Intravenous Fluid Resuscitation Capabilities in Simulated Reduced Gravity.

BACKGROUND: Critical care for exploration space missions may require intravenous (IV) fluid resuscitation therapy. Resource constraints may limit availability of standard, Earth-based infusion technologies. The effect of variable acceleration on infusion flow rates using simple fluid resuscitation supplies was investigated.METHODS: Infusions of water or blood analog (40% glycerol) from a 1 L IV bag were performed using pressure bag augmentation at 0, 150, or 300 mmHg. The solution bag rested on an adjustable mount, configured to different heights to simulate relevant gravitational accelerations (1 G, Martian G, lunar G, and 0 G). The bag emptied through an IV line with a 14- or 20-gauge angiocath into a 3-mmHg venous pressure reservoir. Flow rates were measured using an in-line flow probe. Three determinations were made for each test condition.RESULTS: Temporal flow rate data for all test conditions displayed one-phase exponential decay. At 300 mmHg pressurization, maximum infusion rates ranged from 92-222 mL ⋅ min-1 for water and from 21-49 mL ⋅ min-1 for blood analog. All reduced gravity conditions had significantly longer infusion times in comparison to 1 G for both test solutions.DISCUSSION: Reduced acceleration significantly altered flow rates and infusion times for fluid resuscitation. Fluid resuscitation protocols specify a desired volume to infuse for a target time (e.g., 20-30 mL ⋅ min-1 for a 75-kg adult). This data demonstrates that this protocol parameter can be achieved with infusion pressure bag augmentation alone and provides information for the refinement of fluid resuscitation protocols for exploration space missions.Pantalos GM, Heidel JS, Jain IM, Warner SE, Barefoot TL, Baker RO, Hailey M. Intravenous fluid resuscitation capabilities in simulated reduced gravity. Aerosp Med Hum Perform. 2023; 94(8):596-603.

Use of Gloves to Examine Intermittent Palm Cooling's Impact on Rowing Ergometry.

ABSTRACT: O'Brien, IT, Kozerski, AE, Gray, WD, Chen, L, Vargas, LJ, McEnroe, CB, Vanhoover, AC, King, KM, Pantalos, GM, and Caruso, JF. Use of gloves to examine intermittent palm cooling's impact on rowing ergometry. J Strength Cond Res 35(4): 931-940, 2021-The aim of this study was to examine the use of gloves on intermittent palm cooling's impact on rowing ergometry workouts. Our methods had subjects (n = 34) complete 3 rowing ergometer workouts of up to 8 2-minute stages separated by 45- or 60-second rests. They were randomized to one of the following treatments per workout: no palm cooling (NoPC), intermittent palm cooling as they rowed (PCex), or intermittent palm cooling as they rowed and post-exercise (PCex&post). Palm cooling entailed intermittent cold (initial temperature: 8.1° C) application and totaled 10 (PCex) and 20 (PCex&post) minutes, respectively. Workouts began with 8 minutes of rest after which pre-exercise data were obtained, followed by a ten-minute warm-up and the workout, and 20 minutes of post-exercise recovery. Numerous physiological and performance variables were collected before, during, and after workouts, and each was analyzed with either a two- or three-way analysis of variance. Our results include, with a 0.05 alpha and a simple effects post hoc, the distance rowed analysis produced a significant workout effect with PCex, PCex&post > NoPC. There were also significant interworkout differences for heart rate (HR) (NoPC > PCex) and blood lactate concentration (NoPC > PCex, PCex&post). We conclude that lower HRs and blood lactate concentrations from intermittent cooling caused subjects to experience less fatigue during those workouts and enabled more work to be performed. Continued research should identify optimal cooling characteristics to expedite body heat removal. Practical applications suggest that intermittent palm cooling administered with gloves enhance performance by abating physiological markers of fatigue.

Ergogenic and Physiological Outcomes Derived From a Novel Skin Cooling Device.

