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Introduction: There is no consistency in current practice pertaining to the prescription and progression of upper limb resistance exercise following cardiac surgery via median sternotomy. The aim of this study is to investigate whether less restrictive sternal precautions with the addition of early-supervised resistance training exercise improves upper limb function and facilitates recovery following median sternotomy., Methods and Analysis: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants., Ethics and Dissemination: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences., Trial Registration Number: International Standard Randomised Controlled Trials Number (ISRCTN17842822)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA 2 DS 2 -VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no-occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no-occlusion group, a mean difference of -$612 (95% CI, -$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of -$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA 2 DS 2 -VASc score of ≥2 undergoing cardiac surgery.

Background: Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi-center randomized controlled trial, demonstrated clinical non-inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long-term health-related quality of life (HRQOL)., Study Design and Methods: In this planned sub-study of Australian patients in TRICS III, we sought to determine the non-inferiority of restrictive versus liberal transfusion strategy on long-term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36-item short form survey version 2 (SF-36v2). Primary outcome was non-inferiority of summary measures of SF-36v2 at 12 months, (non-inferiority margin: -0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non-inferiority of HRQOL at 18 and 24 months., Results: Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery., Discussion: The non-inferiority of a restrictive compared to a liberal transfusion strategy was not established for long-term HRQOL in this dataset., (© 2022 AABB.)

Aims: To investigate the effects of a 12-week early moderate-intensity resistance training program compared to aerobic-based rehabilitation on postoperative cognitive recovery following cardiac surgery via median sternotomy., Methods: This was a multicentre, prospective, pragmatic, non-blinded, pilot randomised controlled trial (1:1 randomisation) of two parallel groups that compared a 12-week early moderate-intensity resistance training group to a control group, receiving aerobic-based rehabilitation. English-speaking adults (≥18 years) undergoing elective cardiac surgery via median sternotomy were randomised using sealed envelopes, with allocation revealed before surgery. The primary outcome was cognitive function, assessed using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline, 14 weeks and 6 months postoperatively., Results: The ADAS-cog score at 14 weeks was significantly better for the resistance training group (n=14, 7.2±1.4; 95% CI 4.3, 10.2, vs n=17, 9.2±1.3; 95% CI 6.6, 11.9, p=0.010). At 14 weeks postoperatively, 53% of the aerobic-based rehabilitation group (n=9/17) experienced cognitive decline by two points or more from baseline ADAS-cog score, compared to 0% of the resistance training group (n=0/14; p=0.001)., Conclusion: Early resistance training appears to be safe and may improve cognitive recovery compared to standard, aerobic-based rehabilitation following cardiac surgery via median sternotomy, however as this was a pilot study, the sample size was small and further research is needed to determine a causal relationship., (Copyright © 2021 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Aim: To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients., Materials and Methods: The multinational, open-label, randomized controlled TRICS-III trial assessed a restrictive transfusion strategy (haemoglobin [Hb] transfusion threshold <75 g/L) compared with a liberal strategy (Hb <95 g/L for operating room or intensive care unit; or <85 g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all-cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days., Results: Of the 5092 patients analysed, 1396 (27.4%) had diabetes (restrictive, n = 679; liberal, n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95% CI] 1.10 [0.93-1.31]) nor the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95% CI] 1.04 [0.68-1.59] vs. no diabetes OR 1.02 [0.85-1.22]; P interaction  = .92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95% CI] 0.28 [0.21-0.36]; no diabetes OR [95% CI] 0.40 [0.35-0.47]; P interaction  = .04)., Conclusions: The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery., (© 2021 John Wiley & Sons Ltd.)

