The Importance of Venous Return in Starling-Like Control of Rotary Ventricular Assist Devices.

Rotary ventricular assist devices (VADs) are less sensitive to preload than the healthy heart, resulting in inadequate flow regulation in response to changes in patient cardiac demand. Starling-like physiological controllers (SLCs) have been developed to automatically regulate VAD flow based on ventricular preload. An SLC consists of a cardiac response curve (CRC) which imposes a nonlinear relationship between VAD flow and ventricular preload, and a venous return line (VRL) which determines the return path of the controller. This study investigates the importance of a physiological VRL in SLC of dual rotary blood pumps for biventricular support. Two experiments were conducted on a physical mock circulation loop (MCL); the first compared an SLC with an angled physiological VRL (SLC-P) against an SLC with a vertical VRL (SLC-V). The second experiment quantified the benefit of a dynamic VRL, represented by a series of specific VRLs, which could adapt to different circulatory states including changes in pulmonary (PVR) and systemic (SVR) vascular resistance versus a fixed physiological VRL which was calculated at rest. In both sets of experiments, the transient controller responses were evaluated through reductions in preload caused by the removal of fluid from the MCL. The SLC-P produced no overshoot or oscillations following step changes in preload, whereas SLC-V produced 0.4 L/min (12.5%) overshoot for both left and right VADs. Additionally, the SLC-V had increased settling time and reduced controller stability as evidenced by transient controller oscillations. The transient results comparing the specific and standard VRLs demonstrated that specific VRL rise times were improved by between 1.2 and 4.7 s ( x ¯ = 3.05 s), while specific VRL settling times were improved by between 2.8 and 16.1 seconds ( x ¯ = 8.38 s) over the standard VRL. This suggests only a minor improvement in controller response time from a dynamic VRL compared to the fixed VRL. These results indicate that the use of a fixed physiologically representative VRL is adequate over a wide variety of physiological conditions.

In vitro evaluation of an adaptive Starling-like controller for dual rotary ventricular assist devices.

Rotary ventricular assist devices (VADs) operated clinically under constant speed control (CSC) cannot respond adequately to changes in patient cardiac demand, resulting in sub-optimal VAD flow regulation. Starling-like control (SLC) of VADs mimics the healthy ventricular flow regulation and automatically adjusts VAD speed to meet varying patient cardiac demand. The use of a fixed control line (CL - the relationship between ventricular preload and VAD flow) limits the flow regulating capability of the controller, especially in the case of exercise. Adaptive SLC (ASLC) overcomes this limitation by allowing the controller to adapt the CL to meet a diverse range of circulatory conditions. This study evaluated ASLC, SLC and CSC in a biventricular supported mock circulation loop under the simulated conditions of exercise, sleep, fluid loading and systemic hypertension. Each controller was evaluated on its ability to remain within predefined limits of VAD flow, preload, and afterload. The ASLC produced superior cardiac output (CO) during exercise (10.1 L/min) compared to SLC (7.3 L/min) and CSC (6.3 L/min). The ASLC produced favourable haemodynamics during sleep, fluid loading and systemic hypertension and could remain within a predefined haemodynamic range in three out of four simulations, suggesting improved haemodynamic performance over SLC and CSC.

Evaluation of an intraventricular balloon pump for short-term support of patients with heart failure.

The high cost of ventricular assist devices results in poor cost-effectiveness when used as a short-term bridging solution, thus a low-cost alternative is desirable. The present study aimed to develop an intraventricular balloon pump (IVBP) for short-term circulatory support, and to evaluate the effect of balloon actuation timing on the degree of cardiac support provided to a simulated in vitro severe heart failure (SHF) patient. A silicone IVBP was designed to avoid contact with internal left ventricular (LV) features (ie, papillary muscles, chordae, aortic, and mitral valves) based on LV computed tomography data of 10 SHF patients with dilated cardiomyopathy. The hemodynamic effects of varying balloon inflation and deflation timing parameters (inflation duty [D] and end-inflation point [σ]) were evaluated in a purpose-built systemic mock circulatory loop. Three IVBP actuation timing categories were defined: co-, transitional, and counterpulsation. Compared to the SHF baseline, co-pulsation increased aortic flow from 3.5 to 5.2 L/min, mean arterial pressure from 72.1 to 94.8 mmHg and ejection fraction from 14.4% to 21.5%, while mean left atrial pressure decreased from 14.6 to 10 mmHg. Transitional and counterpulsation resulted in a double ventricular pulse and extended the duration of increased ventricular pressure, potentially impeding diastolic filling and coronary perfusion. This in vitro study showed the IVBP could restore the hemodynamic balance of a simulated SHF patient with dilated cardiomyopathy to healthy levels.

