Embedded cyber-physical system for physiological control of ventricular assist devices

Ventricular Assist Devices (VADs) play a crucial role in both bridging to transplantation and serving as destination therapy for congestive heart failure (CHF) management. This study aims to address the limitations of existing control strategies for VADs, specifically their inability to adapt automatically to hemodynamic changes. It proposes a novel embedded cyber-physical system (CPS) based on real-time data processing, reconfigurable architecture, and communication protocols aligned with Health 4.0 concepts to enhance physiological control over VADs (PC-VAD). The research employs a multi-objective PC-VAD approach within a hybrid cardiovascular simulator. An embedded CPS is introduced to overcome challenges related to differences in controller characteristics between computers and embedded systems. The study assesses the performance of the embedded CPS by comparing it with a computer-based control system. The embedded CPS demonstrates outcomes comparable to the computer-based control system, maintaining mean arterial pressure and cardiac output at physiological levels. Even in the face of variations in ejection fraction, the embedded CPS dynamically adjusts the pump's rotational speed based on simulated clinical conditions. Notably, there is no aortic reflux to the ventricle through the VAD during testing. These findings affirm the satisfactory control performance of the embedded CPS in regulating VADs. The study concludes that the embedded CPS effectively addresses the limitations of current VAD control strategies, exhibiting control performance comparable to computer-based systems. However, further experimentation and in vivo studies are necessary to validate and ensure its applicability in real-world scenarios.

Biofunctionalization of surfaces to minimize undesirable effects in cardiovascular assistance devices

BACKGROUND: The reactivity of blood with non-endothelial surface is a challenge for long-term Ventricular Assist Devices development, usually made with pure titanium, which despite of being inert, low density and high mechanical resistance it does not avoid the thrombogenic responses. Here we tested a modification on the titanium surface with Laser Induced Periodic Surface Structures followed by Diamond Like Carbon (DLC) coating in different thicknesses to customize the wettability profile by changing the surface energy of the titanium. METHODS: Four different surfaces were proposed: (1) Pure Titanium as Reference Material (RM), (2) Textured as Test Sample (TS), (3) Textured with DLC 0.3µm as (TSA) and (4) Textured with 2.4µm DLC as (TSB). A single implant was positioned in the abdominal aorta of Wistar rats and the effects of hemodynamic interaction were evaluated without anticoagulant drugs. RESULTS: After twelve weeks, the implants were extracted and subjected to qualitative analysis by Scanning Electron Microscopy under low vacuum and X-ray Energy Dispersion. The regions that remained in contact with the wall of the aorta showed encapsulation of the endothelial tissue. TSB implants, although superhydrophilic, have proven that the DLC coating inhibits the adhesion of biological material, prevents abrasive wear and delamination, as observed in the TS and TSA implants. Pseudo- neointimal layers were heterogeneously identified in higher concentration on Test Surfaces.

Biofunctionalization of surfaces to minimize undesirable effects in cardiovascular assistance devices.

BACKGROUND: The reactivity of blood with non-endothelial surface is a challenge for long-term Ventricular Assist Devices development, usually made with pure titanium, which despite of being inert, low density and high mechanical resistance it does not avoid the thrombogenic responses. Here we tested a modification on the titanium surface with Laser Induced Periodic Surface Structures followed by Diamond Like Carbon (DLC) coating in different thicknesses to customize the wettability profile by changing the surface energy of the titanium. METHODS: Four different surfaces were proposed: (1) Pure Titanium as Reference Material (RM), (2) Textured as Test Sample (TS), (3) Textured with DLC 0.3µm as (TSA) and (4) Textured with 2.4µm DLC as (TSB). A single implant was positioned in the abdominal aorta of Wistar rats and the effects of hemodynamic interaction were evaluated without anticoagulant drugs. RESULTS: After twelve weeks, the implants were extracted and subjected to qualitative analysis by Scanning Electron Microscopy under low vacuum and X-ray Energy Dispersion. The regions that remained in contact with the wall of the aorta showed encapsulation of the endothelial tissue. TSB implants, although superhydrophilic, have proven that the DLC coating inhibits the adhesion of biological material, prevents abrasive wear and delamination, as observed in the TS and TSA implants. Pseudo- neointimal layers were heterogeneously identified in higher concentration on Test Surfaces.

