Computational methods for parametric evaluation of the biventricular mechanics of direct cardiac compression.

Despite the increasing incidence of heart failure, advancements in mechanical circulatory support have become minimal. A new type of mechanical circulatory support, direct cardiac compression, is a novel support paradigm that involves a soft deformable cup around the ventricles, compressing it during systole. No group has yet investigated the biomechanical consequences of such an approach. This article uses a multiscale cardiac simulation software to create a patient-specific beating heart dilated cardiomyopathy model. Left and right ventricle (LV and RV) forces are applied parametrically, to a maximum of 2.9 and 0.46 kPa on each ventricle, respectively. Compression increased the ejection fraction in the left and right ventricles from 15.3% and 27.4% to 24.8% and 38.7%, respectively. During applied compression, the LV freewall thickening increased while the RV decreased; this was found to be due to a change in the balance of the preload and afterload in the freewalls. Principal strain renderings demonstrated strain concentrations on the anterior and posterior LV freewall. Strains in these regions were found to exponentially increase after 0.75 normalized LV force was applied. Component analysis of these strains illuminated a shift in the dominating strain from transmural to cross fiber once 0.75 normalized LV force is exceeded. An optimization plot was created by nondimensionalizing the stroke volume and maximum principal strain for each compression profile, selecting five potential compression schemes. This work demonstrates not only the importance of a computational approach to direct cardiac compression but a framework for tailoring compression profiles to patients.

Potential mechanisms for muscle-powered cardiac support.

Biomechanical actuation of an implanted ventricular assist device (VAD) is an attractive means of providing long-term circulatory support. Studies show that energy from electrically stimulated skeletal muscle can, in principle, be used to provide tether-free cardiac assistance without the need for percutaneous drivelines or bulky energy transmission hardware. A mechanical prosthesis designed to harness the contractile power of in situ skeletal muscle has been developed in this laboratory that collects energy from the latissimus dorsi muscle and transmits it in the form of hydraulic power. In order to use this technique to pump blood however, a practical means to deliver this energy to the bloodstream must be devised. Presented here are six prospective mechanisms designed to accomplish this task, five of which also eliminate blood contacting surfaces that often lead to thromboembolic complications in chronic VAD patients.

Computational Studies on the Effects of Applied Apical Torsion for Cardiac Assist on Regional Wall Mechanics.

OBJECTIVE: Here we report the results of parametric computational simulations evaluating the biomechanical effects of applied apical torsion (AAT) on a patient-specific bi-ventricular failing heart model. METHODS: We examined the resulting effects on cardiac biomechanics with varying device coverage areas and applied rotation angles to determine the practical working limits of AAT on a dilated cardiomyopathy heart model. RESULTS: The largest maximum principal stresses and strains observed in the heart failure model were 80.21 kPa (at the basal node of the left ventricular epicardium) and 0.56 (at the node of the device base of the left ventricular free wall). Results show that increasing levels of AAT beyond 45 degrees produce supra-physiologic levels of stress and strain in the myocardium. CONCLUSION: Maximum principal stresses greater than 100 kPa were observed at multiple nodes along the epicardium and endocardium of the ventricular base and in the endocardium at the device base. Maximum principal strains greater than 0.60 were observed at multiple nodes along the epicardium and endocardium of the ventricular base. SIGNIFICANCE: This suggests that while AAT has the potential to provide meaningful returns to hemodynamic function in failing hearts, the large deformations produced by this approach with the upper bounds of applied rotation angle realistically excludes supra-physiological rotations as a means for cardiac support. However, lower AAT angles - closer to that of the native left-ventricular torsion - coupled with another means of external cardiac compression may prove to be a viable method of cardiac assist.

Muscle-Powered Counterpulsation for Untethered, Non-Blood-Contacting Cardiac Support: A Path to Destination Therapy.

Conventional long-term ventricular assist devices continue to be extremely problematic due to infections caused by percutaneous drivelines and thrombotic events associated with the use of blood-contacting surfaces. Here we describe a muscle-powered cardiac assist device that avoids both these problems by using an internal muscle energy converter to drive a non-blood-contacting extra-aortic balloon pump. The technology was developed previously in this lab and operates by converting the contractile energy of the latissimus dorsi muscle into hydraulic power that can be used, in principle, to drive any blood pump amenable to pulsatile actuation. The two main advantages of this implantable power source are that it 1) significantly reduces infection risk by avoiding a constant skin wound, and 2) improves patient quality-of-life by eliminating all external hardware components. The counterpulsatile balloon pumps, which compress the external surface of the ascending aorta during the diastolic phase of the cardiac cycle, offer another critical advantage in the setting of long-term circulatory support in that they increase cardiac output and improve coronary perfusion without touching the blood. The goal of this work is to combine these two technologies into a single circulatory support system that eliminates driveline complications and avoids surface-mediated thromboembolic events, thereby providing a safe, tether-free means to support the failing heart over extended - or even indefinite - periods of time.

