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In a randomized trial, 5243 patients undergoing cardiac surgery were assigned to a restrictive or a liberal red-cell transfusion threshold. The restrictive threshold was noninferior to the liberal one for the composite outcome of death, myocardial infarction, stroke, or renal failure.

PurposeTo evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery.MethodsIn 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.ResultsAmong 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.ConclusionsA 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.Trial registrationClinicaltrials.gov Identifier: NCT 02866578. https://clinicaltrials.gov/ct2/show/NCT02866578

\"Lake Charles: 1908-1926 Along the cool sequester'd vale of life, They kept the noiseless tenor of their way. September 23, 1996 KLM Flight 287 rolled to a seamless stop on the tarmac, and settled on its wheels under the translucent Moscow sky. A contingent of American heart surgeons and support staff blinked and stretched. Their leader was famous for dozing off as soon as the wheels were up on any flight of length, and more than one of his retinue had mimicked that feat on this last leg of their journey from Houston via Amsterdam. This was not the first sojourn to Russia for their Chief - that had been back in 1958, when the country had another name and quite another polity. Many other visits had followed, accompanied by accolades and fetes, mostly with a Cold War political undertone he neither shared nor acknowledged. By nature he was fond of reflecting on change and history, and he did not miss the significance of returning to this place, the both of them now so different, in a position to alter the life path of a man who, himself, was responsible for much of this country's metamorphosis. The President of Russia, Boris Yeltsin, was suffering from congestive heart failure and severe coronary artery disease. The situation was grave; he was not expected to live without open-heart surgery - coronary bypass - but it was not clear that he could survive the procedure itself. The leading Russian heart surgeons and cardiologists had asked this Houston team to come to Moscow to assess the risks and provide recommendations as to how to proceed. In the geopolitically-charged climate of the immediate post-Cold War period, bringing in a coterie of Americans as consultants on the medical care of the most powerful man in Russia provoked all manner of responses on both sides of the Atlantic. The world's major news organizations focused on the story, covering every aspect. This fuss was of little consequence to the team from Texas, however. They were there to do a job, and their very presence in the Russian capital was as much of a validation as any that they were the most qualified group in the world for the task\"-- Provided by publisher.

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.

In this large randomized trial involving patients undergoing cardiac surgery who were at moderate-to-high risk, the outcomes at 6 months show that a restrictive red-cell transfusion strategy was noninferior to a liberal strategy with respect to the composite outcome.

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

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.

Cardiopulmonary rehabilitation, which often follows major acute cardiac events, is traditionally focused on aerobic exercise and has been associated with decreased morbidity and mortality. Its benefit among cardiac surgery patients is less clear, as is the role of resistance-based exercise programs and their sex-specific effects. This study seeks to evaluate the safety and feasibility of a 12-week resistance training program in patients post cardiac surgery through a sex-specific lens. We conducted a nonrandomized feasibility trial with a 12-week strength training exercise intervention. The primary outcome was safety and feasibility. Secondary outcomes included changes in strength, endurance, and functional capacity; and sex differences among these. Adult participants post open-heart surgery who had completed traditional cardiac rehabilitation were consented. Both patients who completed (cases) or did not complete (controls) a tailored 12-week resistance training program underwent comprehensive assessment of physiologic and physical fitness measures pre- and postintervention. Nine participants enrolled in the trial, including 6 in the intervention arm (median age 61 years; 67% male) and 3 in the control arm (median age 66 years; 67% male). No serious adverse events were noted, indicating safety of the intervention. Participants completed a mean of 34.8/36 (96.7%) of sessions, indicating the feasibility of the program. Although not powered for statistical significance, patients experienced positive trends of improvement in measures of hand grip strength, endurance, and functional capacity with the intervention. When stratified, females experienced greater gains than males in these measures. This proof-of-concept study found that resistance-based exercise after cardiac surgery is well tolerated and feasible. Although all patients experienced improvements in exercise parameters, females reported greater relative improvement than males. •The role of resistance-based exercise programs after cardiac surgery is unclear.•Prior data suggest that women may benefit more than men from exercise.•In this feasibility trial, all participants in a structured strength training program experienced benefits in strength, endurance, and functional capacity.•Women experienced greater gains than men.