In vitro evaluation of multi­objective physiological control of the centrifugal blood pump

Left ventricular assist devices (LVADs) have been used as a bridge to transplantation or as destination therapy to treat patients with heart failure (HF). The inability of control strategy to respond automatically to changes in hemodynamic conditions can impact the patients' quality of life. The developed control system/algorithm consists of a control system that harmoniously adjusts pump speed without additional sensors, considering the patient's clinical condition and his physical activity. The control system consists of three layers: (a) Actuator speed control; (b) LVAD flow control (FwC); and (c) Fuzzy control system (FzC), with the input variables: heart rate (HR), mean arterial pressure (MAP), minimum pump flow, level of physical activity (data from patient), and clinical condition (data from physician, INTERMACS profile). FzC output is the set point for the second LVAD control schemer (FwC) which in turn adjusts the speed. Pump flow, MAP, and HR are estimated from actuator drive parameters (speed and power). Evaluation of control was performed using a centrifugal blood pump in a hybrid cardiovascular simulator, where the left heart function is the mechanical model and right heart function is the computational model. The control system was able to maintain MAP and cardiac output in the physiological level, even under variation of EF. Apart from this, also the rotational pump speed is adjusted following the simulated clinical condition. No backflow from the aorta in the ventricle occurred through LVAD during tests. The control algorithm results were considered satisfactory for simulations, but it still should be confirmed during in vivo tests.

A strategy for designing of customized electromechanical actuators of blood pumps

Congestive heart failure is a pathology of global incidence that affects millions of people worldwide. When the heart weakens and fails to pump blood at physiological rates commensurate with the requirements of tissues, two main alternatives are cardiac transplant and ventricular assist devices (VADs). This article presents the design strategy for development of a customized VAD electromagnetic actuator. Electromagnetic actuator is a brushless direct current motor customized to drive the pump impeller by permanent magnets located in rotor­stator coupling. In this case, ceramic pivot bearings support the VAD impeller. Electronic circuitry controls rotation switching current in stator coils. The proposed methodology consisted of analytical numerical design, tridimensional computational modeling, numerical simulations using Maxwell software, actuator prototyping, and validation in the dynamometer. The axial flow actuator was chosen by its size and high power density compared to the radial flow type. First step consisted of estimating the required torque to drive the pump. Torque was estimated at 2100 rpm and mean current of 0.5 A. Numerical analysis using finite element method mapped vectors and fields to build stator coils and actuator assemblage. After tests in the dynamometer, experimental results were compared with numerical simulation and validated the proposed model. In conclusion, the proposed methodology for designing of VAD electromechanical actuator was considered satisfactory in terms of data consistency, feasibility, and reliability.

In vitro evaluation of multi-objective physiological control of the centrifugal blood pump.

Left ventricular assist devices (LVADs) have been used as a bridge to transplantation or as destination therapy to treat patients with heart failure (HF). The inability of control strategy to respond automatically to changes in hemodynamic conditions can impact the patients' quality of life. The developed control system/algorithm consists of a control system that harmoniously adjusts pump speed without additional sensors, considering the patient's clinical condition and his physical activity. The control system consists of three layers: (a) Actuator speed control; (b) LVAD flow control (FwC); and (c) Fuzzy control system (FzC), with the input variables: heart rate (HR), mean arterial pressure (MAP), minimum pump flow, level of physical activity (data from patient), and clinical condition (data from physician, INTERMACS profile). FzC output is the set point for the second LVAD control schemer (FwC) which in turn adjusts the speed. Pump flow, MAP, and HR are estimated from actuator drive parameters (speed and power). Evaluation of control was performed using a centrifugal blood pump in a hybrid cardiovascular simulator, where the left heart function is the mechanical model and right heart function is the computational model. The control system was able to maintain MAP and cardiac output in the physiological level, even under variation of EF. Apart from this, also the rotational pump speed is adjusted following the simulated clinical condition. No backflow from the aorta in the ventricle occurred through LVAD during tests. The control algorithm results were considered satisfactory for simulations, but it still should be confirmed during in vivo tests.

A strategy for designing of customized electromechanical actuators of blood pumps.