Cardiac Assist Devices: Early Concepts, Current Technologies, and Future Innovations.

Congestive heart failure (CHF) is a debilitating condition that afflicts tens of millions of people worldwide and is responsible for more deaths each year than all cancers combined. Because donor hearts for transplantation are in short supply, a safe and durable means of mechanical circulatory support could extend the lives and reduce the suffering of millions. But while the profusion of blood pumps available to clinicians in 2019 tend to work extremely well in the short term (hours to weeks/months), every long-term cardiac assist device on the market today is limited by the same two problems: infections caused by percutaneous drivelines and thrombotic events associated with the use of blood-contacting surfaces. A fundamental change in device design is needed to address both these problems and ultimately make a device that can support the heart indefinitely. Toward that end, several groups are currently developing devices without blood-contacting surfaces and/or extracorporeal power sources with the aim of providing a safe, tether-free means to support the failing heart over extended periods of time.

Ventricle-specific epicardial pressures as a means to optimize direct cardiac compression for circulatory support: A pilot study.

Direct cardiac compression (DCC) holds enormous potential as a safe and effective means to treat heart failure patients who require long-term, or even permanent, biventricular support. However, devices developed to date are not tuned to meet the individual compression requirements of the left and right ventricles, which can differ substantially. In this paper, a systematic study examining the relationship, range, and effect of independent pressures on the left and right epicardial surfaces of a passive human heart model was performed as a means to optimize cardiac output via DCC support. Hemodynamic and tissue deformation effects produced by varying epicardial compressions were examined using finite element analysis. Results indicate that 1) designing a direct cardiac compression pump that applies separate pressures to the left and right ventricles is critical to maintain equivalent stroke volume for both ventricles, and 2) left and right ventricular epicardial pressures of 340 mmHg and 44 mmHg, respectively, are required to induce normal ejection fractions in a passive heart. This pilot study provides fundamental insights and guidance towards the design of improved direct cardiac compression devices for long-term circulatory support.

Left ventricular simulation of cardiac compression: Hemodynamics and regional mechanics.

Heart failure is a global epidemic. Left ventricular assist devices provide added cardiac output for severe cases but cause infection and thromboembolism. Proposed direct cardiac compression devices eliminate blood contacting surfaces, but no group has optimized the balance between hemodynamic benefit and excessive ventricular wall strains and stresses. Here, we use left ventricular simulations to apply compressions and analyze hemodynamics as well as regional wall mechanics. This axisymmetric model corresponds with current symmetric bench prototypes. At nominal pressures of 3.1 kPa applied over the epicardial compression zone, hemodynamics improved substantially. Ejection fraction changed from 17.6% at baseline to 30.3% with compression and stroke work nearly doubled. Parametric studies were conducted by increasing and decreasing applied pressures; ejection fraction, peak pressure, and stroke work increased linearly with changes in applied compression. End-systolic volume decreased substantially. Regional mechanics analysis showed principal stress increases at the endocardium, in the middle of the compression region. Principal strains remained unchanged or increased moderately with nominal compression. However, at maximum applied compression, stresses and strains increased substantially providing potential constraints on allowable compressions. These results demonstrate a framework for analysis and optimization of cardiac compression as a prelude to biventricular simulations and subsequent animal experiments.

Computational Parametric Studies Investigating the Global Hemodynamic Effects of Applied Apical Torsion for Cardiac Assist.