Objectives: To investigate the specific clinical features of pain following cardiac surgery and evaluate the information derived from different pain measurement tools used to quantify and describe pain in this population., Methods: A prospective observational study was undertaken at two tertiary care hospitals in Australia. Seventy-two (72) adults (mean age, 63±11 years) were included following cardiac surgery via a median sternotomy. Participants completed the Patient Identified Cardiac Pain using numeric and visual prompts (PICP), the McGill Pain Questionnaire-Short Form version 2 (MPQ-2) and the Medical Outcome Study 36-item version 2 (SF-36v2) Bodily Pain domain (BP), which were administered prior to hospital discharge, 4 weeks and 3 months postoperatively., Results: Participants experienced a high incidence of mild (n=45, 63%) to moderate (n=22, 31%) pain prior to discharge, which reduced at 4 weeks postoperatively: mild (n=28, 41%) and moderate (n=5, 7%) pain; at 3 months participants reported mild (n=14, 20%) and moderate (n=2, 3%) pain. The most frequent location of pain was the anterior chest wall, consistent with the location of the surgical incision and graft harvest. Most participants equated "pressure/weight" to "aching" or a "heaviness" in the chest region (based on descriptor of pain in the PICP) and the pain topography was persistent at 4 weeks and 3 months postoperatively. Each pain measurement tool provided different information on pain location, severity and description, with significant change (p<0.005) over time., Conclusion: Mild-to-moderate pain was frequent after sternotomy, improved over time and was mostly located over the incision and mammary (internal thoracic) artery harvest site. Persistent pain at 3 months remained a significant problem in the community within this surgical population., (Copyright © 2021 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.)

Background: Catecholamine inotropes are frequently used after cardiopulmonary bypass (CPB) but may have undesirable effects. The aim was to identify whether the routine use of inhaled pulmonary vasodilators might reduce the requirement for inotrope drugs after cardiac surgery., Methods: Retrospective cohort study of sequential patients undergoing cardiac surgery at the Royal Melbourne Hospital performed by a single surgeon and anesthesia care team, within 14 months before and after routine implementation of inhaled pulmonary vasodilators, August 2017. Milrinone 4 mg and iloprost 20 µg were inhaled using a vibrating mesh nebulizer (Aerogen) before initiation of CPB and at chest closure. Other aspects of clinical management were unaltered over the time period. Two investigators blinded to each other extracted data from electronic and written medical records. The primary outcome was any use of inotropes in the perioperative period; a Fisher exact test was used to analyze any differences between the 2 groups. Demographic data, hemodynamic data, and use of inotropes and vasopressors were collected from induction of anesthesia to 36 hours postoperative in the intensive care unit (ICU). Hospital and ICU length of stay, cost, and complications were collected., Results: Any use of inotropes was significantly lower with inhaled pulmonary dilators (62.5% vs 86.8%, odds ratio [95% confidence interval {CI}], 0.253 (0.083-0.764); P = .011), including intraoperative inotrope use (37.5% vs 86.8%, odds ratio [95% CI], 0.091 (0.03-0.275); P < .001). ICU length of stay was significantly lower with inhaled pulmonary dilators (45 hours, interquartile range [IQR], 27-65 vs 50 hours, IQR, 45-74; P = .026). There were no significant differences among major postoperative complications or costs between groups., Conclusions: Routine use of inhaled milrinone 4 mg and iloprost 20 µg before and after CPB is associated with reduced postoperative inotrope use.

Introduction: Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than in the general population, with older age and comorbidities further increasing the risk of cognitive decline. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the effect of early moderate-intensity resistance training, compared to standard care, on cognitive recovery following cardiac surgery via a median sternotomy. The safety, feasibility and effect on functional recovery will also be examined., Methods: This study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. The primary outcome, cognitive function, will be assessed using the Alzheimer's Disease Assessment Scale and cognitive subscale. Secondary measures include safety, feasibility, muscular strength, physical function, multiple-domain quality of recovery, dynamic balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months., Discussion: The results of this pilot study will be used to determine the feasibility of a future large-scale randomised controlled trial that promotes the integration of early resistance training into existing aerobic-based cardiac rehabilitation programs in Australia., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001430325p . Registered on 9 October 2017. Universal Trial Number (UTN): U1111-1203-2131.

