Search

Accurate device optimization of the Syncardia temporary total artificial heart is difficult while waiting for heart transplantation. In this challenging clinical cohort, using an implantable hemodynamic monitor (CardioMEMS HF system) can assist in volume and hemodynamic assessments. (Level of Difficulty: Advanced.), Central Illustration

Total artificial heart (TAH) represents the only valid alternative to heart transplantation, whose number is continuously increasing in recent years. The TAHused in this work, is a biventricular pulsatile, electrically powered, hydraulically actuated flow pump with all components embodied in a single device. One of the major issues for TAHs is the washout capability of the device, strictly correlated with the presence of blood stagnation sites. The aim of this work was to develop a numerical methodology to study the washout coupled with the fluid dynamics evaluation ofa total artificial heart under nominal working conditions. The first part of this study focussed on the CT scan analysis of the hybrid membrane kinematics during TAH operation, which was replicated with a fluid-structure interaction simulation in the second part. The difference in percentage between the in vitro and in silico flow rates and stroke volume is 9.7% and 6.3%, respectively. An injection of contrast blood was simulated, and a goodwashout performancewas observed and quantified with the volume fraction of the contrast blood still in the ventricle. The left chamber of the device showed a superior washout performance, with a contrast volume still inside the device after four washout cycles of 6.2%, with the right chamber showing 15%.

It has been reported that long-term use of continuous-flow mechanical circulatory support devices (CF-MCSDs) may induce complications associated with diminished pulsatility. Pulsatile-flow mechanical circulatory support devices (PF-MCSDs) have the potential of overcoming these shortcomings with the advance of technology. In order to promote in-depth understanding of PF-MCSD technology and thus encourage future mechanical circulatory support device innovations, engineering perspectives of PF-MCSD systems, including mechanical designs, drive mechanisms, working principles, and implantation strategies, are reviewed in this article. Some emerging designs of PF-MCSDs are introduced, and possible elements for next-generation PF-MCSDs are identified.

The CARMAT-Total Artificial Heart (C-TAH) is designed to provide heart replacement therapy for patients with end-stage biventricular failure. This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac output, automatically. Auto-mode is set perioperatively after initial postcardiopulmonary bypass hemodynamic stabilization. All patients showed a range of average inflow pressures of between 5 and 20 mm Hg during their daily activities, resulting in cardiac output responses of between 4.3 and 7.3 L/min. Operator adjustments were cumulatively only required on 20 occasions. This report demonstrates that the C-TAH auto-mode effectively produces appropriate physiologic responses reflective of changing patients’ daily needs and represents one of the unique characteristics of this device in providing almost physiologic heart replacement therapy.

Although the activated partial thromboplastin time (aPTT) has historically been the method of choice for anticoagulation monitoring in patients undergoing mechanical circulatory support with intravenous unfractionated heparin, it is being progressively superseded by the anti-factor Xa (anti-Xa) method. A retrospective single-arm, single-centre analysis of 20 patients who underwent total artificial heart implantation entailed simultaneous determinations of aPTT and anti-Xa. Agreement between these parameters was assessed using the Bland–Altman method. Despite a positive correlation between aPTT and anti-Xa, normal target ranges were poorly aligned: from 5th to 30th postoperative day, for anti-Xa values of 0.2 and 0.4 U/ml corresponding aPTT values were 52.1 and 65.2 s, 7.9 and 14.8 lower than predicted values, respectively. This was not associated with thromboembolic sequalae. It was not possible to demonstrate a significant relationship between the predictor variables (postoperative day; white blood cell count; C-reactive protein concentration; alanine transaminase and alkaline phosphatase level; bilirubin; haemoglobin; albumin and total protein concentration) and the agreement between aPTT and anti-Xa levels. In summary, when anti-Xa levels were used to guide anticoagulation therapy, corresponding aPTT levels were low with respect to target range. Methodology applied in this study is generalizable to other forms of mechanical circulatory support., The activated partial thromboplastin time (aPTT) has been the historical method of choice for anticoagulation monitoring in patients undergoing mechanical circulatory support with intravenous unfractionated heparin (IVUFH).

Mechanical circulatory support has been performed as a bridge to cardiac retransplantation in selected patients with graft failure. However, there is limited published experience on the use and potential benefit of the total artificial heart (TAH) as a bridge to cardiac retransplantation. We report on our institutional experience with 3 patients that received TAH as a bridge to retransplant, with 1 patient surviving post-retransplantation. This case series demonstrates the high-risk nature of this undertaking in cardiac retransplant candidates and highlights the issue of sensitization portending greater risk for poor outcomes after TAH as bridge to retransplantation.

