High-risk Cardiac Surgery Patients Research Articles

Right anterolateral thoracotomy as an alternative approach to resternotomy for high-risk cardiac surgery patients

Right anterolateral thoracotomy as an alternative approach to resternotomy for high-risk cardiac surgery patients

Preoperative intra-aortic balloon pump inserted in acute myocardial infarction patients without cardiogenic shock undergoing surgical coronary revascularization.

The benefit of preoperative intra-aortic balloon pump implantation in high-risk cardiac surgery patients is still debated. The role of preoperative intra-aortic balloon pump insertion in acute myocardial infarction patients without cardiogenic shock undergoing off-pump coronary artery bypass grafting remains unknown. This study aimed to determine the efficacy and safety of the preoperative intra-aortic balloon pump insertion in those patients undergoing off-pump coronary artery bypass grafting. A total of 421 consecutive acute myocardial infarction patients without cardiogenic shock who underwent isolated off-pump coronary artery bypass grafting were enrolled in this retrospective observational propensity score-matched analysis study. Patients who received intra-aortic balloon pump before off-pump coronary artery bypass grafting (the intra-aortic balloon pump group, n = 157) were compared with those who had not (control group, n = 264). The 30-day postoperative survival, postoperative complications, and postoperative hospital length of stay were compared between the two groups. A total of 99 pairs of patients were matched. The preoperative intra-aortic balloon pump did not show a 30-day postoperative survival benefit compared with the control group (hazard ratio, 0.9; 95% confidence interval, 0.2-4.2; p = 0.92). Patients with preoperative intra-aortic balloon pump were more likely to have shorter postoperative lengths of stay (8 (6-11) days vs. 10 (6-15) days, p = 0.02) and decreased total days in the hospital (median days: 18.2 vs. 21.8, p = 0.02) compared to patients without balloon pumps. Preoperative intra-aortic balloon pump insertion in acute myocardial infarction patients without cardiogenic shock undergoing off-pump coronary artery bypass grafting improved convalescence as shown by significantly shorter postoperative lengths of hospital stay.

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Outcomes with intra-aortic balloon pump in high risk cardiac surgery patients

ABSTRACT Introduction: In high-risk cardiac surgical patients the intra-aortic balloon pump (IABP) is the most frequent used tool for temporary mechanical circulatory support during the perioperative phase. The effects of IABP are an increase in diastolic blood pressure, an improvement in coronary perfusion and a reduction of ventricular afterload, so it increases the stroke volume and cardiac output. Objective: To study the effect of preoperative use of intra-aortic balloon pump (IABP) on the outcome of high-risk patients that were subjected to coronary artery bypass graft (CABG) surgery. Methods: From June 2009 to June 2011. Group of 100 patients considered as high-risk patients were subjected to elective bypass cardiac surgery at our center. Forty patients subjected to preoperative IABP as a prophylactic measure and 60 patients were not subjected to IABP. This is retrospective study of prospectively collected data .The definition of High risk was the presence of two or more known risk factors. The patient’s outcome is compared regarding the predicted mortality of the Euro SCORE. The preoperative effect of IABP on the outcome, mortality and 30 days follow-up was statistically analyzed. Results: Forty patients subjected to preoperative IABP as prophylactic measure due to higher Euro SCORE-predicted mortality than other 60 patients did not subject to IABP(60% vs 40 %, P = ˂0.05). Seventy patients (70%) were male while (30%) were female with a mean age of 58.62 ± 9.65 years. Patients subjected to preoperative IABP had increased a percentage of hospital mortality (P = ˂0.05) but this percentage is relatively lower than predicted by Euro SCORE. Patients subjected to preoperative IABP had lower rate of postoperative complication (acute kidney insult (P = 0.045), cardiac surgical intensive care unit (CSICU) stay (P = 0.032) and decrease the need for postoperative inotrope (P = 0.046)) compared to patients without preoperative IABP use. Other complications postoperative were low and similar in both groups. Conclusions: We conclude that patients have high-risk CABG, the preoperative IABP in this group with higher predicted mortality was associated with a relative reduction than predicted by Euro score. The preoperative IABP in this group has a reliable and acceptable outcome on postoperative complications. Keywords: intra-aortic balloon pump, High Risk, Cardiac Surgery

3081 Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients with High Flow Nasal Cannula