Objectives: We sought to compare the effects of conventional wire cerclage with that of the band and plate fixation of the sternum., Methods: A parallel randomized open-label trial with 1:1 allocation ratio compared healing after adult cardiac surgery using 'figure-of-8' stainless steel wire cerclage or a band and plate system (plates). The primary end point was maximal sternal edge displacement during active coughing of ≥2 mm in ≥2 of 4 sites measured with ultrasound by 2 assessors blinded to the other at 6 weeks postoperatively. Secondary end points at 12 weeks included ultrasound assessment, computed tomography (CT) scan and multidimensional assessment of quality of recovery using the Postoperative Quality of Recovery Scale., Results: Of 50 patients, 26 received plates and 24 wires. Two patients died and 1 withdrew consent leaving 25 plates and 22 wires for primary end point analysis. Operations included 37 coronary, 5 valve and 8 combined coronary and valve procedures. At 6 weeks, less sternal movement was observed in patients with plates than those with wires, 4% (1/25) vs 32% (7/22), P = 0.018. Agreement between observers was high, kappa = 0.850. At 12 weeks, less ultrasound motion was seen in patients with plates, 0% (0/23) than those with wires, 25% (5/20), P = 0.014. Recovery from pain was higher for patients with plates 92% (22/24) than those with wires 67% (14/21), P = 0.004. CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036. CT mild bone synthesis or greater was similar between patients with plates 21% (5/24) and wires 14% (3/21), P = 0.71., Conclusions: Patients receiving the band and plate system had significantly less sternal edge motion than those receiving wires, 6 and 12 weeks after cardiac surgery and experienced less pain., Clinical Trial Registration: clinicaltrials.gov NCT03282578., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: To compare agreement and variability of cardiac output measurement of 2-dimensional (2D) and 3D transesophageal echocardiography (TEE) with thermodilution before and after bypass., Design: Prospective observational study., Setting: Two tertiary hospitals., Interventions: Cardiac output (CO) was measured simultaneously with thermodilution and TEE by multiplying either the left ventricular outflow tract area (LVOTA) or aortic valve area (AVA), the velocity-time integral (VTI) of flow at the same site, and heart rate. The LVOTA was calculated using diameter for 2D TEE. Planimetry was used for 3D TEE. The AVA was measured using planimetry., Participants: The study comprised 82 adult patients undergoing coronary or valve surgery., Measurements and Main Results: One hundred fifty-four complete sets of measurements were obtained (82 prebypass and 72 postbypass). All TEE methods had acceptable correlation and absence of proportional or fixed bias except for the left ventricular outflow tract (LVOT) VTI modal trace method, which had poor correlation and proportional but not fixed bias (regression coefficient [95% confidence interval], bias [percentage of mean CO]): 2D LVOT VTI modal trace 0.67 (0.54-0.80), -36.4%; 2D LVOT VTI outer edge trace 0.96 (0.80-1.12), -15.3%; 2D AVA planimetry 0.96 (0.75-1.18), +4.9%; 3D LVOT area planimetry 1.18 (0.96-1.41), +0.8%; 3D AVA planimetry 1.20 (0.93-1.46), +0.4%. All TEE methods had wide levels of agreement compared with thermodilution (-3.94 to +0.23 L/min, -2.83 to +1.28 L/min, -2.23 to +2.73 L/min, -2.35 to +2.42 L/min, and -2.57 to +2.61 L/min, respectively). Measurement variability was superior for all TEE methods compared with thermodilution before but not after bypass., Conclusions: Although limits of agreement of CO measurement with 3D TEE and thermodilution are wide, 2D planimetry of the AVA and continuous wave Doppler may be substituted for thermodilution before and after bypass., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: Despite no evidence to support weight limitations following median sternotomy, sternal precautions continue to be routinely prescribed. Moreover, international cardiac rehabilitation guidelines lack sufficient detail for the implementation of resistance training. This systematic review and meta-analysis aimed to determine what the literature defines as resistance training; how resistance training is applied, progressed and evaluated; and, whether resistance training improves physical and functional recovery postoperatively in the cardiac surgical population., Data Sources: Five (5) electronic databases were searched from inception to 28 September 2018 for studies published in English that investigated the effects of a resistance training intervention on physical and functional recovery following median sternotomy., Results: Eighteen (18) trials (n=3,462) met eligibility criteria and were included in the analysis. Seven (7) randomised controlled trials shared common outcome measures, allowing meta-analysis. The performance of resistance training appears to be safe and feasible, and resulted in similar improvements in both cardiopulmonary capacity and anthropometry, when compared to aerobic training alone. However, the definition and application of resistance training is frequently a lower intensity and volume than recommended by the American College of Sports Medicine. Furthermore, sternal precautions are not reflective of the kinematics and weights used when performing many activities of daily living. For this reason, resistance training needs to be task-specific, reflecting functional tasks to promote recovery., Conclusion: Resistance training, in isolation or when combined with aerobic training, may lead to greater improvements in physical and functional recovery following cardiac surgery via median sternotomy; however, further research is required to inform clinical guidelines., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Objective: The aim of this systematic review was to identify exercise parameters and outcome measures used in cardiac rehabilitation programs following median sternotomy, in the elderly cardiac population., Data Sources: Five (5) electronic databases were searched for relevant studies published in English after 1997., Study Selection: The screening process was completed by two independent researchers, with a third independent reviewer for overall agreement. Studies were selected if they included only cardiac patients aged ≥65 years who had undergone valve surgery and/or coronary artery bypass grafting via median sternotomy, and who had undertaken a postoperative cardiac rehabilitation exercise intervention assessing physical function and/or cognitive recovery as outcomes., Data Extraction: Two researchers independently completed the data extraction and quality assessment. Quality was assessed using a modified Downs and Black tool., Data Synthesis: In total, 11 articles were included for appraisal with respect to the quality of the study. Only two randomised controlled trials were suitable for meta-analysis. A higher volume of exercise was shown to have a positive effect on functional recovery, assessed using the 6-minute walk test (6MWT) (mean difference=26.97m; 95% confidence interval [CI], 6.96-46.97; p=0.008; I 2 =0%). No significant improvement was shown between additional exercise compared to standard care in improving VO 2peak , maximal power output or quality of life. No studies evaluated the effect of exercise on cognitive recovery., Conclusions: Exercise significantly improves functional recovery in the post-surgical elderly cardiac population, however uncertainty still exists with regard to which modes of exercise and their specific parameters are most effective in improving cognitive recovery., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Background: Despite a paucity of evidence, patients following cardiac surgery via median sternotomy are routinely prescribed sternal precautions that restrict upper limb and trunk movements, with the rationale of reducing postoperative sternal complications such as sternal wound dehiscence, instability, infection and/or pain. The primary aim of this study was to measure motion at the sternal edges during dynamic upper limb and trunk tasks to better inform future sternal precautions and optimise postoperative recovery. Motion at the sternal edges was measured using ultrasound, which has been demonstrated to be a clinically valid and reliable measure in patients following cardiac surgery., Methods: Seventy-five (75) patients following cardiac surgery via median sternotomy with conventional stainless steel wire closure were recruited. Motion at the sternal edges in the lateral (coronal plane) and anterior-posterior (sagittal plane) directions was measured at the level of the fourth intercostal space (mid-sternum) using ultrasound. Ultrasound measures were taken at rest and during five dynamic upper limb and trunk tasks (deep inspiration, cough, unilateral and bilateral upper limb elevation and sit to stand), over the first 3 postoperative months (3 to 7 days, 6 weeks and 3 months postoperatively). Sternal pain, functional status and sternal healing were also observed over the same postoperative period., Results: The magnitude of overlap of the sternal edges in the lateral direction, and separation of the sternal edges in the anterior-posterior direction, both significantly decreased by 0.01cm, over the first 3 postoperative months (p<0.01). Coughing, however, produced a significant increase in separation of the sternal edges in the lateral direction (0.01-0.02cm) and pain (12-63%), compared to rest and all other tasks, at each postoperative time point (p<0.01). Additionally, there was a significant decrease in sternal pain (81%) and increase in postoperative function (79%) over the same postoperative period (p<0.01). At 3 months postoperatively, five (7%) participants demonstrated radiological sternal union and one (1%) participant was diagnosed with clinical sternal instability., Conclusions: A small magnitude of multi-planar motion at the sternal edges, at the mid-sternum, was demonstrated during dynamic upper limb and trunk tasks in a cohort of cardiac surgery patients post-sternotomy, over the first 3 postoperative months. Future research investigating motion at different levels of the sternum, with varying methods of sternal closure, and over a longer postoperative period is warranted to better inform sternal precautions and optimise postoperative recovery., (Copyright © 2018 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Background: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery., Methods: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients ( n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery., Results: Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease., Interpretation: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388., Competing Interests: Competing interests: P.J. Devereaux has received grants from Abbott Diagnostics, Boehringer Ingelheim, Covidien, Octapharma, Philips Healthcare, Roche Diagnostics and Stryker for projects outside the work reported here. Chirag Parikh reports personal fees from AbbVie Pharmaceutical Research and Development and GENFIT Biopharmaceutical Company; funding from Renalytix AI; and grants from the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Heart, Lung and Blood Institute. Vlado Perkovic reports receiving personal fees for advisory boards or scientific presentations from Retrophin, Janssen, Merck and Servier. Vlado Perkovic was a member of the SONAR Steering Committee; has served on steering committees for trials funded by AbbVie, Boehringer Ingelheim, GlaxoSmithKline, Janssen, Novo Nordisk, Retrophin and Tricida; and has participated in scientific presentations and advisory boards with AbbVie, Astellas, Astra-Zeneca, Bayer, Baxter, Bristol-Myers Squibb, Boehringer Ingelheim, Dimerix, Durect, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk, Pfizer, PharmaLink, Relypsa, Retrophin, Sanofi, Servier, Vifor and Tricida. Richard Whitlock reports grants and personal fees from Boehringer Ingelheim. No other competing interests were declared., (© 2019 Joule Inc. or its licensors.)