In Vitro Evaluation of an Immediate Response Starling-Like Controller for Dual Rotary Blood Pumps.

Rotary ventricular assist devices (VADs) are used to provide mechanical circulatory support. However, their lack of preload sensitivity in constant speed control mode (CSC) may result in ventricular suction or venous congestion. This is particularly true of biventricular support, where the native flow-balancing Starling response of both ventricles is diminished. It is possible to model the Starling response of the ventricles using cardiac output and venous return curves. With this model, we can create a Starling-like physiological controller (SLC) for VADs which can automatically balance cardiac output in the presence of perturbations to the circulation. The comparison between CSC and SLC of dual HeartWare HVADs using a mock circulation loop to simulate biventricular heart failure has been reported. Four changes in cardiovascular state were simulated to test the controller, including a 700 mL reduction in circulating fluid volume, a total loss of left and right ventricular contractility, reduction in systemic vascular resistance ( SVR) from 1300 to 600 dyne  s/cm5, and an elevation in pulmonary vascular resistance ( PVR) from 100 to 300 dyne  s/cm5. SLC maintained the left and right ventricular volumes between 69-214 mL and 29-182 mL, respectively, for all tests, preventing ventricular suction (ventricular volume = 0 mL) and venous congestion (atrial pressures > 20 mm Hg). Cardiac output was maintained at sufficient levels by the SLC, with systemic and pulmonary flow rates maintained above 3.14 L/min for all tests. With the CSC, left ventricular suction occurred during reductions in SVR, elevations in PVR, and reduction in circulating fluid simulations. These results demonstrate a need for a physiological control system and provide adequate in vitro validation of the immediate response of a SLC for biventricular support.

In Vivo Evaluation of Active and Passive Physiological Control Systems for Rotary Left and Right Ventricular Assist Devices.

Preventing ventricular suction and venous congestion through balancing flow rates and circulatory volumes with dual rotary ventricular assist devices (VADs) configured for biventricular support is clinically challenging due to their low preload and high afterload sensitivities relative to the natural heart. This study presents the in vivo evaluation of several physiological control systems, which aim to prevent ventricular suction and venous congestion. The control systems included a sensor-based, master/slave (MS) controller that altered left and right VAD speed based on pressure and flow; a sensor-less compliant inflow cannula (IC), which altered inlet resistance and, therefore, pump flow based on preload; a sensor-less compliant outflow cannula (OC) on the right VAD, which altered outlet resistance and thus pump flow based on afterload; and a combined controller, which incorporated the MS controller, compliant IC, and compliant OC. Each control system was evaluated in vivo under step increases in systemic (SVR ∼1400-2400 dyne/s/cm(5) ) and pulmonary (PVR ∼200-1000 dyne/s/cm(5) ) vascular resistances in four sheep supported by dual rotary VADs in a biventricular assist configuration. Constant speed support was also evaluated for comparison and resulted in suction events during all resistance increases and pulmonary congestion during SVR increases. The MS controller reduced suction events and prevented congestion through an initial sharp reduction in pump flow followed by a gradual return to baseline (5.0 L/min). The compliant IC prevented suction events; however, reduced pump flows and pulmonary congestion were noted during the SVR increase. The compliant OC maintained pump flow close to baseline (5.0 L/min) and prevented suction and congestion during PVR increases. The combined controller responded similarly to the MS controller to prevent suction and congestion events in all cases while providing a backup system in the event of single controller failure.