Congestive heart failure is a pathology of global incidence that affects millions of people worldwide. When the heart weakens and fails to pump blood at physiological rates commensurate with the requirements of tissues, two main alternatives are cardiac transplant and ventricular assist devices (VADs). This article presents the design strategy for development of a customized VAD electromagnetic actuator. Electromagnetic actuator is a brushless direct current motor customized to drive the pump impeller by permanent magnets located in rotor-stator coupling. In this case, ceramic pivot bearings support the VAD impeller. Electronic circuitry controls rotation switching current in stator coils. The proposed methodology consisted of analytical numerical design, tridimensional computational modeling, numerical simulations using Maxwell software, actuator prototyping, and validation in the dynamometer. The axial flow actuator was chosen by its size and high power density compared to the radial flow type. First step consisted of estimating the required torque to drive the pump. Torque was estimated at 2100 rpm and mean current of 0.5 A. Numerical analysis using finite element method mapped vectors and fields to build stator coils and actuator assemblage. After tests in the dynamometer, experimental results were compared with numerical simulation and validated the proposed model. In conclusion, the proposed methodology for designing of VAD electromechanical actuator was considered satisfactory in terms of data consistency, feasibility, and reliability.

Numerical Analyses for Low Reynolds Flow in a Ventricular Assist Device.

Scientific and technological advances in blood pump developments have been driven by their importance in cardiac patient treatments and in the expansion of life quality in assisted people. To improve and optimize the design and development, numerical tools were incorporated into the analyses of these mechanisms and have become indispensable in their advances. This study analyzes the flow behavior with low impeller Reynolds number, for which there is no consensus on the full development of turbulence in ventricular assist devices (VAD). For supporting analyses, computational numerical simulations were carried out in different scenarios with the same rotation speed. Two modeling approaches were applied: laminar flow and turbulent flow with the standard, RNG and realizable κ - ε; the standard and SST κ - ω models; and Spalart-Allmaras models. The results agree with the literature for VAD and the range for transient flows in stirred tanks with an impeller Reynolds number around 2800 for the tested scenarios. The turbulent models were compared, and it is suggested, based on the expected physical behavior, the use of κ-ε RNG, standard and SST κ-ω, and Spalart-Allmaras models to numerical analyses for low impeller Reynolds numbers according to the tested flow scenarios.

Study of a centrifugal blood pump in a mock loop system.

An implantable centrifugal blood pump (ICBP) is being developed to be used as a ventricular assist device (VAD) in patients with severe cardiovascular diseases. The ICBP system is composed of a centrifugal pump, a motor, a controller, and a power supply. The electricity source provides power to the controller and to a motor that moves the pump's rotor through magnetic coupling. The centrifugal pump is composed of four parts: external conical house, external base, impeller, and impeller base. The rotor is supported by a pivot bearing system, and its impeller base is responsible for sheltering four permanent magnets. A hybrid cardiovascular simulator (HCS) was used to evaluate the ICBP's performance. A heart failure (HF) (when the heart increases beat frequency to compensate for decrease in blood flow) was simulated in the HCS. The main objective of this work is to analyze changes in physiological parameters such as cardiac output, blood pressure, and heart rate in three situations: healthy heart, HF, and HF with left circulatory assistance by ICBP. The results showed that parameters such as aortic pressure and cardiac output affected by the HF situation returned to normal values when the ICBP was connected to the HCS. In conclusion, the test results showed satisfactory performance for the ICBP as a VAD.

Study of a centrifugal blood pump in a mock loop system

Abstract: An implantable centrifugal blood pump (ICBP)is being developed to be used as a ventricular assist device(VAD) in patients with severe cardiovascular diseases.TheICBP system is composed of a centrifugal pump, a motor, acontroller, and a power supply. The electricity source providespower to the controller and to a motor that moves thepump’s rotor through magnetic coupling. The centrifugalpump is composed of four parts: external conical house,external base, impeller, and impeller base.The rotor is supportedby a pivot bearing system, and its impeller base isresponsible for sheltering four permanent magnets. Ahybrid cardiovascular simulator (HCS) was used to evaluatethe ICBP’s performance. A heart failure (HF) (whenthe heart increases beat frequency to compensate fordecrease in blood flow) was simulated in the HCS. Themain objective of this work is to analyze changes in physiologicalparameters such as cardiac output, blood pressure,and heart rate in three situations: healthy heart, HF, andHF with left circulatory assistance by ICBP. The resultsshowed that parameters such as aortic pressure and cardiacoutput affected by the HF situation returned to normalvalues when the ICBP was connected to the HCS. Inconclusion, the test results showed satisfactory performancefor the ICBP as a VAD. Key Words: Ventricularassist device—Centrifugal blood pump—Cardiovascularsimulator.

