Experimental Study of Micro-Scale Taylor Vortices Within a Co-Axial Mixed-Flow Blood Pump.

Taylor vortices in a miniature mixed-flow rotodynamic blood pump were investigated using micro-scale particle image velocimetry (µ-PIV) and a tracer particle visualization technique. The pump featured a cylindrical rotor (14.9 mm diameter) within a cylindrical bore, having a radial clearance of 500 µm and operated at rotational speeds varying from 1000 to 12 000 rpm. Corresponding Taylor numbers were 700-101 800, respectively. The critical Taylor number was observed to be highly dependent on the ratio of axial to circumferential velocity, increasing from 1200 to 18 000 corresponding to Rossby numbers from 0 to 0.175. This demonstrated a dramatic stabilizing effect of the axial flow. The size of Taylor vortices was also found to be inversely related to Rossby number. It is concluded that Taylor vortices can enhance the mixing in the annular gap and decrease the dwell time of blood cells in the high-shear-rate region, which has the potential to decrease hemolysis and platelet activation within the blood pump.

Effects of Thoratec pulsatile ventricular assist device timing on the abdominal aortic wave intensity pattern.

Arterial waves are seen as possible independent mediators of cardiovascular risks, and the wave intensity analysis (WIA) has therefore been proposed as a method for patient selection for ventricular assist device (VAD) implantation. Interpreting measured wave intensity (WI) is challenging, and complexity is increased by the implantation of a VAD. The waves generated by the VAD interact with the waves generated by the native heart, and this interaction varies with changing VAD settings. Eight sheep were implanted with a pulsatile VAD (PVAD) through ventriculoaortic cannulation. The start of PVAD ejection was synchronized to the native R wave and delayed between 0 and 90% of the cardiac cycle in 10% steps or phase shifts (PS). Pressure and velocity signals were registered, with the use of a combined Doppler and pressure wire positioned in the abdominal aorta, and used to calculate the WI. Depending on the PS, different wave interference phenomena occurred. Maximum unloading of the left ventricle (LV) coincided with constructive interference and maximum blood flow pulsatility, and maximum loading of the LV coincided with destructive interference and minimum blood flow pulsatility. We believe that noninvasive WIA could potentially be used clinically to assess the mechanical load of the LV and to monitor the peripheral hemodynamics such as blood flow pulsatility and risk of intestinal bleeding.

Analysis of pressure head-flow loops of pulsatile rotodynamic blood pumps.

The clinical importance of pulsatility is a recurring topic of debate in mechanical circulatory support. Lack of pulsatility has been identified as a possible factor responsible for adverse events and has also demonstrated a role in myocardial perfusion and cardiac recovery. A commonly used method for restoring pulsatility with rotodynamic blood pumps (RBPs) is to modulate the speed profile, synchronized to the cardiac cycle. This introduces additional parameters that influence the (un)loading of the heart, including the timing (phase shift) between the native cardiac cycle and the pump pulses, and the amplitude of speed modulation. In this study, the impact of these parameters upon the heart-RBP interaction was examined in terms of the pressure head-flow (HQ) diagram. The measurements were conducted using a rotodynamic Deltastream DP2 pump in a validated hybrid mock circulation with baroreflex function. The pump was operated with a sinusoidal speed profile, synchronized to the native cardiac cycle. The simulated ventriculo-aortic cannulation showed that the level of (un)loading and the shape of the HQ loops strongly depend on the phase shift. The HQ loops displayed characteristic shapes depending on the phase shift. Increased contribution of native contraction (increased ventricular stroke work [WS ]) resulted in a broadening of the loops. It was found that the previously described linear relationship between WS and the area of the HQ loop for constant pump speeds becomes a family of linear relationships, whose slope depends on the phase shift.

A physiological controller for turbodynamic ventricular assist devices based on a measurement of the left ventricular volume.