Anatomy and Physiology of Left Ventricular Suction Induced by Rotary Blood Pumps.

This study in five large greyhound dogs implanted with a VentrAssist left ventricular assist device focused on identification of the precise site and physiological changes induced by or underlying the complication of left ventricular suction. Pressure sensors were placed in left and right atria, proximal and distal left ventricle, and proximal aorta while dual perivascular and tubing ultrasonic flow meters measured blood flow in the aortic root and pump outlet cannula. When suction occurred, end-systolic pressure gradients between proximal and distal regions of the left ventricle on the order of 40-160 mm Hg indicated an occlusive process of variable intensity in the distal ventricle. A variable negative flow difference between end systole and end diastole (0.5-3.4 L/min) was observed. This was presumably mediated by variable apposition of the free and septal walls of the ventricle at the pump inlet cannula orifice which lasted approximately 100 ms. This apposition, by inducing an end-systolic flow deficit, terminated the suction process by relieving the imbalance between pump requirement and delivery from the right ventricle. Immediately preceding this event, however, unnaturally low end-systolic pressures occurred in the left atrium and proximal left ventricle which in four dogs lasted for 80-120 ms. In one dog, however, this collapse progressed to a new level and remained at approximately -5 mm Hg across four heart beats at which point suction was relieved by manual reduction in pump speed. Because these pressures were associated with a pulmonary capillary wedge pressure of -5 mm Hg as well, they indicate total collapse of the entire pulmonary venous system, left atrium, and left ventricle which persisted until pump flow requirement was relieved by reducing pump speed. We suggest that this collapse caused the whole vascular region from pulmonary capillaries to distal left ventricle to behave as a Starling resistance which further reduced right ventricular output thus contributing to a major reduction in pump flow. We contend that similar complications of manual speed control also occur in the human subject and remain a major unsolved problem in the clinical management of patients implanted with rotary blood pumps.

Hemodynamic response to exercise and head-up tilt of patients implanted with a rotary blood pump: a computational modeling study.

The present study investigates the response of implantable rotary blood pump (IRBP)-assisted patients to exercise and head-up tilt (HUT), as well as the effect of alterations in the model parameter values on this response, using validated numerical models. Furthermore, we comparatively evaluate the performance of a number of previously proposed physiologically responsive controllers, including constant speed, constant flow pulsatility index (PI), constant average pressure difference between the aorta and the left atrium, constant average differential pump pressure, constant ratio between mean pump flow and pump flow pulsatility (ratioP I or linear Starling-like control), as well as constant left atrial pressure ( P l a ¯ ) control, with regard to their ability to increase cardiac output during exercise while maintaining circulatory stability upon HUT. Although native cardiac output increases automatically during exercise, increasing pump speed was able to further improve total cardiac output and reduce elevated filling pressures. At the same time, reduced venous return associated with upright posture was not shown to induce left ventricular (LV) suction. Although P l a ¯ control outperformed other control modes in its ability to increase cardiac output during exercise, it caused a fall in the mean arterial pressure upon HUT, which may cause postural hypotension or patient discomfort. To the contrary, maintaining constant average pressure difference between the aorta and the left atrium demonstrated superior performance in both exercise and HUT scenarios. Due to their strong dependence on the pump operating point, PI and ratioPI control performed poorly during exercise and HUT. Our simulation results also highlighted the importance of the baroreflex mechanism in determining the response of the IRBP-assisted patients to exercise and postural changes, where desensitized reflex response attenuated the percentage increase in cardiac output during exercise and substantially reduced the arterial pressure upon HUT.

Robust aortic valve non-opening detection for different cardiac conditions.

In recent years, extensive studies have been conducted in the area of pumping state detection for implantable rotary blood pumps. However, limited studies have focused on automatically identifying the aortic valve non-opening (ANO) state despite its importance in the development of control algorithms aiming for myocardial recovery. In the present study, we investigated the performance of 14 ANO indices derived from the pump speed waveform using four different types of classifiers, including linear discriminant analysis, logistic regression, back propagation neural network, and k-nearest neighbors (KNN). Experimental measurements from four greyhounds, which take into consideration the variations in cardiac contractility, systemic vascular resistance, and total blood volume were used. By having only two indices, (i) the root mean square value, and (ii) the standard deviation, we were able to achieve an accuracy of 92.8% with the KNN classifier. Further increase of the number of indices to five for the KNN classifier increases the overall accuracy to 94.6%.