Introductory tests to in vivo evaluation: magnetic coupling influence in motor controller.

An implantable centrifugal blood pump has been developed with original features for a ventricle assist device (VAD). This pump is part of a multicenter and international study with objective to offer simple, affordable, and reliable devices to developing countries. Previous computational fluid dynamics investigations were performed followed by prototyping and in vitro tests. Also, previous blood tests for assessment of hemolysis showed mean normalized index of hemolysis (NIH) results of 0.0054 ± 2.46 × 10⁻³ mg/100 L (at 5 L/min and 100 mm Hg). To precede in vivo evaluation, measurements of magnetic coupling interference and enhancements of actuator control were necessary. Methodology was based on the study of two different work situations (1 and 2) studied with two different types of motors (A and B). Situation 1 is when the rotor of pump is closest to the motor and situation 2 its opposite. Torque and mechanical power were collected with a dynamometer (80 g/cm) and then plotted and compared for two situations and both motors. The results showed that motor A has better mechanical behavior and less influence of coupling. Results for situation 1 showed that it is more often under magnetic coupling influence than situation 2. The studies lead to the conclusion that motor A is the best option for in vivo studies as it has less influence of magnetic coupling in both situations.

Implantable centrifugal blood pump with dual impeller and double pivot bearing system: electromechanical actuator, prototyping, and anatomical studies.

An implantable centrifugal blood pump has been developed with original features for a left ventricular assist device. This pump is part of a multicenter and international study with the objective to offer simple, affordable, and reliable devices to developing countries. Previous computational fluid dynamics investigations and wear evaluation in bearing system were performed followed by prototyping and in vitro tests. In addition, previous blood tests for assessment of normalized index of hemolysis show results of 0.0054±2.46 × 10⁻³ mg/100 L. An electromechanical actuator was tested in order to define the best motor topology and controller configuration. Three different topologies of brushless direct current motor (BLDCM) were analyzed. An electronic driver was tested in different situations, and the BLDCM had its mechanical properties tested in a dynamometer. Prior to evaluation of performance during in vivo animal studies, anatomical studies were necessary to achieve the best configuration and cannulation for left ventricular assistance. The results were considered satisfactory, and the next step is to test the performance of the device in vivo.

A new model of centrifugal blood pump for cardiopulmonary bypass: design improvement, performance, and hemolysis tests.

A new model of blood pump for cardiopulmonary bypass (CPB) application has been developed and evaluated in our laboratories. Inside the pump housing is a spiral impeller that is conically shaped and has threads on its surface. Worm gears provide an axial motion of the blood column. Rotational motion of the conical shape generates a centrifugal pumping effect and improves pumping performance. One annular magnet with six poles is inside the impeller, providing magnetic coupling to a brushless direct current motor. In order to study the pumping performance, a mock loop system was assembled. Mock loop was composed of Tygon tubes (Saint-Gobain Corporation, Courbevoie, France), oxygenator, digital flowmeter, pressure monitor, electronic driver, and adjustable clamp for flow control. Experiments were performed on six prototypes with small differences in their design. Each prototype was tested and flow and pressure data were obtained for rotational speed of 1000, 1500, 2000, 2500, and 3000 rpm. Hemolysis was studied using pumps with different internal gap sizes (1.35, 1.45, 1.55, and 1.7 mm). Hemolysis tests simulated CPB application with flow rate of 5 L/min against total pressure head of 350 mm Hg. The results from six prototypes were satisfactory, compared to the results from the literature. However, prototype #6 showed the best results. Best hemolysis results were observed with a gap of 1.45 mm, and showed a normalized index of hemolysis of 0.013 g/100 L. When combined, axial and centrifugal pumping principles produce better hydrodynamic performance without increasing hemolysis.

Single axis controlled hybrid magnetic bearing for left ventricular assist device: hybrid core and closed magnetic circuit.

