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European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications.

ABSTRACT: BACKGROUND:Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry. DESIGN:The E-CABG registry is a multicenter study and its data are prospectively collected from 13 centers of cardiac surgery in university and community hospitals located in six European countries (England, Italy, Finland, France, Germany, Sweden). Data on major and minor immediate postoperative adverse events will be collected. Data on late all-cause mortality, stroke, myocardial infarction and repeat revascularization will be collected during a 10-year follow-up period. These investigators provided a score from 0 to 10 for any major postoperative adverse events and their rounded medians were used to stratify the severity of these complications in four grades. The sum of these scores for each complication/intervention occurring after coronary artery bypass grafting will be used as an additive score for further stratification of the prognostic importance of these events. DISCUSSION:The E-CABG registry is expected to provide valuable data for identification of risk factors and treatment strategies associated with suboptimal outcome. These information may improve the safety and durability of coronary artery bypass grafting. The proposed classification of postoperative complications may become a valuable research tool to stratify the impact of such complications on the outcome of these patients and evaluate the burden of resources needed for their treatment. CLINICAL TRIALS NUMBER:NCT02319083.

SUBMITTER: Biancari F

PROVIDER: S-EPMC4485338 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications.

Biancari Fausto F Ruggieri Vito G VG Perrotti Andrea A Svenarud Peter P Dalén Magnus M Onorati Francesco F Faggian Giuseppe G Santarpino Giuseppe G Maselli Daniele D Dominici Carmelo C Nardella Saverio S Musumeci Francesco F Gherli Riccardo R Mariscalco Giovanni G Masala Nicola N Rubino Antonino S AS Mignosa Carmelo C De Feo Marisa M Della Corte Alessandro A Bancone Ciro C Chocron Sidney S Gatti Giuseppe G Gherli Tiziano T Kinnunen Eeva-Maija EM Juvonen Tatu T

Journal of cardiothoracic surgery 20150630

<h4>Background</h4>Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry.<h4>Design</h4>The E-CABG registry is a multicenter study and its data are prospectively collected from 13 ...[more]

PMID: 26123033

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Project description:Treatment of multivessel coronary artery disease with traditional single-arterial coronary artery bypass graft (SA-CABG) has been associated with superior intermediate-term survival and reintervention compared with percutaneous coronary intervention (PCI) using either bare-metal stents (BMS) or drug-eluting stents (DES).This study sought to investigate longer-term outcomes including the potential added advantage of multiarterial coronary artery bypass graft (MA-CABG).We studied 8,402 single-institution, primary revascularization, multivessel coronary artery disease patients: 2,207 BMS-PCI (age 66.6 ± 11.9 years); 2,381 DES-PCI (age 65.9 ± 11.7 years); 2,289 SA-CABG (age 69.3 ± 9.0 years); and 1,525 MA-CABG (age 58.3 ± 8.7 years). Patients with myocardial infarction within 24 h, shock, or left main stents were excluded. Kaplan-Meier analysis and Cox regression were used to separately compare 9-year all-cause mortality and unplanned reintervention for BMS-PCI and DES-PCI to respective propensity-matched SA-CABG and MA-CABG cohorts.BMS-PCI was associated with worse survival than SA-CABG, especially from 0 to 7 years (p = 0.015) and to a greater extent than MA-CABG was (9-year follow-up: 76.3% vs. 86.9%; p < 0.001). The surgery-to-BMS-PCI hazard ratios (HR) were as follows: versus SA-CABG, HR: 0.87; and versus MA-CABG, HR: 0.38. DES-PCI showed similar survival to SA-CABG except for a modest 0 to 3 years surgery advantage (HR: 1.06; p = 0.615). Compared with MA-CABG, DES-PCI exhibited worse survival at 5 (86.3% vs. 95.6%) and 9 (82.8% vs. 89.8%) years (HR: 0.45; p <0.001). Reintervention was substantially worse with PCI for all comparisons (all p <0.001).Multiarterial surgical revascularization, compared with either BMS-PCI or DES-PCI, resulted in substantially enhanced death and reintervention-free survival. Accordingly, MA-CABG represents the optimal therapy for multivessel coronary artery disease and should be enthusiastically adopted by multidisciplinary heart teams as the best evidence-based therapy.