ABSTRACT: Gray, WD, Jett, DM, Cocco, AR, Vanhoover, AC, Colborn, CE, Pantalos, GM, Stumbo, J, Quesada, PM, and Caruso, JF. Ergogenic and physiological outcomes derived from a novel skin cooling device. J Strength Cond Res 35(2): 391-403, 2021-Our study's purpose assessed a cooling headband's ergogenic and physiological impacts. Subjects (15 women and 13 men) completed six visits; the final 3 entailed rowing workouts with the following treatment conditions: no head cooling (NoHC), intermittent head cooling during exercise (HCex), and intermittent head cooling during exercise and post-exercise recovery (HCex&post). Data collection occurred at the following times (a) pre-exercise and post-warm-up, (b) between stages of up to eight 2-minute bouts, and (c) at 5, 10, 15, and 20 minutes post-exercise. In addition to distance rowed, thermal, cardiovascular, perceptual, and metabolic measurements were obtained. Results included a small yet significant intertreatment difference (HCex, HCex&post > NoHC) for distance rowed. Our cardiovascular and metabolic indices exhibited sex and time differences but likely did not contribute to the ergogenic effect. Yet, left hand temperatures (LHT) exhibited significant 2-way and 3-way interactions that were the likely source of the ergogenic effect. Auditory canal temperature (AUDT) results suggest the head is sensitive to heat increases, yet LHT data show headband use evoked significantly greater temperature increases at the hand's palmar surface, indicative of heat transfer. We conclude, and our practical applications suggest, the headband's ergogenic effect was manifested by cold-induced vasodilation at the hand's palmar surface, rather than heat losses through the head.

Load-Power Relationships for High-Speed Knee Extension Exercise.

Chen, L, Davison, SW, Selimovic, EA, Mueller, RE, Beatty, SR, Carter, KA, Parmar, PJ, Symons, TB, Pantalos, GM, and Caruso, JF. Load-power relationships for high-speed knee extension exercise. J Strength Cond Res 33(6): 1480-1487, 2019-Seventy subjects did 4 knee extensor workouts with their left legs to assess load-power relationships produced on a high-speed trainer (HST; Newnan, GA, USA). Each workout is composed of 4 sets done on the HST at a different load (1, 4.4, 6.7, 9 kg). A Latin Squares Design determined load sequence per workout. Average power (AP) and peak power (PP) and those same values normalized to body mass (BM) and fat-free mass (AP/BM, PP/BM, AP/FFM, PP/FFM) were each analyzed with 2 (gender) × 4 (load) analysis of variances, with repeated measures for load. We assessed relationships between normalized loads and AP and PP values with correlation coefficients. Average power results revealed a significant interaction, with men > women at 9 kg. Peak power/body mass also yielded an interaction, with women > men at 6.7 and 9 kg. Average power/fat-free mass and PP/FFM each produced interactions, with women > men at 4.4, 6.7, and 9 kg. Correlation coefficients showed significant (r = 0.80-0.82) relationships between normalized loads and AP and PP values. In conclusion, the very low inertial resistance to initiate each repetition on this novel device may in part explain our PP/BM, AP/FFM, PP/FFM results, in which higher values were achieved by women. Our practical applications imply that the low inertial resistance for HST repetitions negates male size and strength advantages typically seen when power is measured.

Comparison of Blood Viscoelasticity in Pediatric and Adult Cardiac Patients.

Evidence is accumulating that blood flow patterns in the cardiovascular system and in cardiovascular devices do, in some instances, depend on blood viscoelasticity. Thus, to better understand the challenges to providing circulatory support and surgical therapies for pediatric and adult patients, viscous and elastic components of complex blood viscoelasticity of 31 pediatric patients were compared to those of 29 adult patients with a Vilastic-3 rheometer. A random effects model with categorical age covariates found statistically significant differences between pediatric and adult patients for log viscosity (p = 0.005). Log strain (p < 0.0001) and hematocrit (p < 0.0001) effects were also significant, as were the hematocrit-by-log-strain (p = 0.0006) and age-by-log strain (p = 0.001) interactions. The hematocrit-by-age interaction was not significant. For log elasticity, age differences were insignificant (p = 0.39). The model for log elasticity had significant log strain (p < 0.0001), log strain squared (p < 0.0001) and hematocrit (p < 0.0001) effects, as well as hematocrit-by-log-strain and hematocrit-by-log-strain-squared interactions (p = 0.014). A model for log viscosity with continuous age was also fit to the data, which can be used to refine cardiovascular device design and operation to the age of the patient. We conclude that there are distinct differences between pediatric and adult blood viscosity, as well as substantial variation within the pediatric population, that may impact the performance of devices and procedures.