The current article presents a novel physiological control algorithm for ventricular assist devices (VADs), which is inspired by the preload recruitable stroke work. This controller adapts the hydraulic power output of the VAD to the end-diastolic volume of the left ventricle. We tested this controller on a hybrid mock circulation where the left ventricular volume (LVV) is known, i.e., the problem of measuring the LVV is not addressed in the current article. Experiments were conducted to compare the response of the controller with the physiological and with the pathological circulation, with and without VAD support. A sensitivity analysis was performed to analyze the influence of the controller parameters and the influence of the quality of the LVV signal on the performance of the control algorithm. The results show that the controller induces a response similar to the physiological circulation and effectively prevents over- and underpumping, i.e., ventricular suction and backflow from the aorta to the left ventricle, respectively. The same results are obtained in the case of a disturbed LVV signal. The results presented in the current article motivate the development of a robust, long-term stable sensor to measure the LVV.

Optimizing CO2 field flooding during sternotomy: In vitro confirmation of the Karolinska studies.

Although CO2 field-flooding was first used during cardiac surgery more than 60 years ago, its efficacy is still disputed. The invisible nature of the gas and the difficulty in determining the "safe" quantity to protect the patient are two of the main obstacles to overcome for its validation. Moreover, CO2 concentration in the chest cavity is highly sensitive to procedural aspects, such suction and hand movements. Based on our review of the existing literature, we identified four major factors that influence the intra-cavity CO2 concentration during open-heart surgery: type of delivery device (diffuser), delivery CO2 flow rate, diffuser position around the wound cavity, and its orientation inside the cavity. In this initial study, only steady state conditions were considered to establish a basic understanding on the effect of the four above-mentioned factors. Transient factors, such as suction or hand movements, will be reported separately.

Patient tilt improves efficacy of CO2 field-flooding in minimally invasive cardiac surgery.

OBJECTIVE: Space limitations during minimally invasive cardiac surgery impede consistent use of CO2 field-flooding. We compared different gas delivery methods, flow rates and the effect of patient inclination. METHODS: A gastight model of MICS surgery with internal organs and right thoracotomy wound was created from a mannequin and equipped with a CO2 concentration sensor in the left ventricle. Maximum achievable CO2 concentration was compared for gas delivery via three commercial CO2 diffusors (CarbonMini, Temed, Andocor) and also via a trocar with side port. Gas flow rates of 1, 3, 5 and 8 L per minute were tested. The model was placed either in supine position or with 20° oblique tilt. A simplified transparent model was also created and placed in an optical test bench to evaluate the gas cloud motions via real-time visualization. RESULTS: The trocar consistently achieved higher CO2 concentrations inside the left ventricle. At 1 l/min, approximately 2.5 min were needed to fill the supine model to its maximum CO2 concentration, which was limited to a range of 48-82% in the left ventricle. At higher flow rates, filling time and concentration were significantly improved. In a tilted model, all devices and all flow rates generated on average 99% CO2 in the ventricle. Imaging revealed constant gas exchange via the main incision, with CO2 outflow via bottom and air inflow via the top of the incision. CONCLUSIONS: CO2 field flooding in minimally invasive cardiac surgery is highly effective if the patient is tilted. Else a flow rate of 5 l/min is recommended to achieve the same protection.

Development of a Gastight Thoracotomy Model for Investigation of Carbon Dioxide Field-Flooding Efficacy.

Carbon dioxide (CO2) field-flooding during cardiac surgery is a prevention technique to avoid blood-air contact and subsequent embolization. Although it was first used more than 60 years ago, there is still some perplexity around its efficacy, mainly because the gas is invisible and air embolization is difficult to quantify. An accurate assessment of field-flooding can, therefore, best be performed in models where various methods can be tried in a controlled environment and evaluated with industrial-grade sensors. Multiple options are available for anatomically correct models that reproduce a sternotomy situation, but models for minimally invasive cardiac surgery are expensive and normally meant for training of surgical techniques where only the top side of the model is important. We created a low-cost and "home-made" gastight mini-thoracotomy model with internal organs and left atrial incision to investigate CO2 insufflation in a simulated minimally invasive mitral valve surgery. The model was validated with CO2 field-flooding tests with a commercial diffuser, while three sensors continuously registered the local concentration of CO2 gas.

Gaseous Microemboli in the Cardiopulmonary Bypass Circuit: Presentation of a Systematic Data Collection Protocol Applied at Istituto Cardiocentro Ticino.

