ABSTRACT
BACKGROUND: Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to ≥70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations. METHODS: We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex). RESULTS: Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit. CONCLUSIONS: The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.).
Subject(s)
Cardiac Surgical Procedures/adverse effects , Myocardial Infarction/diagnosis , Postoperative Complications/diagnosis , Troponin I/blood , Aged , Aortic Valve/surgery , Biomarkers/blood , Cardiac Surgical Procedures/mortality , Coronary Artery Bypass/adverse effects , Female , Humans , Male , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Postoperative Complications/blood , Postoperative Complications/mortality , Prospective Studies , Reference ValuesABSTRACT
BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).
Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Antifibrinolytic Agents/therapeutic use , Canada , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Surgical Procedures, Operative , Thrombosis/chemically induced , Thrombosis/drug therapy , Tranexamic Acid/adverse effects , Tranexamic Acid/therapeutic useABSTRACT
BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.
Subject(s)
Hypertension , Hypotension , Humans , Antihypertensive Agents/therapeutic use , Postoperative Complications/epidemiology , Canada , Hypotension/etiology , Hypotension/prevention & control , Hypertension/drug therapyABSTRACT
BACKGROUND: This study was conducted to test the hypothesis that phosphocreatine (PCr), administered intravenously and as cardioplegia adjuvant in patients undergoing cardiac surgery with prolonged aortic cross clamping and cardiopulmonary bypass (CPB) time, would decrease troponin I concentration after surgery. METHODS: In this randomized, double-blind, placebo-controlled pilot study we included 120 patients undergoing double/triple valve repair/replacement under cardiopulmonary bypass in the cardiac surgery department of a tertiary hospital. The treatment group received: intravenous administration of 2 g of PCr after anesthesia induction; 2.5 g of PCr in every 1 L of cardioplegic solution (concentration = 10 mmol/L); intravenous administration of 2 g of PCr immediately after heart recovery following aorta declamping; 4 g of PCr at intensive care unit admission. The control group received an equivolume dose of normosaline. RESULTS: The primary endpoint was peak concentration of troponin I after surgery. Secondary endpoints included peak concentration of serum creatinine, need for, and dosage of inotropic support, number of defibrillations after aortic declamping, incidence of arrhythmias, duration of Intensive Care Unit (ICU) stay, length of hospitalization. There was no difference in peak troponin I concentration after surgery (PCr, 10,508 pg/ml [IQR 6,838-19,034]; placebo, 11,328 pg/ml [IQR 7.660-22.894]; p = 0.24). There were also no differences in median peak serum creatinine (PCr, 100 µmol/L [IQR 85.0-117.0]; placebo, 99.5 µmol/L [IQR 90.0-117.0]; p = 0.87), the number of patients on vasopressor/inotropic agents (PCr, 49 [88%]; placebo, 57 [91%]; p = 0.60), the inotropic score on postoperative day 1 (PCr, 4.0 (0-7); placebo, 4.0 (0-10); p = 0.47), mean SOFA score on postoperative day 1 (PCr, 5.25 ± 2.33; placebo, 5,45 ± 2,65; p = 0.83), need for defibrillation after declamping of aorta (PCr, 22 [39%]; placebo, 25 [40%]; p = 0.9),, duration of ICU stay and length of hospitalization as well as 30-day mortality (PCr, 0 (0%); placebo,1 (4.3%); p = 0.4). CONCLUSION: PCr administration to patients undergoing double/triple valve surgery under cardiopulmonary bypass is safe but is not associated with a decrease in troponin I concentration. Phosphocreatine had no beneficial effect on clinical outcomes after surgery. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov with the Identifier: NCT02757443. First posted (published): 02/05/2016.