Starling-like flow control of a left ventricular assist device: in vitro validation.

The application of rotary left ventricular (LV) assist devices (LVADs) is expanding from bridge to transplant, to destination and bridge to recovery therapy. Conventional constant speed LVAD controllers do not regulate flow according to preload, and can cause over/underpumping, leading to harmful ventricular suction or pulmonary edema, respectively. We implemented a novel adaptive controller which maintains a linear relationship between mean flow and flow pulsatility to imitate native Starling-like flow regulation which requires only the measurement of VAD flow. In vitro controller evaluation was conducted and the flow sensitivity was compared during simulations of postural change, pulmonary hypertension, and the transition from sleep to wake. The Starling-like controller's flow sensitivity to preload was measured as 0.39 L/min/mm Hg, 10 times greater than constant speed control (0.04 L/min/mm Hg). Constant speed control induced LV suction after sudden simulated pulmonary hypertension, whereas Starling-like control reduced mean flow from 4.14 to 3.58 L/min, maintaining safe support. From simulated sleep to wake, Starling-like control increased flow 2.93 to 4.11 L/min as a response to the increased residual LV pulsatility. The proposed controller has the potential to better match device outflow to patient demand in comparison with conventional constant speed control.

A sliding mode-based starling-like controller for implantable rotary blood pumps.

Clinically adequate implementation of physiological control of a rotary left ventricular assist device requires a sophisticated technique such as the recently proposed method based on the Frank-Starling mechanism. In this mechanism, the stroke volume of the heart increases in response to an increase in the volume of blood filling the left ventricle at the end of diastole. To emulate this process, changes in pump speed need to automatically regulate pump flow to ensure that the combined output of the left ventricle and pump match the output of the right ventricle across changing cardiovascular states. In this approach, we exploit the linear relationship between estimated mean pump flow (Q ̅ est) and pump flow pulsatility (PIQp) in a tracking control algorithm based on sliding mode control. The immediate response of the controller was assessed using a lumped parameter model of the cardiovascular system (CVS) and pump from which could be extracted both Q ̅ est and PIQp. Two different perturbations from the resting state in the presence of left ventricular failure were tested. The first was blood loss requiring a reduction in pump flow to match the reduced output from the right ventricle and to avoid the complication of ventricular suction. The second was exercise, requiring an increase in pump flow. The sliding mode controller induced the required changes in Qp within approximately five heart beats in the blood loss simulation and eight heart beats in the exercise simulation without clinically significant transients or steady-state errors.

Exercise studies in patients with rotary blood pumps: cause, effects, and implications for starling-like control of changes in pump flow.

This multicenter study examines in detail the spontaneous increase in pump flow at fixed speed that occurs in exercise. Eight patients implanted with the VentrAssist rotary blood pump were subjected to maximal and submaximal cycle ergometry studies, the latter being completed with patients supine and monitored with right heart catheter and echocardiography. Maximal exercise studies conducted in each patient at three different pump speeds on separate days established initially the magnitude and consistency of increases in pump flow that correlated well with changes in heart rate. However, there was considerable variation, coefficients of variation for mean heart rate and pump flow being 47.9 and 49.3%, respectively. Secondly, these studies indicated that increasing pump flows caused significant improvements in maximal exercise capacity. An increase of 2.1 L/min (35%) in maximum blood flow caused 12 W (16%) further increase in achievable work, 1.26 (9.3%) mL/kg/min in maximal oxygen uptake, and 2.3 (23%) mL/kg/min in anaerobic threshold. Mean increases in lactate were 0.85 mm (24%), but mean B-type natiuretic peptide fell by 126 mm, (-78%). From submaximal supine exercise studies, multiple linear regression of pump flow on factors thought to underlie the spontaneous increase in pump flow indicated that it was associated with increases in heart rate (P = 0.039), pressure gradient across the left ventricle (P = 0.032), and right atrial pressure (P = 0.003). These changes have implications for the recently reported Starling-like controller for pump flow based on pump pulsatility values, which emulates the Starling curve relating pump output to left ventricular preload. Unmodified, the controller would not permit the full benefits of this effect to be afforded to patients implanted with rotary blood pumps. A modification to the pump control algorithm is proposed to eliminate this problem.

