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Intravenous ivabradine versus placebo in patients with low cardiac output syndrome treated by dobutamine after elective coronary artery bypass surgery: a phase 2 exploratory randomized controlled trial.

ABSTRACT: BACKGROUND:Low cardiac output syndrome (LCOS) is a severe condition which can occur after cardiac surgery, especially among patients with pre-existing left ventricular dysfunction. Dobutamine, its first-line treatment, is associated with sinus tachycardia. This study aims to assess the ability of intravenous ivabradine to decrease sinus tachycardia associated with dobutamine infused for LCOS after coronary artery bypass graft (CABG) surgery. METHODS:In a phase 2, multi-center, single-blind, randomized controlled trial, patients with left ventricular ejection fraction below 40% presenting sinus tachycardia of at least 100 beats per minute (bpm) following dobutamine infusion for LCOS after CABG surgery received either intravenous ivabradine or placebo (three ivabradine for one placebo). Treatment lasted until dobutamine weaning or up to 48 h. The primary endpoint was the proportion of patients achieving a heart rate (HR) in the 80- to 90-bpm range. Secondary endpoints were invasive and non-invasive hemodynamic parameters and arrhythmia events. RESULTS:Nineteen patients were included. More patients reached the primary endpoint in the ivabradine than in the placebo group (13 (93%) versus 2 (40%); P?=?0.04). Median times to reach target HR were 1.0 h in the ivabradine group and 5.7 h in the placebo group. Ivabradine decreased HR (112 to 86 bpm, P?<0.001) while increasing cardiac index (P?=?0.02), stroke volume (P?<0.001), and systolic blood pressure (P?=?0.03). In the placebo group, these parameters remained unchanged from baseline. In the ivabradine group, five patients (36%) developed atrial fibrillation (AF) and one (7%) was discontinued for sustained AF; two (14%) were discontinued for bradycardia. CONCLUSION:Intravenous ivabradine achieved effective and rapid correction of sinus tachycardia in patients who received dobutamine for LCOS after CABG surgery. Simultaneously, stroke volume and systolic blood pressure increased, suggesting a beneficial effect of this treatment on tissue perfusion. TRIAL REGISTRATION:European Clinical Trials Database: EudraCT 2009-018175-14 . Registered February 2, 2010.

SUBMITTER: Nguyen LS

PROVIDER: S-EPMC6097391 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Intravenous ivabradine versus placebo in patients with low cardiac output syndrome treated by dobutamine after elective coronary artery bypass surgery: a phase 2 exploratory randomized controlled trial.

Nguyen Lee S LS Squara Pierre P Amour Julien J Carbognani Daniel D Bouabdallah Kamel K Thierry Stéphane S Apert-Verneuil Caroline C Moyne Aurélie A Cholley Bernard B

Critical care (London, England) 20180817 1

<h4>Background</h4>Low cardiac output syndrome (LCOS) is a severe condition which can occur after cardiac surgery, especially among patients with pre-existing left ventricular dysfunction. Dobutamine, its first-line treatment, is associated with sinus tachycardia. This study aims to assess the ability of intravenous ivabradine to decrease sinus tachycardia associated with dobutamine infused for LCOS after coronary artery bypass graft (CABG) surgery.<h4>Methods</h4>In a phase 2, multi-center, sin ...[more]

PMID: 30115103

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Project description:Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function.To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome.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).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.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.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 ?-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.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.EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.

Project description:BackgroundCardiac output (CO) is a key measure of adequacy of organ and tissue perfusion, especially in critically ill or complex surgical patients. CO monitoring technology continues to evolve. Recently developed CO monitors rely on unique algorithms based on pulse contour analysis of an arterial blood pressure (ABP) waveform. The objective of this investigation was to compare the accuracy of two monitors using different methods of pulse contour analysis - the Retia Argos device and the Edwards Vigileo-FloTrac device - with pulmonary artery catheter (PAC)-thermodilution as a reference.MethodsFifty-eight patients undergoing off-pump coronary artery bypass surgery formed the study cohort. A total of 572 triplets of CO measurements from each device - Argos, Vigileo-FloTrac (third generation), and thermodilution - were available before and after interventions (e.g., vasopressors, fluids, and inotropes). Bland-Altman analysis accounting for repeated measurements per subject and concordance analysis were applied to assess the accuracy of the CO values and intervention-induced CO changes of each pulse contour device against thermodilution. Cluster bootstrapping was employed to statistically compare the root-mean-squared-errors (RMSE = √(μ2 + σ2), where μ and σ are the Bland-Altman bias and precision errors) and concordance rates of the two devices.ResultsThe RMSE (mean (95% confidence intervals)) for CO values was 1.16 (1.00-1.32) L/min for the Argos device and 1.54 (1.33-1.77) L/min for the Vigileo-FloTrac device; the concordance rate for intervention-induced CO changes was 87 (82-92)% for the Argos device and 72 (65-78)% for the Vigileo-FloTrac device; and the RMSE for the CO changes was 17 (15-19)% for the Argos device and 21 (19-23)% for the Vigileo-FloTrac device (p < 0.0167 for all comparisons).ConclusionsIn comparison with CO measured by the PAC, the Argos device proved to be more accurate than the Vigileo-FloTrac device in CO trending and absolute CO measurement in patients undergoing off-pump coronary artery bypass surgery.

Project description:Physical inactivity and a sedentary lifestyle are associated with a chronic low-level inflammatory state which has been implicated in the pathogenesis of cardiovascular disease. There is growing interest in exercise programs as part of surgical 'prehabilitation'. We therefore studied preoperative physical activity levels of patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery, and performed an exploratory analysis of the influence of physical activity on postoperative outcome. The Short Questionnaire to Assess Health (SQUASH) was used to assess physical activity among 100 patients, of mean (SD) age 65.4 (7.6) years. Additionally, handgrip strength was measured, and the get-up-and-go test was conducted. Anxiety, depression, and quality of life were assessed, and a computerised cognitive test battery was used to assess cognitive performance preoperatively, and three months after surgery. Preoperatively, 76% of patients met the recommended national guidelines for physical activity. The incidence of pre-existing medical conditions, and other pre-operative patient features were similar in active and inactive patients. Preoperative physical activity was significantly inversely related to the logistic EuroSCORE. The level of physical activity was also significantly inversely related with preoperative C-reactive protein (CRP) and peak postoperative CRP, but physical activity did not appear to be associated with any adverse postoperative outcomes or extended length of hospital stay. The incidence of postoperative neurocognitive disorder (PNCD) at 3 months postoperatively was 26%. Cognitive performance was not related with physical activity levels. In summary, this was the first study to assess activity levels of cardiac surgical patients with the SQUASH questionnaire. The majority of patients were physically active. Although physical activity was associated with lower levels of inflammation in this pilot study, it was not associated with an improved clinical or cognitive postoperative outcome.

Dataset Information

Intravenous ivabradine versus placebo in patients with low cardiac output syndrome treated by dobutamine after elective coronary artery bypass surgery: a phase 2 exploratory randomized controlled trial.

Publications

Intravenous ivabradine versus placebo in patients with low cardiac output syndrome treated by dobutamine after elective coronary artery bypass surgery: a phase 2 exploratory randomized controlled trial.

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