Dataset Information

Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock.

ABSTRACT:

Objective

Patients with profound cardiogenic shock may require venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for circulatory support most commonly via the femoral vessels. The rate of cardiac recovery in this population remains low, possibly because peripheral VA-ECMO increases ventricular afterload. Whether direct ventricular unloading in peripheral VA-ECMO enhances cardiac recovery is unknown, but is being more frequently utilized. A randomized trial is warranted to evaluate the clinical effectiveness of percutaneous left ventricle venting to enhance cardiac recovery in the setting of VA-ECMO.

Methods

We describe the rationale, design, and initial testing of a randomized controlled trial of VA-ECMO with and without percutaneous left ventricle venting using a percutaneous micro-axial ventricular assist device.

Results

This is an ongoing prospective randomized controlled trial in adult patients with primary cardiac failure presenting in cardiogenic shock requiring peripheral VA-ECMO, designed to test the safety and effectiveness of percutaneous left ventricle venting in improving the rate of cardiac recovery.

Conclusions

The results of this nonindustry-sponsored trial will provide critical information on whether left ventricle unloading in peripheral VA-ECMO is safe and effective.

SUBMITTER: Ibrahim M

PROVIDER: S-EPMC9390694 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock.

Ibrahim Michael M Acker Michael A MA Szeto Wilson W Gutsche Jacob J Williams Matthew M Atluri Pavan P Woods Matthew M Richards Thomas T Gardner Timothy J TJ McGarvey Jeremy J Epler Mark M Wald Joyce J Rame Eduardo E Birati Edo E Bermudez Christian C

JTCVS open 20210730

<h4>Objective</h4>Patients with profound cardiogenic shock may require venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for circulatory support most commonly via the femoral vessels. The rate of cardiac recovery in this population remains low, possibly because peripheral VA-ECMO increases ventricular afterload. Whether direct ventricular unloading in peripheral VA-ECMO enhances cardiac recovery is unknown, but is being more frequently utilized. A randomized trial is warranted to eval ...[more]

PMID: 36004109

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Project description:ObjectiveLeft ventricular (LV) distention is a feared complication in patients receiving venoarterial (VA) extracorporeal membrane oxygenation (ECMO). LV unloading can be achieved indirectly with intra-aortic balloon pump (IABP) or directly with an Impella device (Abiomed, Danvers, Mass). We sought to assess the clinical and hemodynamic effects of IABP and Impella devices on patients supported with VA ECMO.MethodsWe conducted a retrospective review of VA ECMO patients at our institution from January 2015 to June 2020. Patients were categorized as either ECMO alone or ECMO with LV unloading. LV unloading was characterized as either ECMO with IABP or ECMO with Impella. We recorded baseline characteristics, survival, complications, and hemodynamic changes associated with device initiation.ResultsDuring the study, 143 patients received ECMO alone whereas 140 received ECMO with LV unloading (68 ECMO with IABP, 72 ECMO with Impella). ECMO with Impella patients had a higher incidence of bleeding events compared with ECMO alone or ECMO with IABP (52.8% vs 37.1% vs 17.7%; P < .0001). Compared with ECMO alone, ECMO with IABP patients had better survival at 180 days (log rank P = .005) whereas survival in ECMO with Impella patients was not different (log rank P = .66). In a multivariable Cox hazard analysis, age (hazard ratio [HR], 1.02; 95% confidence interval [CI], 1.00-1.03; P = .015), male sex (HR, 0.54; 95% CI, 0.38-0.80; P = .002), baseline lactate (HR, 1.06; 95% CI, 1.02-1.11; P = .004), baseline creatinine (HR, 1.06; 95% CI, 1.00-1.11; P = .032), need for extracorporeal membrane oxygenation-cardiopulmonary resuscitation (HR, 2.09; 95% CI, 1.40-3.39; P = .001), and presence of pre-ECMO IABP (HR, 0.45; 95% CI, 0.25-0.83; P = .010) were associated with reduced mortality. There was no significant difference in hemodynamic changes in the ECMO with IABP versus ECMO with Impella cohorts.ConclusionsConcomitant support with IABP might help reduce morbidity and improve 180-day survival in patients receiving VA ECMO for cardiogenic shock.