Project description:The purpose of this study is to evaluate the relationship between preoperative physical performance (grip strength, gait speed, timed up and go) and postoperative pulmonary complications (PPCs) in patients who have undergone coronary artery bypass grafting (CABG). From September 2019 to August 2021, a total of 497 CABG patients who met the inclusion criteria of this study were examined for grip strength, 4-m gait speed, and timed up and go (TUG) before CABG surgery. Among them, 438 were included in the final analysis. PPCs were classified according to the operational definition of Kroenke et al. and patients with clinically significant PPCs were included in the data analysis. Logistic regression was utilised to analyse the relationship between physical performance and clinically significant PPCs. Besides, the receiver operating characteristic (ROC) curve was applied to analyse the predictive effect of grip strength, gait speed, and TUG on clinically significant PPCs after the CABG procedure. In total, 103 (23.5%) patients developed clinically significant PPCs after CABG. After making adjustments for the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and confounding factors, we established that low grip/weight (OR 0.510; 95% CI 0.363-0.715), slow gait speed (OR 0.619; 95% CI 0.517-0.741), and prolonged TUG (OR 1.617; 95% CI 1.379-1.895) were all independently correlated with clinically significant PPCs after CABG. The ROC curve analysis indicated that the area under the ROC curve of the integrated model of the three indicators (AUC 0.792 vs. 0.682, 0.754, 0.765) was larger than that of the model with a single indicator. Besides the predictive effect of the integrated model was superior to the models using grip/weight, gait speed, or TUG alone. Physical performance, including grip/weight, gait speed, and TUG, is a predictive factor for PPCs in CABG patients, and can be used in preoperative evaluations to and help improve the management of high-risk patients.

Project description:BackgroundPostoperative delirium (POD) presents as a serious neuropsychiatric syndrome in patients undergoing off-pump coronary artery bypass grafting (OPCABG) surgery. This is correlated with higher mortality, cognitive decline, and increased costs. The Age-adjusted Charlson Comorbidity Index (ACCI) is recognized as an independent predictor for mortality and survival rate. The purpose of our study is to estimate the predictive value of the ACCI on the POD in patients undergoing OPCABG surgery.MethodsThis prospective cohort study enrolled patients undergoing OPCABG surgery between December 2020 and May 2021 in Qilu Hospital. Patients were divided into the low-ACCI group (score, 0-3) and the high-ACCI group (score ≥4) according to their ACCI scores. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and CAM were used to diagnose POD within 7 days after surgery. The general, laboratory, and clinical data of the patients were recorded and collected. The characteristic ROC curve was applied to further assess the predictive value of the ACCI for POD in patients following OPCABG surgery.ResultsA total of 89 patients were enrolled, including 45 patients in the low-ACCI group and 44 patients in the high-ACCI group. The incidence of POD was higher in the high-ACCI group than in the low-ACCI group (45.5% vs. 15.6%, P = 0.003). Multivariate logistic regression analyses showed that the ACCI (OR, 2.433; 95% CI, 1.468-4.032; P = 0.001) was an independent risk factor for POD. The ACCI accurately predicted POD in patients following OPCABG surgery with an AUC of 0.738, and the Hosmer-Lemeshow goodness of fit test yielded X2 = 5.391 (P = 0.145).ConclusionThe high-ACCI group showed a high incidence of POD. The ACCI was an independent factor associated with POD in patients following OPCABG surgery. In addition, the ACCI could accurately predict POD in patients following OPCABG surgery.Clinical trial registrationClinicalTrials.gov, identifier CHiCTR2100052811.