Background: We reported previously that, in patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive transfusion strategy was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or 28 days after surgery, whichever came first. We now report the clinical outcomes at 6 months after surgery., Methods: We randomly assigned 5243 adults undergoing cardiac surgery to a restrictive red-cell transfusion strategy (transfusion if the hemoglobin concentration was <7.5 g per deciliter intraoperatively or postoperatively) or a liberal red-cell transfusion strategy (transfusion if the hemoglobin concentration was <9.5 g per deciliter intraoperatively or postoperatively when the patient was in the intensive care unit [ICU] or was <8.5 g per deciliter when the patient was in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery. An expanded secondary composite outcome included all the components of the primary outcome as well as emergency department visit, hospital readmission, or coronary revascularization occurring within 6 months after the index surgery. The secondary outcomes included the individual components of the two composite outcomes., Results: At 6 months after surgery, the primary composite outcome had occurred in 402 of 2317 patients (17.4%) in the restrictive-threshold group and in 402 of 2347 patients (17.1%) in the liberal-threshold group (absolute risk difference before rounding, 0.22 percentage points; 95% confidence interval [CI], -1.95 to 2.39; odds ratio, 1.02; 95% CI, 0.87 to 1.18; P=0.006 for noninferiority). Mortality was 6.2% in the restrictive-threshold group and 6.4% in the liberal-threshold group (odds ratio, 0.95; 95% CI, 0.75 to 1.21). There were no significant between-group differences in the secondary outcomes., Conclusions: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy for red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis at 6 months after surgery. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