Healthy hearts have an inherent twisting motion that is caused by large changes in muscle fiber orientation across the myocardial wall and is believed to help lower wall stress and increase cardiac output. It was demonstrated that applied apical torsion (AAT) of the heart could potentially treat congestive heart failure (CHF) by improving hemodynamic function. We report the results of parametric computational experiments where the effects of using a torsional ventricular assist device (tVAD) to treat CHF were examined using a patient-specific bi-ventricular computational model. We examined the effects on global hemodynamics as the device coverage area (CA) and applied rotation angle (ARA) were varied to determine ideal tVAD design parameters. When compared to a baseline, pretreatment CHF model, increases in ARA resulted in moderate to substantial increases in ejection fraction (EF), peak systolic pressures (PSP) and stroke work (SW) with concomitant decreases in end-systolic volumes (ESV). Increases in device CA resulted in increased hemodynamic function. The simulation representing the most aggressive level of cardiac assist yielded significant increases in left ventricular EF and SW, 49 and 72% respectively. Results with this more realistic computational model reinforce previous studies that have demonstrated the potential of AAT for cardiac assist.

Effect of a flexible ventricular restraint device on cardiac remodeling after acute myocardial infarction.

The effects of a flexible ventricular restraint device on left ventricular (LV) dilatation and hypertrophy after transmural infarction are examined in an ovine model. Left ventricular remodeling and dilatation occurs after extensive myocardial infarction. A flexible ventricular restraint made from a nitinol mesh was evaluated in adult female sheep (n=14). Cardiac magnetic resonance imaging scans and hemodynamic measurements were completed before and 6 weeks after anterior myocardial infarction. Treatment animals (n=7) received passive ventricular restraint concurrently with LV infarction; the others (n=7) served as controls. Increases in LV end-diastolic volume index were significantly less in the restraint group than in controls (0.20+/-0.41 vs 0.83+/-0.50 ml/kg, p<0.03). End-systolic volumes increased less in treatment animals (0.43+/-0.28 vs 0.90+/-0.38 ml/kg, p<0.03). Control hearts showed an increase in LV mass after infraction, whereas LV mass decreased in restrained hearts (0.14+/-0.19 vs -0.25+/-0.36 g/kg, p<0.03). Hemodynamic studies showed similar changes after infarction for the control and the device group. Gross and microscopic examination showed no device-induced epicardial injury. A flexible ventricular restraint device attenuated remodeling after acute myocardial infarction in sheep.

A femoral artery cannula that allows distal blood flow.

OBJECTIVE: A femoral artery cannula is used for certain types of circulatory support but can cause ischemia, especially during prolonged perfusion. This study tests the function of a femoral cannula designed to allow proximal and distal blood flow. METHODS: Five pigs were used in the study. In each animal a distal-flow cannula was implanted in the femoral artery of one leg, and the same-sized standard cannula was implanted in the other. Blood was drained from the left atrium and delivered to the femoral artery through the distal-flow cannula or standard cannula by using a centrifugal pump. An ultrasonic flow probe and microspheres were used to quantify flow and perfusion distal to the cannula. RESULTS: Distal femoral flow and tissue perfusion were present in all animals (5/5) with the distal-flow cannula but only in 1 of 5 animals with the standard cannula (P < .048). Distal flow did not change with pump flow. Mean distal flow at each level of pump flow was higher with the distal-flow cannula (P < .05). Tissue perfusion was also higher with the distal-flow cannula (0.052 +/- 0.028 vs 0.010 +/- 0.022 mL x min(-1) x g(-1), P < .03). CONCLUSIONS: In the swine model the distal-flow cannula allowed greater and more consistent distal flow than the standard cannula. The use of a distal-flow cannula for circulatory support might reduce the risk of distal limb ischemia.

Lower sternal reinforcement improves the stability of sternal closure.

BACKGROUND: This study uses a mechanical testing system to evaluate three methods of sternal closure. METHODS: Twelve sternal replicas composed of a polyurethane foam bone analogue were divided in the midline and reapproximated using three stainless steel wire techniques: six simple wires (6S), six figure-of-eight wires (6F8), or seven simple wires (7S), which included an extra wire at the lower sternum. The closures were subjected to increasing lateral distraction from 0 to 400 Newtons (N) (1 N = 0.224 lbs), and motion was measured using transducers stationed across the manubrium, midsternum, and lower sternum. RESULTS: With each method of closure, the manubrium was the most stable, the lower sternum the least stable, and the midsternum intermediate between the other two. There were also differences between sternal closure methods, but only at the lower sternum. Less sternal distraction was measured with the 7S than the 6S and 6F8 methods, starting at 100 N (0.20 +/- 0.06 mm vs 0.48 +/- 0.19 and 0.39 +/- 0.10, p = 0.003), and progressively increasing until the study was stopped at 400 N (1.64 +/- 0.39 mm vs 4.92 +/- 1.73 and 5.1 +/- 1.43 mm, p = 0.003). CONCLUSIONS: These data show that the lower sternum is the site of greatest instability and that reinforcement of this area with an additional wire effectively stabilizes the closure. Figure-of-eight wires are not superior to simple wires.