Subject(s)
Cardiac Surgical Procedures , Troponin I , Humans , Phosphocreatine , Creatinine , Treatment Outcome , Cardiopulmonary BypassABSTRACT
BACKGROUND: Volatile (inhaled) anesthetic agents have cardioprotective effects, which might improve clinical outcomes in patients undergoing coronary-artery bypass grafting (CABG). METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year. RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction. CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
Subject(s)
Anesthesia, Intravenous , Anesthetics, General/pharmacology , Coronary Artery Bypass , Coronary Artery Disease/surgery , Administration, Inhalation , Aged , Anesthesia, General , Anesthetics, Intravenous , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Elective Surgical Procedures , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Mortality , Single-Blind Method , Stroke VolumeABSTRACT
Background: This study investigated the influence of volatile anesthesia (VA) on major complications and mortality in patients undergoing coronary artery bypass graft surgery (CABG). Methods: This post-hoc analysis included 1586 patients from the MYRIAD trial managed using the same perioperative protocol at a single institution. Patients were randomized to receive either volatile anesthesia (sevoflurane, isoflurane, or desflurane) or total intravenous anesthesia (TIVA). The assessed study outcomes were the rate of complications, including: myocardial infarction, stroke, acute kidney injury, prolonged ventilation ( > 24 h), receipt of high-dose inotropic support (inotropic score > 10), and need for mechanical circulatory support. The duration of intensive care unit (ICU) stay, length of hospitalization, hospital readmission during follow-up, 30-days and 1-year mortality were also analyzed. Results: 1586 patients were enrolled between September 2014-September 2017 and randomly assigned to the volatile anesthesia group (n = 794) and the TIVA group (n = 792). The median patient age was 63 years, with a median ejection fraction of 60%. There were no significant differences in the rates of major complications, duration of ICU stay, and hospitalization between the groups. The median total dose of fentanyl was 12.0 mcg/kg in volatile group and 14.4 mcg/kg in TIVA group (p < 0.001). One-year mortality rates were 2.5% (n = 20) and 3.2% (n = 25) in the volatile and TIVA groups, respectively. Two patients were lost at the 30-day and 1-year follow-ups in the volatile group compared to four patients in TIVA group. Regression analysis showed that cardiopulmonary bypass (CPB) duration, fentanyl dose, and baseline serum creatinine level were associated with 30-days mortality, while ejection fraction was associated with 1-year mortality. Conclusions: The use of VA in patients undergoing CABG did not result in a reduction in major complications or mortality compared with TIVA. A higher dose of fentanyl was used in the TIVA group and was associated with an increase in the 30-days mortality. These findings warrant further investigation. Clinical Trial Registration: ClinicalTrials.gov (NCT02105610).
ABSTRACT
Postoperative neurologic complications have a significant effect on morbidity, mortality, and long-term disability in patients undergoing cardiac surgery. The etiology of brain injury in patients undergoing cardiac surgery is multifactorial and remains unclear. There are several perioperative causative factors for neurologic complications, including microembolization, hypoperfusion, and systemic inflammatory response syndrome. Despite technologic advances and the development of new anesthetic drugs, there remains a high rate of postoperative neurologic complications. Moreover, despite the strong evidence that volatile anesthesia exerts cardioprotective effects in patients undergoing cardiac surgery, the neuroprotective effects of volatile agents remain unclear. Several studies have reported an association of using volatile anesthetics with improvement of biochemical markers of brain injury and postoperative neurocognitive function. However, there is a need for additional studies to define the optimal anesthetic drug for protecting the brain in patients undergoing cardiac surgery.