Project description:BackgroundCell salvage reduces allogenic blood transfusion requirements in surgery. We present a pilot study exploring the impact of anticoagulant choice, citrate or heparin, on the quality of cell salvaged blood in adults undergoing coronary artery bypass grafting (CABG).Materials and methodsElective on pump CABG patients were randomly allocated to citrate or heparin anticoagulation. We measured red blood cell characteristics and inflammation in both the blood collection reservoir and the washed red blood cell concentrate. Postoperatively, the level of biomarkers and the coagulation profile in the peripheral blood as well as the transfusion requirements of allogenic blood products were studied.ResultsThirty eight patients were included, 19 in the citrate group and 19 in the heparin group. Baseline characteristics were similar. In the washed red blood cell concentrate, Mean Hb (g/dl) and Ht (%) were lower in the citrate group [Hb: 18.1 g/dL (SD 1.3) vs. 21.1 (1.6), p < 0.001; Ht: 59.9% (54.7-60.9) vs. 63.7% (62.3-64.8); p < 0.001]; Mean corpuscular volume (MCV, μm 3) was higher [99.1fL (9.4) vs. 88 (4.2), p < 0.001] and mean corpuscular hemoglobin concentration (MCHC, g/dl) lower in the citrate group [31.9 g/dl (29.6-32.4) vs. 33.6 (33.1-34.0) p < 0.001]. Thrombocyte count (1000/μl) was higher in the citrate group [31.0 (26.0-77.0) vs. 13.0 (10.0-39.0); p = 0.006]. There were no differences in the requirement for allogenic blood products' transfusion (intraoperatively and postoperatively) or in the coagulation parameters after washed red blood cell concentrate infusion. Higher IL-10 was found in the citrate group in the blood collection reservoir, higher neutrophil-derived myeloperoxidase (MPO) in the heparin group after washed red blood cell concentrate infusion.ConclusionThough red blood cells in washed red blood cell concentrate were more swollen and diluted in the citrate group with more residual thrombocytes, published quality guidelines were met in both groups. Our pilot study suggests that differences in inflammatory markers in the blood collection reservoir and after infusion of washed red blood cell concentrate indicate a possible pro-inflammatory effect of heparin compared to citrate. A larger study is warranted to confirm these results and their possible clinical consequences. Trial registration ClinicalTrials.gov : NCT02674906. Registered 5 February 2016.

Project description:BackgroundProlonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. We developed the continuous postoperative pericardial flushing (CPPF) therapy to improve wound drainage and reduce postoperative blood loss and bleeding-related complications after cardiac surgery. This study compared CPPF to standard care in patients after coronary artery bypass grafting (CABG).MethodsThis is a single center, open label, randomized trial that enrolled patients at the Amsterdam UMC, location AMC, Amsterdam, the Netherlands. The study was registered at the 'Netherlands Trial Register', study identifier NTR5200 [1]. Adults undergoing CABG were randomly assigned to receive CPPF therapy or standard care, participants and investigators were not masked to group assignment. The primary end point was postoperative blood loss in the first 12-hours after surgery.FindingsBetween the January 15, 2014 and the March 13, 2017, 169 patients were enrolled and assigned to CPPF therapy (study group; n = 83) or standard care (control group; n = 86). CPPF reduced postoperative blood loss when compared to standard care (median differences -385 ml, reduction 76% p=≤0.001), with the remark that these results are overestimated due to a measurement error in part of the study group. None of patients in the study group required reoperation for non-surgical bleeding versus 3 (4%, 95% CI -0.4% to 7.0%) in the control group. None of the patients in the study group suffered from cardiac tamponade, versus 3 (4%, 95% CI -0,4% to 7.0%) in the control group. The incremental cost-effectiveness ratio was €116.513 (95% bootstrap CI €-882.068 to €+897.278).InterpretationThe use of CPPF therapy after CABG seems to reduce bleeding and bleeding related complications. With comparable costs and no improvement in Qualty of Life (QoL), cost consideration for the implementation of CPPF is not relevant. None of the patients in the study group required re-interventions for non-surgical bleeding or acute cardiac tamponade, which underlines the proof of concept of this novel therapy.FundingThis study was funded by ZonMw, the Netherlands organization for health research and development (project 837001405).

Dataset Information

European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications.

Publications

European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications.

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