Project description:BackgroundStudies reporting long-term outcomes of venoarterial extracorporeal membrane oxygenation-treated coronary artery bypass grafting patients are scarce. The objective of this study was to examine the survival outcomes and identify mortality risk factors for coronary artery bypass grafting patients who received venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.MethodsData from 121 consecutive venoarterial extracorporeal membrane oxygenation-treated coronary artery bypass grafting patients at the Beijing Anzhen Hospital between January 2012 and December 2016 were analyzed. Multivariable Cox regression modeling was used to identify factors independently associated with 36-month mortality.ResultsSeventy-seven patients (64%) could be weaned from venoarterial extracorporeal membrane oxygenation, 56 patients (46%) survived to hospital discharge, and 41 patients (34%) survived to 36 months. Older age (hazard ratio, 1.06; 95% confidence interval [CI], 1.03-1.10; p < 0.001), left main coronary artery disease (hazard ratio, 1.64; 95% CI, 1.04-2.59; p < 0.001), and vasoactive inotropic score (hazard ratio, 1.09; 95% CI, 1.02-1.16; p = 0.011) were independent risk factors associated with 36-month mortality. The area under the receiver operating characteristic curve for the logistic regression model, which was constructed with three pre-extracorporeal membrane oxygenation parameters-age ⩾ 60 years, left main coronary artery disease, and vasoactive inotropic score > 60-was 0.87 (95% CI, 0.81-0.94). Age and left main coronary artery disease significantly increased the discriminatory performance of Sepsis-related Organ Failure Assessment score (0.79 vs. 0.91, p = 0.025).ConclusionsOlder age, left main coronary artery disease, and vasoactive inotropic score were associated with 36-month mortality in coronary artery bypass grafting patients who received venoarterial extracorporeal membrane oxygenation.

Project description:BackgroundVenoarterial extracorporeal membrane oxygenation (VA-ECMO) increases left ventricular (LV) afterload, potentially provoking LV distention and impairing recovery. LV mechanical unloading (MU) with intra-aortic balloon pump (IABP) or percutaneous ventricular assist device (pVAD) can prevent LV distension, potentially at the risk of more complications, and net clinical benefit remains uncertain.ObjectivesThis study aims to determine the association between MU and outcomes for patients undergoing VA-ECMO.MethodsThe authors queried the Extracorporeal Life Support Organization registry for adults receiving peripheral VA-ECMO from 2010 to 2019 and stratified them by MU with IABP or pVAD. The primary outcome was in-hospital mortality; secondary outcomes included on-support mortality and complications during VA-ECMO.ResultsAmong 12,734 VA-ECMO patients, 3,399 (26.7%) received MU: 2,782 (82.9%) IABP and 580 (17.1%) pVAD. MU patients were older (age 56.3 vs 52.7 years) and, before extracorporeal membrane oxygenation, more often required >2 vasopressors (41.7% vs 27.2%) and had respiratory (21.1% vs 15.9%), renal (24.6% vs 15.8%), and liver failure (4.4% vs 3.1%) (all P < 0.001). MU patients had lower in-hospital mortality (56.6% vs 59.3%, P = 0.006), which persisted in multivariable modeling (adjusted OR [aOR]: 0.84; 95% CI: 0.77-0.92; P < 0.001). MU was associated with more cannula site bleeding (aOR: 1.25; 95% CI: 1.11-1.40; P < 0.001) and hemolysis (aOR: 1.27; 95% CI: 1.03-1.57; P = 0.02). Compared to pVAD, MU patients with IABP had similar mortality (aOR: 0.80; 95% CI: 0.64-1.01; P = 0.06) and less medical bleeding (aOR: 0.45; 95% CI: 0.31-0.64; P < 0.001), cannula site bleeding (aOR: 0.72; 95% CI: 0.54-0.96; P = 0.03), and renal injury (aOR: 0.78; 95% CI: 0.62-0.98; P = 0.03).ConclusionsAmong adults receiving VA-ECMO, MU was associated with lower in-hospital mortality despite increased complications including hemolysis and cannulation site bleeding. Compared to pVAD, MU with IABP was associated with similar mortality and lower complication rates.

Dataset Information

Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock.

Objective

Methods

Results

Conclusions

Publications

Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock.

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