Does conventional intra-aortic balloon pump trigger timing produce optimal hemodynamic effects in vivo?

PURPOSE: The intra-aortic balloon pump (IABP) provides circulatory support through counterpulsation. The hemodynamic effects of the IABP may vary with assisting frequency and depend on IAB inflation/deflation timing. We aimed to assess in vivo the IABP benefits on coronary, aortic, and left ventricular hemodynamics at different assistance frequencies and trigger timings. METHODS: Six healthy, anesthetized, open-chest sheep received IABP support at 5 timing modes (EC, LC, CC, CE, CL, corresponding to early/late/conventional/conventional/conventional inflation and conventional/conventional/conventional/early/late deflation, respectively) with frequency 1:3 and 1:1. Aortic (Q(ao)) and coronary (Q(cor)) flow, and aortic (P(ao)) and left ventricular (PLV) pressure were recorded simultaneously, with and without IABP support. Integrating systolic Q(ao) yielded stroke volume (SV). RESULTS: EC at 1:1 produced the lowest end-diastolic P(ao) (59.5 ± 7.8 mmHg [EC], 63.4 ± 11.1 mmHg [CC]), CC at 1:1 the lowest systolic PLV (69.1 ± 6.5 mmHg [CC], 76.4 ± 6.5 mmHg [control]), CC at 1:1 the highest SV (88.5 ± 34.4 ml [CC], 76.6 ± 31.9 ml [control]) and CC at 1:3 the highest diastolic Qcor (187.2 ± 25.0 ml/min [CC], 149.9 ± 16.6 ml/min [control]). Diastolic P(ao) augmentation was enhanced by both assistance frequencies alike, and optimal timings were EC for 1:3 (10.4 ± 2.8 mmHg [EC], 6.7 ± 3.8 mmHg [CC]) and CC for 1:1 (10.8 ± 6.7 mmHg [CC], -3.0 ± 3.8 mmHg [control]). CONCLUSIONS: In our experiments, neither a single frequency nor a single inflation/deflation timing, including conventional IAB timing, has shown superiority by uniformly benefiting all studied hemodynamic parameters. A choice of optimal frequency and IAB timing might need to be made based on individual patient hemodynamic needs rather than as a generalized protocol.

End-diastolic flow reversal limits the efficacy of pediatric intra-aortic balloon pump counterpulsation.

BACKGROUND: Counterpulsation with an intra-aortic balloon pump (IABP) has not achieved the same success or clinical use in pediatric patients as in adults. In a pediatric animal model, IABP efficacy was investigated to determine whether IABP timing with a high-fidelity blood pressure signal may improve counterpulsation therapy versus a low-fidelity signal. METHODS: In Yorkshire piglets (n = 19; weight, 13.0 ± 0.5 kg) with coronary ligation-induced acute ischemic left ventricular failure, pediatric IABPs (5 or 7 mL) were placed in the descending thoracic aorta. Inflation and deflation were timed with traditional criteria from low-fidelity (fluid-filled) and high-fidelity (micromanometer) blood pressure signals during 1:1 support. Aortic, carotid, and coronary hemodynamics were measured with pressure and flow transducers. Myocardial oxygen consumption was calculated from coronary sinus and arterial blood samples. Left ventricular myocardial blood flow and end-organ blood flow were measured with microspheres. RESULTS: Despite significant suprasystolic diastolic augmentation and afterload reduction at heart rates of 105 ± 3 beats per minute, left ventricular myocardial blood flow, myocardial oxygen consumption, the myocardial oxygen supply/demand relationship, cardiac output, and end-organ blood flow did not change. Statistically significant end-diastolic coronary, carotid, and aortic flow reversal occurred with IABP deflation. Inflation and deflation timed with a high-fidelity versus low-fidelity signal did not attenuate systemic flow reversal or improve the myocardial oxygen supply/demand relationship. CONCLUSIONS: Systemic end-diastolic flow reversal limited counterpulsation efficacy in a pediatric model of acute left ventricular failure. Adjustment of IABP inflation and deflation timing with traditional criteria and a high-fidelity blood pressure waveform did not improve IABP efficacy or attenuate flow reversal. End-diastolic flow reversal may limit the efficacy of IABP counterpulsation therapy in pediatric patients with traditional timing criteria. Investigation of alternative deflation timing strategies is warranted.

