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Purpose: To evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery.Methods: In a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm H2O) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm H2O). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days.Results: Among 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups.Conclusions: A perioperative open-lung ventilation including ventilation during CPB does not reduce the incidence of postoperative pulmonary complications as compared with usual care. This finding does not support the use of such a strategy in patients undergoing on-pump cardiac surgery.

Background Cardiopulmonary bypass (CPB) triggers marked cytokine release often followed by a systemic inflammatory response syndrome, associated with adverse postoperative outcomes. This trial investigates the intraoperative use of haemoadsorption (HA) during cardiac surgery with CPB to assess its impact on postoperative systemic inflammatory response. Methods In this prospective randomised controlled trial (ethics approval no. 5094-14DRKS00007928), patients (> 65 years) undergoing elective on-pump cardiac surgery were randomised to intraoperative HA (CytoSorb) during CPB or standard care without HA. Primary outcome was the difference in mean interleukin (IL)-6 serum concentrations between groups on intensive care unit (ICU) admission. The secondary outcomes included various clinical and biochemical endpoints. Statistical methods included paired and unpaired t-tests, Wilcoxon, Mann–Whitney U-tests, and chi-square tests. Results Thirty-eight patients were allocated to receive either intraoperative HA (n = 19) or standard care (n = 19). The primary outcome, IL-6 levels on ICU admission, did not differ between the study group and controls (214.4 ± 328.8 vs. 155.8 ± 159.6 pg/ml, p  = 0.511). During surgery pre- versus post-adsorber IL-2, IL-6, IL-8, IL-10, heparan sulfate and myoglobin post- levels were reduced. Furthermore, IL-6 levels did not differ between the study groups on day 1 and 2 in the ICU. While sequential organ failure assessment scores, lactate levels, and C-reactive protein and procalcitonin (PCT) showed no statistically significant differences. Regarding haemodynamic stability in the treatment group the cardiac index (3.2 ± 0.7 vs. 2.47 ± 0.47 l/min/m 2 , p  = 0.012) on ICU day 2 increased, and lower fluid requirements as well as decreased fibrinogen requirement were observed. Need for renal replacement therapy did not differ though a shorter duration was observed in the treatment group. Time on ventilator, respiratory parameters, infectious complications, delirium scores, ICU and hospital lengths of stay, and mortality did not differ between groups. Conclusion HA did not reduce the IL-6 level on ICU admission or afterwards. Even though HA reduced cytokine load during cardiac surgery in the treatment group. There were no significant differences between groups in the postoperative course of other cytokine concentrations, organ dysfunction, ICU and hospital lengths of stay and mortality rates. Trial registration prospectively DRKS00007928 and published under: Baumann A, Buchwald D, Annecke T, Hellmich M, Zahn PK, Hohn A. RECCAS - REmoval of Cytokines during Cardiac Surgery: study protocol for a randomised controlled trial. Trials. 2016;17: 137. Graphical abstract

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

PurposeWhether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.MethodsCLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.ResultsOf 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), − 1.58–2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI − 0.55–2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.ConclusionAmong patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.

Background Delirium and postoperative cognitive dysfunction (POCD) are common complications post-cardiac surgery, yet no specific medical intervention is currently recommended for prevention. This study aimed to evaluate the efficacy of gastrodin infusion in preventing delirium and POCD in critically ill patients following cardiac surgery. Material and Methods A double-blind, randomized, placebo-controlled trial was conducted on patients aged 18–75, scheduled for coronary artery bypass grafting (CABG) surgery, with or without valve replacement. Participants were randomized in a 1:1 ratio to receive gastrodin infusion 600 mg twice daily or placebo from the day of surgery until the postoperative day (POD) 6. The co-primary outcomes were the incidences of delirium and POCD, assessed from ICU admission until POD 7 and at 1 and 3 months postoperatively. This study was registered with the Chinese Clinical Trials Registry (ChiCTR1800020414). Results Of 160 randomized participants, 155 were analyzed (77 gastrodin, 78 placebo) according to a modified intention to treat principle. The incidence of postoperative delirium was 19.5% in the gastrodin group and 35.9% in the placebo group, with a significant relative risk of 0.54 (95% CI 0.32–0.93, p  = 0.022). The incidence of in-hospital POCD was 2.9% and 4.0% in the placebo and gastrodin groups, respectively. The odds of hospital discharge were significantly greater in the gastrodin group (subhazard ratio, 1.20; 95% CI 1.00–1.84;  p  = 0.049). Adverse events occurred in 9.1% (7/77) of patients administered gastrodin and 14.1% (11/78) of patients administered the placebo, with none being drug-related. Conclusion Gastrodin infusion significantly reduced postoperative delirium and improved discharge outcomes in patients undergoing CABG, but larger studies are needed to confirm its efficacy in preventing delirium.

