Dataset Information

Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model.

ABSTRACT: While the number of patients supported with temporary cardiac assist is growing, the existing devices are limited by a multitude of complications, mostly related to contact with the blood. The CorInnova epicardial compressive heart assist device was tested in six sheep using an acute heart failure model. High esmolol dose, targeting a 50% reduction in CO from healthy baseline, resulted in a failure state with mean CO 1.9 L/min. Heart assist with the device during failure state resulted in an average absolute increase in CO of 1.0 L/min, along with a decline in ventricular work to 67.5% of the total LV SW. Combined with repeated success of minimally invasive device implant, the resulting increases in cardiac hemodynamics achieved while still unloading the heart demonstrate the potential of the CorInnova device for temporary heart assist.

SUBMITTER: Hord EC

PROVIDER: S-EPMC6497617 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model.

Hord Erica C EC Bolch Christina M CM Tuzun Egemen E Cohn William E WE Leschinsky Boris B Criscione John C JC

Journal of cardiovascular translational research 20190102 2

While the number of patients supported with temporary cardiac assist is growing, the existing devices are limited by a multitude of complications, mostly related to contact with the blood. The CorInnova epicardial compressive heart assist device was tested in six sheep using an acute heart failure model. High esmolol dose, targeting a 50% reduction in CO from healthy baseline, resulted in a failure state with mean CO 1.9 L/min. Heart assist with the device during failure state resulted in an ave ...[more]

PMID: 30604307

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Project description:This study investigates the use of a Bayesian statistical model to address the limited predictive capacity of existing risk scores derived from multivariate analyses. This is based on the hypothesis that it is necessary to consider the interrelationships and conditional probabilities among independent variables to achieve sufficient statistical accuracy.Right ventricular failure (RVF) continues to be a major adverse event following left ventricular assist device (LVAD) implantation.Data used for this study were derived from 10,909 adult patients from the Inter-Agency Registry for Mechanically Assisted Circulatory Support (INTERMACS) who had a primary LVAD implanted between December 2006 and March 2014. An initial set of 176 pre-implantation variables were considered. RVF post-implant was categorized as acute (<48 h), early (48 h to 14 daysays), and late (>14 days) in onset. For each of these endpoints, a separate tree-augmented naïve Bayes model was constructed using the most predictive variables employing an open source Bayesian inference engine.The acute RVF model consisted of 33 variables including systolic pulmonary artery pressure (PAP), white blood cell count, left ventricular ejection fraction, cardiac index, sodium levels, and lymphocyte percentage. The early RVF model consisted of 34 variables, including systolic PAP, pre-albumin, lactate dehydrogenase level, INTERMACS profile, right ventricular ejection fraction, pro-B-type natriuretic peptide, age, heart rate, tricuspid regurgitation, and body mass index. The late RVF model included 33 variables and was predicted mostly by peripheral vascular resistance, model for end-stage liver disease score, albumin level, lymphocyte percentage, and mean and diastolic PAP. The accuracy of all Bayesian models was between 91% and 97%, with an area under the receiver operator characteristics curve between 0.83 and 0.90, sensitivity of 90%, and specificity between 98% and 99%, significantly outperforming previously published risk scores.A Bayesian prognostic model of RVF based on the large, multicenter INTERMACS registry provided highly accurate predictions of acute, early, and late RVF on the basis of pre-operative variables. These models may facilitate clinical decision making while screening candidates for LVAD therapy.

Project description:Patients with acute myocardial infarction (AMI) complicated by acute heart failure or cardiogenic shock have high mortality with conventional management.This study evaluated outcomes of patients with AMI who received durable ventricular assist devices (VAD).Patients in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry who underwent VAD placement in the setting of AMI were included and compared with patients who received VAD for non-AMI indications.VAD were implanted in 502 patients with AMI: 443 left ventricular assist devices; 33 biventricular assist devices; and 26 total artificial hearts. Median age was 58.3 years, and 77.1% were male. At implantation, 66% were INTERMACS profile 1. A higher proportion of AMI than non-AMI patients had pre-operative intra-aortic balloon pumps (57.6% vs. 25.3%; p < 0.01), intubation (58% vs. 8.3%; p < 0.01), extracorporeal membrane oxygenation (17.9% vs. 1.7%, p < 0.01), cardiac arrest (33.5% vs. 3.3%, p < 0.01), and higher-acuity INTERMACS profiles. At 1 month post-VAD, 91.8% of AMI patients were alive with ongoing device support, 7.2% had died on device, and 1% had been transplanted. At 1-year post-VAD, 52% of AMI patients were alive with ongoing device support, 25.7% had been transplanted, 1.6% had left VAD explanted for recovery, and 20.7% had died on device. The AMI group had higher unadjusted early phase hazard (hazard ratio [HR]: 1.24; p = 0.04) and reduced late-phase hazard of death (HR: 0.57; p = 0.04) than the non-AMI group did. After accounting for established risk factors, the AMI group no longer had higher early mortality hazard (HR: 0.89; p = 0.30), but it had lower late mortality hazard (HR: 0.55; p = 0.02).Patients with AMI who receive VAD have outcomes similar to other VAD populations, despite being more critically ill pre-implantation. VAD therapy is an effective strategy for patients with AMI and acute heart failure or shock in whom medical therapy is failing.

Dataset Information

Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model.

Publications

Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model.

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