Validation of a bone analog model for studies of sternal closure.

BACKGROUND: The incidence of serious sternal wound complications may be reduced with improvements in closure methods. Biomechanical testing of median sternotomy closures in cadavers has proven useful but is limited by availability, high cost, and wide variations in the material properties of the sterna. This study tests whether artificial sterna can be used to replace whole cadavers in sternal closure testing. METHODS: Two common wire closure techniques were tested using both whole cadavers and artificial sternal models formed from bone analogue material. Sternal models were molded from polyurethane foam (20 lbs/ft3) to simulate the mechanical properties observed in human cadaveric sterna. The force vector previously identified as the most detrimental to sternal cohesion (lateral traction) was used to stress the closures. Separation of the incision site was measured at the manubrium, midsternum, and xiphoid and data were compared between cadaver and bench test groups. RESULTS: Sternal separations recorded in cadavers were found to be similar to bench test results for both closure types. Data variability within test groups was found to be consistently lower using artificial sterna, where peak standard deviations for sternal motion averaged less than half that measured in cadavers. CONCLUSIONS: Results suggest that anatomic sternal models formed from solid polyurethane foam can be used to approximate the biomechanical properties of cadaveric sterna and that reliable information regarding sternal closure stability can be secured through this means. Moreover, bench test data were shown to be less variable than cadaveric results, thus enhancing the power to detect small differences in sternal fixation stability.

Improvement of sternal closure stability with reinforced steel wires.

BACKGROUND: Sternal dehiscence occurs when steel wires pull through sternal bone. This study tests the hypothesis that closure stability can be improved by jacketing sternal wires with stainless steel coils, which distribute the force exerted on the bone over a larger area. METHODS: Midline sternotomies were performed in 6 human cadavers (4 male). Two sternal closure techniques were tested: (1) approximation with six interrupted wires, and (2) the same closure technique reinforced with 3.0-mm-diameter stainless steel coils that jacket wires at the lateral and posterior aspects of the sternum. Intrathoracic pressure was increased with an inflatable rubber bladder placed beneath the anterior chest wall, and sternal separation was measured by means of sonomicrometry crystals. In each trial, intrathoracic pressure was increased until 2.0 mm of motion was detected. Differences in displacement pressures between groups were examined at 0.25-mm intervals using the paired Student's t test. RESULTS: The use of coil-reinforced closures produced significant improvement in sternal stability at all eight displacement levels examined (p < 0.03). Mean pressure required to cause displacement increased 140% (15.5 to 37.3 mm Hg) at 0.25 mm of separation, 103% (34.3 to 69.8 mm Hg) at 1.0 mm of separation, and 122% (46.8 to 103.8 mm Hg) at 2.0 mm of separation. CONCLUSIONS: Reinforcement of sternal wires with stainless steel coils substantially improves stability of sternotomy closure in a human cadaver model.

Comparison of dog and pig models for testing substernal cardiac compression devices.

Subtle anatomic differences between species can be a critical consideration when determining whether a given animal model is appropriate for surgical research purposes, especially when testing biomechanical implants. This study compares the effectiveness of two common animal models (dogs and pigs) in testing a balloon based cardiac compression device designed for substernal placement. Pigs were used in acute studies using an infarction model of heart failure, whereas dogs were used in chronic experiments in which heart failure was induced via rapid pacing. Systolic cardiac compression was accomplished in both species using identical balloons inflated between the sternum and right ventricle with every heartbeat. Results showed the device to be much more effective in pigs, where cardiac stroke volumes returned to normal with balloon assistance (14.7 +/- 1.9 to 37.8 +/- 9.2 mL, p < 0.005). Stroke volumes in dogs, however, remained essentially unaltered by balloon activation (28.1 +/- 14.1 to 29.6 +/- 14.7 mL, p = NS). Retrospective comparisons showed pig models to be a much closer approximation to the human anatomy because of a more similar thoracic cavity shape and heart orientation. These findings suggest that certain large animal models should not be used in research in which chest wall shape or cardiac orientation within the thoracic cavity may influence outcomes.

Capturing in situ skeletal muscle power for circulatory support: a new approach to device design.

