Cost Analysis of Aprotinin Reintroduction in French Cardiac Surgery Centres: A Real-World Data-Based Analysis

International audienceIntroduction: The European Medicines Agency restored aprotinin (APR) use for preventing blood loss in patients undergoing isolated coronary artery bypass graft (iCABG) in 2016 but requested the collection of patient and surgery data in a registry (NAPaR). The aim of this analysis was to evaluate the impact of APR reintroduction in France on the main hospital costs (operating room, transfusion and intensive unit stay) compared to the current use of tranexamic acid (TXA), which was the only antifibrinolytic available before APR reinstatement.Methods: A multicenter before-after post-hoc analysis to compare APR and TXA was carried out in four French university hospitals. APR use followed the ARCOTHOVA (French Association of Cardiothoracic and Vascular Anesthetists) protocol, which had framed three main indications in 2018. Data from 236 APR patients were retrieved from the NAPaR (N = 874); 223 TXA patients were retrospectively retrieved from each center database and matched to APR patients upon indication classes. Budget impact was evaluated using both direct costs associated with antifibrinolytics and transfusion products (within the first 48 h) and other costs such as surgery duration and ICU stay.Results: The 459 collected patients were distributed as: 17% on-label; 83% off-label. Mean cost per patient until ICU discharge tended to be lower in the APR group versus the TXA group, which resulted in an estimated gross saving of €3136 per patient. These savings concerned operating room and transfusion costs but were mainly driven by reduced ICU stays. When extrapolated to the whole French NAPaR population, the total savings of the therapeutic switch was estimated at around €3 million.Conclusion: The budget impact projected that using APR according to ARCOTHOVA protocol resulted in decreased requirement for transfusion and complications related to surgery. Both were associated with substantial cost savings from the hospital’s perspective compared with exclusive use of TXA

Non-steroidal anti-inflammatory drugs use in cardiac surgery: A survey of practices and new insights for future studies

International audienc

Is the EuroSCORE II reliable to estimate operative mortality among octogenarians?

<div><p>Objectives</p><p>Concerns have been raised about the predictive performance (PP) of the EuroSCORE I (ES I) to estimate operative mortality (OM) of patients aged ≥80. The EuroSCORE II (ES II) has been described to have better PP of OM but external validations are scarce. Furthermore, the PP of ES II has not been investigated among the octogenarians. The goal of the study was to compare the PP of ES II and ES I among the overall population and patients ≥ 80.</p><p>Methods</p><p>The ES I and ES II were computed for 7161 consecutive patients who underwent major cardiac surgery in a 7-year period. Discrimination was assessed by using the c- index and calibration with the Hosmer-Lemeshow (HL) and calibration plot by comparing predicted and observed mortality.</p><p>Results</p><p>From the global cohort of 7161 patients, 832 (12%) were ≥80. The mean values of ES I and ES II were 7.4±9.4 and 5.2±9.1 respectively for the whole cohort, 6.3±8.6 and 4.7±8.5 for the patients <80, 15.1±11.8 and 8.5±11.0 for the patients ≥80. The mortality was 9.38% (≥80) versus 5.18% (<80). The discriminatory power was good for the two algorithms among the whole population and the <80 but less satisfying among the ≥80 (AUC 0.64 [0.58–0.71] for ES I and 0.67 [0.60–0.73] for the ES II without significant differences (p = 0.35) between the two scores. For the octogenarians, the ES II had a fair calibration until 10%-predicted values and over-predicted beyond.</p><p>Conclusions</p><p>The ES II has a better PP than the ES I among patients <80. Its discrimination and calibration are less satisfying in patients ≥80, showing an overestimation in the elderly at very high-surgical risk. Nevertheless, it shows an acceptable calibration until 10%- predicted mortality.</p></div

Postoperative Cardiac Troponin I Thresholds Associated With 1-Year Cardiac Mortality After Adult Cardiac Surgery: An Attempt to Link Risk Stratification With Management Stratification in an Observational Study

