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966 result(s) for "Off-pump"
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Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass
A total of 2203 patients at 18 medical centers were randomly assigned to undergo on-pump or off-pump CABG. Mortality at 5 years was significantly lower with on-pump CABG than with off-pump CABG. No secondary outcomes indicated a benefit of off-pump surgery.
Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial
Abstract Objective To assess whether perioperative management guided by near-infrared spectroscopy to determine tissue oxygen saturation and haemodynamic monitoring reduces postoperative complications after off-pump coronary artery bypass grafting. Design Assessor blinded, single centre, randomised controlled trial (Bottomline-CS trial). Setting A tertiary teaching hospital in China. Participants 1960 patients aged 60 years or older who were scheduled for elective off-pump coronary artery bypass grafting. Interventions All patients had multisite monitoring of tissue oxygen saturation (bilateral forehead and unilateral forearm brachioradialis) and haemodynamic monitoring. Both groups received usual care, including arterial blood pressure, central venous pressure, electrocardiography, and transoesophageal echocardiography when indicated. Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values, established 24-48 hours before surgery, from the start of anaesthesia until extubation or for up to 24 hours postoperatively. In the usual care group, tissue oximetry and haemodynamic data were concealed, and care was routine. Main outcome measures The primary outcome was the incidence of a composite of 30 day postoperative complications, which were cerebral, cardiac, respiratory, renal, infectious, and mortality complications. Secondary outcomes included the individual components of the composite outcome, new-onset atrial fibrillation, and hospital length of stay. Results Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed. During anaesthesia, the area under the curve for tissue oxygen saturation measurements outside the plus and minus 10% baseline range was significantly smaller with guided care than only usual care: left forehead 32.4 versus 57.6 (%×min, P<0.001), right forehead 37.9 versus 62.6 (P<0.001), and forearm 14.8 versus 44.7 (P<0.001). The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83). No secondary outcomes differed significantly between groups. The largest observed difference was in incidence of pneumonia, which was less frequent in the guided care group (88/967, 9.1%) than in the usual care group (121/974, 12.4%) and not statistically significant after adjusting for multiple comparisons. Conclusions Guided care by use of multisite near-infrared spectroscopy and haemodynamic monitoring effectively maintained tissue oxygenation near baseline levels compared with usual care. However, no clear evidence was noted that this approach reduced the incidence of major postoperative complications. These findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump coronary artery bypass grafting. Trial registration ClinicalTrials.gov NCT04896736.
15-year outcomes of the JOCRI study (JOCRIED study): a randomised comparison of off-pump and on-pump multiple arterial coronary revascularisation
Objective The Japanese Off-Pump Coronary Revascularization Investigation (JOCRI) study reported a non-significant difference in early outcomes and graft patency between off-pump coronary artery bypass grafting and on-pump coronary artery bypass grafting in 2005. The JOCRIED study aimed to review the long-term outcomes of the JOCRI study participants. Method and results The JOCRIED study enrolled 123 of the JOCRI study participants completing the clinical follow-up between August 2018 and August 2020; 61 patients in the off-pump group and 62 patients in the on-pump group. The follow-up period was 13.8 ± 2.8 years. The groups were compared regarding mortality, the incidence of major adverse cardiac and cerebrovascular events and repeat revascularisation. The 15-year cumulative survival rate (off-pump vs on-pump, respectively; 77.7% vs 75.3%; p  = 0.85), major adverse events-free survival rate (62.5% vs 55.6%; p  = 0.27) and repeat revascularisation-free rate (84.8% vs 78.0%; p  = 0.16) were not significantly different between the two groups. Revascularisation was the most common major adverse events in the JOCRIED participants. Although percutaneous coronary intervention was performed in 8 patients (13%) in the off-pump group and in 14 patients (23%) in the on-pump group ( p  = 0.23), no patients underwent redo coronary artery bypass grafting. Conclusions Off-pump coronary artery bypass grafting provides comparable 15-year outcomes to on-pump coronary artery bypass grafting.
Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial
Female sex is considered a significant risk in cardiac surgery and is included in the majority of scores for risk assessment. However, the evidence is controversial and older women undergoing cardiac surgery have not specifically been investigated. We assessed the influence of female sex on surgical risk (30-day mortality) in a secondary analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass grafting in the Elderly (GOPCABE) trial, comparing on- to off-pump) and also evaluated its impact on risk prediction from commonly used risk scores. We performed logistic regression analyses on the GOPCABE trial population, where patients were randomized to either on- or off-pump CABG. The study was performed in 12 cardiac surgery centers in Germany and analyzed 2394 patients having undergone CABG at age ≥75 years (1187 on-pump, 1207 off-pump). Of the 2394 patients, 755 (32%) were women. The logistic EuroSCORE and the German KCH score were calculated as expected (E) mortality and values were compared to observed (O) 30-day mortality (O/E ratio). There was no difference in mortality or major cardiovascular adverse events after 30 days between men and women for both on- and off-pump CABG (men: on- vs. off-pump OR = 0.90, 95%-CI: [0.63;1.27]; women: on- vs. off-pump OR = 1.07, 95%-CI: [0.62;1.87]). Therefore, groups were combined for further analyses. Both men and women had considerable and similar comorbidities. Expected mortality was significantly higher for women than for men (logistic EuroSCORE: 8.88±6.71% vs. 7.99±6.69%, p = 0.003; KCH score: 4.42±3.97% vs. 3.57±3.65%, p = 0.001). However, observed mortality rates (O) tended to be even lower in women (2.1% vs. 3.0%). The O/E ratio was closer to 1 in men than in women (0.84 vs. 0.47). Excluding female sex from the risk models increased O/E ratio to 0.69. Female sex is not a risk factor in coronary bypass surgery in the GOPCABE population. The result is the same for on- and off-pump surgery. Since female sex is a component of most risk scores, the findings may identify a potential inaccuracy in current surgical risk assessment, specifically for elderly women. Clinicaltrials.gov GOPCABE trial No. NCT00719667.
On-Pump versus Off-Pump Coronary-Artery Bypass Surgery
This comparative-effectiveness trial showed that clinical outcomes at 1 year were better with on-pump than with off-pump coronary-artery bypass grafting (CABG), and there was also better graft patency. There were no significant differences in neuropsychological outcomes. This comparative-effectiveness trial showed that clinical outcomes at 1 year were better with on-pump than with off-pump coronary-artery bypass grafting (CABG), and there was also better graft patency. During the past 30 years, coronary-artery bypass grafting (CABG) primarily was performed with the use of cardiopulmonary bypass (“on pump”) with cardioplegic arrest. Historically, on-pump CABG was shown to improve ischemic symptoms and, in selected patients, prolong survival. 1 – 3 In the mid-1990s, interest emerged in performing CABG without the use of cardiopulmonary bypass (off pump), in order to reduce postoperative complications associated with the use of cardiopulmonary bypass, 4 – 7 including generalized systemic inflammatory response, 8 , 9 cerebral dysfunction, 10 – 12 myocardial depression, and hemodynamic instability. 13 , 14 At the time this trial was being planned, initial enthusiasm for off-pump CABG became tempered by . . .
Efficacy and safety of remimazolam tosylate for patients undergoing off-pump coronary artery bypass grafting: a study protocol for a non-inferiority randomised controlled trial in China
IntroductionMaintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG.Method and analysisThis two-armed non-inferiority randomised controlled trial will include 88 patients aged 18–75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach.Ethics and disseminationThis study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal.Trial registration numberChiCTR.gov.cn: ChiCTR2400079615.
Rationale and design of The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization Study: A large international randomized trial in cardiac surgery
Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart (off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relatively short follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- and long-term impact of the 2 approaches to CABG. We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or off pump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at 30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will also undertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitive dysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life. As of May 3, 2011, CORONARY has recruited >3,884 patients from 79 centers in 19 countries. Currently, patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and 34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triple vessel disease. CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its results will lead to a better understanding of the safety and efficacy of off-pump CABG.