Air emboli are reported to enter the cardiovascular system during cardiac surgery despite air-bubble filters in the arterial line of the cardiopulmonary bypass (CPB). A potential association with stroke, covert cerebral insults and cognitive decline after cardiac surgery has been hypothesized. Although most of the previous studies failed to prove it, this hypothesis cannot be rejected because the situation in the operating room (OR) is multifactorial and complex. Therefore, rigorous and standardized protocols are needed to investigate sources, patterns, as well as effective quantity and volume of air embolism.  We hereby present our protocol in detail for systematic data collection as a standard quality control measure at our center, where air bubbles in the cardiopulmonary bypass circuit are measured by a commercial bubble counter. We also show a preview of the type of information that can be obtained for future analysis. The eventual aim is to determine a potential association between air emboli and adverse postoperative outcomes, as well as to identify major sources of air bubbles generation and in the long run to find effective prevention strategies.

Embedded Computational Heart Model for External Ventricular Assist Device Investigations.

PURPOSE: External cardiac assist devices are based on a promising and simple concept for treating heart failure, but they are surprisingly difficult to design. Thus, a structured approach combining experiments with computer-based optimization is essential. The latter provides the motivation for the work presented in this paper. METHODS: We present a computational modeling framework for realistic representation of the heart's tissue structure, electrophysiology and actuation. The passive heart tissue is described by a nonlinear anisotropic material law, considering fiber and sheetlet directions. For muscle contraction, an orthotropic active-strain model is employed, initiated by a periodically propagating electrical potential. The model allows for boundary conditions at the epicardium accounting for external assist devices, and it is coupled to a circulation network providing appropriate pressure boundary conditions inside the ventricles. RESULTS: Simulated results from an unsupported healthy and a pathological heart model are presented and reproduce accurate deformations compared to phenomenological measurements. Moreover, cardiac output and ventricular pressure signals are in good agreement too. By investigating the impact of applying an exemplary external actuation to the pathological heart model, it shows that cardiac patches can restore a healthy blood flow. CONCLUSION: We demonstrate that the devised computational modeling framework is capable of predicting characteristic trends (e.g. apex shortening, wall thickening and apex twisting) of a healthy heart, and that it can be used to study pathological hearts and external activation thereof.

A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes.

BACKGROUND: There is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS). AIMS: The aim of this study was to assess the safety and efficacy of the NeVa (Vesalio) mechanical thrombectomy device (MTD) in ACS patients with LTB. METHODS: Consecutive patients with ACS and LTB were treated with the NeVa MTD as the primary vessel recanalisation and thrombus removal modality, followed by conventional intervention. We further developed a bench model and applied to a subset of patients, a vacuum-assisted aspiration technique, exploiting 6 Fr-compatible conventional guiding catheter extensions, as an adjudicative manoeuvre to the use of stent-based MTD. A core laboratory reviewed the angiographic images for procedural complications, Thrombolysis In Myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and TIMI thrombus grade (TTG). RESULTS: Between November 2019 and March 2021, 61 patients underwent thrombectomy with the NeVa device. Non-flow limiting and reversible coronary spasm occurred in 14 (23%) patients. One patient (#10) suffered from side branch embolisation, which was successfully treated with the NeVa, triggering the development of a vacuum-assisted aspiration technique in a bench model, which was then applied to the subsequent 51 patients. No other device-related complications occurred. After NeVa use, TIMI flow <3 decreased from 68.3% at baseline to 10.3% (p<0.001), MBG <2 from 65% to 27.6% (p<0.001), TTG ≥3 from 96.7% to 43.2% (p<0.001), respectively. CONCLUSIONS: In patients with LTB, the NeVa MTD was safe and associated with high rates of vessel recanalisation and thrombus removal. The concomitant use of vacuum-assisted aspiration has potential to improve the effectiveness and safety of the technique.

Effect of pulsatility on the mathematical modeling of rotary blood pumps.

