associated with mortality after cardiac surgery, but its added value with EuroScore 2 remains to be confirmed. In a prospective registry cohort of 4,980 patients undergoing cardiac surgery, the prognostic performance of EuroScore 2 and preoperative BNP was assessed regarding postoperative in-hospital mortality. Discrimination feature was evaluated using receiver-operator-characteristics analysis with area under curve (AUROC). Calibration feature was assessed using Hosmer-Lemeshow test. Multivariable analysis was performed to assess the association between covariates and in-hospital mortality. In-hospital mortality was 3.7%. The AUROC of EuroScore 2 was 0.82 (95% confidence interval (95%CI) 0.79-0.85, p < 0.0001). The AUROC of BNP was 0.66 (95%CI 0.62-0.70, p < 0.0001). The combined model with an AUROC of 0.67 (95%CI 0.63-0.71, p = 0.0001) did not yield better AUROC than EuroScore 2 alone (p < 0.0001 in disfavor of the combined model), nor BNP alone (p = 0.79). In multivariable analysis, EuroScore 2 remained independently associated with mortality (adj.OR of 1.12 (1.10-1.14), p < 0.0001), but BNP was not. Preoperative BNP was not an independent risk factor of postoperative mortality and did not add prognostic information, as compared to EuroScore 2 alone.Clinical trial registry Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry (RIPOSTE) database (NCT03209674).

Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses.

OBJECTIVES: The aim of this study was to compare the incidence of permanent pacemaker (PPM) implantation after aortic valve replacement by rapid-deployment bioprosthesis (RDB) and standard valve (Standard). METHODS: All patients undergoing aortic valve replacement between 2015 and 2018, in 1 centre, were included. A multivariate analysis on the whole cohort and then a propensity score matching were used to compare the 2 groups. The primary end point was PPM implantation. RESULTS: We studied 924 patients (256 RDBs and 668 Standards). Overall, 67 PPM were implanted, 37 (14.5%) in the RDB group and 26 (3.9%) in the Standard group (P < 0.0001, univariate analysis). The multivariate analysis in the unmatched population found 4 independent factors associated with PPM implantation: right bundle branch block with odds ratios (ORs 3.7, 95% CI 2.9-6.7; P < 0.0001), RDB (OR 3.6, 95% CI 2.0-6.2; P < 0.0001), age (OR 1.1, 95% CI 1.0-1.1; P < 0.006) and endocarditis (OR 3.4, 95% CI 1.0-11.0; P < 0.04). In the propensity score-matched RDB group (203 patients per group), 25 patients required PPM implantation versus 3 in the Standard group (12.3% vs 1.5%, P < 0.0001). RDBs also had more postoperative left bundle branch block and new onset of atrial fibrillation (30.2% vs 5.1%, P < 0.0001 and 34.0% vs 24.1%, P = 0.029). RDBs had lower operating times (in min): aortic cross-clamping = 62 (44-76.5) vs 72 (57.5-91.5) and cardiopulmonary bypass = 81 (63-98.5) vs 91 (75-112), P < 0.0001. There was no significant difference in other outcomes. CONCLUSIONS: RDBs were associated with reduced operating times, increased risk of atrial fibrillation and PPM implantation as compared with standard aortic valves.

Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA.

BACKGROUND AND AIMS: We reported the validation of the 18-item version of the 'Inconforts des Patients de REAnimation (IPREA)' questionnaire that includes 2 new items exploring feeling depressed and shortness of breath during an intensive care unit (ICU) stay. METHODS: The validation process was integrated in a multicenter, cluster-randomized, controlled, two-parallel group study built to assess the effectiveness of a tailored multicomponent program for reducing self-perceived discomfort in the ICU. All patients aged 18 years or older who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Data collection included demographics (sex, age), type of admission (medical and surgical), health status scores at admission (Knaus score and McCabe index, Simplified Acute Physiology Score (SAPS) II), specific ICU therapeutics such as mechanical ventilation (MV), noninvasive ventilation (NIV), use of vasopressors, or renal replacement therapy (RRT), and ICU stay duration. RESULTS: A total of 994 patients were included. The initial structure of IPREA was confirmed using confirmatory factor analysis showing satisfactory fit (RMSEA at 0.042, CFI at 0.912). No multidimensional structure was identified, allowing the calculation of an overall discomfort score. The three highest discomforts were sleep deprivation, thirst, and perfusion lines and other devices, and the 3 lowest discomforts were limited visiting hours, hunger, and isolation. The overall discomfort score of the 18-item version of IPREA did not differ between men and women. Higher age was significantly correlated with a lower overall discomfort score. While MV was not linked to self-reported discomfort, patients treated by NIV reported higher overall discomfort scores than patients not treated by NIV. CONCLUSION: The 18-item version of IPREA is easy to use and possesses satisfactory psychometric properties. The availability of a reliable and valid French questionnaire asking about patients' self-perceived ICU discomforts enables feedback from the health care team to be incorporated in a continuous quality health care improvement strategy. TRIAL REGISTRATION: clinicaltrial.gov NCT02442934 (registration date: May 18, 2015, retrospectively registered).