OBJECTIVES/SPECIFIC AIMS: More than half a million adult patients nationally undergo cardiac surgery each year. Reintubation following cardiac surgery is common and associated with higher short- and long-term mortality, increased cost, and longer lengths of stay. The reintubation incidence is estimated at 5-10%. Patients undergoing cardiac surgery are increasing in age and comorbidity burden, and receive increasingly complex cardiac surgical procedures, complicating decision making around when to extubate postoperative patients. Compounding this complexity are financial pressures to maintain high throughput and maximize ICU bed availability. Providers are often compelled to extubate high-risk patients earlier, despite the potential for an increased risk of reintubation. Understanding the risk factors for reintubation after cardiac surgery and identifying effective interventions to reduce these reintubations is of critical importance to optimize patient outcomes. High-flow nasal cannula (HFNC) provides up to 60 liters per minute of 100% oxygen, dead space washout, and humidification to improve secretion clearance, and has shown some benefits in improving hypoxia and reducing reintubation in select populations. However, its benefit in high-risk patients undergoing cardiac surgical procedures is not known and therefore clinicians may still be reluctant to extubate these patients early and introduce HFNC, despite the known risks of prolonged intubation. To address this important issue, we aim to develop and validate a model to predict postoperative reintubation after cardiac surgery using data readily available from the electronic health record (EHR) and use this data to complete a pilot randomized controlled trial (RCT) of post-extubation HFNC to prevent reintubation in cardiac surgery patients identified as at high risk for reintubation. METHODS/STUDY POPULATION: Based on retrospective data demonstrating a 4.7% reintubation incidence within 48 hours in our CVICU, we estimate that there will be 340 reintubations available for analysis of the risk factors for reintubation to develop our predictive model from November 2, 2017 (our EHR go-live). We require 15 events per predictive variable to avoid overfitting the model, giving us at least 22 variables for analysis and inclusion in the model. Model validation and calibration will be performed using a bootstrapped validation cohort. Next, we will prospectively study 120 patients with a greater than 10% predicted risk of reintubation (double the baseline risk of the overall population) and randomly assign them to either HFNC or usual care, to test the hypothesis that HFNC decreases the rate of reintubation in high-risk patients. RESULTS/ANTICIPATED RESULTS: In addition to developing a predictive model, refining it, and validating its ability to predict the primary outcome of reintubation within 48 hours, I will further assess whether HFNC reduces total duration of mechanical ventilation, hospital length of stay, and ICU length of stay in this high-risk population. I will use these data to establish the feasibility of EHR-integrated predictive modeling and randomization, as well as to guide a future multicenter clinical trial that will pragmatically leverage the EHR for patient selection, enrollment, randomization, and data collection. DISCUSSION/SIGNIFICANCE OF IMPACT: Assuming HFNC decreases reintubation rates by 50%, at a 1:1 ratio of cases to controls, we will require 435 patients in each group (970 total), to have an 80% power and alpha of 0.05 to detect a difference. As this will require a multicenter study, we will instead focus on using data from this pilot study to: 1) refine our sample size estimates. 2) demonstrate the feasibility of our novel EHR-integrated pragmatic trial design. 3) identify and screen collaborators at other institutions, including obtaining important regulatory and legal approval. 4) establish a data safety monitoring board for the trial. 5) refine the data collection infrastructure, leveraging commercially available resources in one of the largest enterprise EHR systems (Epic) and associated resource-sharing products, such as Epic’s App Orchard.

Supplemental immune globulins in sepsis: a critical appraisal

For 'the total population of patients with sepsis, sepsis syndrome or SIRS', the question of whether intravenous immune globulin (IVIG) reduces mortality is neither proved nor disproved. For the sepsis subgroups 'postoperative sepsis with a sepsis score more than 19' and 'endotoxaemic, early septic shock', a significant reduction in mortality by IVIG has been documented in a single, placebo-controlled, small trial of each subgroup; subsequent studies are needed for confirmation. The incidence of some severe infections in defined 'patients at risk' and 'operations at risk' is lowered by IVIG prophylaxis. Postoperative APACHE II-score identification of high-risk cardiac surgery patients prone to sepsis and severe SIRS may represent one approach to optimize individual, early therapy. Applying this concept to immune globulin treatment in a pilot study, the administration of IgG-IVIG and IgGMA-IVIG yielded similar results.