In this study, the effect of time derivatives of flow rate and rotational speed was investigated on the mathematical modeling of a rotary blood pump (RBP). The basic model estimates the pressure head of the pump as a dependent variable using measured flow and speed as predictive variables. Performance of the model was evaluated by adding time derivative terms for flow and speed. First, to create a realistic working condition, the Levitronix CentriMag RBP was implanted in a sheep. All parameters from the model were physically measured and digitally acquired over a wide range of conditions, including pulsatile speed. Second, a statistical analysis of the different variables (flow, speed, and their time derivatives) based on multiple regression analysis was performed to determine the significant variables for pressure head estimation. Finally, different mathematical models were used to show the effect of time derivative terms on the performance of the models. In order to evaluate how well the estimated pressure head using different models fits the measured pressure head, root mean square error and correlation coefficient were used. The results indicate that inclusion of time derivatives of flow and speed can improve model accuracy, but only minimally.

Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device.

The PediaFlow pediatric ventricular assist device is a miniature magnetically levitated mixed flow pump under development for circulatory support of newborns and infants (3-15 kg) with a targeted flow range of 0.3-1.5 L/min. The first generation design of the PediaFlow (PF1) was manufactured with a weight of approximately 100 g, priming volume less than 2 mL, length of 51 mm, outer diameter of 28 mm, and with 5-mm blood ports. PF1 was evaluated in an in vitro flow loop for 6 h and implanted in ovines for three chronic experiments of 6, 17, and 10 days. In the in vitro test, normalized index of hemolysis was 0.0087 ± 0.0024 g/100L. Hemodynamic performance and blood biocompatibility of PF1 were characterized in vivo by measurements of plasma free hemoglobin, plasma fibrinogen, total plasma protein, and with novel flow cytometric assays to quantify circulating activated ovine platelets. The mean plasma free hemoglobin values for the three chronic studies were 4.6 ± 2.7, 13.3 ± 7.9, and 8.8 ± 3.3 mg/dL, respectively. Platelet activation was low for portions of several studies but consistently rose along with observed animal and pump complications. The PF1 prototype generated promising results in terms of low hemolysis and platelet activation in the absence of complications. Hemodynamic results validated the magnetic bearing design and provided the platform for design iterations to meet the objective of providing circulatory support for young children with exceptional biocompatibility.

Effect of cannulation site on emboli travel during cardiac surgery.

BACKGROUND: During cardiac surgery, micro-air emboli regularly enter the blood stream and can cause cognitive impairment or stroke. It is not clearly understood whether the most threatening air emboli are generated by the heart-lung machine (HLM) or by the blood-air contact when opening the heart. We performed an in vitro study to assess, for the two sources, air emboli distribution in the arterial tree, especially in the brain region, during cardiac surgery with different cannulation sites. METHODS: A model of the arterial tree was 3D printed and included in a hydraulic circuit, divided such that flow going to the brain was separated from the rest of the circuit. Air micro-emboli were injected either in the HLM ("ECC Bubbles") or in the mock left ventricle ("Heart Bubbles") to simulate the two sources. Emboli distribution was measured with an ultrasonic bubble counter. Five repetitions were performed for each combination of injection site and cannulation site, where air bubble counts and volumes were recorded. Air bubbles were separated in three categories based on size. RESULTS: For both injection sites, it was possible to identify statistically significant differences between cannulation sites. For ECC Bubbles, axillary cannulation led to a higher amount of air bubbles in the brain with medium-sized bubbles. For Heart Bubbles, aortic cannulation showed a significantly bigger embolic load in the brain with large bubbles. CONCLUSIONS: These preliminary in vitro findings showed that air embolic load in the brain may be dependent on the cannulation site, which deserves further in vivo exploration.

Direct visualization of carbon dioxide field flooding: Optical and concentration level comparison of diffusor effectiveness.

