Dataset Information

Algisyl-LVR™ with coronary artery bypass grafting reduces left ventricular wall stress and improves function in the failing human heart.

ABSTRACT:

Background

Left ventricular (LV) wall stress reduction is a cornerstone in treating heart failure. Large animal models and computer simulations indicate that adding non-contractile material to the damaged LV wall can potentially reduce myofiber stress. We sought to quantify the effects of a novel implantable hydrogel (Algisyl-LVR™) treatment in combination with coronary artery bypass grafting (i.e. Algisyl-LVR™+CABG) on both LV function and wall stress in heart failure patients.

Methods and results

Magnetic resonance images obtained before treatment (n=3), and at 3 months (n=3) and 6 months (n=2) afterwards were used to reconstruct the LV geometry. Cardiac function was quantified using end-diastolic volume (EDV), end-systolic volume (ESV), regional wall thickness, sphericity index and regional myofiber stress computed using validated mathematical modeling. The LV became more ellipsoidal after treatment, and both EDV and ESV decreased substantially 3 months after treatment in all patients; EDV decreased from 264 ± 91 ml to 146 ± 86 ml and ESV decreased from 184 ± 85 ml to 86 ± 76 ml. Ejection fraction increased from 32 ± 8% to 47 ± 18% during that period. Volumetric-averaged wall thickness increased in all patients, from 1.06 ± 0.21 cm (baseline) to 1.3 ± 0.26 cm (3 months). These changes were accompanied by about a 35% decrease in myofiber stress at end-of-diastole and at end-of-systole. Post-treatment myofiber stress became more uniform in the LV.

Conclusions

These results support the novel concept that Algisyl-LVR™+CABG treatment leads to decreased myofiber stress, restored LV geometry and improved function.

SUBMITTER: Lee LC

PROVIDER: S-EPMC3748222 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Publications

Algisyl-LVR™ with coronary artery bypass grafting reduces left ventricular wall stress and improves function in the failing human heart.

Lee Lik Chuan LC Wall Samuel T ST Klepach Doron D Ge Liang L Zhang Zhihong Z Lee Randall J RJ Hinson Andy A Gorman Joseph H JH Gorman Robert C RC Guccione Julius M JM

International journal of cardiology 20130208 3

<h4>Background</h4>Left ventricular (LV) wall stress reduction is a cornerstone in treating heart failure. Large animal models and computer simulations indicate that adding non-contractile material to the damaged LV wall can potentially reduce myofiber stress. We sought to quantify the effects of a novel implantable hydrogel (Algisyl-LVR™) treatment in combination with coronary artery bypass grafting (i.e. Algisyl-LVR™+CABG) on both LV function and wall stress in heart failure patients.<h4>Metho ...[more]

PMID: 23394895

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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:BACKGROUND:To date, studies evaluating outcome improvements associated with participation in physician-led collaboratives have been limited by the absence of a contemporaneous control group. We examined post cardiac surgery pneumonia rates associated with participation in a statewide, quality improvement collaborative relative to a national physician reporting program. METHODS AND RESULTS:We evaluated 911 754 coronary artery bypass operations (July 1, 2011, to June 30, 2017) performed across 1198 hospitals participating in a voluntary national physician reporting program (Society of Thoracic Surgeons [STS]), including 33 that participated in a Michigan-based collaborative (MI-Collaborative). Unlike STS hospitals not participating in the MI-Collaborative (i.e., STSnonMI) that solely received blinded reports, MI-Collaborative hospitals received a multi-faceted intervention starting November 2012 (quarterly in-person meetings showcasing unblinded data, webinars, site visits). Eighteen of the MI-Collaborative hospitals received additional support to implement recommended pneumonia prevention practices ("MI-CollaborativePlus"), whereas 15 did not ("MI-CollaborativeOnly"). We evaluated rates of postoperative pneumonia, adjusting for patient mix and hospital effects. Baseline patient characteristics were qualitatively similar between groups and time. During the preintervention period (Q3/2011 through Q3/2012), there was no statistically significant difference in the adjusted odds of pneumonia for STS hospitals participating in the MI-Collaborative compared to the STS non-MI hospitals. However, during the intervention period (Q4/2012 through Q2/2017), there was a significant 2% reduction per quarter in the adjusted odds of pneumonia for MI-Collaborative hospitals (n=33) relative to the STS-nonMI hospitals. There was a significant 3% per quarter reduction in the adjusted odds of pneumonia for the MI-CollaborativeOnly (n=15) hospitals relative to the STS-nonMI hospitals. Over the course of the overall study period, the STS-nonMI hospitals had a 1.96% reduction in risk-adjusted pneumonia (pre- vs. intervention periods), which was less than the MI-Collaborative (3.23%, P=0.011). Over the same time period, the MI-CollaborativePlus (n=18) reduced adjusted pneumonia rates by 10.29%, P=0.001. CONCLUSIONS:Participation in a physician-led collaborative was associated with significant reductions in pneumonia relative to a national quality reporting program. Interventions including collaborative learning may yield superior outcomes relative to solely using physician feedback reporting. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02068716.

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

Algisyl-LVR™ with coronary artery bypass grafting reduces left ventricular wall stress and improves function in the failing human heart.

Background

Methods and results

Conclusions

Publications

Algisyl-LVR™ with coronary artery bypass grafting reduces left ventricular wall stress and improves function in the failing human heart.

Similar Datasets

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