Perioperative point of care platelet function testing and postoperative blood loss in high-risk cardiac surgery patients

Postoperative coagulopathic bleeding is common in cardiac surgery and associated with increased morbidity and mortality. Platelet function is affected by multiple factors, including patient and procedural characteristics. Point-of-care (POC) multiple electrode aggregometry (MEA) can rapidly detect and quantify platelet dysfunction and could contribute to optimal patient blood management.In patients undergoing CABG and heart valve surgery platelet function was assessed using POC MEA at four different perioperative timepoints in response to stimulation with four specific receptor agonists (ADP, AA, COL, TRAP). Postoperative bleeding was recorded during 24 h after surgery. Regression analyses were performed to establish associations between perioperative platelet function and postoperative blood loss.Ninety-nine patients were included in the study. Fifty-nine patients (60%) were on antiplatelet therapy (APT) at time of surgery. ADP- and AA-induced platelet aggregation declined during CPB and after decannulation from CPB, with a maximum decrease of 55% for ADP (35 vs. 77 AU at baseline; P < 0.001) and 78% for ASPI (14 vs. 64 AU at baseline; P < 0.001). A linear relationship was present between ADP-induced platelet aggregometry at baseline and postoperative blood loss (r = −0.249; P = 0.015). In aspirin users, the maximum decline in platelet function between baseline and CPB decannulation was related to postoperative blood loss (r = 0.308; P = 0.037). In multivariate analysis, a reduced ADP platelet function prior to surgery remained associated with postoperative blood loss (r = −0.239; P = 0.012).Reduced ADP-induced platelet aggregation at baseline is associated with increased postoperative blood loss in high-risk cardiac surgery patients.

Which Transfusion Strategy for High-Risk Cardiac Surgery Patients?

In the international Transfusion Requirements in Cardiac Surgery (TRICS) III trial (NCT02042898), a restrictive red-cell transfusion strategy was shown

Effect of a Perioperative Intra-Aortic Balloon Pump in High-Risk Cardiac Surgery Patients: A Randomized Clinical Trial.

The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. Heart Institute of São Paulo University. High-risk patients undergoing elective coronary artery bypass surgery. Patients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use. The primary outcome was a composite endpoint of 30-day mortality and major morbidity (cardiogenic shock, stroke, acute renal failure, mediastinitis, prolonged mechanical ventilation, and a need for reoperation). A total of 181 patients (mean [SD] age 65.4 [9.4] yr; 32% female) were randomized. The primary outcome was observed in 43 patients (47.8%) in the intra-aortic balloon pump group and 42 patients (46.2%) in the control group (p = 0.46). The median duration of inotrope use (51 hr [interquartile range, 32-94 hr] vs 39 hr [interquartile range, 25-66 hr]; p = 0.007) and the ICU length of stay (5 d [interquartile range, 3-8 d] vs 4 d [interquartile range, 3-6 d]; p = 0.035) were longer in the intra-aortic balloon pump group than in the control group. A meta-analysis of 11 randomized controlled trials confirmed a lack of survival improvement in high-risk cardiac surgery patients with perioperative intra-aortic balloon pump use. In high-risk patients undergoing cardiac surgery, the perioperative use of an intra-aortic balloon pump did not reduce the occurrence of a composite outcome of 30-day mortality and major complications compared with usual care alone.

Prophylaxis of postoperative nausea and vomiting after cardiac surgery in high-risk patients: A randomized controlled study.

