Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working model.

Objective: The need for safe and reliable mechanical circulatory support (MCS) for smaller children with severe heart failure (HF) is well defined. More specifically, in pediatric patients with advanced congenital HF, there is no implantable total artificial heart (TAH) device available for small patients. Herein, we report the development of the infant continuous-flow total artificial heart (I-CFTAH), a fully implantable in infants and newborns.

A less-invasive left atrial assist device concept for diastolic heart failure: First in vitro and in vivo assessment.

Objective: A less-invasive left atrial assist device (LAADx) is a novel and implantable, extracardiac blood pump concept, intended for the treatment of diastolic heart failure, represented by heart failure with preserved ejection fraction.

Methods: A mixed-flow pump was used as the working LAADx model. Its performance was evaluated at 3 speeds, using an in vitro pulsatile mock circulatory loop, with a pneumatic pump that can simulate diastolic heart failure conditions by adjusting the diastolic drive pressure.

Improving hydraulic performance of the left atrial assist device using computational fluid dynamics.

Background: The left atrial assist device (LAAD) is a novel continuous-flow pump designed to treat patients with heart failure with preserved ejection fraction, a growing type of heart failure, but with limited device-treatment options. The LAAD is implanted in the mitral plane and pumps blood from the left atrium into the left ventricle. The purpose of this study was to refine the initial design of the LAAD, using results from computational fluid dynamics (CFD) analyses to inform changes that could improve hydraulic performance and flow patterns within the LAAD.

Cleveland Clinic Continuous-Flow Total Artificial Heart: Progress Report and Technology Update.

Cleveland Clinic's continuous-flow total artificial heart (CFTAH) is being developed at our institution and has demonstrated system reliability and optimal performance. Based on the results from recent chronic in vivo experiments, CFTAH has been revised, especially to improve biocompatibility. The purpose of this article is to report our progress in developing CFTAH.

Preservation of pulsatility with universal ventricular assist device: In vitro assessment for biventricular support.

Background: The objective of this study was to assess the pulsatility preservation capability of the universal ventricular assist device (UVAD) when used as a biventricular assist device (BVAD). This evaluation was conducted through an in vitro experiment, utilizing a pulsatile biventricular circulatory mock loop.

Methods: Two UVAD pumps were tested in a dual setup (BVAD) in the circulatory model with the simulated conditions of left heart failure (HF), right HF, and moderate/severe biventricular HF (BHF).

Human fitting of pediatric and infant continuous-flow total artificial heart: visual and virtual assessment.

Background: This study aimed to determine the fit of two small-sized (pediatric and infant) continuous-flow total artificial heart pumps (CFTAHs) in congenital heart surgery patients.

Methods: This study was approved by Cleveland Clinic Institutional Review Board. Pediatric cardiac surgery patients ( = 40) were evaluated for anatomical and virtual device fitting (3D-printed models of pediatric [P-CFTAH] and infant [I-CFTAH] models).

Artificial Deep Neural Network for Sensorless Pump Flow and Hemodynamics Estimation During Continuous-Flow Mechanical Circulatory Support.

The objective of this study was to compare the estimates of pump flow and systemic vascular resistance (SVR) derived from a mathematical regression model to those from an artificial deep neural network (ADNN). Hemodynamic and pump-related data were generated using both the Cleveland Clinic continuous-flow total artificial heart (CFTAH) and pediatric CFTAH on a mock circulatory loop. An ADNN was trained with generated data, and a mathematical regression model was also generated using the same data.

Biventricular circulatory support using single-device and dual-device configurations: Initial pump characterization in simulated heart failure model.

Objective: Severe biventricular heart failure (BHF) can be remedied using a biventricular assist device (BVAD). Two devices are currently in development: a universal ventricular assist device (UVAD), which will be able to assist either the left, right, or both ventricles, and a continuous-flow total artificial heart (CFTAH), which replaces the entire heart. In this study, the hemodynamic performances of two UVADs are compared to a CFTAH acting as a BVAD.

Biventricular assist devices and total artificial heart: Strategies and outcomes.

In contrast to the advanced development of the left ventricular assist device (LVAD) therapy for advanced heart failure, the mechanical circulatory support (MCS) with biventricular assist device (BVAD) and total artificial heart (TAH) options remain challenging. The treatment strategy of BVAD and TAH therapy largely depends on the support duration. For example, an extracorporeal centrifugal pump, typically referred to as a temporary surgical extracorporeal right ventricular assist device, is implanted for the short term with acute right ventricular failure following LVAD implantation.

Mechanical circulatory support devices and treatment strategies for right heart failure.

The importance of right heart failure (RHF) treatment is magnified over the years due to the increased risk of mortality. Additionally, the multifactorial origin and pathophysiological mechanisms of RHF render this clinical condition and the choices for appropriate therapeutic target strategies remain to be complex. The recent change in the United Network for Organ Sharing (UNOS) allocation criteria of heart transplant may have impacted for the number of left ventricular assist devices (LVADs), but LVADs still have been widely used to treat advanced heart failure, and 4.