Purpose Patients with a body mass index (BMI) ≥30 kg/m 2 experience more severe atelectasis following cardiac surgery than those with normal BMI and its resolution is slower. This study aimed to compare extubation of patients post-cardiac surgery with a BMI ≥30 kg/m 2 onto high-flow nasal cannulae (HFNC) with standard care to determine whether HFNC could assist in minimising post-operative atelectasis and improve respiratory function. Methods In this randomised controlled trial, patients received HFNC or standard oxygen therapy post-extubation. The primary outcome was atelectasis on chest X-ray. Secondary outcomes included oxygenation, respiratory rate (RR), subjective dyspnoea, and failure of allocated treatment. Results One hundred and fifty-five patients were randomised, 74 to control, 81 to HFNC. No difference was seen between groups in atelectasis scores on Days 1 or 5 (median scores = 2, p  = 0.70 and p  = 0.15, respectively). In the 24-h post-extubation, there was no difference in mean PaO 2 /FiO 2 ratio (HFNC 227.9, control 253.3, p  = 0.08), or RR (HFNC 17.2, control 16.7, p  = 0.17). However, low dyspnoea levels were observed in each group at 8 h post-extubation, median (IQR) scores were 0 (0–1) for control and 1 (0–3) for HFNC ( p  = 0.008). Five patients failed allocated treatment in the control group compared with three in the treatment group [Odds ratio 0.53, (95 % CI 0.11, 2.24), p  = 0.40]. Conclusions In this study, prophylactic extubation onto HFNC post-cardiac surgery in patients with a BMI ≥30 kg/m 2 did not lead to improvements in respiratory function. Larger studies assessing the role of HFNC in preventing worsening of respiratory function and intubation are required.

Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE. Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA2DS2-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism. The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF. ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

IntroductionCardiac surgery patients often experience significant pain after median sternotomy. The transversus thoracis muscle plane (TTP) block is a newly developed, single-shot nerve block technique that provides analgesia for the anterior chest wall. In this double-blind pilot study, we assessed the feasibility of performing this novel block as an analgesic adjunct.MethodsAll patients aged 18–90 undergoing elective cardiac surgery were randomized to the block or standard care control group on admission to the intensive care unit after surgery. Under ultrasound guidance, patients in the block group received the TTP block with 20 mL of either 0.3% or 0.5% ropivacaine bilaterally, based on weight. The control group did not receive any injections. All blocks were performed by a single anesthesiologist, and data collection was performed by blinded assessors. The primary feasibility outcomes were rate of recruitment, adherence, and adverse events. The rate of recruitment was defined as the ratio of patients giving informed consent to the number of eligible patients who were approached to participate. Secondary outcomes included 12-hour and 24-hour Numeric Rating Scale (NRS) pain scores, 24-hour hydromorphone and acetaminophen requirements, time to extubation, time to first opioid administration, and patient satisfaction (on a yes/no questionnaire) at 24 hours.ResultsTwenty patients were approached for this study and 19 were enrolled. Eight patients received the intended intervention in each group. The recruitment rate was 95% of all approached eligible patients, and the adherence rate to treatment group was 94%. There were no block-related adverse events. The mean (SD) NRS pain scores at rest were 3.3 (3.2) in the block group vs 5.6 (3.2) in the control group at 12 hours. At 24 hours, the pain scores were 4.1 (3.9) vs 4.1 (3.3) in the block and control group, respectively. The mean (SD) 24-hour hydromorphone administration was 1.9 (1.1) mg in the block group vs 1.8 (0.9) mg in the control group.DiscussionThe TTP block is a novel pain management strategy poststernotomy. The results reveal a high patient recruitment, adherence, and satisfaction rate, and provide some preliminary data supporting safety.Trial registration numberNCT03128346.