Context:The role of prophylaxis for postoperative nausea and vomiting (PONV) in cardiac surgery is under debate.Aims:To study the risk factors for PONV after cardiac surgery and the role of betamethasone with or without droperidol for its prevention.Setting and Design:Randomized open-label controlled study comparing standard care with PONV prophylaxis from February to November 2016.Methods:Five hundred and two patients with planned nonemergent cardiac surgery were included. Interventions: In the intervention arm, PONV prophylaxis (4 mg betamethasone with/without 0.625 mg droperidol) was administered in high-risk patients (two or more risk factors). Patients in the control arm were treated as per routine hospital practices.Results:Female sex, past history of PONV, and migraines were associated with a significantly increased risk of PONV, while motion sickness, smoking status, and volatile anesthetics were not. Pain and treatment with nefopam or ketoprofen were associated with an increased risk of PONV. PONV was less frequent in the active arm compared to controls (45.5% vs. 54.0%, P = 0.063; visual analogic scale 10.9 vs. 15.3 mm, P = 0.043). Among the 180 patients (35.6%) with ≥2 risk factors, prophylaxis was associated with reduced PONV (intention-to-treat: 46.8% vs. 67.8%, P = 0.0061; per-protocol: 39.2% vs. 69%, P = 0.0002). In multivariate analysis, prophylaxis was independently associated with PONV (odds ratio [OR]: 0.324, 95% confidence interval: 0.167–0.629, P = 0.0009), as were female sex, past history of PONV, and migraines (OR: 3.027, 3.031, and 2.160 respectively). No drug-related side effects were reported.Conclusion:Betamethasone with/without droperidol was effective in decreasing PONV in high risk cardiac surgical patients without any side effect.

Levosimendan Reduces Mortality and Postoperative Acute Kidney Injury in High-Risk Cardiac Surgery Patients: A Meta-analysis of 3,130 Patients

Levosimendan Reduces Mortality and Postoperative Acute Kidney Injury in High-Risk Cardiac Surgery Patients: A Meta-analysis of 3,130 Patients

Levosimendan for patients with severely reduced left ventricular systolic function and/or low cardiac output syndrome undergoing cardiac surgery: a systematic review and meta-analysis

BackgroundPrevious studies have shown beneficial effects of levosimendan in high-risk patients undergoing cardiac surgery. Two large randomized controlled trials (RCTs), however, showed no advantages of levosimendan.MethodsWe performed a systematic review and meta-analysis (MEDLINE and Embase from inception until March 30, 2017), investigating whether levosimendan offers advantages compared with placebo in high-risk cardiac surgery patients, as defined by preoperative left ventricular ejection fraction (LVEF) ≤ 35% and/or low cardiac output syndrome (LCOS). The primary outcomes were mortality at longest follow-up and need for postoperative renal replacement therapy (RRT). Secondary postoperative outcomes investigated included myocardial injury, supraventricular arrhythmias, development of LCOS, acute kidney injury (AKI), duration of mechanical ventilation, intensive care unit and hospital lengths of stay, and incidence of hypotension during drug infusion.ResultsSix RCTs were included in the meta-analysis, five of which investigated only patients with LVEF ≤ 35% and one of which included predominantly patients with LCOS. Mortality was similar overall (OR 0.64 [0.37, 1.11], p = 0.11) but lower in the subgroup with LVEF < 35% (OR 0.51 [0.32, 0.82], p = 0.005). Need for RRT was reduced by levosimendan both overall (OR 0.63 [0.42, 0.94], p = 0.02) and in patients with LVEF < 35% (OR 0.55 [0.31, 0.97], p = 0.04). Among secondary outcomes, we found lower postoperative LCOS in patients with LVEF < 35% receiving levosimendan (OR 0.49 [0.27, 0.89], p = 0.02), lower overall AKI (OR 0.62 [0.42, 0.92], p = 0.02), and a trend toward lower mechanical support, both overall (p = 0.07) and in patients with LVEF < 35% (p = 0.05).ConclusionsLevosimendan reduces mortality in patients with preoperative severely reduced LVEF but does not affect overall mortality. Levosimendan reduces the need for RRT after high-risk cardiac surgery.

Adding vancomycin to perioperative prophylaxis decreases deep sternal wound infections in high-risk cardiac surgery patients.