Characterization of left atrial assist device implantation: Early results of ex vivo anatomical assessment.

Background: The left atrial assist device (LAAD) is a novel pump that was developed specifically for the treatment of heart failure with preserved ejection fraction. The device is surgically implanted in the mitral position. This study aimed to characterize the various device-fitting configurations in the mitral annular position.

Novel approaches for left atrial pressure relief: Device-based monitoring and management in heart failure.

The importance of the left atrium (LA) has been emphasized in recent years as the features of heart failure (HF), especially with regard to variability in patient and pathology phenotypes, continue to be uncovered. Of note, among the population with HF with preserved ejection fraction (HFpEF), pressure or size of the LA have become a target for advanced monitoring and a therapeutic approach. In the case of diastolic dysfunction or pulmonary hypertension, which are often observed in patients with HFpEF, a conventional approach with clinical symptoms and physical signs of decompensation turned out to have a poor correlation with LA pressure.

Pulsatility hemodynamics during speed modulation of continuous-flow total artificial heart in a chronic in vivo model.

Background: The evaluation of pulsatile flow created by the new Cleveland Clinic continuous-flow total artificial heart (CFTAH100), which has a re-designed right impeller and motor, had not been tested in vivo. The purpose of this study was to evaluate the feasibility of pulsatility with the CFTAH100 during the application of pump speed modulation protocols in a chronic animal model.

Methods: A 30-day chronic animal experiment was conducted with a calf.

Evaluation of centrifugal blood pump performances for biventricular support in the virtual simulation model.

Background: Despite the advances in the left ventricular assist device (LVAD), there are still situations that require a biventricular assist device (BVAD) system. The purpose of this study was to explore and compare the system performance interactions with the HeartMate3 (HM3) and HeartWare (HVAD) in a BVAD configuration using the virtual mock loop (VML) simulation tool.

Methods: The VML simulation tool is an in silico implementation of a lumped parameter model of the cardiovascular system with mechanical circulatory support.

Left Atrial Circulatory Assistance in Simulated Diastolic Heart Failure Model: First in Vitro and in Vivo.

Background: We are developing a left atrial assist device (LAAD) that is implanted at the mitral position to treat diastolic heart failure (DHF) represented by heart failure with preserved ejection fraction.

Methods: The LAAD was tested at 3 pump speeds on a pulsatile mock loop with a pneumatic pump that simulated DHF conditions by adjusting the diastolic drive. The LAAD was implanted in 6 calves, and the hemodynamics were assessed.

Ocular surface microcirculation is better preserved with pulsatile versus continuous flow during cardiopulmonary bypass-An experimental pilot.

Background: Non-pulsatile cardiopulmonary bypass (CPB) may induce microvascular dysregulation. In piglets, we compared ocular surface microcirculation during pulsatile versus continuous flow (CF) bypass.

Methods: Ocular surface microcirculation in small tissue volumes (~0.

Hemodynamic evaluation of a new pulsatile blood pump during low flow cardiopulmonary bypass support.

Background: The VentriFlo True Pulse Pump (VentriFlo, Inc, Pelham, NH, USA) is a new pulsatile blood pump intended for use during short-term circulatory support. The purpose of this study was to evaluate the feasibility of the VentriFlo and compare it to a conventional centrifugal pump (ROTAFLOW, Getinge, Gothenberg, Sweden) in acute pig experiments.

Methods: Pigs (40-45 kg) were supported by cardiopulmonary bypass (CPB) with the VentriFlo (n = 9) or ROTAFLOW (n = 5) for 6 h.

Characterization and Development of Universal Ventricular Assist Device: Computational Fluid Dynamics Analysis of Advanced Design.

We are developing a universal, advanced ventricular assist device (AVAD) with automatic pressure regulation suitable for both left and right ventricular support. The primary goal of this computational fluid dynamics (CFD) study was to analyze the biventricular performance of the AVAD across its wide range of operating conditions. An AVAD CFD model was created and validated using in vitro hydraulic performance measurements taken over conditions spanning both left ventricular assist device (LVAD) and right ventricular assist device (RVAD) operation.

Large animal models of heart failure with preserved ejection fraction.

Heart failure with preserved ejection fraction (HFpEF) is characterized by diastolic dysfunction and multiple comorbidities. The number of patients is continuously increasing, with no improvement in its unfavorable prognosis, and there is a strong need for novel treatments. New devices and drugs are difficult to assess at the translational preclinical step due to the lack of high-fidelity large animal models of HFpEF.

Computational Fluid Dynamics Model of Continuous-Flow Total Artificial Heart: Right Pump Impeller Design Changes to Improve Biocompatibility.

Cleveland Clinic is developing a continuous-flow total artificial heart (CFTAH). This novel design operates without valves and is suspended both axially and radially through the balancing of the magnetic and hydrodynamic forces. A series of long-term animal studies with no anticoagulation demonstrated good biocompatibility, without any thromboemboli or infarctions in the organs.