Efforts to harness in situ skeletal muscle for circulatory support have been extensive, but implants designed to tap this power source have yet to meet the strict performance standards incumbent upon such devices. A fourth generation muscle energy converter (MEC4) is described that represents a significant departure from previous hydraulic muscle pump designs, all of which have assumed a long cylindrical profile. The MEC4, in contrast, features a puck shaped metallic bellows oriented so that its end fittings lie parallel to the chest wall. The fixed end is centered over a fluid port that passes into the thoracic cavity across one resected rib. The opposite end of the bellows supports a roller bearing that moves beneath a linear cam fixed to a reciprocating shaft. The shaft exits the housing through a spring loaded seal and is attached to a sintered anchor pad for muscle tendon fixation. This configuration was chosen to improve bellows durability, lower device profile, and reduce tissue encumbrance to actuator recoil. Bench tests show that modest actuation forces can effect full actuator displacement in 0.25 seconds against high pressure loads, transmitting up to 0.9 J/stroke at 60% efficiency. In vitro tests also confirm that key device performance parameters can be computed from pressure readings transmitted via radiotelemetry, clearing the way for long-term implant studies in conscious animals.

Method for anchoring biomechanical implants to muscle tendon and chest wall.

Reliable tissue fixation is of fundamental importance to the successful development of muscle powered motor prostheses. This report describes a series of canine implant trials used to develop stable tissue-device interface mechanisms. Muscle pumps were fitted with prototype tendon and chest wall anchoring schemes and secured to the ribs and humeral insertion of latissimus dorsi (LD) muscles. LD stimulation was initiated 1 week postimplantation and continued throughout the implant period to stress these fixation sites. Design modification and implant testing were continued until both muscle and chest wall attachment points were found to be stable. Chest wall fixation was best achieved using perforated metallic plates wired to the ribs, as opposed to bone screws or wire mesh, which were subject to degradation. Direct attachment of the native tendon by means of spiked clamping plates proved ineffective. Stable muscle attachment was ultimately achieved by replacing the humeral tendon with an artificial substitute formed from fine polyester fibers gathered into 6-8 bundles and sewn into the LD insertion. Braided into a single cord, these fibers were fixed to the device by means of spiked clamping plates. Based on these findings, we conclude that perforated anchor plates and multifibrous artificial tendons can function as effective tissue-device interface mechanisms.

In vivo performance of a muscle-powered drive system for implantable blood pumps.

A unique biomechanical implant has been developed to convert muscle power into hydraulic energy for the purpose of driving an implanted blood pump. This device, called a muscle energy converter (MEC), is designed to attach to the humeral insertion of the latissimus dorsi (LD) muscle, so that stimulated contractions cause a rotary cam to compress a fluid-filled bellows. Here we report results from the latest in a series of canine implant trials where the MEC was connected to an adjustable pressure load to measure power output and assess long-term function. Full-length (2 cm) actuator strokes were maintained for a period of 1 month with no discernable discomfort to the animal. Load conditions were cycled periodically to measure stroke work capacity and pressure production. The peak driveline pressure recorded in this experiment was 1743 mm Hg. Steady state power generation was measured to 478 +/- 21 mJ/stroke (mean +/- SD) with stroke work levels reaching 785 mJ in one test. Normal left and right ventricular stroke work levels in dogs this size (35 kg) are 700 and 150 mJ, respectively. These data confirm that MEC/LD power levels--maintained in tandem with an appropriate cardiac assist device--are sufficient to provide significant long-term circulatory support. Further testing, however, is still needed to demonstrate the long-term stability of this drive system.

Improved mechanism for capturing muscle power for circulatory support.

Although it is now understood that trained skeletal muscle can generate enough steady-state power to provide significant circulatory support, there are currently no means by which to tap this endogenous energy source to aid the failing heart. To that end, an implantable muscle energy converter (MEC) has been constructed and its function has been improved to optimize durability, anatomic fit, and mechanical efficiency. Bench tests show that MEC transmission losses average less than 10% of total work input and that about 85% of this muscle power is successfully transferred to the working fluid of the pump. Results from canine implant trials confirm excellent biocompatibility and demonstrate that contractile work of the latissimus dorsi muscle-measured to 290 mJ/stroke in one dog-can be transmitted within the body at levels consistent with cardiac assist requirements. These findings suggest that muscle-powered cardiac assist devices are feasible and that efforts to further develop this technology are warranted.