Question: In people who have undergone cardiac surgery via median sternotomy, does modifying usual sternal precautions to make them less restrictive improve physical function, pain, kinesiophobia and health-related quality of life?, Design: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis., Participants: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included., Intervention: Participants were randomly allocated to one of two groups at 4 (SD 1) days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions). The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions) for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks., Outcome Measures: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded., Results: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI -0.2 to 2.3) and 12 weeks (MD 0.4, 95% CI -0.9 to 1.6) postoperatively. There were no statistically significant between-group differences in secondary outcomes., Conclusion: Modified (ie, less restrictive) sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with traditional or modified sternal precautions., Trial Registration: Australian and New Zealand Clinical Trials Registry ANZCTRN12615000968572. [Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D (2018) Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. Journal of Physiotherapy 64: 97-106]., (Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.)

Objectives: To determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity., Design: Transfusion Requirements in Cardiac Surgery (TRICS) III was a multicenter, international, open-label randomized controlled trial of two commonly used transfusion strategies in patients having cardiac surgery using a noninferiority trial design (ClinicalTrials.gov number, NCT02042898)., Setting: Eligible patients were randomized prior to surgery in a 1:1 ratio., Participants: Potential participants were 18 years or older undergoing planned cardiac surgery using cardiopulmonary bypass (CPB) with a preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more., Interventions: Five thousand patients; those allocated to a restrictive transfusion group received a red blood cell (RBC) transfusion if the hemoglobin concentration (Hb) was less than 7.5 g/dL intraoperatively and/or postoperatively. Patients allocated to a liberal transfusion strategy received RBC transfusion if the Hb was less than 9.5 g/dL intraoperatively or postoperatively in the intensive care unit or less than 8.5 g/dL on the ward., Measurements and Main Results: The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or new onset renal dysfunction requiring dialysis at hospital discharge or day 28, whichever comes first. The primary outcome was analyzed as a per-protocol analysis. The trial monitored adherence closely as adherence to the transfusion triggers is important in ensuring that measured outcomes reflect the transfusion strategy., Conclusion: By randomizing prior to surgery, the TRICS III trial captured the most acute reduction in hemoglobin during cardiopulmonary bypass., (Copyright © 2018. Published by Elsevier Inc.)