Extracorporeal membrane oxygenation versus counterpulsatile, pulsatile, and continuous left ventricular unloading for pediatric mechanical circulatory support.

OBJECTIVES: Despite progress with adult ventricular assist devices, limited options exist to support pediatric patients with life-threatening heart disease. Extracorporeal membrane oxygenation remains the clinical standard. To characterize (patho)physiologic responses to different modes of mechanical unloading of the failing pediatric heart, extracorporeal membrane oxygenation was compared to intra-aortic balloon pump, pulsatile-flow ventricular assist device, or continuous-flow ventricular assist device support in a pediatric heart failure model. DESIGN: Experimental. SETTING: Large animal laboratory operating room. SUBJECTS: Yorkshire piglets (n = 47; 11.7 ± 2.6 kg). INTERVENTIONS: In piglets with coronary ligation-induced cardiac dysfunction, mechanical circulatory support devices were implanted and studied during maximum support. MEASUREMENTS AND MAIN RESULTS: Left ventricular, right ventricular, coronary, carotid, systemic arterial, and pulmonary arterial hemodynamics were measured with pressure and flow transducers. Myocardial oxygen consumption and total-body oxygen consumption were calculated from arterial, venous, and coronary sinus blood sampling. Blood flow was measured in 17 organs with microspheres. Paired Student t tests compared baseline and heart failure conditions. One-way repeated-measures analysis of variance compared heart failure, device support mode(s), and extracorporeal membrane oxygenation. Statistically significant (p < 0.05) findings included 1) an improved left ventricular blood supply/demand ratio during pulsatile-flow ventricular assist device, continuous-flow ventricular assist device, and extracorporeal membrane oxygenation but not intra-aortic balloon pump support, 2) an improved global myocardial blood supply/demand ratio during pulsatile-flow ventricular assist device and continuous-flow ventricular assist device but not intra-aortic balloon pump or extracorporeal membrane oxygenation support, and 3) diminished pulsatility during extracorporeal membrane oxygenation and continuous-flow ventricular assist device but not intra-aortic balloon pump and pulsatile-flow ventricular assist device support. A profile of systems-based responses was established for each type of support. CONCLUSIONS: Each type of pediatric ventricular assist device provided hemodynamic support by unloading the heart with a different mechanism that created a unique profile of physiological changes. These data contribute novel, clinically relevant insight into pediatric mechanical circulatory support and establish an important resource for pediatric device development and patient selection.

Pediatric Mechanical Support with an External Cardiac Compression Device.

The PediBooster external cardiac compression device is a minimally invasive, non-blood contacting Biventricular Assist Device (BiVAD) intended for pediatric use. It is being developed as a palliative therapy for acute Postcardiotomy Shock (PCS). The PediBooster extracardiac wrap is pneumatically actuated to circumferentially compress the heart, providing co-pulsation support. Attachment is via a novel hydrogel coating. Early versions of the wrap were tested in vivo using a single ventricle congenital heart disease model with postcardiotomy shock, which proved unstable and demonstrated high peri-operative mortality. The final wrap design was tested in 4 acute studies with piglets (5.1 ± 0.3 kg), where the combination of ASD and PA banding induced acute right ventricular dysfunction. Data collected included routine hemodynamic values, TEE, video of the exposed heart, and cardiac histology. The model proved stable for support durations ranging from 2 to 16 hours. The wrap restricted the heart in 3 of the 4 animals, as evidenced by increased diastolic LVP during support compared to the baseline failure condition. TEE and video data showed good attachment and function of the wrap, particularly during the final 16 hr study. This model of congenital heart disease shows promise for chronic (24-72 hr) studies. Ventricular filling during support may be improved by adjusting wrap dimensions to eliminate end diastolic restriction.