OBJECTIVE: Carbon dioxide field flooding during open-heart surgery is intended to avoid blood-air contact, bubble formation, and embolism, and therefore potential neurologic and other ischemic complications. The inert gas is invisible, and thus its use and effectiveness are heavily debated. We intended to provide better insight in the behavior of the gas via direct concentration measurements and visualization of the gas cloud. METHODS: A transparent rectangular model of the open thorax was created, foreseen with carbon dioxide concentration sensors in 2 locations (atrial and aortic incisions), and placed in an optical test bench that amplifies the diffraction gradients. Six different commonly used carbon dioxide diffusors (3 commercial, 3 improvised) were tested with different flow rates of gas delivery (1, 4, 7, 10 standard liter per minute [SLPM]) and combined with the application of suction. RESULTS: The imaging reveals that commercially available diffusors generally create less turbulent flow than improvised diffusors, which is supported by the concentration measurements where improvised diffusors cannot generate a 100% carbon dioxide atmosphere at the aorta incision location. The atrial incision is easier to protect: 0% air with all commercial devices for all flow rates greater than 1 SLPM. A flow rate of 1 SLPM does not create an inert atmosphere with any device. CONCLUSIONS: The optically observed carbon dioxide atmosphere is unstable and influenced by many factors. The device used for diffusion and the flow rate are important determinants of the maximum gas concentration that can be achieved, as is the location where this is measured.

The importance of dQ/dt on the flow field in a turbodynamic pump with pulsatile flow.

Fluid dynamic analysis of turbodynamic blood pumps (TBPs) is often conducted under steady flow conditions. However, the preponderance of clinical applications for ventricular assistance involves unsteady, pulsatile flow-due to the residual contractility of the native heart. This study was undertaken to demonstrate the importance of pulsatility and the associated time derivative of the flow rate (dQ/dt) on hemodynamics within a clinical-scale TBP. This was accomplished by performing flow visualization studies on a transparent model of a centrifugal TBP interposed within a cardiovascular simulator with controllable heart rate and stroke volume. Particle image velocimetry triggered to both the rotation angle of the impeller and phase of the cardiac cycle was used to quantify the velocity field in the outlet volute and in between the impeller blades for 16 phases of the cardiac cycle. Comparison of the unsteady flow fields to corresponding steady conditions at the same (instantaneous) flow rates revealed marked differences. In particular, deceleration of flow was found to promote separation within the outlet diffuser, while acceleration served to stabilize the velocity field. The notable differences between the acceleration and deceleration phases illustrated the prominence of inertial fluid forces. These studies emphasize the importance of dQ/dt as an independent variable for thorough preclinical validation of TBPs intended for use as a ventricular assist device.

Pulsatile in vitro simulation of the pediatric univentricular circulation for evaluation of cardiopulmonary assist scenarios.

The characteristic depressed hemodynamic state and gradually declining circulatory function in Fontan patients necessitates alternative postoperative management strategies incorporating a system level approach. In this study, the single-ventricle Fontan circulation is modeled by constructing a practical in vitro bench-top pulsatile pediatric flow loop which demonstrates the ability to simulate a wide range of clinical scenarios. The aim of this study is to illustrate the utility of a novel single-ventricle flow loop to study mechanical cardiac assist to Fontan circulation to aid postoperative management and clinical decision-making of single ventricle patients. Two different pediatric ventricular assist devices, Medos and Pediaflow Gen-0, are anastomosed in two nontraditional configurations: systemic venous booster (SVB) and pulmonary arterial booster (PAB). Optimum ventricle assist device strategy is analyzed under normal and pathological (pulmonary hypertension) conditions. Our findings indicate that the Medos ventricular assist device in SVB configuration provided the highest increase in pulmonary (46%) and systemic (90%) venous flow under normal conditions, whereas for the hypertensive condition, highest pulmonary (28%) and systemic (55%) venous flow augmentation were observed for the Pediaflow ventricular assist device inserted as a PAB. We conclude that mechanical cardiac assist in the Fontan circulation effectively results in flow augmentation and introduces various control modalities that can facilitate patient management. Assisted circulation therapies targeting single-ventricle circuits should consider disease state specific physiology and hemodynamics on the optimal configuration decisions.

Reversed Auxiliary Flow to Reduce Embolism Risk During TAVI: A Computational Simulation and Experimental Study.