Subject(s)
Anesthesia , Anesthetics, Inhalation , Anesthetics , Cardiac Surgical Procedures , Anesthesia, Intravenous , Anesthetics, Intravenous , Brain , Cardiac Surgical Procedures/adverse effects , HumansABSTRACT
OBJECTIVE: To investigate the effect of volatile anesthetics on the rates of postoperative myocardial infarction (MI) and cardiac death after coronary artery bypass graft (CABG). DESIGN: A post hoc analysis of a randomized trial. SETTING: Cardiac surgical operating rooms. PARTICIPANTS: Patients undergoing elective, isolated CABG. INTERVENTIONS: Patients were randomized to receive a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or total intravenous anesthesia (TIVA). The primary outcome was hemodynamically relevant MI (MI requiring high-dose inotropic support or prolonged intensive care unit stay) occurring within 48 hours from surgery. The secondary outcome was 1-year death due to cardiac causes. MEASUREMENTS AND MAIN RESULTS: A total of 5,400 patients were enrolled between April 2014 and September 2017 (2,709 patients randomized to the volatile anesthetics group and 2,691 to TIVA). The mean age was 62 ± 8.4 years, and the median baseline ejection fraction was 57% (50-67), without differences between the 2 groups. Patients in the volatile group had a lower incidence of MI with hemodynamic complications both in the per-protocol (14 of 2,530 [0.6%] v 27 of 2,501 [1.1%] in the TIVA group; p = 0.038) and as-treated analyses (16 of 2,708 [0.6%] v 29 of 2,617 [1.1%] in the TIVA group; p = 0.039), but not in the intention-to-treat analysis (17 of 2,663 [0.6%] v 28 of 2,667 [1.0%] in the TIVA group; p = 0.10). Overall, deaths due to cardiac causes were lower in the volatile group (23 of 2,685 [0.9%] v 40 of 2,668 [1.5%] than in the TIVA group; p = 0.03). CONCLUSIONS: An anesthetic regimen, including volatile agents, may be associated with a lower rate of postoperative MI with hemodynamic complication in patients undergoing CABG. Furthermore, it may reduce long-term cardiac mortality.
Subject(s)
Anesthetics, Inhalation , Myocardial Infarction , Propofol , Aged , Anesthetics, Intravenous , Coronary Artery Bypass/methods , Humans , Middle Aged , Myocardial Infarction/drug therapy , Myocardial Infarction/epidemiology , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , SevofluraneABSTRACT
BACKGROUND: Perioperative cardiac arrest is a rare complication with an incidence of around 1 in 1400 cases, but it carries a high burden of mortality reaching up to 70% at 30 days. Despite its specificities, guidelines for treatment of perioperative cardiac arrest are lacking. Gathering the available literature may improve quality of care and outcome of patients. METHODS: The PERIOPCA Task Force identified major clinical questions about the management of perioperative cardiac arrest and framed them into the therapy population [P], intervention [I], comparator [C], and outcome [O] (PICO) format. Systematic searches of PubMed, Embase, and the Cochrane Library for articles published until September 2020 were performed. Consensus-based treatment recommendations were created using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The strength of consensus among the Task Force members about the recommendations was assessed through a modified Delphi consensus process. RESULTS: Twenty-two PICO questions were addressed, and the recommendations were validated in two Delphi rounds. A summary of evidence for each outcome is reported and accompanied by an overall assessment of the evidence to guide healthcare providers. CONCLUSIONS: The main limitations of our work lie in the scarcity of good quality evidence on this topic. Still, these recommendations provide a basis for decision making, as well as a guide for future research on perioperative cardiac arrest.
Subject(s)
Heart Arrest/therapy , Perioperative Period/trends , Consensus , Delphi Technique , Heart Arrest/etiology , HumansABSTRACT
OBJECTIVES: To assess current practice in adult cardiac surgery during cardiopulmonary bypass (CPB) across European and non-European countries. DESIGN: International, multicenter, web-based survey including 28 multiple choice questions addressing hemodynamic and tissue oxygenation parameters, organ protection measures, and the monitoring and usage of anesthetic drugs as part of the anesthetic and perfusion practice during CPB. SETTING: Online survey endorsed by the European Association of Cardiothoracic Anesthesiologists. PARTICIPANTS: Representatives of anesthesiology departments in European and non-European adult cardiac surgical centers. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The survey was distributed via e-mail to European Association of Cardiothoracic Anesthesiologists members (nâ¯=â¯797) and kept open for 1 month. The response rate was 34% (nâ¯=â¯271). After exclusion of responses from the same centers and of incomplete answers, data from 202 cardiac centers in 56 countries, of which 67% of centers were university hospitals, were analyzed. Optimization of pump flows and tissue oxygenation parameters during CPB were applied by the majority of centers, with target flow rates of >2.2 L/min/m2 in 93% (nâ¯=â¯187) of centers and mean arterial blood pressures between 51 and 90 mmHg in 85% (nâ¯=â¯172). Hemoglobin transfusion triggers were either individualized or between 7 and 8 g/dL in 92% (nâ¯=â¯186) of centers. Mixed venous oxyhemoglobin saturations were assessed routinely in 59% (nâ¯=â¯120) and lactate in 88% (nâ¯=â¯178) of cardiac surgery units. Noninvasive cerebral saturation monitoring was used in a subgroup of patients or routinely in 84% (nâ¯=â¯169) of sites, and depth-of-anesthesia monitoring was used routinely in 53% (nâ¯=â¯106). Transesophageal echocardiography and pulmonary artery catheters were used routinely or in subgroups of patients in 97% (nâ¯=â¯195) and 71% (nâ¯=â¯153) of centers, respectively. The preferred site for temperature monitoring was the nasopharynx in 66% (nâ¯=â¯134) of centers. Anesthetic techniques were variable, with 26% of centers (nâ¯=â¯52) using low-tidal-volume ventilation and 28% (nâ¯=â¯57) using continuous positive airway pressure during CPB. Volatile agents were used routinely as the only agent during CPB in 36% sites (nâ¯=â¯73) and propofol in 47% (nâ¯=â¯95). Other drugs routinely administered included magnesium in 45% (nâ¯=â¯91), steroids in 18% (nâ¯=â¯37), tranexamic acid in 88% (nâ¯=â¯177), and aprotinin in 15% (nâ¯=â¯30) of the centers. CONCLUSION: This international CPB survey revealed that techniques for optimization of pump flow and oxygenation during CPB usually were applied. Furthermore, cerebral and hemodynamic monitoring devices were frequently used during CPB. However, most CPB-related anesthetic techniques and medications were more variable. More high-quality randomized controlled trials are needed to assess anesthetic techniques and organ protection.
Subject(s)
Cardiac Surgical Procedures , Cardiopulmonary Bypass , Adult , Anesthesiologists , Humans , Lung , PerfusionABSTRACT
BACKGROUND: Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta-analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 µg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality. RESULTS: The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], -5.7 to 5.9; P=0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, -2 hours; 95% CI, -5 to 1; P=0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, -12 hours; 95% CI, -21 to 2; P=0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, -1 to 2; P=0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias. CONCLUSIONS: In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825 .).
Subject(s)
Cardiac Output, Low/drug therapy , Cardiac Surgical Procedures , Cardiotonic Agents/therapeutic use , Hemodynamics/drug effects , Hydrazones/therapeutic use , Mortality , Pyridazines/therapeutic use , Aged , Cardiotonic Agents/administration & dosage , Cardiotonic Agents/adverse effects , Double-Blind Method , Female , Humans , Hydrazones/administration & dosage , Hydrazones/adverse effects , Infusions, Intravenous , Length of Stay , Male , Middle Aged , Perioperative Period , Postoperative Complications/drug therapy , Pyridazines/administration & dosage , Pyridazines/adverse effects , Respiration, Artificial , Simendan , Stroke Volume/drug effects , Treatment FailureABSTRACT
PURPOSE: To assess the dynamic of various health-related quality of life (HRQoL) parameters 3 years after pulmonary thromboendarterectomy (PTE), and to identify factors affecting HRQoL parameters in patients with chronic thromboembolic pulmonary hypertension (CTEPH) in the long-term follow-up after surgery. METHODS: This prospective cohort study included 128 patients with CTEPH before and after the PTE (3 year follow-up). The HRQoL was examined using the Short-Form 36 Health Survey Questionnaire (SF-36). RESULTS: In patients with CTEPH 3 years after PTE, a significant improvement in all the HRQoL parameters. The summary indicators of the physical and mental components of health remained at the same level as 1 year after the PTE and did not exceed 50 points. The residual pulmonary hypertension was a leading factor limiting parameters of physical and mental health 3 years after a PTE. In addition, the parameters of physical activity were adversely affected by age and the age-adjusted Charlson Comorbidity Index. CONCLUSIONS: In the study group of patients with CTEPH, PTE contributes to a significant improvement in all HRQoL parameters, which observed both 1 year and 3 years after surgery. The leading factor adversely affecting the physical and emotional components of health in the long-term period after PTE was residual pulmonary hypertension recorded in the early postoperative period. In addition, some physical HRQoL parameters are affected by age and age-adjusted Charlson Comorbidity Index.