A hermetically sealed, fluid-filled surgical enclosure for microgravity.

INTRODUCTION: Expeditionary spaceflight is fraught with significant risks to human health, including trauma and other emergency medical events. To address several of the basic challenges of surgical care in reduced gravity, we are developing the Aqueous Immersion Surgical System (AISS), an optically clear enclosure pressurized by a fluid medium. The AISS is designed to prevent contamination of the spacecraft with blood and tissue debris, reduce intraoperative blood loss, and maintain visualization of the operative field. METHODS: An early prototype of the AISS was tested in reduced gravity during parabolic flight. A clear, aqueous field was created in a watertight chamber containing a mock vascular network. Hemorrhage was simulated by severing several of the analogue vessels. Experiments were performed to evaluate the benefits of surrounding a surgical cavity with fluid medium, as compared to an air environment, with respect to maintaining a clear view and achieving hemostasis. RESULTS: Qualitative evaluation of audio and video recorded during parabolic flight confirm AISS capacity to maintain visualization of the surgical field during a hemorrhage situation and staunch bleeding by raising interchamber pressure. DISCUSSION: Evaluation of the AISS in reduced gravity corroborates observations in the literature regarding the difficulty in maintaining visualization of the surgical field when performing procedures in an air environment. By immersing the surgical field in fluid we were able to apply suction directly to the hemorrhage and also achieve hemostasis.

Mock circulation simulation of extracorporeal membrane oxygenation support for systemic ventricular failure in an infant: the effect of atrial septostomy.

Extracorporeal membrane oxygenation (ECMO) is often used to provide cardiopulmonary support for infants experiencing severe levels of cardiac or respiratory failure. In patients with two ventricles and no intra-atrial communication, ECMO is often complicated by limited venous return to the circuit and marked left atrial hypertension. This condition may be treated by performing an atrial septostomy to create an intentional atrial septal defect (ASD). A pediatric mock circulation with a conduit connecting the left and right atrium was used to examine the size of ASD that would relieve left atrial hypertension and restore acceptable hemodynamics in a 4 to 5 kg infant. After creation of left ventricular failure and subsequent institution of ECMO, the ASD was opened in a graded fashion while the resulting hemodynamic changes were recorded. An ASD equivalent to a 6.3 mm diameter hole decreased the left atrial pressure 30 mmHg to an acceptable level with a net left-to-right shunt of 393 ml/min. Further opening of the ASD resulted in additional hemodynamic improvement, but was eventually limited in further effect. This study demonstrates that a mock circulation can be used to investigate the size of an ASD necessary to effect sufficient clinical improvement in a two-ventricle infant on ECMO.

Intraaortic balloon pump timing discrepancies in adult patients.

The objective of this clinical study was to quantify the incidence and magnitude of intraaortic balloon pump (IABP) inflation and deflation landmark discrepancies associated with the IABP catheter arterial pressure waveform. Cardiac surgery patients with an IABP inserted prior to surgery were recruited. Following cardiac exposure, a high-fidelity pressure catheter was inserted into the aortic root for digital recording. The radial artery pressure signal was simultaneously recorded from the patient monitor along with the arterial pressure and electrocardiogram waveforms from the IABP console while operating at 1:1 and 1:2 synchronization. In selected patients, recordings were obtained with the IABP timed to the high-fidelity aortic root waveform. In all 11 patients, inflation and deflation landmark delays were observed when comparing the aortic root waveforms to the IABP arterial pressure waveforms (inflation delay = 74 ± 29 [23-117] ms; deflation delay = 71 ± 37 [24-141] ms, mean ± standard deviation [min-max]). Delays were greater when compared to the radial artery waveform (inflation delay = 175 ± 50 [100-233] ms; deflation delay = 168 ± 52 [100-274] ms). In all cases, the landmark delays were statistically different from zero (P < 0.001). Diastolic augmentation and afterload reduction varied with waveform source. Conflicting indications of afterload reduction occurred in four patients. Timing to the aortic root waveform resulted in greater diastolic pressure augmentation and afterload reduction but mixed changes in stroke volume. Delay and distortion of the arterial waveform was consistently found when measured through the IABP catheter lumen. These delays can alter IABP efficacy and may be eliminated by using high-fidelity sensing of aortic pressure.

