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Combined transepicardial and transseptal implantation of autologous CD 133+ bone marrow cells during bypass grafting improves cardiac function in patients with low ejection fraction.

ABSTRACT: OBJECTIVES:Autologous CD133+ bone marrow stem cells may improve cardiac function. This randomized, single-blind clinical trial inquired whether a combined transepicardial and transseptal implantation of CD133+ stem cells during coronary artery bypass grafting (CABG) improve cardiac function with ejection fraction (EF) changes as a primary endpoint in patients with low EF. METHODS:Thirty patients with coronary heart disease and EF <35% were randomized to undergo CABG alone or CABG with transseptal and transepicardial implantation of CD133+. Cardiac function was evaluated using cardiac magnetic resonance imaging (MRI) before and 6 months after CABG. RESULTS:Preoperative EF was lower in the intervention group (25.88%?±?5.66%) than in the control group (30.18%?±?3.85%; P?=?.04). The adverse event incidence was similar between both groups. At 6 months, EF changes were significantly higher (8.69%?±?9.49; P?=?.04) in the CD133+ group than in the CABG-only group. Compared to the control group, significant improvements were seen in the wall motion score index (P?=?.003) and scar size proportion (P?=?.047) in the CD133+ group. The quality of life (QOL), assessed by a 6-minute walking test, showed considerable improvement in the CD133+ group compared to that in the control group (P?=?.03). The Minnesota Living with Heart Failure Questionnaire (MLHFQ) scale did not show improvement in the intervention group (P?=?.09, vs control). CONCLUSION:Combined transepicardial and transseptal autologous CD133+ BMC implantation during bypass grafting improved cardiac function in low EF coronary artery disease patients.

SUBMITTER: Soetisna TW

PROVIDER: S-EPMC7187333 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Combined transepicardial and transseptal implantation of autologous CD 133+ bone marrow cells during bypass grafting improves cardiac function in patients with low ejection fraction.

Soetisna Tri Wisesa TW Sukmawan Renan R Setianto Budhi B Mansyur Muchtaruddin M Murni Tri Wahyu TW Listiyaningsih Erlin E Santoso Anwar A

Journal of cardiac surgery 20200212 4

<h4>Objectives</h4>Autologous CD133+ bone marrow stem cells may improve cardiac function. This randomized, single-blind clinical trial inquired whether a combined transepicardial and transseptal implantation of CD133+ stem cells during coronary artery bypass grafting (CABG) improve cardiac function with ejection fraction (EF) changes as a primary endpoint in patients with low EF.<h4>Methods</h4>Thirty patients with coronary heart disease and EF <35% were randomized to undergo CABG alone or CABG ...[more]

PMID: 32048356

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Project description:BackgroundWhile reduced left ventricular ejection fraction (LVEF) is a known risk factor for complications after coronary artery bypass grafting (CABG), the relevance of higher LVEF values has not been established. Currently, most risk stratification tools consider LVEF values above a certain point as normal. However, since this does not account for insufficient ventricular filling or increased adrenergic tone, higher values may have clinical significance. To improve our understanding of this situation, we investigated the relationship of preoperative LVEF values with short- and long-term outcomes after CABG using a strategy that allowed for the identification of nonlinear relationships. We hypothesised that both higher and lower values are independently associated with increased postoperative complications and death in this population.MethodsWe performed a single-centre retrospective cohort study of patients undergoing isolated CABG surgery. All patients had a preoperative measurement of their LVEF. Surgery involving mitral valve repair was excluded in order to eliminate the impact of mitral regurgitation. The primary outcome was long-term mortality; secondary outcomes included atrial fibrillation, operative mortality, and a composite outcome including any postoperative adverse event. Fractional polynomial equations were used to model the relationship between LVEF and outcomes so we could account for nonlinear relationships if present. Adjustments for confounders were made using multivariable logistic regression and Cox models.ResultsA total of 7,932 subjects were included in the study. After adjusting for patient and surgical characteristics, LVEF remained associated with the primary outcome as well as the composite outcome of any postoperative adverse event. Both these relationships were best described by a J-shaped curve given that higher LVEF values were associated with increased risk, albeit not as high has lower values. Regarding long-term mortality, individuals with a preoperative LVEF of 60% demonstrated the longest survival. A statistically significant relationship was not found between LVEF and operative mortality or atrial fibrillation after adjustment for confounders.ConclusionsHigher preoperative LVEF values may be associated with increased risk for patients undergoing CABG surgery. Future studies are needed to better characterise this phenotype.