Heart failure is a progressive and often fatal pathology among the main causes of death in the world. An implantable total artificial heart (TAH) is an alternative to heart transplantation. Blood damage quantification is imperative to assess the behavior of an artificial ventricle and is strictly related to the hemodynamics, which can be investigated through numerical simulations. The aim of this study is to develop a computational model that can accurately reproduce the hemodynamics inside the left pumping chamber of an existing TAH (Carmat-TAH) together with the displacement of the leaflets of the biological aortic and mitral valves and the displacement of the pericardium-made membrane. The proposed modeling workflow combines fluid-structure interaction (FSI) simulations based on a fixed grid method with computational fluid dynamics (CFD). In particular, the kinematics of the valves is accounted for by means of a dynamic mesh technique in the CFD. The comparison between FSI- and CFD-calculated velocity fields confirmed that the presence of the valves in the CFD model is essential for realistically mimicking blood dynamics, with a percentage difference of 2% during systole phase and 13% during the diastole. The percentage of blood volume in the CFD simulation with a shear stress above the threshold of 50 Pa is less than 0.001%. In conclusion, the application of this workflow to the Carmat-TAH provided consistent results with previous clinical studies demonstrating its utility in calculating local hemodynamic quantities in the presence of complex moving boundaries.

Mechanical circulatory assistance has become a frequent therapeutic option for patients with advanced heart failure. For patients with acute cardiogenic shock and impaired organ function, short-term assistance with venoarterial extracorporeal membrane oxygenation is the leading therapeutic option. It enables a "bridge to decision-making" i.e. withdrawal of the device after myocardial recovery or after recognition of therapeutic futility, or as a bridge-to-transplantation or to long-term mechanical support. For Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) class 2-6 patients, implantation of a long-term ventricular assist-device (VAD) should be considered before progression to multiple organ failure if heart transplantation is not a first-line option. Most patients receive a miniaturized axial or centrifugal fully implantable left VAD as a bridge-to-transplantation or as "destination therapy" in this setting.

History, modernity and probable prospects in the problem of terminal myocardial dysfunctions and heart failure surgical treatment are presented in this article. Innovations in these two methods of end-stage heart diseases treatment gave hope to hundreds of thousands of fateful patients. Problems of the near future are: heart xenotransplantation in children, miniaturization and creation of a new generation of peristaltic pumps of assisted circulation.

PurposeThe gold standard therapy for patients with advanced heart failure is heart transplant. The gap between donors and patients in waiting lists promoted the development of circulatory support devices, such as the total artificial heart (TAH). Focusing on in vitro tests performed with CardioWest™TAH (CW) driven by the SynCardia Freedom®portable driver (FD) the present study goals are: i) prove the reliability of a hydraulic circuit used as patient simulator to replicate a quasi-physiological scenario for various hydrodynamic conditions, ii) investigate the hydrodynamic performance of the CW FD, iii) help clinicians in possible interpretation of clinical cases outcomes.MethodsIn vitro tests were performed using a mechanic-hydraulic patient simulator. Cardiac output (CO), CW ventricles filling, atrial, ventricles, aortic and pulmonary artery pressures were measured for different values of vascular resistance in both systemic (SVR) and pulmonary (PVR) physiological range.ResultsAfter increasing the PVR, the left atrial pressure decreased according to the expected physiological trend, while aortic pressure remained almost stable, proving the ability of the simulator to mimic a physiological scenario. Unexpectedly, the mean pulmonary artery pressure (P) was found to increase above 30 mmHg in the range of physiological PVR (2.6 WU) and for constant CO.ConclusionsThe increase in PPAis probably associated with the pre-set driving setup of the FD. The finding suggests a possible explanation of the clinical course of a patient who experienced complications soon after being supported by the FD, with the occurrence of dyspnea and pulmonary edema despite a high cardiac index.

The development of durable ventricular assist devices (VADs) has improved mortality rates and quality of life in patients with end stage heart failure. While the use of VADs has increased dramatically in recent years, there is limited experience with VAD implantation in patients with complex congenital heart disease (CHD), despite the fact that the number of patients with end stage congenital heart disease has grown due to improvements in surgical and medical care. VAD use has been limited in patients with congenital heart disease and end stage heart failure due to anatomic (systemic right ventricle, single ventricle, surgically altered anatomy, valve dysfunction, etc.) and physiologic constraints (diastolic dysfunction). The total artificial heart (TAH), which has right and left sided pumps that can be arranged in a variety of orientations, can accommodate the anatomic variation present in CHD patients. This review provides an overview of the potential use of the TAH in patients with CHD.

Acanthamoeba encephalitis is an uncommon but often fatal infection complication. Here we report the first case of Acanthamoeba encephalitis in a patient with a Total Artificial Heart device.

