Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery.
In a multicenter, randomized, placebo-controlled, ...phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 μg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 μg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5.
A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval CI, 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups.
Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).
Landiolol is an ultrashort-acting beta-blocker with high beta-1 receptor affinity and less blood pressure–lowering properties than other beta-blockers available for intravenous use in Germany. The ...present analysis aimed to determine whether perioperative treatment with landiolol in cardiac surgical patients is cost-effective under the conditions of the German Diagnosis-Related Groups health cost reimbursement system.
On the basis of clinical outcome data from a meta-analysis that included 622 patients from 7 randomized controlled trials, a decision-model was developed to determine the cost-effectiveness of landiolol versus standard-of-care (SoC).
Hospital setting.
Hospital patients undergoing a representative mix of cardiac surgical procedures (MIX-CS) and isolated coronary artery bypass grafting (CABG).
Landiolol versus SoC in prevention of atrial fibrillation immediately after cardiac surgery.
The model benefit was expressed in a reduction of postoperative atrial fibrillation (POAF) episodes and reduced complications. The model calculated total inpatient costs over the hospital length of stay. Costs from published sources were used for the German hospital perspective. SoC was associated with POAF rates of 36.0% to 39.2% and 24.4% to 30.1% in the MIX-CS and CABG populations, respectively. Patients with POAF had a higher morbidity and mortality. Estimated total costs for SoC patients in the MIX-CS and CABG groups were 28.792 € and 25.630 €, respectively. Landiolol reduced the incidence of POAF to 12.6% in the MIX-CS and 12.1% in the CABG groups. This was associated with a cost reduction of 2.209 € and 1.470 €.
This analysis suggests that preventing POAF with landiolol is highly cost-effective. Additional studies are needed to assess whether a comparable reduction in POAF and associated cost savings may be achieved using conventional intravenous beta-blockers or amiodarone.
This article is one of ten reviews selected from the Annual Update in Intensive Care and Emergency Medicine 2021. Other selected articles can be found online at ...https://www.biomedcentral.com/collections/annualupdate2021 . Further information about the Annual Update in Intensive Care and Emergency Medicine is available from https://link.springer.com/bookseries/8901 .
The current study was designed to determine the relation between preoperative cerebral oxygen saturation (Sco2), variables of cardiopulmonary function, mortality, and morbidity in a heterogeneous ...cohort of cardiac surgery patients.
In this study, 1,178 consecutive patients scheduled for on-pump surgery were prospectively studied. Preoperative Sco2, demographics, N-terminal pro-B-type natriuretic peptide, high-sensitive troponin T, clinical outcomes, and 30-day and 1-yr mortality were recorded.
Median additive EuroSCORE was 5 (range: 0-19). Thirty-day and 1-yr mortality and major morbidity (at least two major complications and/or a high-dependency unit stay of at least 10 days) were 3.5%, 7.7%, and 13.3%, respectively. Median minimal preoperative oxygen supplemented Sco2 (Sco2min-ox) was 64% (range: 15-92%). Sco2min-ox was correlated (all: P value <0.0001) with N-terminal pro-B-type natriuretic peptide (ρ: -0.35), high-sensitive troponin T (ρ: -0.28), hematocrit (ρ: 0.34), glomerular filtration rate (ρ: 0.19), EuroSCORE (τ: 0.20), and left ventricular ejection fraction class (τ: 0.12). Thirty-day nonsurvivors had a lower Sco2min-ox than survivors (median 58% 95% CI, 50.7-62% vs. 64% 95% CI, 64-65%; P < 0.0001). Receiver-operating curve analysis of Sco2min-ox and 30-day mortality revealed an area-under-the-curve of 0.71 (95% CI, 0.68-0.73%; P < 0.0001) in the total cohort and an area-under-the-curve of 0.77 (95% CI, 0.69-0.86%; P < 0.0001) in patients with a EuroSCORE more than 10. Logistic regression based on different EuroSCORE categories (0-2; 3-5, 6-10, >10), Sco2min-ox, and duration of cardiopulmonary bypass showed that a Sco2min-ox equal or less than 50% is an independent risk factor for 30-day and 1-yr mortality.
Preoperative Sco2 levels are reflective of the severity of cardiopulmonary dysfunction, associated with short- and long-term mortality and morbidity, and may add to preoperative risk stratification in patients undergoing cardiac surgery.