Subject(s)
Hypertension, Pulmonary/surgery , Pulmonary Embolism/surgery , Adult , Chronic Disease , Cohort Studies , Female , Humans , Hypertension, Pulmonary/psychology , Male , Middle Aged , Prospective Studies , Pulmonary Embolism/psychology , Quality of Life/psychology , Treatment OutcomeABSTRACT
BACKGROUND: The aim of this study was to evaluate the long-term outcomes of spinal cord stimulation in patients with critical limb ischemia and to test the hypothesis that the dynamics of clinical changes one year after therapy depend both on the clinical determinants associated with the underlying disease and on factors related to systemic atherosclerosis. METHODS: This prospective cohort study included 56 patients with critical limb ischemia. All patients before and after spinal cord stimulation were examined in terms of the dynamics of their clinical changes using the Rutherford scale and transcutaneous oxygen tension (TcPO2, mm Hg) in the affected foot. The active orthostatic test was used to assess the functional state of peripheral perfusion. RESULTS: One year after spinal cord stimulation, 74% of patients showed positive clinical outcomes. No changes were observed in 9.3% of patients, whereas adverse clinical outcomes were revealed in 16.7% of cases. The TcPO2 values were significantly reduced before spinal cord stimulation: 10.5 (6.4-16.0) mm Hg. The functional status of the peripheral microvasculature was also disturbed. One year after therapy, TcPO2 significantly increased and the adaptive mechanisms of the microvasculature were improved in more than 70% of patients. Logistic regression analysis showed that the initially low TcPO2 values (<10 mm Hg) with a lack of gain in TcPO2 during the orthostatic test are associated with the negative clinical outcomes after spinal cord stimulation. The gain in TcPO2 during the orthostatic test to >10 mm Hg is associated with the positive clinical outcomes after spinal cord stimulation. The age-adjusted Charlson Comorbidity Index >5 and duration of critical ischemic symptoms also had a negative effect on the clinical outcomes after spinal cord stimulation. CONCLUSIONS: The positive clinical outcomes were revealed in most patients with critical limb ischemia one year after spinal cord stimulation. The low values of peripheral tissue metabolism with the disturbed functional status of the microvasculature are associated with the negative clinical outcome. The patients with baseline TcPO2 <10 mm Hg can recover if they still have a sufficient microcirculatory reserve capacity. Duration of critical ischemic symptoms and high comorbidity burden with allowance for age are negative factors affecting the clinical outcome.
Subject(s)
Ischemia/therapy , Peripheral Arterial Disease/therapy , Spinal Cord Stimulation , Aged , Biomarkers/blood , Blood Gas Monitoring, Transcutaneous , Critical Illness , Female , Humans , Ischemia/blood , Ischemia/diagnosis , Ischemia/physiopathology , Male , Microcirculation , Middle Aged , Oxygen/blood , Peripheral Arterial Disease/blood , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Prospective Studies , Recovery of Function , Regional Blood Flow , Time Factors , Treatment OutcomeABSTRACT
Catecholamines remain the mainstay of therapy for acute cardiovascular dysfunction. However, adrenergic receptors quickly undergo desensitization and downregulation after prolonged stimulation. Moreover, prolonged exposure to high circulating catecholamines levels is associated with several adverse effects on different organ systems. Unfortunately, in critically ill patients, adrenergic downregulation translates into progressive reduction of cardiovascular response to exogenous catecholamine administration, leading to refractory shock. Accordingly, there has been a growing interest in recent years toward use of noncatecholaminergic inotropes and vasopressors. Several studies investigating a wide variety of catecholamine-sparing strategies (eg, levosimendan, vasopressin, ß-blockers, steroids, and use of mechanical circulatory support) have been published recently. Use of these agents was associated with improvement in hemodynamics and decreased catecholamine use but without a clear beneficial effect on major clinical outcomes. Accordingly, additional research is needed to define the optimal management of catecholamine-resistant shock.