The CardioWest Total Artificial Heart (CW-TAH) has been approved as a temporary device for bridge to cardiac transplantation and is under investigation for destination therapy by US Food and Drug Administration (FDA). We herein report the longest worldwide survival out of hospital (1374 days) of a patient supported with Cardio West Total Artificial Heart (CW-TAH). This experience is intended as a proof of concept of using CW-TAH as the destination therapy in patients with biventricular failure.

The SynCardia Total Artificial Heart (TAH) (SynCardia Systems, Tucson, AZ) is a pneumatic, pulsatile, biventricular replacement system that is surgically implanted orthotopically following cardiac excision.1 The SynCardia TAH received Food and Drug Administration (FDA) approval for in-hospital bridge to transplantation in 2004. In the pivotal regulatory trial of the TAH, greater than 80% of patients were ambulatory within 2 weeks post-op.2 However, as initially configured, the SynCardia TAH system remains limited by the reliance on a large bulky pneumatic driver console (“Circulatory Support System” [CSS], aka “Big Blue Driver”), weighing more than 350 pounds, which the supported patient is incapable of maneuvering, relying on several assistants to move the console during ambulation (Figure 1A). Figure 1. Modified small mobile pneumatic driver system to power the total artificial heart (TAH). A: Original TAH Circulatory Support System (CSS) console (Big Blue Driver). B: Modified Excor drive system mounted on dolly (photo is same scale as Big Blue for comparison). ... We explored the possibility of developing a system which would afford the TAH patient greater mobility as well as self-mobility, while being effective as a means of powering the TAH. Although work has been ongoing in designing and testing a specific portable driver for the TAH—the Freedom driver, as an initial step, to examine the clinical viability of this approach, we adapted a small pneumatic pulsatile driver, the Berlin Excor Mobile Drive System (Berlin Heart, Berlin, Germany), which had heretofore been developed to power pulsatile VADs, for use with the TAH. We hypothesized that a small pulsatile driver with adequate pneumatic output would effectively drive the TAH in clinically stable, recovered patients, affording them greater mobility, discharge from the hospital to the home environment, with overall ambulatory freedom. In this article, we report on an initial pilot progressive “switchover” study examining the efficacy of the modified drive system to support TAH patients followed by a larger study examining the efficacy and safety of the modified driver system in TAH patients, both in the hospital and upon discharge to home.

Successful anatomic fitting of a total artificial heart (TAH) is vital to achieve optimal pump hemodynamics after device implantation. Although many anatomic fitting studies have been completed in humans prior to clinical trials, few reports exist that detail the experience in animals for in vivo device evaluation. Optimal hemodynamics are crucial throughout the in vivo phase to direct design iterations and ultimately validate device performance prior to pivotal human trials. In vivo evaluation in a sheep model allows a realistically sized representation of a smaller patient, for which smaller third-generation TAHs have the potential to treat. Our study aimed to assess the anatomic fit of a single device rotary TAH in sheep prior to animal trials and to use the data to develop a threedimensional, computer-aided design (CAD)-operated anatomic fitting tool for future TAH development. Following excision of the native ventricles above the atrio-ventricular groove, a prototype TAH was inserted within the chest cavity of six sheep (28–40 kg).Adjustable rods representing inlet and outlet conduits were oriented toward the center of each atrial chamber and the great vessels, with conduit lengths and angles recorded for future analysis. A threedimensional, CAD-operated anatomic fitting tool was then developed, based on the results of this study, and used to determine the inflow and outflow conduit orientation of the TAH. The mean diameters of the sheep left atrium, right atrium, aorta, and pulmonary artery were 39, 33, 12, and 11 mm, respectively. The center-to-center distance and outer-edge-to-outer-edge distance between the atria, found to be 39 ± 9 mm and 72 ± 17 mm in this study, were identified as the most critical geometries for successful TAH connection. This geometric constraint restricts the maximum separation allowable between left and right inlet ports of a TAH to ensure successful alignment within the available atrial circumference.

A biventricular bypass type total artificial heart (BVB-TAH) utilizing two pusher-plate pumps was developed and implanted in a sheep for 48 days with excellent results. A Hall effect sensor was utilized to operate each pump independently with a full stroke at variable rates (VR). With this system, the animal's hemodynamics was kept physiologically, and all metabolic parameters except hemoglobin and hematocrit returned to normal three weeks after implantation. However, signs of infection appeared on the forty-second day, and consequently the animal fell into a state of shock. Even at that time the BVB-TAH maintained circulation by increasing pumping rate automatically. On the forty-eighth day, the animal could not stand and suffered from anuria; the experiment was then terminated after 1,140 h pumping. At autopsy, there was an enlarged heart with an atrophic change, 1,900 ml of pleural effusion, and 3,100ml of ascites fluid. Blood culture taken on the forty-seventh day yielded Acinetobacter calcoaceticus. The BVB-TAH operated in an independent VR mode maintained entire circulation, and has a capability of substituting the native heart function in any situation.