Perioperative prophylaxis with cephalosporins reduces sternal wound infections (SWIs) after cardiac surgery. However, more than 50% of coagulase-negative staphylococci, an important pathogen, are cephalosporin resistant. The aim of this study was to determine the impact of adjunctive vancomycin on SWIs in high-risk patients. We conducted a pre- and postintervention study in an academic hospital. Preintervention (2010-2011), all patients received prophylaxis with 1.5 g of cefuroxime for 48 h. During the intervention period (2012-2013), high-risk patients additionally received 1 g of vancomycin. High-risk status was defined as body mass index ≤18 or ≥ 30 kg/m2, reoperation, renal failure, diabetes mellitus, chronic obstructive pulmonary disease or immunosuppressive medication. Time series analysis was performed to study SWI trends and logistic regression to determine the effect of adding vancomycin adjusting for high-risk status. A total of 3902 consecutive patients (n = 1915 preintervention and n = 1987 postintervention) were included, of which 1493 (38%) patients were high-risk patients. In the high-risk group, 61 of 711 (8.6%) patients had SWI before and 30 of 782 (3.8%) patients after the intervention. Focusing on deep SWI (DSWI), 33 of 711 (4.6%) patients had DSWI before and 13 of 782 (1.7%) patients afterwards; the absolute risk difference of 2.9% yielded a number-needed-to-treat of 34 to prevent 1 DSWI. Corrected for high-risk status, adding vancomycin significantly reduced the overall SWI rate (odds ratio 0.42, 95% confidence interval 0.26-0.67; P < 0.001) and the subset of DSWI (odds ratio 0.30, 95% confidence interval 0.14-0.62; P = 0.001). The rate of SWI in low-risk patients remained unchanged. Adding vancomycin to standard antibiotic prophylaxis in high-risk patients significantly reduced DSWI after cardiac surgery.

OR65: A Randomized Trial of Selenium Supplementation in High-Risk Cardiac Surgery Patients: Results of a Multicentre Pilot Study

OR65: A Randomized Trial of Selenium Supplementation in High-Risk Cardiac Surgery Patients: Results of a Multicentre Pilot Study

Long-term Effects of Remote Ischemic Preconditioning on Kidney Function in High-risk Cardiac Surgery Patients

In a multicenter, randomized trial, the authors enrolled patients at high-risk for acute kidney injury as identified by a Cleveland Clinic Foundation score of 6 or more. The authors enrolled 240 patients at four hospitals and randomized them to remote ischemic preconditioning or control. The authors found that remote ischemic preconditioning reduced acute kidney injury in high-risk patients undergoing cardiac surgery. The authors now report on the effects of remote ischemic preconditioning on 90-day outcomes. In this follow-up study of the RenalRIP trial, the authors examined the effect of remote ischemic preconditioning on the composite endpoint major adverse kidney events consisting of mortality, need for renal replacement therapy, and persistent renal dysfunction at 90 days. Secondary outcomes were persistent renal dysfunction and dialysis dependence in patients with acute kidney injury. Remote ischemic preconditioning significantly reduced the occurrence of major adverse kidney events at 90 days (17 of 120 [14.2%]) versus control (30 of 120 [25.0%]; absolute risk reduction, 10.8%; 95% CI, 0.9 to 20.8%; P = 0.034). In those patients who developed acute kidney injury after cardiac surgery, 2 of 38 subjects in the remote ischemic preconditioning group (5.3%) and 13 of 56 subjects in the control group (23.2%) failed to recover renal function at 90 days (absolute risk reduction, 17.9%; 95% CI, 4.8 to 31.1%; P = 0.020). Acute kidney injury biomarkers were also increased in patients reaching the major adverse kidney event endpoint compared to patients who did not. Remote ischemic preconditioning significantly reduced the 3-month incidence of a composite endpoint major adverse kidney events consisting of mortality, need for renal replacement therapy, and persistent renal dysfunction in high-risk patients undergoing cardiac surgery. Furthermore, remote ischemic preconditioning enhanced renal recovery in patients with acute kidney injury.

Acute kidney injury in high-risk cardiac surgery patients: roles of inflammation and coagulation.

Acute kidney injury (AKI) is a common complication following cardiac surgery. Cardiopulmonary bypass elicits coagulation and inflammation activation and oxidative stress, all involved in AKI but never simultaneously assessed. We aimed to evaluate relations between oxidative stress, inflammatory and coagulation systems activation and postoperative renal function in patients with normal preoperative renal function. Forty-one high-risk patients (EuroSCORE >6 and preoperative haemoglobin <12 g/dl in women and <13 g/dl in men) were prospectively enrolled. Prothrombin fragment 1.2 (coagulation marker), interleukin-6 and interleukin-10 (pro/anti-inflammatory markers) and 8-oxo-2'-deoxyguanosine (oxidative stress marker) were evaluated until postoperative day 5. Patients were divided into two groups according to estimated glomerular filtration rate reduction observed postoperatively (reduction <25% in 26 patients: NO-AKI group; reduction >25% in 15 patients: AKI group). No differences were found for inflammatory markers. Oxidative stress slightly increased in the AKI group. Twenty-four hours after the operation prothrombin fragment 1.2 levels were significantly higher in the AKI group (506.6 ± 548 vs. 999 ± 704.1 pmol/l; P = 0.018), and they were independently associated with estimated glomerular filtration rate reduction, with an area under the receiving operating characteristic of 0.744. Thrombin generation is higher in patients with renal function worsening, and it is an independent risk factor for AKI in patients with anaemia, possibly leading to microcirculation impairment and tubular cells damage.