How much of the intraaortic balloon volume is displaced toward the coronary circulation?

OBJECTIVE: During intraaortic balloon inflation, blood volume is displaced toward the heart (V(tip)), traveling retrograde in the descending aorta, passing by the arch vessels, reaching the aortic root (V(root)), and eventually perfusing the coronary circulation (V(cor)). V(cor) leads to coronary flow augmentation, one of the main benefits of the intraaortic balloon pump. The aim of this study was to assess V(root) and V(cor) in vivo and in vitro, respectively. METHODS: During intraaortic balloon inflation, V(root) was obtained by integrating over time the aortic root flow signals measured in 10 patients with intraaortic balloon assistance frequencies of 1:1 and 1:2. In a mock circulation system, flow measurements were recorded simultaneously upstream of the intraaortic balloon tip and at each of the arch and coronary branches of a silicone aorta during 1:1 and 1:2 intraaortic balloon support. Integration over time of the flow signals during inflation yielded V(cor) and the distribution of V(tip). RESULTS: In patients, V(root) was 6.4% +/- 4.8% of the intraaortic balloon volume during 1:1 assistance and 10.0% +/- 5.0% during 1:2 assistance. In vitro and with an artificial heart simulating the native heart, V(cor) was smaller, 3.7% and 3.8%, respectively. The distribution of V(tip) in vitro varied, with less volume displaced toward the arch and coronary branches and more volume stored in the compliant aortic wall when the artificial heart was not operating. CONCLUSION: The blood volume displaced toward the coronary circulation as the result of intraaortic balloon inflation is a small percentage of the nominal intraaortic balloon volume. Although small, this percentage is still a significant fraction of baseline coronary flow.

Expanded pediatric cardiovascular simulator for research and training.

A mock circulation system has been developed to approximate key anatomic features and simulate the pressures and flows of an infant. Pulsatile flow is generated by 10 cc pulsatile ventricles (Utah infant ventricular assist device). Systemic vasculature is mimicked through the use of 3/8" ID bypass tubing with two flexible reservoirs to provide compliance. Vascular resistance, including pulmonary, aortic, and major branches, is controlled via a series of variable pinch clamps. The coronary branch has a dynamic resistor so that the majority of flow occurs during diastole. The system is instrumented to measure key pressures and flows. Right atrial pressure, left atrial pressure, pulmonary artery pressure, and mean aortic pressure are measured with high-fidelity pressure catheters (Millar Instruments, Houston, TX). Flows are measured by transit time ultrasonic flow probes (Transonic Systems, Ithaca, NY) in the pulmonary artery, aorta, coronary artery, and brachiocephalic artery along with assist device flow. The system can be tuned to create the hemodynamic values of a pediatric patient under normal or heart failure conditions. Once tuned to the desired hemodynamic conditions, the loop may be used to test the performance of various circulatory support systems including the intra-aortic balloon pump, left and right ventricular assist devices, or cardiopulmonary support systems such as extracorporeal membrane oxygenation.

Discerning aortic waves during intra-aortic balloon pumping and their relation to benefits of counterpulsation in humans.

An explanation of the mechanisms leading to the beneficial hemodynamic effects of the intra-aortic balloon pump (IABP) is lacking. We hypothesized that inflation and deflation of the balloon would generate a compression (BCW) and an expansion (BEW) wave, respectively, which, when analyzed with wave intensity analysis, could be used to explain the hemodynamic benefits of IABP support. Simultaneous ascending aortic pressure (P(ao)) and flow rate (Q(ao)) were recorded in 25 patients during control conditions and with IABP support of 1:1 and 1:2. Diastolic aortic pressure augmentation (P(aug)) and end-diastolic aortic pressure (ED P(ao)) reduction were calculated from P(ao). Energies of the BCW and BEW were obtained by integrating the wave intensity contour over time. P(aug) was 19.1 mmHg (SD 13.6) during 1:2 support. During 1:1 support significantly higher P(aug) of 21.1 mmHg (SD 13.4) was achieved (P < 0.001). ED P(ao) decreased from 50.9 mmHg (SD 15.1) to 43.9 mmHg (SD 15.7) (P < 0.0001) during 1:1 assistance and the decrease was not statistically different with 1:2. During 1:1 support the energy of BCW was correlated positively to P(aug) (r = 0.83, P < 0.0001) and energy of the BEW correlated negatively to ED P(ao) (r = 0.78, P < 0.005); these relationships were not statistically different during 1:2. In conclusion, the energies of the BCW and BEW are directly related to P(aug) and ED P(ao), which are the conventional hemodynamic parameters indicating IABP benefits. These findings imply a cause and effect mechanism between the energies of BCW and BEW, and IABP hemodynamic effects.