Project description:ImportanceData are lacking on the outcomes of patients with severely reduced left ventricular ejection fraction (LVEF) who undergo revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).ObjectiveTo compare the long-term outcomes in patients undergoing revascularization by PCI or CABG.Design, setting, and participantsThis retrospective cohort study performed in Ontario, Canada, from October 1, 2008, and December 31, 2016, included data from Ontario residents between 40 and 84 years of age with LVEFs less than 35% and left anterior descending (LAD), left main, or multivessel coronary artery disease (with or without LAD involvement) who underwent PCI or CABG. Exclusion criteria were concomitant procedures, previous CABG, metastatic cancer, dialysis, CABG and PCI on the same day, and emergency revascularization within 24 hours of a myocardial infarction (MI). Data analysis was performed from June 2, 2018, to December 28, 2018.ExposuresRevascularization by PCI or CABG.Main outcomes and measuresThe primary outcome was all-cause mortality. Secondary outcomes were death from cardiovascular disease, major adverse cardiovascular events (MACE; defined as stroke, subsequent revascularization, and hospitalization for MI or heart failure), and each of the individual MACE.ResultsA total of 12 113 patients (mean [SD] age, 64.8 (11.0) years for the PCI group and 65.6 [9.7] years for the CABG group; 5084 (72.5%) male for the PCI group and 4229 (82.9%) male for the PCI group) were propensity score matched on 30 baseline characteristics: 2397 patients undergoing PCI and 2397 patients undergoing CABG. The median follow-up was 5.2 years (interquartile range, 5.0-5.3). Patients who received PCI had significantly higher rates of mortality (hazard ratio [HR], 1.6; 95% CI, 1.3-1.7), death from cardiovascular disease (HR 1.4, 95% CI, 1.1-1.6), MACE (HR, 2.0; 95% CI, 1.9-2.2), subsequent revascularization (HR, 3.7; 95% CI, 3.2-4.3), and hospitalization for MI (HR, 3.2; 95% CI, 2.6-3.8) and heart failure (HR, 1.5; 95% CI, 1.3-1.6) compared with matched patients who underwent CABG.Conclusions and relevanceIn this study, higher rates of mortality and MACE were seen in patients who received PCI compared with those who underwent CABG. The findings may provide insight to physicians who are involved in decision-making for these patients.

Project description:Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function.To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome.Randomized, double-blind, placebo-controlled trial conducted in 13 French cardiac surgical centers. Patients with a left ventricular ejection fraction less than or equal to 40% and scheduled for isolated or combined coronary artery bypass grafting with cardiopulmonary bypass were enrolled from June 2013 until May 2015 and followed during 6 months (last follow-up, November 30, 2015).Patients were assigned to a 24-hour infusion of levosimendan 0.1 µg/kg/min (n?=?167) or placebo (n?=?168) initiated after anesthetic induction.Composite end point reflecting low cardiac output syndrome with need for a catecholamine infusion 48 hours after study drug initiation, need for a left ventricular mechanical assist device or failure to wean from it at 96 hours after study drug initiation when the device was inserted preoperatively, or need for renal replacement therapy at any time postoperatively. It was hypothesized that levosimendan would reduce the incidence of this composite end point by 15% in comparison with placebo.Among 336 randomized patients (mean age, 68 years; 16% women), 333 completed the trial. The primary end point occurred in 87 patients (52%) in the levosimendan group and 101 patients (61%) in the placebo group (absolute risk difference taking into account center effect, -7% [95% CI, -17% to 3%]; P?=?.15). Predefined subgroup analyses found no interaction with ejection fraction less than 30%, type of surgery, and preoperative use of ?-blockers, intra-aortic balloon pump, or catecholamines. The prevalence of hypotension (57% vs 48%), atrial fibrillation (50% vs 40%), and other adverse events did not significantly differ between levosimendan and placebo.Among patients with low ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite end point of prolonged catecholamine infusion, use of left ventricular mechanical assist device, or renal replacement therapy. These findings do not support the use of levosimendan for this indication.EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.

Project description:Background and objectiveHeart failure (HF) is a global health issue, and coronary artery bypass graft (CABG) is one of the most effective surgical treatments for HF with coronary artery disease. Unfortunately, the incidence of postoperative acute kidney injury (AKI) is high in HF patients following CABG, and there are few tools to predict AKI after CABG surgery for such patients. The aim of this study is to establish a nomogram to predict the incidence of AKI after CABG in patients with impaired left ventricular ejection fraction (LVEF).MethodsFrom 2012 to 2017, Clinical information of 1208 consecutive patients who had LVEF< 50% and underwent isolated CABG was collected to establish a derivation cohort. A novel nomogram was developed using the logistic regression model to predict postoperative AKI among these patients. According to the same inclusion criteria and the same period, we extracted the data of patients from 6 other large cardiac centers in China (n = 540) from the China Heart Failure Surgery Registry (China-HFSR) database for external validation of the new model. The nomogram was compared with 3 other available models predicting renal failure after cardiac surgery in terms of calibration, discrimination and net benefit.ResultsIn the derivation cohort (n = 1208), 90 (7.45%) patients were diagnosed with postoperative AKI. The nomogram included 7 independent risk factors: female, increased preoperative creatinine(> 2 mg/dL), LVEF< 35%, previous myocardial infarction (MI), hypertension, cardiopulmonary bypass(CPB) used and perioperative blood transfusion. The area under the receiver operating characteristic curve (AUC) was 0.738, higher than the other 3 models. By comparing calibration curves and decision curve analyses (DCA) with other models, the novel nomogram showed better calibration and greater net benefit. Among the 540 patients in the validation cohort, 104 (19.3%) had postoperative AKI, and the novel nomogram performed better with respect to calibration, discrimination and net benefit.ConclusionsThe novel nomogram is a reliable model to predict postoperative AKI following isolated CABG for patients with impaired LVEF.

Dataset Information

Combined transepicardial and transseptal implantation of autologous CD 133+ bone marrow cells during bypass grafting improves cardiac function in patients with low ejection fraction.

Publications

Combined transepicardial and transseptal implantation of autologous CD 133+ bone marrow cells during bypass grafting improves cardiac function in patients with low ejection fraction.

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