Propensity Score Analysis Supports the Benefit of the Heart Team Meeting on Mortality in High-Risk Cardiac Surgery

Introduction: The Heart Team (HT) is a multidisciplinary team that advises on optimisation and management of complex patients. There is limited evidence about the effects of the HT on high-risk cardiac surgery patients. Methods: The study population included cardiac patients operated at Liverpool Hospital or referred to the HT between 2013 and 2014. Patients’ mortality risks were estimated using existing risk scoring models (RSM). High-risk patients were identified using the high-risk cut-off point derived from the RSM analysis in a separate study. Propensity score matching was performed for the high-risk cohorts and the effect of the HT for the matched populations was examined. Compliance to the HT recommendations was reported. Results: Compliance to recommendations was 78.5%. Overall, 898 surgical patients were used for the HT analysis. Two high-risk cohorts were formed using high-risk cut-off points for EuroSCORE II (ES2≥3, n = 249) and Society of Thoracic Surgeon score (STS≥1.705, n = 241). Forty-three and 35 matched pairs between the HT and the non-HT cohort were obtained for the ES2 and STS high-risk cohort respectively. A trend to decrease mortality was observed between matched HT and non-HT high-risk ES2 cohort (16.0% vs 23.0%; p = 0.510) and number needed to discuss was 14.3 to save one mortality. Conclusion: Analysis of propensity score matched cohorts showed an acceptable number needed to treat and evidence supported the HT benefit. The HT should be used when managing complex cardiac surgery patients in order to provide an equipoised evidenced-based clinical decision tailored to the needs of the patient.

A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients

Inhaled milrinone (iMil) has been used for the treatment of pulmonary hypertension (PH) but its efficacy, safety, and prophylactic effects in facilitating separation from cardiopulmonary bypass (CPB) and preventing right ventricular (RV) dysfunction have not yet been evaluated in a clinical trial. The purpose of this study was to investigate if iMil administered before CPB would be superior to placebo in facilitating separation from CPB. High-risk cardiac surgical patients with PH were randomized to receive iMil or placebo after the induction of anesthesia and before CPB. Hemodynamic parameters and RV function were evaluated by means of pulmonary artery catheterization and transesophageal echocardiography. The groups were compared for the primary outcome of the level of difficulty in weaning from CPB. Among the secondary outcomes examined were the reduction in the severity of PH, the incidence of RV failure, and mortality. Of the 124 patients randomized, the mean (standard deviation [SD]) EuroSCORE II was 8.0 (2.6), and the baseline mean (SD) systolic pulmonary artery pressure (SPAP) was 53 (9) mmHg. The use of iMil was associated with increases in cardiac output (P = 0.03) and a reduction in SPAP (P = 0.04) with no systemic hypotension. Nevertheless, there was no difference in the combined incidence of difficult or complex separation from CPB between the iMil and control groups (30% vs 28%, respectively; absolute difference, 2%; 95% confidence interval [CI], -14 to 18; P = 0.78). There was also no difference in RV failure between the iMil and control groups (15% vs 14%, respectively; difference, 1%; 95% CI, -13 to 12; P = 0.94). Mortality was increased in patients with RV failure vs those without (22% vs 2%, respectively; P < 0.001). In high-risk cardiac surgery patients with PH, the prophylactic use of iMil was associated with favourable hemodynamic effects that did not translate into improvement of clinically relevant endpoints. This trial was registered at ClinicalTrials.gov; identifier: NCT00819377.

A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design

Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Persistent Organ Dysfunction plus Death as a Novel Composite Outcome in High-Risk Cardiac Surgery Patients

Persistent Organ Dysfunction plus Death as a Novel Composite Outcome in High-Risk Cardiac Surgery Patients