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

Hord, Erica C.; Bolch, Christina M.; Tüzün, Egemen; Cohn, William E.; Leschinsky, Boris; Criscione, John C.

doi:10.1007/s12265-018-9854-5

Cited by 21 publications

(23 citation statements)

References 13 publications

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“…These robotic sleeves are still being tested in pre-clinical animal models. CorInnova Inc has developed such a pneumatically actuated robotic device for biventricular support with a polyurethane membrane on a self-expanding nitinol frame that can be deployed through a mini-thoracotomy with a sutureless pneumatic attachment to the heart– it has shown promising results in pre-clinical ovine models with the first-in-human studies are being planned ( 91 ). This device is intended as a short-term cardiac assist device as bridge-to-decision or bridge-to-transplant and for long-term use in patients with advanced heart failure who are ineligible for VADs.…”

Section: Cardiac Soft-robotic Sleevesmentioning

confidence: 99%

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Kir

Munagala

2022

Front. Cardiovasc. Med.

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Heart failure through the spectrum of reduced (HFrEF), mid-range (or mildly reduced or HFmEF), and preserved ejection fraction (HFpEF), continues to plague patients' quality of life through recurrent admissions and high mortality rates. Despite tremendous innovation in medical therapy, patients continue to experience refractory congestive symptoms due to adverse left ventricular remodeling, significant functional mitral regurgitation (FMR), and right-sided failure symptoms due to significant functional tricuspid regurgitation (FTR). As most of these patients are surgically challenging for open cardiac surgery, the past decade has seen the development and evolution of different percutaneous structural interventions targeted at improving FMR and FTR. There is renewed interest in the sphere of left ventricular restorative devices to effect reverse remodeling and thereby improve effective stroke volume and patient outcomes. For patients suffering from HFpEF, there is still a paucity of disease-modifying effective medical therapies, and these patients continue to have recurrent heart failure exacerbations due to impaired left ventricular relaxation and high filling pressures. Structural therapies involving the implantation of inter-atrial shunt devices to decrease left atrial pressure and the development of implantable devices in the pulmonary artery for real-time hemodynamic monitoring would help redefine treatment and outcomes for patients with HFpEF. Lastly, there is pre-clinical data supportive of soft robotic cardiac sleeves that serve to improve cardiac function, can assist contraction as well as relaxation of the heart, and have the potential to be customized for each patient. In this review, we focus on the role of structural interventions in heart failure as it stands in current clinical practice, evaluate the evidence amassed so far, and review promising structural therapies that may transform the future of heart failure management.

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Section: Cardiac Soft-robotic Sleevesmentioning

confidence: 99%

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Kir

Munagala

2022

Front. Cardiovasc. Med.

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“…While useful, LVADs are not without their complications, with one of the most common and devastating being thromboembolic events (4,5). To address this problem, several groups have started to explore direct cardiac compression (DCC), a method of applying compression to the epicardial surface of the heart to augment cardiac output while avoiding blood contact (6)(7)(8). While LVADs treat the heart as a passive reservoir for blood, DCC interacts directly with the heart tissue.…”

Section: Original Articlementioning

confidence: 99%

Exploring the timing and distribution effects of direct cardiac compression in a beating heart model