Background: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear., Methods: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes., Results: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes., Conclusions: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

Background: The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery., Methods/design: This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported., Discussion: The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy., Trial Registration: Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

Objectives: The use of limited transthoracic echocardiography (TTE) has been restricted in patients after cardiac surgery due to reported poor image quality. The authors hypothesized that the hemodynamic state could be evaluated in a high proportion of patients at repeated intervals after cardiac surgery., Design: Prospective observational study., Setting: Tertiary university hospital., Participants: The study comprised 51 patients aged 18 years or older presenting for cardiac surgery., Interventions: Patients underwent TTE before surgery and at 3 time points after cardiac surgery. Images were assessed offline using an image quality scoring system by 2 expert observers. Hemodynamic state was assessed using the iHeartScan protocol, and the primary endpoint was the proportion of limited TTE studies in which the hemodynamic state was interpretable at each of the 3 postoperative time points., Measurements and Main Results: Hemodynamic state interpretability varied over time and was highest before surgery (90%) and lowest on the first postoperative day (49%) (p<0.01). This variation in interpretability over time was reflected in all 3 transthoracic windows, ranging from 43% to 80% before surgery and from 2% to 35% on the first postoperative day (p<0.01). Image quality scores were highest with the apical window, ranging from 53% to 77% across time points, and lowest with the subcostal window, ranging from 4% to 70% across time points (p< 0.01)., Conclusions: Hemodynamic state can be determined with TTE in a high proportion of cardiac surgery patients after extubation and removal of surgical drains., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Inflammation after cardiopulmonary bypass may contribute to postoperative delirium and cognitive dysfunction. The authors evaluated the effect of high-dose methylprednisolone to suppress inflammation on the incidence of delirium and postoperative quality of recovery after cardiac surgery., Methods: Five hundred fifty-five adults from three hospitals enrolled in the randomized, double-blind Steroids in Cardiac Surgery trial were randomly allocated to placebo or 250 mg methylprednisolone at induction and 250 mg methylprednisolone before cardiopulmonary bypass. Each completed the Postoperative Quality of Recovery Scale before surgery and on days 1, 2, and 3 and 1 and 6 months after surgery and the Confusion Assessment Method scale for delirium on days 1, 2, and 3. Recovery was defined as returning to preoperative values or improvement at each time point., Results: Four hundred eighty-two participants for recovery and 498 participants for delirium were available for analysis. The quality of recovery improved over time but without differences between groups in the primary endpoint of overall recovery (odds ratio range over individual time points for methylprednisolone, 0.39 to 1.45; 95% CI, 0.08-2.04 to 0.40-5.27; P = 0.943) or individual recovery domains (all P > 0.05). The incidence of delirium was 10% (control) versus 8% (methylprednisolone; P = 0.357), with no differences in delirium subdomains (all P > 0.05). In participants with normal (51%) and low baseline cognition (49%), there were no significant differences favoring methylprednisolone in any domain (all P > 0.05). Recovery was worse in patients with postoperative delirium in the cognitive (P = 0.004) and physiologic (P < 0.001) domains., Conclusions: High-dose intraoperative methylprednisolone neither reduces delirium nor improves the quality of recovery in high-risk cardiac surgical patients.