Heart failure with preserved ejection fraction as an independent risk factor of mortality after cardiothoracic surgery.

BACKGROUND: The prognostic role of heart failure with preserved ejection fraction (HFpEF) remains unclear. This study aimed to assess HFpEF prognostic value after cardiothoracic surgery, adjusting for European System for Cardiac Operative Risk (EuroSCORE II) criteria. METHODS: Patients with left ventricular ejection fraction (LVEF) ≥ 50% undergoing cardiothoracic surgery between 2012 and 2016 were included. Patients with HFpEF were compared to control patients with LVEF ≥ 50%. HFpEF was defined following 2016 European Society of Cardiology guidelines: LVEF ≥ 50%, symptomatic HF with New York Heart Association (NYHA) class 2 or greater, elevated brain natriuretic peptide (BNP) and relevant echocardiographic findings (LV hypertrophy, LA enlargement, or diastolic filling anomaly). The primary endpoint was in-hospital mortality, and the secondary endpoint was postoperative shock. Multivariate analyses were performed to determine mortality and shock risk-factors. RESULTS: Among 1743 patients, 427 (24.5%) presented HFpEF. HFpEF was highly associated with in-hospital mortality (hazard ratio = 1.86; 95% confidence interval [CI], 1.16-2.98; P = .01). This association remained independent when adjusting for EuroSCORE II (adjusted hazard ratio = 1.6; 95% CI, 1.0-2.6; P = .049). Postoperative shock occurred more in HFpEF than in control patients (17.8% vs 6.7%; P < .001). HFpEF was an independent risk factor of postoperative shock (adjusted odds ratio = 2.9; 95% CI, 1.5-3.0; P < .001). CONCLUSIONS: HFpEF was an independent risk-factor of mortality and postoperative shock after cardiothoracic surgery, after adjustment regarding EuroSCORE II.

Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. DESIGN: The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen <200 mmHg at 1 hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. DISCUSSION: The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, with a primary composite outcome including death, respiratory failure and postoperative pneumonia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03098524 . Registered on 27 February 2017.

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial.

PURPOSE: Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. METHODS: In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. RESULTS: During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. CONCLUSIONS: This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT02442934.

Frequency of Recovery from Complete Atrioventricular Block After Cardiac Surgery.

Best timing for permanent pacemaker implantation to treat complete atrioventricular block (AVB) after cardiac surgery is unclear, as late pacemaker dependency was found low in recent observational studies. This study aimed to identify factors associated with spontaneous recovery from AVB. In a prospective and observational cohort, all patients who underwent cardiothoracic surgery during a 14-month-period were included (n = 1,200). Risk factors of postoperative AVB were assessed by logistic regression. Among patients who developed AVB, variables associated with recovery from AVB were assessed by Cox and logistic regression. Overall incidence of postoperative AVB was 6.0%. Risk factors of AVB were age (OR 1.03 [1.00 to 1.06], p = 0.023); female gender (OR 2.06 [1.24 to 3.41], p = 0.005), active endocarditis (OR 3.31 [1.33 to 8.26], p = 0.01), and aortic valve replacement (OR 3.17 [1.92 to 5.25], p <0.001). Among aortic valve replacement, sutureless aortic valve replacement was associated with more AVB (26.7% vs 8.1%, p <0.01). Recovery from AVB occurred in 30 patients (41.7%) in a median period of 3 days [interquartile range = 1;5]. Among patients who would recover from AVB, 90% of patients did so before day 7. None of the studied variable was independently associated with recovery from AVB. In conclusion, identified risk factors of postoperative AVB after cardiac surgery were age, female gender, endocarditis, and aortic valve replacement. Because most patients who would recover did so before day 7, this study validates modern guidelines suggesting permanent pacemaker implantation on day 7.