Aspirin plus clopidogrel for optimal platelet inhibition following off-pump coronary artery bypass surgery: results from the CRYSSA (prevention of Coronary arteRY bypaSS occlusion After off-pump procedures) randomised study
Objective To determine the individual variability in the response to aspirin and/or clopidogrel and its impact on graft patency after off-pump coronary artery bypass grafting. Design A single-centre prospective randomised controlled study designed according to the Consolidated Standards of Reporting Trials statement. Randomisation was obtained by a computer-generated algorithm. Setting University medical school in Italy. Patients 300 patients who underwent off-pump coronary artery bypass grafting were randomised to receive aspirin (n=150) or aspirin plus clopidogrel (n=150). Intervention Aspirin 100 mg or aspirin 100 mg plus clopidogrel 75 mg daily was initiated when postoperative chest tube drainage was ≤50 ml/h for 2 h and patients were followed up for 12 months. Main outcome measures Qualitative and quantitative assessment of platelet function, angiographic evaluation of coronary revascularisation by 64-slice CT and clinical outcome. Results In the aspirin group, 49 patients (32.6%) were aspirin resistant and, in the aspirin-clopidogrel group, 19 patients (12.6%) were aspirin and clopidogrel resistant. The platelet response to aspirin was similar in all aspirin responders despite the study arm (Aspirin Reaction Units 313.2±44.8 vs 323.6±53.6; p=0.07). The platelet response to clopidogrel was enhanced by aspirin in patients responsive to both aspirin and clopidogrel (synergistic effect) compared with responders to clopidogrel only (P2Y12 Reaction Units 139.9±15.5 vs 179.4±18.5; p<0.001). Combined therapy was associated with a reduced vein graft occlusion rate (7.4% vs 13.1%; p=0.04). Antiplatelet resistance was a predictor of graft occlusion (RR 3.6, 95% CI 2.5 to 6.9; p<0.001). Synergistic aspirin and clopidogrel activity was a strong predictor of vein graft patency (RR 5.1, 95% CI 1.4 to 16.3; p<0.01). Conclusions Combined clopidogrel and aspirin overcome single drug resistances, are safe for bleeding and improve venous graft patency.
Selenium, Vitamin C and N-Acetylcysteine do not Reduce the Risk of Acute Kidney Injury after Off-Pump CABG: a Randomized Clinical Trial
The aim of this study was to investigate the impact of perioperative administration of N-acetylcysteine, selenium and vitamin C on the incidence and outcomes of acute kidney injury after off-pump coronary bypass graft surgery. 291 patients requiring elective off-pump coronary bypass graft surgery were randomized to receive either N-acetylcysteine, vitamin C and selenium 600 mg, 1500 mg, 0.5 mg, and nothing orally twice a day, respectively, from the day before to 2 days after surgery. They were assessed for the development of acute kidney injury using Acute Kidney Injury Network criteria, time of onset, its severity and duration, duration of mechanical ventilation, intensive care unit and hospital length of stay, and in-hospital mortality. 272 patients completed the study. The total incidence of acute kidney injury was 22.1% (n=60) with 14 (20.9%), 15 (22.1%), 21 (31.8%), and 10 (14.1%) patients in the vitamin C, NAC, selenium, and control groups, respectively (P=0.096). We did not register significant differences in the incidence, the time of occurrence, the severity and the duration of acute kidney injury, as well as the duration of mechanical ventilation, the intensive care unit and hospital length of stay, and the in-hospital mortality among the four groups. We found that perioperative administration of N-acetylcysteine, vitamin C and selenium were not effective in preventing acute kidney injury and associated morbidity and mortality after off-pump coronary bypass graft surgery.
Efficacy of early goal-directed therapy for hemodynamics stability in off-pump coronary artery bypass surgery
Off-pump coronary artery bypass surgery causes hemodynamic changes due to position and surgical manipulation, which directly affect cardiovascular function and increase the rate of postoperative complications. The study’s goal was to evaluate the efficacy of early goal-directed therapy for hemodynamic stability in off-pump coronary artery bypass surgery. A case–control study was conducted between May 2022 and December 2024 in the Department of Anesthesiology and Critical Care at Military Hospital 175. Patients were monitored intraoperatively with ten time points using either the FloTrac/EV1000 system or conventional methods. Hemodynamic stability was measured by hemodynamic parameters (directly) and post-operative lactate levels (indirectly). The study included 70 patients (EGDT group: 36, Control group: 34). Baseline characteristics were similar between groups. Open surgery was performed in 90% of cases. Patients undergoing analysis recorded intraoperative hemodynamics with insignificant fluctuations of less than 5% in both groups. Both groups experienced a MAP nadir at T4 - post-anchoring suture (Control: 59.56 vs. EGDT: 62.42 mmHg). The EGDT group maintained significantly higher MAP After these points, the EGDT group showed faster MAP recovery. The EGDT implementation was associated with a 70% reduction in postoperative hyperlactatemia risk (OR 0.29; 95% CI 0.08–0.97; p  = 0.023). Application of early goal-directed therapy in off-pump coronary artery bypass surgery showed hemodynamic stability, better control, and a statistical significance reduction in the risk of postoperative hyperlactatemia by 70%.