Levosimendan is a calcium sensitizer and adenosine triphosphate-dependent potassium channel opener, which exerts sustained hemodynamic, symptomatic, and organ-protective effects. It is registered for ...the treatment of acute heart failure, and when inotropic support is considered appropriate. In the past 15 years, levosimendan has been widely used in clinical practice and has also been tested in clinical trials to stabilize at-risk patients undergoing cardiac surgery. Recently, 3 randomized, placebo-controlled, multicenter studies (LICORN, CHEETAH, and LEVO-CTS) have been published reporting on the perioperative use of levosimendan in patients with compromised cardiac ventricular function. Taken together, many smaller trials conducted in the past suggested beneficial outcomes with levosimendan in perioperative settings. By contrast, the latest 3 studies were neutral or inconclusive. To understand the reasons for such dissimilarity, a group of experts from Austria, Belgium, Finland, France, Germany, Italy, Switzerland, and Russia, including investigators from the 3 most recent studies, met to discuss the study results in the light of both the previous literature and current clinical practice. Despite the fact that the null hypothesis could not be ruled out in the recent multicenter trials, we conclude that levosimendan can still be viewed as a safe and effective inodilator in cardiac surgery.
Postoperative delirium is an important problem in patients undergoing major surgery. Cerebral oximetry is a non-invasive method to detect imbalances in the cerebral oxygen supply/demand-ratio. Low ...preoperative cerebral oxygen saturation (ScO₂) levels have been associated with postoperative delirium in non-cardiac surgery patients. The present prospective observational study determines the relationship between pre- and intra-operative ScO₂ levels and postoperative delirium in patients undergoing on-pump cardiac surgery.
After approval of the local ethical committee and written informed consent, N = 231 patients scheduled for elective/urgent cardiac surgery were enrolled. Delirium was assessed by the confusion-assessment-method for the intensive care unit (CAM-ICU) on the first three days after surgery. ScO₂ was obtained on the day before surgery, immediately before surgery and throughout the surgical procedure. Preoperative cognitive function, demographic, surgery related, and intra- and post-operative physiological data were registered.
Patients with delirium had lower pre- and intra-operative ScO₂ readings, were older, had lower mini-mental-status-examination(MMSE) scores, higher additive EuroScore and lower preoperative haemoglobin-levels. The binary logistic regression identified older age, lower MMSE, neurological or psychiatric disease and lower preoperative ScO₂ as independent predictors of postoperative delirium.
The presented study shows that a low preoperative ScO₂ is associated with postoperative delirium after on-pump cardiac surgery.
Preoperative implantation of an intra-aortic balloon pump has been shown to reduce mortality in high-risk cardiac surgery cases. However, one main contraindication for its use is severe aortic ...regurgitation. We describe a case of safe and beneficial use in a patient presenting with moderate to severe aortic regurgitation and highly reduced ejection fraction undergoing aortic valve replacement.
Objectives This study sought to determine the usefulness of plasma growth differentiation factor 15 (GDF-15) for risk stratification in patients undergoing cardiac surgery in comparison with the ...additive European System of Cardiac Operative Risk Evaluation (EuroSCORE), N-terminal pro–B-type natriuretic peptide (NTproBNP), and high-sensitive troponin T (hsTNT). Background GDF-15 is emerging as a humoral marker for risk stratification in cardiovascular disease. No data are available if this marker may also be used for risk stratification in cardiac surgery. Methods In total, 1,458 consecutive patients were prospectively studied. Pre-operative plasma GDF-15, NTproBNP, hsTNT, clinical outcomes, and 30-day and 1-year mortality were recorded. GDF-15 was determined with a pre-commercial electrochemiluminescence immunoassay. Results Median additive EuroSCORE (addES) was 5 (interquartile range: 3 to 8); 30-day and 1-year mortality were 3.4% and 7.6%, respectively. Median GDF-15 levels were 1.04 ng/ml (95% confidence interval CI: 1.0 to 1.07 ng/ml) in 30-day survivors and 2.62 ng/ml (95% CI: 1.88 to 3.88) in 30-day nonsurvivors (p < 0.0001). C-statistics showed that the area under the curve of a combined model of GDF-15 and addES for 30-day mortality was significantly greater (0.85 vs. 0.81; p = 0.0091) than of the addES alone. For the EuroSCORE categories (0 to 2, 3 to 5, 6 to 10, >10) the presence of GDF-15 ≥1.8 ng/ml resulted in a significant 41.4% (95% CI: 19.2 to 63.7%; p < 0.001) net reclassification improvement and an integrated discrimination improvement of 0.038 (95% CI: 0.022 to 0.0547; p < 0.0001) compared to the model including only the addES, whereas the presence of NTproBNP (cutoff ≥2,000 pg/ml) or hsTNT (cutoff 14 pg/ml) did not result in significant reclassification. Conclusions The pre-operative plasma GDF-15 level is an independent predictor of post-operative mortality and morbidity in cardiac surgery patients, can further stratify beyond established risk scores and cardiovascular markers, and thus adds important additional information for risk stratification in these patients. (The Usefulness of Growth Differentiation Factor 15 GDF-15 for Risk Stratification in Cardiac Surgery; NCT01166360 ).
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