In vitro characterization and performance testing of the ension pediatric cardiopulmonary assist system.

In the last 40 years, mechanical circulatory support devices have become an effective option for the treatment of end-stage heart failure in adults. Few possibilities, however, are available for pediatric cardiopulmonary support. Ension Inc. (Pittsburgh, PA) is developing a pediatric cardiopulmonary assist system (pCAS) intended to address the limitations of existing devices used for this patient population. The pCAS device is an integrated unit containing an oxygenator and pump within a single casing, significantly reducing the size and blood-contacting surface area in comparison to current devices. Prototype pCAS devices produce appropriate flows and pressures while minimizing priming volume and preparation time. The pCAS was tested on a mock circulation designed to approximate the hemodynamic parameters of a small infant using a 10-Fr. extracorporeal membrane oxygenation inflow cannula and an 8-Fr. extracorporeal membrane oxygenation outflow cannula. Revision 4 of the device provided a flow rate of 0.42 L/min at 6,500 RPM. Revision 5, featuring improved impeller and diffuser designs, provided a flow rate of 0.57 L/min at 5,000 RPM. The performance tests indicate that for this cannulae combination, the pCAS pump is capable of delivering sufficient flows for patients <5 kg.

Intraoperative evaluation of the HeartMate II flow estimator.

BACKGROUND: Direct measurement of blood flow output has been incorporated into ventricular assist devices (VADs), but long-term reliability of the additional device components has raised concerns regarding sensor drift and failure. As an alternative approach, the HeartMate II axial VAD (Thoratec Corp, Pleasanton, CA) estimates device flow output from power consumption and rotational speed of the device motor. This study evaluated the accuracy of HeartMate II flow estimation at the time of implantation. METHODS: In 20 patients, intraoperative blood flow measurement of the HeartMate II flow estimator was compared with flow values obtained with an ultrasonic flow probe placed around the device outflow graft. Estimated and measured VAD flow data were simultaneously recorded and digitally stored while the device motor speed varied from 7,800 to 11,000 rpm and while achieving device flow outputs of 2 to 7 liters/min. Estimated and measured flows were compared using linear regression analyses and root mean square error. RESULTS: HeartMate II flow estimation (FE) demonstrated a linear correlation with ultrasonic flow probe (FP) measurements: FE = 0.74 FP + 0.99 (R(2) = 0.56, p = 0.0001). A root mean square error of 0.8 liters/min was observed between flow estimation and direct flow measurement and suggests a 15% to 20% difference at flows of 4 of 6 liters/min. CONCLUSIONS: These results suggest that HeartMate II flow estimation may be used to provide directional information for trend purposes rather than absolute values of device blood flow output. Patient management should include but not be limited to this information.

Human, bovine and porcine systematic vascular input impedances are not equivalent: implications for device testing and xenotransplantation in heart failure.