In previous studies, we presented main strategies for suspending the rotor of a mixed-flow type (centrifugal and axial) ventricular assist device (VAD), originally presented by the Institute Dante Pazzanese of Cardiology (IDPC), Brazil. Magnetic suspension is achieved by the use of a magnetic bearing architecture in which the active control is executed in only one degree of freedom, in the axial direction of the rotor. Remaining degrees of freedom, excepting the rotation, are restricted only by the attraction force between pairs of permanent magnets. This study is part of a joint project in development by IDPC and Escola Politecnica of São Paulo University, Brazil. This article shows advances in that project, presenting two promising solutions for magnetic bearings. One solution uses hybrid cores as electromagnetic actuators, that is, cores that combine iron and permanent magnets. The other solution uses actuators, also of hybrid type, but with the magnetic circuit closed by an iron core. After preliminary analysis, a pump prototype has been developed for each solution and has been tested. For each prototype, a brushless DC motor has been developed as the rotor driver. Each solution was evaluated by in vitro experiments and guidelines are extracted for future improvements. Tests have shown good results and demonstrated that one solution is not isolated from the other. One complements the other for the development of a single-axis-controlled, hybrid-type magnetic bearing for a mixed-flow type VAD.

Cardiovascular simulator improvement: pressure versus volume loop assessment.

This article presents improvement on a physical cardiovascular simulator (PCS) system. Intraventricular pressure versus intraventricular volume (PxV) loop was obtained to evaluate performance of a pulsatile chamber mimicking the human left ventricle. PxV loop shows heart contractility and is normally used to evaluate heart performance. In many heart diseases, the stroke volume decreases because of low heart contractility. This pathological situation must be simulated by the PCS in order to evaluate the assistance provided by a ventricular assist device (VAD). The PCS system is automatically controlled by a computer and is an auxiliary tool for VAD control strategies development. This PCS system is according to a Windkessel model where lumped parameters are used for cardiovascular system analysis. Peripheral resistance, arteries compliance, and fluid inertance are simulated. The simulator has an actuator with a roller screw and brushless direct current motor, and the stroke volume is regulated by the actuator displacement. Internal pressure and volume measurements are monitored to obtain the PxV loop. Left chamber internal pressure is directly obtained by pressure transducer; however, internal volume has been obtained indirectly by using a linear variable differential transformer, which senses the diaphragm displacement. Correlations between the internal volume and diaphragm position are made. LabVIEW integrates these signals and shows the pressure versus internal volume loop. The results that have been obtained from the PCS system show PxV loops at different ventricle elastances, making possible the simulation of pathological situations. A preliminary test with a pulsatile VAD attached to PCS system was made.

Specification of supervisory control systems for ventricular assist devices.

One of the most important recent improvements in cardiology is the use of ventricular assist devices (VADs) to help patients with severe heart diseases, especially when they are indicated to heart transplantation. The Institute Dante Pazzanese of Cardiology has been developing an implantable centrifugal blood pump that will be able to help a sick human heart to keep blood flow and pressure at physiological levels. This device will be used as a totally or partially implantable VAD. Therefore, an improvement on device performance is important for the betterment of the level of interaction with patient's behavior or conditions. But some failures may occur if the device's pumping control does not follow the changes in patient's behavior or conditions. The VAD control system must consider tolerance to faults and have a dynamic adaptation according to patient's cardiovascular system changes, and also must attend to changes in patient conditions, behavior, or comportments. This work proposes an application of the mechatronic approach to this class of devices based on advanced techniques for control, instrumentation, and automation to define a method for developing a hierarchical supervisory control system that is able to perform VAD control dynamically, automatically, and securely. For this methodology, we used concepts based on Bayesian network for patients' diagnoses, Petri nets to generate a VAD control algorithm, and Safety Instrumented Systems to ensure VAD system security. Applying these concepts, a VAD control system is being built for method effectiveness confirmation.

Cardiovascular simulator improvement: pressure versus volume loop assessment

This article presents improvement on a physical cardiovascular simulator (PCS) system. Intraventricular pressure versus intraventricular volume (PxV) loop was obtained to evaluate performance of a pulsatile chambermimicking the human left ventricle. PxV loop shows heart contractility and is normally used to evaluate heartperformance. In many heart diseases, the stroke volume decreases because of low heart contractility.This pathologicalsituation must be simulated by the PCS in order to evaluate the assistance provided by a ventricular assistdevice (VAD).The PCS system is automatically controlled by a computer and is an auxiliary tool for VAD controlstrategies development. This PCS system is according to a Windkessel model where lumped parameters are used for cardiovascular system analysis. Peripheral resistance, arteriescompliance, and fluid inertance are simulated.The simulator has an actuator with a roller screw and brushlessdirect current motor, and the stroke volume is regulated by the actuator displacement. Internal pressure and volume measurements are monitored to obtain the PxV loop. Left chamber internal pressure is directly obtained by pressure transducer; however, internal volume has been obtained indirectly by using a linear variable differential transformer, which senses the diaphragm displacement. Correlationsbetween the internal volume and diaphragm position are made. LabVIEW integrates these signals and shows the pressure versus internal volume loop. The results that have been obtained from the PCS system show PxV loops at different ventricle elastances, makingpossible the simulation of pathological situations. A preliminary test with a pulsatile VAD attached to PCS systemwas made.