INTRODUCTION: Endovascular treatments, such as transcatheter aortic valve implantation (TAVI), carry a risk of embolization due to debris dislodgement during various procedural steps. Although embolic filters are already available and marketed, mechanisms underlying cerebral embolism still need to be elucidated in order to further reduce cerebrovascular events. METHODS: We propose an experimental framework with an in silico duplicate allowing release of particles at the level of the aortic valve and their subsequent capture in the supra-aortic branches, simulating embolization under constant inflow and controlled hemodynamic conditions. The effect of a simple flow modulation, consisting of an auxiliary constant flow via the right subclavian artery (RSA), on the amount of particle entering the brachiocephalic trunk was investigated. Preliminary computational fluid dynamics (CFD) simulations were performed in order to assess the minimum retrograde flow-rate from RSA required to deviate particles. RESULTS: Our results show that a constant reversed auxiliary flow of 0.5 L/min from the RSA under a constant inflow of 4 L/min from the ascending aorta is able to protect the brachiocephalic trunk from particle embolisms. Both computational and experimental results also demonstrate that the distribution of the bulk flow dictates the distribution of the particles along the aortic branches. This effect has also shown to be independent of release location and flow rate. CONCLUSIONS: The present study confirms that the integration of in vitro experiments and in silico analyses allows designing and benchmarking novel solutions for cerebral embolic protection during TAVI such as the proposed embo-deviation technique based on an auxiliary retrograde flow from the right subclavian artery.

Towards the development of a pediatric ventricular assist device.

The very limited options available to treat ventricular failure in children with congenital and acquired heart diseases have motivated the development of a pediatric ventricular assist device at the University of Pittsburgh (UoP) and University of Pittsburgh Medical Center (UPMC). Our effort involves a consortium consisting of UoP, Children's Hospital of Pittsburgh (CHP), Carnegie Mellon University, World Heart Corporation, and LaunchPoint Technologies, Inc. The overall aim of our program is to develop a highly reliable, biocompatible ventricular assist device (VAD) for chronic support (6 months) of the unique and high-risk population of children between 3 and 15 kg (patients from birth to 2 years of age). The innovative pediatric ventricular assist device we are developing is based on a miniature mixed flow turbodynamic pump featuring magnetic levitation, to assure minimal blood trauma and risk of thrombosis. This review article discusses the limitations of current pediatric cardiac assist treatment options and the work to date by our consortium toward the development of a pediatric VAD.

The PediaFlow pediatric ventricular assist device.

The very limited options available to treat ventricular failure in patients with congenital and acquired heart diseases have motivated the development of a pediatric ventricular assist device (VAD). Our effort involves a consortium consisting of the University of Pittsburgh, Carnegie Mellon University, Children's Hospital of Pittsburgh, World Heart Corporation, and LaunchPoint Technologies, LLC. The overall aim of our program is to develop a highly reliable, biocompatible VAD for chronic support (6 months) of the unique and high-risk population of children between 3 kg and 15 kg (patients from birth to 2 years of age). The innovative pediatric VAD we are developing (PediaFlow) is based on a miniature mixed-flow turbodynamic pump featuring magnetic levitation, with the design goal being to assure minimal blood trauma and risk of thrombosis. This article discusses the limitations of current pediatric cardiac assist treatment options and the work to date by our consortium toward the development of a pediatric VAD.

Modeling ventricular function during cardiac assist: does time-varying elastance work?

The time-varying elastance theory of Suga et al. is widely used to simulate left ventricular function in mathematical models and in contemporary in vitro models. We investigated the validity of this theory in the presence of a left ventricular assist device. Left ventricular pressure and volume data are presented that demonstrate the heart-device interaction for a positive-displacement pump (Novacor) and a rotary blood pump (Medos). The Novacor was implanted in a calf and used in fixed-rate mode (85 BPM), whereas the Medos was used at several flow levels (0-3 l/min) in seven healthy sheep. The Novacor data display high beat-to-beat variations in the amplitude of the elastance curve, and the normalized curves deviate strongly from the typical bovine curve. The Medos data show how the maximum elastance depends on the pump flow level. We conclude that the original time-varying elastance theory insufficiently models the complex hemodynamic behavior of a left ventricle that is mechanically assisted, and that there is need for an updated ventricular model to simulate the heart-device interaction.