Effect of parameter variations on the hemodynamic response under rotary blood pump assistance.

Numerical models, able to simulate the response of the human cardiovascular system (CVS) in the presence of an implantable rotary blood pump (IRBP), have been widely used as a predictive tool to investigate the interaction between the CVS and the IRBP under various operating conditions. The present study investigates the effect of alterations in the model parameter values, that is, cardiac contractility, systemic vascular resistance, and total blood volume on the efficiency of rotary pump assistance, using an optimized dynamic heart-pump interaction model previously developed in our laboratory based on animal experimental measurements obtained from five canines. The effect of mean pump speed and the circulatory perturbations on left and right ventricular pressure volume loops, mean aortic pressure, mean cardiac output, pump assistance ratio, and pump flow pulsatility from both the greyhound experiments and model simulations are demonstrated. Furthermore, the applicability of some of the previously proposed control parameters, that is, pulsatility index (PI), gradient of PI with respect to pump speed, pump differential pressure, and aortic pressure are discussed based on our observations from experimental and simulation results. It was found that previously proposed control strategies were not able to perform well under highly varying circulatory conditions. Among these, control algorithms which rely on the left ventricular filling pressure appear to be the most robust as they emulate the Frank-Starling mechanism of the heart.

Numerical optimization studies of cardiovascular-rotary blood pump interaction.

A heart-pump interaction model has been developed based on animal experimental measurements obtained with a rotary blood pump in situ. Five canine experiments were performed to investigate the interaction between the cardiovascular system and the implantable rotary blood pump over a wide range of operating conditions, including variations in cardiac contractility and heart rate, systemic vascular resistance (SVR), and total blood volume (V(total) ). It was observed in our experiments that SVR decreased with increasing mean pump speed under the healthy condition, but was relatively constant during the speed ramp study under reduced cardiac contractility conditions. Furthermore, we also found a significant increase in pulmonary vascular resistance with increasing mean pump speed and decreasing total blood volume, despite a relatively constant SVR. Least squares parameter estimation methods were utilized to fit a subset of model parameters in order to achieve better agreement with the experimental data and to evaluate the robustness and validity of the model under various operating conditions. The fitted model produced reasonable agreement with the experimental measurements, both in terms of mean values and steady-state waveforms. In addition, all the optimized parameters were within physiological limits.

Theoretical foundations of a Starling-like controller for rotary blood pumps.

A clinically intuitive physiologic controller is desired to improve the interaction between implantable rotary blood pumps and the cardiovascular system. This controller should restore the Starling mechanism of the heart, thus preventing overpumping and underpumping scenarios plaguing their implementation. A linear Starling-like controller for pump flow which emulated the response of the natural left ventricle (LV) to changes in preload was then derived using pump flow pulsatility as the feedback variable. The controller could also adapt the control line gradient to accommodate longer-term changes in cardiovascular parameters, most importantly LV contractility which caused flow pulsatility to move outside predefined limits. To justify the choice of flow pulsatility, four different pulsatility measures (pump flow, speed, current, and pump head pressure) were investigated as possible surrogates for LV stroke work. Simulations using a validated numerical model were used to examine the relationships between LV stroke work and these measures. All were approximately linear (r(2) (mean ± SD) = 0.989 ± 0.013, n = 30) between the limits of ventricular suction and opening of the aortic valve. After aortic valve opening, the four measures differed greatly in sensitivity to further increases in LV stroke work. Pump flow pulsatility showed more correspondence with changes in LV stroke work before and after opening of the aortic valve and was least affected by changes in the LV and right ventricular (RV) contractility, blood volume, peripheral vascular resistance, and heart rate. The system (flow pulsatility) response to primary changes in pump flow was then demonstrated to be appropriate for stable control of the circulation. As medical practitioners have an instinctive understanding of the Starling curve, which is central to the synchronization of LV and RV outputs, the intuitiveness of the proposed Starling-like controller will promote acceptance and enable rational integration into patterns of hemodynamic management.