Early detection of patients at risk of sternal complications is essential to facilitate prevention and optimize timely intervention. A systematic review and meta-analysis was conducted to identify risk factors associated with sternal complications. The review included 17 full-text studies, of which 10 were entered into meta-analyses. Female gender, diabetes mellitus, obesity, bilateral internal mammary artery grafts, reoperation for postoperative complications, and blood product requirement were reported as significant predictors of sternal infection. The compilation of these risk factors may help to screen and stratify patients at risk of impaired sternal healing and warrants further investigation., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Cardiorespiratory complications are common after cardiac surgery and current monitors used to diagnose these are invasive and have limitations. Transthoracic echocardiography and lung ultrasound are noninvasive and frequently improve diagnosis in critically ill patients but have not been reported for routine postoperative monitoring after coronary, valve, and aortic surgery. The aim was to determine whether both repeated postoperative transthoracic echocardiography and lung ultrasound revealed or excluded clinically important cardiac and respiratory disorders compared to conventional monitoring and chest x-ray., Design: Prospective observational study., Setting: Tertiary university hospital., Participants: Ninety-one patients aged older than 18 undergoing cardiac surgery, Interventions: Postoperative clinical patient assessment for significant cardiac and respiratory disorders by the treating physician was recorded at 3 time points (day after surgery, after extubation and removal of chest drains and at discharge) using conventional monitoring and chest x-ray. After each assessment, transthoracic echocardiography and lung ultrasound were performed, and differences in diagnosis from conventional assessment were recorded., Measurements and Main Results: Transthoracic echocardiography was interpretable in at least 1 echocardiographic window in 99% of examinations. Transthoracic echocardiography and/or lung ultrasound changed the diagnosis of important cardiac and/or respiratory disorders in 61 patients (67%). New cardiac findings included cardiac dysfunction (38 patients), pericardial effusion (5), mitral regurgitation (2), and hypovolemia (1). New respiratory findings included pleural effusion (30), pneumothorax (4), alveolar interstitial syndrome (3) and consolidation (1)., Conclusions: Routine repeated monitoring with cardiac and lung ultrasound after cardiac surgery is feasible and frequently alters diagnosis of clinically important cardiac and respiratory pathology., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Persistent incisional pain is common after cardiac surgery and is believed to be in part related to inflammation and poorly controlled acute pain. Methylprednisolone is a corticosteroid with substantial antiinflammatory and analgesic properties and is thus likely to ameliorate persistent surgical pain. Therefore, the authors tested the primary hypothesis that patients randomized to methylprednisolone have less persistent incisional pain than those given placebo., Methods: One thousand forty-three patients having cardiopulmonary bypass for cardiac surgery via a median sternotomy were included in this substudy of Steroids in Cardiac Surgery (SIRS) trial. Patients were randomized to 500 mg intraoperative methylprednisolone or placebo. Incisional pain was assessed at 30 days and 6 months after surgery, and the potential risk factors were also evaluated., Results: Methylprednisolone administration did not reduce pain at 30 days or persistent incisional pain at 6 months, which occurred in 78 of 520 patients (15.7%) in the methylprednisolone group and in 88 of 523 patients (17.8%) in the placebo group. The odds ratio for methylprednisolone was 0.93 (95% CI, 0.79 to 1.09, P = 0.37). Furthermore, there was no difference in worst pain and average pain in the last 24 h, pain interference with daily life, or use of pain medicine at 6 months. Younger age, female sex, and surgical infections were associated with the development of persistent incisional pain., Conclusions: Intraoperative methylprednisolone administration does not reduce persistent incisional pain at 6 months in patients recovering from cardiac surgery.

Purpose: Following cardiac surgery via median sternotomy, patients are routinely advised to adhere to upper limb restrictions to prevent the development of sternal complications. However, there is no definitive evidence to support the clinical application of such restrictions. The purpose of this study was to investigate current physiotherapy practice regarding upper limb exercise guidelines for this population, within outpatient cardiac rehabilitation in Australia., Methods: Physiotherapists working within outpatient cardiac rehabilitation programs in Australia were invited to complete a Web survey., Results: The response rate was 77%. The majority of respondents (96%) prescribed upper limb exercises to patients following median sternotomy, with 95% placing restrictions on these exercises. At 6 weeks postoperatively, 58% and 73% of respondents still placed restrictions on unloaded and loaded unilateral upper limb elevation exercises respectively; similarly, 55% and 74% placed restrictions on unloaded and loaded bilateral upper limb elevation exercises, respectively. However, there was a lack of consensus on the type and timing of these restrictions, with patient-reported pain being the main parameter used to guide upper limb exercise prescription and progression. Only 43% reported screening for sternal instability, and if detected, the majority based their management on clinical experience., Conclusions: There is significant variation in practice with respect to the prescription and progression of upper limb exercises, within outpatient cardiac rehabilitation in Australia. Further research is warranted to establish evidence-based guidelines for the upper limb rehabilitation of patients following cardiac surgery via median sternotomy.