International audienceObjectives: Cardiac troponin (cTn) concentrations are measured routinely in some centers after cardiac surgery as part of risk stratification, but there are no data on how increased cTn concentrations could change patients' management. The aim of this study was to estimate relevant cTnI thresholds and identify potential interventions (additional monitoring/therapeutic interventions) that could be part of management changes of patients with cTnI greater than relevant thresholds.Design: Retrospective, single-center, observational study.Setting: Bichat-Claude Bernard Hospital, Paris, France, between January 1, 2009, and December 31, 2012.Participants: Consecutive adult patients undergoing cardiac surgery.Measurements and main results: cTnI was measured on the 20th postoperative hour. Causes of death and possible interventions were determined by analysis of individual medical records. cTnI thresholds for 1-year cardiac mortality with a specificity >80% were calculated. For this study, 3,228 procedures were analyzed; 129 deaths occurred (4%), 83 of which (2.6%) were cardiac deaths. Threshold cTnI values were 4.2 µg/L for coronary artery bypass grafting (95% confidence interval [CI] 3.9-4.5) and 10.7 µg/L for non-coronary artery bypass grafting (95% CI 10.0-11.3). In multivariable analysis, the EuroSCORE II (odds ratio 1.1 [95% CI 1.06-1.13]; p < 0.001) and cTnI concentrations greater than the thresholds (odds ratio 5.62 [95% CI 3.37-9.37]; p < 0.001) were associated with significantly increased risk of death. The additive and absolute Net Reclassification Index were 0.288% and 14.1%, respectively, for a logistic model including cTnI and EuroSCORE II (area under the curve C-index 0.82 [95% CI 0.77-0.87]) compared with a model including only EuroSCORE II (area under the curve C-index 0.80 [95% CI 0.75-0.84]). Fifty-three of the 83 patients who experienced cardiac death (64%) had a cTnI concentration greater than the threshold, and an intervention was deemed possible in 47 of those 53 (89%) (mostly patients with mild postoperative cardiac dysfunction). For noncardiac deaths, 28% of patients had a cTnI concentration greater than the threshold and no interventions were deemed possible.Conclusions: In an attempt to evolve from risk to management stratification, this study's results identified a subgroup of patients with mild cardiac dysfunction and a cTnI concentration greater than the threshold who could be the target for interventions in future validation studies concerning changes in patient management

Observed and predicted mortality of the study population.

<p>Observed and predicted mortality of the study population.</p

Calibration of ES I and ES II for in-hospital mortality among the overall population and according to age.

<p>Calibration of ES I and ES II for in-hospital mortality among the overall population and according to age.</p

Discrimination for in-hospital mortality among the overall population and according to age.

<p>Discrimination for in-hospital mortality among the overall population and according to age.</p

Rapid Occurrence of Chronic Kidney Disease in Patients Experiencing Reversible Acute Kidney Injury after Cardiac Surgery

International audienceBackground: There is recent evidence to show that patients suffering from acute kidney injury are at increased risk of devel-oping chronic kidney disease despite the fact that surviving tubular epithelial cells have the capacity to fully regenerate renal tubules and restore renal function within days or weeks. The aim of the study was to investigate the impact of acute kidney injury on de novo chronic kidney disease.Methods: The authors conducted a retrospective population-based cohort study of patients initially free from chronic kidney disease who were scheduled for elective cardiac surgery with cardiopulmonary bypass and who developed an episode of acute kidney injury from which they recovered. The study was conducted at two French university hospitals between 2005 and 2015. These individuals were matched with patients without acute kidney injury according to a propensity score for develop-ing acute kidney injury.Results: Among the 4,791 patients meeting the authors’ inclusion criteria, 1,375 (29%) developed acute kidney injury and 685 fully recovered. Propensity score matching was used to balance the distribution of covariates between acute kidney injury and non- acute kidney injury control patients. Matching was possible for 597 cases. During follow-up, 34 (5.7%) had reached a diagnosis of chronic kidney disease as opposed to 17 (2.8%) in the control population (hazard ratio, 2.3; bootstrapping 95% CI, 1.9 to 2.6).Conclusions: The authors’ data consolidate the recent paradigm shift, reporting acute kidney injury asa strong risk factor for the rapid development of chronic kidney disease

Calibration plots for the two models, for the entire population (Fig 2A) and the two studied groups (Fig 2B: ≥80 and Fig 2C: <80).

<p>Calibration plots for the two models, for the entire population (Fig 2A) and the two studied groups (Fig 2B: ≥80 and Fig 2C: <80).</p