Response of rotary blood pumps to changes in preload and afterload at a fixed speed setting are unphysiological when compared with the natural heart.

Responses of four rotary blood pumps (Incor, Heartmate II, Heartware, and Duraheart) at a single speed setting to changes in preload and afterload were assessed using the human left ventricle as a benchmark for comparison. Data for the rotary pumps were derived from pressure flow relations reported in the literature while the natural heart was characterized by the Frank-Starling curve adjusted to fit outputs at different afterloads reported in the literature. Preload sensitivity (mean ± SD) for all pumps at all afterloads tested was 0.105 ± 0.092 L/min/mm Hg, while afterload sensitivity was 0.09 ± 0.034 L/min/mm Hg-values that were not significantly different (t-test, P = 0.56). By contrast, preload sensitivity of the natural heart was over twice as high (0.213 ± 0.03 L/min/mm Hg) and afterload sensitivity about one-third (0.03 ± 0.01 L/min/mm Hg) the values recorded for rotary pumps (t-test, P < 0.001). Maximum preload sensitivity and minimum afterload sensitivity allow the right and left ventricles to synchronize outputs without neural or humoral intervention. This theoretical study reinforces the need to provide preload sensitive control mechanisms of sufficient power to enable the pump and left ventricle in combination to adapt to changes in right ventricular output automatically.

Noninvasive activity-based control of an implantable rotary blood pump: comparative software simulation study.

A control algorithm for an implantable centrifugal rotary blood pump (RBP) based on a noninvasive indicator of the implant recipient's activity level has been proposed and evaluated in a software simulation environment. An activity level index (ALI)-derived from a noninvasive estimate of heart rate and the output of a triaxial accelerometer-forms the noninvasive indicator of metabolic energy expenditure. Pump speed is then varied linearly according to the ALI within a defined range. This ALI-based control module operates within a hierarchical multiobjective framework, which imposes several constraints on the operating region, such as minimum flow and minimum speed amplitude thresholds. Three class IV heart failure (HF) cases of varying severity were simulated under rest and exercise conditions, and a comparison with other popular RBP control strategies was performed. Pump flow increases of 2.54, 1.94, and 1.15 L/min were achieved for the three HF cases, from rest to exercise. Compared with constant speed control, this represents a relative flow change of 30.3, 19.8, and -15.4%, respectively. Simulations of the proposed control algorithm exhibited the effective intervention of each constraint, resulting in an improved flow response and the maintenance of a safe operating condition, compared with other control modes.

Physiological principles of Starling-like control of rotary ventricular assist devices.

Introduction: This review explores the Starling-like physiological control method (SLC) for rotary ventricular assist devices (VADs) for severe heart failure. The SLC, based on mathematical models of the circulation, has two functions modeling each ventricle. The first function controls the output of the VAD to the arterial pool according to Starling's law, while the second function accounts for how the blood returns to the heart from the veins. The article aims to expose clinicians to SLC in an accessible and clinically relevant discussion. Areas Covered: The article explores the physiology underlying the controller, its development and how that physiology can be adapted to SLC. Examples of controller performance are demonstrated and discussed using a benchtop model of the cardiovascular system. A discussion of the limitations and criticisms of SLC is presented, followed by a future outlook on the clinical adoption of SLC. Expert Opinion: Due to its simplicity and emulation of the natural cardiac autoregulation, SLC is the superior physiological control method for rotary VADs. However, current technical and regulatory challenges prevent the clinical translation of SLC of VADs. Further technical and regulatory development will enable the clinical translation of SLCs of VADs in the coming years.

Quantifying recirculation in extracorporeal membrane oxygenation: a new technique validated.