Subject(s)
Adrenergic Agents , Shock , Catecholamines , Critical Care , Down-Regulation , Humans , Vasoconstrictor Agents/therapeutic useABSTRACT
The search for safe and effective patient management strategies during weaning from cardiopulmonary bypass is ongoing; intravenous calcium is occasionally used as a first-line drug. The physiologic role of calcium suggests that it can support the function of the cardiovascular system during this critical period. Patients may be mildly hypocalcemic after cardiopulmonary bypass; however, this degree of hypocalcemia does not significantly impair the cardiovascular system. The transient beneficial effects of calcium administration (increase in arterial blood pressure, systemic vascular resistance, cardiac index, stroke volume, and coronary perfusion pressure) might be helpful in cases of moderate contractility reduction or vasoplegia. Nonetheless, effects on clinically relevant endpoints are unknown, and possible systemic side effects, such as transient reduction in internal mammary artery graft flow, attenuation of the effects of ß-sympathomimetics, "stone heart" phenomenon, and pancreatic cellular injury, may limit the use of calcium salts. Further studies are needed to expand the understanding of the effects of calcium administration on patient outcomes.
Subject(s)
Calcium , Mammary Arteries , Cardiopulmonary Bypass/adverse effects , Humans , Vascular Resistance , WeaningABSTRACT
OBJECTIVES: To evaluate the dynamics of the cerebral oxygen supply in patients aged ≥65 years, during coronary artery bypass grafting (CABG), and to test the hypothesis that lower intraoperative brain oxygen saturation is associated with postoperative neurological complications. DESIGN: Prospective cohort study. SETTING: The E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russia. PARTICIPANTS: The study comprised 200 elderly patients who underwent CABG between April, 2018 and November, 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The regional hemoglobin oxygen saturation (rSO2, %) of the right and left brain hemispheres were assessed during the intraoperative period using bilateral near-infrared spectroscopy. Furthermore, neurological complications during hospitalization were evaluated. At the anesthesia induction stage, the average levels of rSO2 for the right and left hemispheres were within 65% and did not differ significantly at any stage of CABG (p>0.05). The risk of neurological complications was associated with rSO2 decrease during cardiopulmonary bypass (CPB). An increased risk was associated with rSO2 decrease by 20% or more during CPB, relative to the stage of anesthesia induction, which was observed in 19% of patients. CONCLUSIONS: In elderly patients, the decrease in rSO2 during CPB is associated with an increased risk of neurological complications during hospitalization. This risk increases with a decrease in rSO2 by 20% or more during CPB relative to the stage of anesthesia induction, by a 5-fold and 7-fold for the left and right hemispheres, respectively.
Subject(s)
Coronary Artery Bypass , Oxygen , Aged , Brain , Cardiopulmonary Bypass , Humans , Prospective Studies , RussiaABSTRACT
OBJECTIVES: To describe international practices on the use of calcium salts during cardiopulmonary bypass (CPB) weaning in adult cardiac surgery patients. DESIGN: Multiple-choice survey on current practice of CPB weaning. SETTING: Online survey using the SurveyMonkey platform. PARTICIPANTS: Departments of cardiac anesthesiology worldwide. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Out of 112 surveys sent, 100 centers from 32 countries replied. The majority of centers (88 of 100â¯=â¯88%) administer calcium salts intraoperatively: 71 of 100 (71%) are using these drugs for CPB weaning and 78 of 100 (78%) for correction of hypocalcemia. Among the 88 centers that use calcium salts intraoperatively, 66% (58 of 88) of respondents use calcium chloride, 22% (19 of 88) use calcium gluconate, and 12% (11 of 88) use both drugs. Calcium salts are routinely used during normal (47 of 71 centersâ¯=â¯66%) and difficult (59 of 71 centersâ¯=â¯83%) weaning from CPB. Doses of 5 to 15 mg/kg during termination of CPB were used by 55 of 71 centers (77%) either by bolus (39 of 71, 55%) or over a time period longer than 1 minute (32 of 71â¯=â¯45%). Norepinephrine is the most commonly used first line vasopressor or inotropic agent used to support hemodynamics during termination of CPB in 32 out of 100 centers (32%), and calcium is the second one, used by 23 out of 100 centers (23%). CONCLUSION: This survey demonstrates that the majority of cardiac centers use calcium in adult patients undergoing cardiac surgery, especially during weaning from CPB. There is variability on the type of drug, dose, and modality of drug administration.