•This study presents a Bayesian re-analysis of the STRESS trial, which evaluated prophylactic methylprednisolone versus placebo in 1,200 infants undergoing heart surgery with cardiopulmonary bypass.•The Bayesian approach found a 92% posterior probability that methylprednisolone provides benefit (odds ratio < 1) and only a 8% probability of harm, with a mean odds ratio of 0.87 favoring methylprednisolone.•The absolute risk difference for death, transplant, or major complications was approximately –2% (95% CI –3%, +1%) for methylprednisolone compared to placebo, indicating a modest but clinically relevant reduction in adverse outcomes.•Sensitivity analyses using a range of prior beliefs and strengths consistently favored methylprednisolone, with 8 out of 9 scenarios showing ≥80% probability of benefit and ≥1% absolute risk reduction.•The findings suggest that prophylactic methylprednisolone is likely beneficial and unlikely to cause harm, supporting its continued use despite previous “negative” frequentist trial results. Prophylactic steroids are often used to reduce the systemic inflammatory response to cardiopulmonary bypass in infants undergoing heart surgery. The STRESS trial found that the odds of a worse outcome did not differ between infants randomized to methylprednisolone (n = 599) versus placebo (n = 601) (adjusted odds ratio [OR], 0.86; P = .14). However, secondary analyses showed possible benefits with methylprednisolone. To investigate further using a different probabilistic approach, we re-analyzed the STRESS trial using Bayesian analytics. We used a covariate-adjusted proportional odds model using the original STRESS trial primary endpoint, a ranked composite of death, transplant, major complication and post op length of stay. We performed Markov Chain Monte Carlo simulations to assess the probability of benefit (OR < 1) versus harm (OR > 1). Primary analysis assumed a neutral probability of benefit versus harm with weak prior belief strength (nearly noninformative prior distribution). To illustrate magnitude of effect, we calculated predicted risk of death, transplant or major complications for methylprednisolone and placebo. Sensitivity analyses evaluated pessimistic (5%-30% prior likelihood of benefit), neutral and optimistic (70%-95%) prior beliefs, and controlled strength of prior belief as weak (30% variance), moderate (15%) and strong (5%). A secondary analysis derived empirical priors using data from four previous steroid trials. The posterior probability of any benefit from methylprednisolone was 92% and probability of harm was 8%. Composite death or major complication occurred in 18.8% of subjects with an absolute risk difference of −2% (95% CI −3%, +1%) for methylprednisolone. Each of 9 sensitivity analyses demonstrated greater probability of benefit than harm in the methylprednisolone group with 8 of 9 demonstrating >80% probability of benefit and ≥1% absolute difference in risk of death, transplant or major complications. In secondary analysis deriving priors from previous steroid trials, results were consistent with a 95% posterior probability of benefit. Our Bayesian re-analysis of the STRESS trial, using a range of prior beliefs, demonstrated a high probability that perioperative methylprednisolone reduces the risk of death or major complications in infants undergoing cardiopulmonary bypass compared with placebo. This more in-depth analysis expands the initial clinical evaluation of methylprednisolone provided by the STRESS trial. Clinicaltrials.gov: NCT03229538 (https://clinicaltrials.gov/study/NCT03229538).

Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial. The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC. The primary effectiveness end point is the time to first occurrence of ischemic stroke or systemic embolism. The primary safety end point includes all-cause death, ischemic stroke, systemic embolism, or device- or procedural-related event requiring open cardiac surgery or major endovascular intervention. This is a multinational, multicenter prospective randomized trial. Patients meeting the inclusion criteria with CHA2DS2-VASc score≥2 and who are deemed by 2 study physicians to be unsuitable for OAC will be randomized in a 2:1 allocation ratio to Watchman versus control. Control patients will be prescribed single antiplatelet therapy or no therapy at the discretion of the study physician. Up to 888 randomized subjects will be enrolled from up to 100 global investigational sites. Both device group and control patients will have follow-up visits at 3, 6, and 12months and then every 6months through 60months. This trial will assess the safety and efficacy of Watchman in this challenging population of high–stroke risk AF patients.