The dislodgement of atheroma from the ascending aorta and proximal arch is a major cause of stroke and neurological injury following cardiac surgery. The accurate detection of atheroma prior to aortic manipulation is necessary to facilitate surgical strategies to reduce the risk of embolisation. The traditional method for atheroma detection is manual palpation by the surgeon. This technique misses about half the number of the atheroma lesions, as the soft (non-calcified) lesions offer little resistance to the surgeon's fingers. Trans-oesophageal echocardiography (TOE) is commonly used in cardiac surgery, but the interposition of the bronchus between the aorta and the oesophagus causes an ultrasound 'blind spot' in the ascending aorta and proximal arch, such that it does not offer improved detection compared to manual palpation. Accurate detection of atheroma requires direct ultrasound assessment using epiaortic scanning, with a high-frequency, linear-array probe. This allows the surgeon to correctly assess and localise any atheroma. In this article, a suggested epiaortic examination sequence is described and strategies for surgeons to avoid atheroma are discussed.

A considerable number of patients who undergo cardiac surgery have a variety of comorbid conditions that includes diastolic dysfunction. Abnormalities of diastolic function may lead to diastolic heart failure that can complicate their postoperative course. This form of failure occurs more commonly in patients with hypertensive or valvular heart disease, diabetes mellitus, myocardial ischaemia, as well as in hypertrophic or restrictive cardiomyopathy, and is more prevalent in the elderly. In spite of it being a common cause of heart failure it remains underreported in the postoperative heart. We reviewed relevant literature analysing the different therapeutic approaches and formulated a management plan for diastolic heart failure in the postoperative heart in the intensive care environment based on the most current understanding of this form of cardiac failure.

Unlabelled: Baseline measurements of systolic and diastolic function performed after the induction of anesthesia may be compared with subsequent measurements acquired under different physical conditions such as open pericardium and different heart rate or rhythm. We acquired data from 21 patients undergoing coronary artery surgery. Combined echocardiographic and pulmonary artery catheter measurements were performed before and after pericardial opening, atrial pacing at the native rate, and atrial pacing 30 bpm faster. Indices of systolic function included fractional area change, afterload corrected fractional area change, and myocardial performance index; diastolic function included mitral inflow and pulmonary vein Doppler profiles, color M-Mode Doppler flow propagation velocity, instantaneous end-diastolic stiffness, and isovolumetric relaxation time. Hemodynamic indices included cardiac index, mean arterial, right atrial, and pulmonary capillary wedge pressures, and systemic vascular resistance index. There were no changes in measurements after opening of the pericardium or with institution of atrial pacing. With increased heart rate, there were no changes in systolic function, but instantaneous end-diastolic stiffness increased. Propagation velocity showed a paradoxical improvement with increased heart rate opposite to other trends. Beat fusion occurs with increasing heart rate for mitral inflow Doppler. We recommend that serial measurements are performed at a similar heart rate., Implications: Pericardial restraint or the institution of atrial pacing do not alter left ventricular function, as assessed by pulmonary artery catheter and transesophageal echocardiography measurements. Diastolic (but not systolic) measurements showed inconsistency with increased heart rate.

Unlabelled: Persistent pain is an underreported morbidity after cardiac surgery. We sent pain surveys to all patients who underwent coronary artery bypass graft surgery from 1997 to 1999 from a single surgeon's experience. Two analgesia strategies were used: high thoracic epidural (HTEA) or IV and oral opiates (OPIOID) for 48-72 h after surgery. Persistent pain was defined as pain still present two or more months after surgery, and all questions referred to the time of survey only. From 356 questionnaires, 305 patients responded, and 61 of them refused consent, leaving 244 patients with complete surveys (HTEA, 150 patients [69%]; OPIOID, 94 patients [68%]). The incidence of persistent pain at any site was 29% and for sternotomy was 25%. The intensity of pain reported was mild, with only 7% reporting interference with daily living. Other common locations of persistent pain were the shoulders (17.4%), back (15.9%), and neck (5.8%). Twenty patients (8%) described symptoms suggestive of the internal mammary artery syndrome. A comparative audit of the HTEA and OPIOID groups showed no significant differences in the frequency or intensity of pain, although the time of survey from operation was longer in the OPIOID group. Mild persistent chest pain after sternotomy is common but infrequently interferes with daily life., Implications: Persistent wound pain after coronary artery bypass surgery is common, but it is usually is mild and infrequently interferes with daily living. An audit of two pain relief strategies (epidural analgesia or opiate analgesia) did not show any difference in the incidence of persistent pain.