RATIONALE: The efficacy of veno-venous extracorporeal membrane oxygenation is limited by the phenomenon of recirculation, which is difficult to quantify. Existing measurement techniques using readily available equipment are unsatisfactory. OBJECTIVES: 1) To compare the accuracy of measurements of recirculation made using equations comparing blood oxygen content or saturation alone at different points in an ex vivo circuit; 2) to validate a new step-change technique for quantifying recirculation in vivo. METHODS: anesthetized greyhound dogs cannulated for veno-arterial support were connected to a circuit that allowed the creation of a known level of recirculation ex vivo and blood oxygen content/saturation monitoring. In two dogs, the accuracy of measurements derived from oxygen content and oxygen saturation were compared. The potential of a new technique for measuring recirculation in vivo by comparing the oxygen content of blood sampled during oxygenator bypass to that following a step-change in circuit oxygenation was demonstrated in a veno-venous pilot study and validated in a three-dog veno-arterial study. RESULTS: Measurements made using oxygen content versus oxygen saturation showed superior correlation with true recirculation (r(2)=0.87 vs. 0.64, p<0.0001) and less proportional measurement bias (10.3% vs. 49.8%, p=0.0045). Measurements of recirculation made using a step-change in circuit oxygenation and comparing oxygen content as is required for measuring in vivo recirculation overestimated by only 18.6% (95% Cl: 3.9-33.2%) and had excellent correlation with true values (r(2)=0.89). CONCLUSIONS: 1) Measurement of recirculation using oxygen content is superior to that using oxygen saturation alone, which demonstrates significant measurement bias; 2) the novel step-change technique is a sufficiently accurate technique for the measurement of recirculation in animal models.

Protocol based on thromboelastograph (TEG) out-performs physician preference using laboratory coagulation tests to guide blood replacement during and after cardiac surgery: a pilot study.

BACKGROUND: Allogenic blood transfusion may affect clinical outcomes negatively. Up to 20% of blood transfusions in the United States are associated with cardiac surgery and so strategies to conserve usage are of importance. This study compares administration according to physician's choice based on laboratory coagulation tests with application of a strict protocol based on the thromboelastograph (TEG). METHODS: Sixty-nine patients presenting for cardiac surgery were randomised to either study or control groups. In the study group a strict protocol was followed covering usage of all blood products according to TEG patterns. In the control group, the physician directed product administration with reference to activated partial thromboplastin time (APTT), international normalised ratio (INR), fibrinogen and platelet count. Bleeding, re-sternotomy, minimum haemoglobin, intubation time, and ICU stay were documented. RESULTS: TEG-based management reduced total product usage by 58.8% in the study group but this was not statistically significant. This was associated with a statistically insignificant trend towards better short-term outcomes. CONCLUSIONS: This pilot study suggests that a strict protocol for blood product replacement based on the TEG might be highly effective in reducing usage without impairing short-term outcome.

Temperature Compensated Fibre Bragg Grating Pressure Sensor for Ventricular Assist Devices.

Rotary blood pumps may be used as ventricular assist devices (VADs) to support patients with end-stage heart failure-'rotary VADs'. Clinically, rotary VADs are operated at a constant speed which is set manually. Due to inadequate haemodynamic monitoring equipment outside of the hospital setting, device speed remains the same for weeks or months at a time, leaving clinicians in the dark, and patients vulnerable to harmful over- or under-pumping events. Therefore, it would be beneficial to have an implantable sensor which can measure blood pressure at the rotary VAD inlet or outlet and detect the onset of adverse events. In this study, a temperature compensated fibre Bragg grating (FBG) based strain sensor which can be incorporated into a VAD and used for continuous, real-time blood pressure monitoring is investigated. Error in the pressure reading between the developed and reference sensor occurred due to changes in temperature. A generalised linear model was used to compensate for temperature related error between 35-39º. Without temperature compensation, the mean error in the pressure reading over the desired range of -25 to 150 mmHg was approximately ±5 mmHg. The temperature compensated mean error over the same range was less than ±2 mmHg. The compensation technique was effective over a wide range of temperatures and pressures, demonstrating the potential of the sensor for continuous real-time blood pressure monitoring.