Aranda‐Michel¹,

Waldman²,

Trumble³

2022

Shanghai Chest

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Background: Direct cardiac compression (DCC) is a promising approach to long-term circulatory support, but new evaluative methods are needed to guide development of DCC devices that optimize hemodynamic benefits without damaging the heart. As a first step toward that end, computational simulations were used to predict the hemodynamic and biomechanical effects produced by changing the timing and pattern of compressions applied to a failing heart.Methods: Multiscale finite element software was used to create a patient-specific beating heart model for in silico testing. Uniform cardiac compressions were simulated and then altered by either applying a sequential compression pattern (apex to base) or shifting the start of uniform compressions earlier and later in the cardiac cycle. Hemodynamics, principal strain, and fiber components were then analyzed for each compression pattern studied.Results: Hemodynamics did not vary significantly among the various compression methods tested.However, the maximum principal strain and fiber components differed substantially. Specifically, sequential apex to base compressions nearly doubled the principal strain on the posterior epicardial surface without improving hemodynamics. Likewise, shifting compression start times by ±50 ms increased principal strain values in this same area, albeit to a lesser degree.Conclusions: Despite the similar hemodynamics seen across the parametric space in these experiments, myocardial biomechanics differed greatly. These results confirm the supposition that hemodynamic measurements alone are not sufficient to fully capture the clinically significant effects of DCC, which can profoundly influence long-term outcomes.

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“…Several approaches to avoiding direct blood contact, commonly referred to as direct cardiac compression devices, have been proposed to overcome such difficulties. The first bridge-to-transplantation based on a pneumatic compression cup ( 5 ) was followed by several other innovative approaches, e.g., ( 6 – 9 ). Review articles provide a more detailed overview of available direct cardiac compression devices ( 3 , 10 ).…”

Section: Introductionmentioning

confidence: 99%

“…Review articles provide a more detailed overview of available direct cardiac compression devices ( 3 , 10 ). For example, systems from AdjuCor GmbH ( 8 ) and CorInnova Inc. ( 9 ), currently in the preclinical testing phase, provide support during systole and are minimally invasive implants. The common principle of these devices is that they develop a pressure (force per area) that acts on the epicardial surface.…”

Section: Introductionmentioning

confidence: 99%

Support Pressure Acting on the Epicardial Surface of a Rat Left Ventricle—A Computational Study

Martonová

Holz

Brackenhammer

et al. 2022

Front. Cardiovasc. Med.

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The present computational study investigates the effects of an epicardial support pressure mimicking a heart support system without direct blood contact. We chose restrictive cardiomyopathy as a model for a diseased heart. By changing one parameter representing the amount of fibrosis, this model allows us to investigate the impairment in a diseased left ventricle, both during diastole and systole. The aim of the study is to determine the temporal course and value of the support pressure that leads to a normalization of the cardiac parameters in diseased hearts. These are quantified via the end-diastolic pressure, end-diastolic volume, end-systolic volume, and ejection fraction. First, the amount of fibrosis is increased to model diseased hearts at different stages. Second, we determine the difference in the left ventricular pressure between a healthy and diseased heart during a cardiac cycle and apply for the epicardial support as the respective pressure difference. Third, an epicardial support pressure is applied in form of a piecewise constant step function. The support is provided only during diastole, only during systole, or during both phases. Finally, the support pressure is adjusted to reach the corresponding parameters in a healthy rat. Parameter normalization is not possible to achieve with solely diastolic or solely systolic support; for the modeled case with 50% fibrosis, the ejection fraction can be increased by 5% with purely diastolic support and 14% with purely systolic support. However, the ejection fraction reaches the value of the modeled healthy left ventricle (65.6%) using a combination of diastolic and systolic support. The end-diastolic pressure of 13.5 mmHg cannot be decreased with purely systolic support. However, the end-diastolic pressure reaches the value of the modeled healthy left ventricle (7.5 mmHg) with diastolic support as well as with the combination of the diastolic and systolic support. The resulting negative diastolic support pressure is −4.5 mmHg, and the positive systolic support pressure is 90 mmHg. We, thereby, conclude that ventricular support during both diastole and systole is beneficial for normalizing the left ventricular ejection fraction and the end-diastolic pressure, and thus it is a potentially interesting therapy for cardiac insufficiency.

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

Cited by 21 publications

References 13 publications

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Restructuring the Heart From Failure to Success: Role of Structural Interventions in the Realm of Heart Failure

Exploring the timing and distribution effects of direct cardiac compression in a beating heart model

Support Pressure Acting on the Epicardial Surface of a Rat Left Ventricle—A Computational Study

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