Specification of supervisory control systems for ventricular assist devices

One of the most important recent improvements in cardiology is the use of ventricular assist devices (VADs) to help patients with severe heart diseases, especially when they are indicated to heart transplantation.TheInstitute Dante Pazzanese of Cardiology has been developing an implantable centrifugal blood pump that will beable to help a sick human heart to keep blood flow and pressure at physiological levels. This device will be used asa totally or partially implantable VAD. Therefore, an improvement on device performance is important for thebetterment of the level of interaction with patient’s behavior or conditions. But some failures may occur if the device’s pumping control does not follow the changes in patient’s behavior or conditions. The VAD control system must consider tolerance to faults and have a dynamic adaptation according to patient’s cardiovascular system changes, and also must attend to changes in patient conditions, behavior, or comportments. This work proposes anapplication of the mechatronic approach to this class of devices based on advanced techniques for control, instrumentation, and automation to define a method for developinga hierarchical supervisory control system that is able to perform VAD control dynamically, automatically, andsecurely. For this methodology, we used concepts based on Bayesian network for patients’ diagnoses, Petri nets to generate a VAD control algorithm, and Safety Instrumented Systems to ensure VAD system security. Applying theseconcepts, a VAD control system is being built for method effectiveness confirmation.

Single axis controlled hybrid magnetic bearing for Left ventricular assist device: hybrid core and closed magnetic circuit

In previous studies,we presented main strategies for suspending the rotor of a mixed-flow type (centrifugal and axial) ventricular assist device (VAD), originally presented by the Institute Dante Pazzanese of Cardiology(IDPC), Brazil. Magnetic suspension is achieved by the use of a magnetic bearing architecture in which the activecontrol is executed in only one degree of freedom, in the axial direction of the rotor.Remaining degrees of freedom,excepting the rotation, are restricted only by the attraction force between pairs of permanent magnets. This study is part of a joint project in development by IDPC and Escola Politecnica of São Paulo University, Brazil. This articleshows advances in that project, presenting two promising solutions for magnetic bearings. One solution uses hybrid cores as electromagnetic actuators, that is, cores thatcombine iron and permanent magnets. The other solution uses actuators, also of hybrid type, but with the magneticcircuit closed by an iron core.After preliminary analysis, a pump prototype has been developed for each solution andhas been tested. For each prototype, a brushless DC motor has been developed as the rotor driver. Each solution wasevaluated by in vitro experiments and guidelines are extracted for future improvements.Tests have shown goodresults and demonstrated that one solution is not isolated from the other. One complements the other for the development of a single-axis-controlled, hybrid-type magnetic bearing for a mixed-flow type VAD.

Implantable centrifugal blood pump with dual impellerand double pivot bearing system: electromechanical actuator, prototyping, and anatomical studies

An implantable centrifugal blood pump hasbeen developed with original features for a left ventricularassist device. This pump is part of a multicenter and internationalstudy with the objective to offer simple, affordable,and reliable devices to developing countries. Previous computationalfluid dynamics investigations and wear evaluationin bearing system were performed followed byprototyping and in vitro tests. In addition, previous bloodtests for assessment of normalized index of hemolysis showresults of 0.0054 2.46 ¥ 10-3 mg/100 L. An electromechanicalactuator was tested in order to define the bestmotor topology and controller configuration. Three differenttopologies of brushless direct current motor (BLDCM)were analyzed.An electronic driver was tested in differentsituations, and the BLDCM had its mechanical propertiestested in a dynamometer. Prior to evaluation of performanceduring in vivo animal studies, anatomical studieswere necessary to achieve the best configuration and cannulationfor left ventricular assistance. The results wereconsidered satisfactory, and the next step is to test theperformance of the device in vivo.