Subject(s)
Calcium , Cardiac Surgical Procedures , Adult , Cardiopulmonary Bypass , Humans , Surveys and Questionnaires , WeaningABSTRACT
OBJECTIVE: To test the feasibility and investigate possible cardiovascular effects of a sustained high-dose intravenous thiamine protocol in patients undergoing combined valvular and coronary artery bypass graft surgery. DESIGN: Randomized, placebo-controlled, pilot feasibility trial. SETTING: Cardiac surgery department of a tertiary hospital. PARTICIPANTS: Forty patients undergoing combined valvular and coronary artery bypass surgery. INTERVENTIONS: Intravenous thiamine (600 mg on the day of surgery, and 400 mg/day on postoperative days 1, 2, and 3) or placebo. MEASUREMENTS AND MAIN RESULTS: The primary feasibility endpoints were recruitment rate and protocol compliance. Secondary endpoints included markers of possible biological and physiological effects. The mean recruitment rate was 8 patients per month and protocol compliance was 97.5%. There were no differences in median peak postoperative lactate (2.7 mmol/L [interquartile range [IQR] 1.4-4.6] for thiamine v 2.5 mmol/L [IQR 1.4-3.6] for placebo; pâ¯=â¯0.53), median peak postoperative creatinine (104 µmol/L [IQR 92.5-129] for thiamine v 99 µmol/L [IQR 86.5-109.5] for placebo; pâ¯=â¯0.53), median nadir postoperative cardiac index (1.8 L/min/m2 [IQR 1.5-2.1] for thiamine v 2.2 L/min/m2 [IQR 1.5-2.5] for placebo; pâ¯=â¯0.25), or the number of patients on vasopressor/inotropic agents (thiamine, 12 [63%]; placebo, 12 [60%]; pâ¯=â¯0.80), or in the total inotrope/vasopressor dose 0.14 µg/kg for thiamine v 0.12 µg/kg for placebo; pâ¯=â¯0.88). CONCLUSIONS: A double-blind trial of sustained high-dose intravenous thiamine supplementation in higher-risk cardiac surgery patients was feasible and appeared to be safe. However, such treatment did not demonstrate evidence of biological or physiological effects.
Subject(s)
Cardiopulmonary Bypass , Thiamine , Coronary Artery Bypass , Dietary Supplements , Double-Blind Method , Feasibility Studies , HumansABSTRACT
SEPARATION from cardiopulmonary bypass (CPB) after cardiac surgery is a progressive transition from full mechanical circulatory and respiratory support to spontaneous mechanical activity of the lungs and heart. During the separation phase, measurements of cardiac performance with transesophageal echocardiography (TEE) provide the rationale behind the diagnostic and therapeutic decision-making process. In many cases, it is possible to predict a complex separation from CPB, such as when there is known preoperative left or right ventricular dysfunction, bleeding, hypovolemia, vasoplegia, pulmonary hypertension, or owing to technical complications related to the surgery. Prompt diagnosis and therapeutic decisions regarding mechanical or pharmacologic support have to be made within a few minutes. In fact, a complex separation from CPB if not adequately treated leads to a poor outcome in the vast majority of cases. Unfortunately, no specific criteria defining complex separation from CPB and no management guidelines for these patients currently exist. Taking into account the above considerations, the aim of the present review is to describe the most common scenarios associated with a complex CPB separation and to suggest strategies, pharmacologic agents, and para-corporeal mechanical devices that can be adopted to manage patients with complex separation from CPB. The routine management strategies of complex CPB separation of 17 large cardiac centers from 14 countries in 5 continents will also be described.
Subject(s)
Cardiac Surgical Procedures , Thoracic Surgery , Ventricular Dysfunction, Right , Cardiopulmonary Bypass/adverse effects , Echocardiography, Transesophageal , HumansABSTRACT
Importance: Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain. Objective: To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery. Design, Setting, and Participants: The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018. Interventions: The dexamethasone group (n = 194) received 1 mg/kg of dexamethasone; the control group (n = 200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction. Main Outcomes and Measures: The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization. Results: All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, -0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P = .20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group. Conclusions and Relevance: Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT02615262.