BACKGROUND: Advanced therapies for heart failure (HF), such as mechanical circulatory support (MCS) devices and xenotransplantation, are usually tested in bovine and porcine models. This approach assumes a priori that animal (patho)physiology will closely match that of humans. Systemic aortic input impedance (Z(ART)) is an important physiologic determinant of left ventricular (LV) performance. We tested the hypothesis that Z(ART) is lower in bovine and porcine than in humans with normal or failing hearts. METHODS: High-fidelity aortic pressure and flow waveforms were recorded intra-operatively at native and paced heart rates of 100 beats per minute (bpm) in adult human patients with normal LV function (n = 13) or end-stage HF (n = 15), and normal calves (n = 10) and pigs (n = 18). Fast Fourier transformation was used to calculate Z(ART), and arterial resistance and compliance were estimated using a 4-element Windkessel model. RESULTS: Humans with HF had greater Z(ART) than those with normal LV function, characterized by higher resistance (1.16 +/- 0.12 vs 1.00 +/- 0.10 mm Hg x s/ml, p < 0.05) and lower compliance (1.53 +/- 0.21 vs 1.88 +/- 0.33 ml x mm Hg, p < 0.05). Healthy calves and pigs had significantly lower resistance (calf: 0.63 +/- 0.07 mm Hg x s/ml; pig: 0.90 +/- 0.07 mm Hg x s/ml) and higher compliance (calf: 2.79 +/- 0.37 ml x mm Hg; pig: 2.80 +/- 0.64 ml x mm Hg) when compared to humans (p < 0.05) with normal or failing hearts. CONCLUSIONS: Z(ART) is significantly lower in calves and pigs than in humans with or without HF. This finding has important implications for the pre-clinical testing of MCS devices and xenotransplants, which are usually examined in bovine and porcine models, respectively. Specifically, these therapies may respond differently in humans than animals due to non-equivalence of systemic after-load.

Acute hemodynamic efficacy of a 32-ml subcutaneous counterpulsation device in a calf model of diminished cardiac function.

The acute hemodynamic efficacy of an implantable counterpulsation device (CPD) was evaluated. The CPD is a valveless single port, 32-ml stroke volume blood chamber designed to be connected to the human axillary artery using a simple surface surgical procedure. Blood is drawn into the pump during systole and ejected during diastole. The acute hemodynamic effects of the 32-ml CPD were compared to a standard clinical 40-ml intra-aortic balloon pump (IABP) in calves (80 kg, n = 10). The calves were treated by a single oral dose of Monensin to produce a model of diminished cardiac function (DCF). The CPD and IABP produced similar increases in cardiac output (6% CPD vs. 5% IABP, p > 0.5) and reduction in left ventricular external work (14% CPD vs. 13% IABP, p > 0.5) compared to DCF (p < 0.05). However, the ratio of diastolic coronary artery flow to left ventricular external work increase from DCF baseline (p < 0.05) was greater with the CPD compared to the IABP (15% vs. 4%, p < 0.05). The CPD also produced a greater reduction in left ventricular myocardial oxygen consumption from DCF baseline (p < 0.05) compared to the IABP (13% vs. 9%, p < 0.05) despite each device providing similar improvements in cardiac output. There was no early indication of hemolysis, thrombus formation, or vascular injury. The CPD provides hemodynamic efficacy equivalent to an IABP and may become a therapeutic option for patients who may benefit from prolonged counterpulsation.

The influence of mock circulation input impedance on valve acceleration during in vitro cardiac device testing.

For a mechanical heart valve, a strong spike in pressure during closing is associated with valve wear and erythrocyte damage; thus, for valid in vitro testing, the mock circulation system should replicate the conditions, including pressure spikes, expected in vivo. To address this issue, a study was performed to investigate how mock circulation input impedance affects valve closure dynamics. A left ventricular model with polyurethane trileaflet inflow valve and tilting disc outflow valve was connected to a Louisville mock circulation system, which incorporates 2 adjustable flow resistors and 2 compliances. In the study, 116 cases matched zero frequency modulus well (982-1147 dyn x s/cm), but higher harmonics were purposely varied. Acceleration measured at the outflow valve ring (42.4-89.4 milli-Gs) was uncorrelated with impedance error (74.1-237 dyn x s/cm relative to target impedance), but was correlated with end-systolic impedance (1082-1319 dyn x s/cm) for cases with high zero frequency modulus, which exhibited just less than full ejection. These differences demonstrate that mock circulation response affects the magnitude of the closing spike, indicating that control of this parameter is necessary for authentic testing of valves. Correlation of acceleration to end-systolic impedance was weak for low zero frequency modulus, which tended toward full or hyperejection, reinforcing common laboratory observations that valve closing also depends on ventricular operating conditions.