Clinical Evaluation of the ECG Noise Extraction Tool as a Component of ECG Analysis Algorithms Evaluation.

OBJECTIVE: The aim of this work is to demonstrate the performance of the ECG noise extraction tool (ECGNExT) which provides estimates of ECG noise that are not significantly different from the inherent noise in an ECG generated by motion artifacts and other sources. In addition, this paper elaborates on use of ECGNExT in an algorithm evaluation context comparing two QRS detection algorithms. METHODS: 140 simultaneous pairs of clean ECGs and ECGs corrupted with motion-induced noise from 29 participants under five different and separate motion conditions were collected and analyzed. Estimates of the noise component of the ECGs recorded with noise were obtained using ECGNExT and were then added to the clean ECGs yielding estimated ECGs with noise. Root mean squared error (RMSE) between the recorded and estimated ECGs with noise was calculated for temporal comparison, and band powers of the signals were calculated for spectral comparison. RESULTS: A t-test revealed that the mean RMSE < 150-microvolts with p-value < 0.001 and, and equivalence tests showed that the band powers of the two ECGs were statistically equivalent with . CONCLUSION: ECGNExT can reliably estimate the underlying ECG noise while preserving temporal and spectral features. SIGNIFICANCE: We previously proposed ECGNExT as a component of ECG analysis algorithm testing during noise conditions and reported its performance based on simulated ECG data. This work provides additional support of the performance and functionality of the ECGNExT algorithm from a study with pairs of simultaneously recorded ECGs with and without noise from human subjects.

Tissue mimicking materials and finger phantom design for pulse oximetry.

Pulse oximetry represents a ubiquitous clinical application of optics in modern medicine. Recent studies have raised concerns regarding the potential impact of confounders, such as variable skin pigmentation and perfusion, on blood oxygen saturation measurement accuracy in pulse oximeters. Tissue-mimicking phantom testing offers a low-cost, well-controlled solution for characterizing device performance and studying potential error sources, which may thus reduce the need for costly in vivo trials. The purpose of this study was to develop realistic phantom-based test methods for pulse oximetry. Material optical and mechanical properties were reviewed, selected, and tuned for optimal biological relevance, e.g., oxygenated tissue absorption and scattering, strength, elasticity, hardness, and other parameters representing the human finger's geometry and composition, such as blood vessel size and distribution, and perfusion. Relevant anatomical and physiological properties are summarized and implemented toward the creation of a preliminary finger phantom. To create a preliminary finger phantom, we synthesized a high-compliance silicone matrix with scatterers for embedding flexible tubing and investigated the addition of these scatterers to novel 3D printing resins for optical property control without altering mechanical stability, streamlining the production of phantoms with biologically relevant characteristics. Phantom utility was demonstrated by applying dynamic, pressure waveforms to produce tube volume change and resultant photoplethysmography (PPG) signals. 3D printed phantoms achieved more biologically relevant conditions compared to molded phantoms. These preliminary results indicate that the phantoms show strong potential to be developed into tools for evaluating pulse oximetry performance. Gaps, recommendations, and strategies are presented for continued phantom development.

Mock circulatory loop generated database for dynamic characterization of pressure-based cardiac output monitoring systems.

Pulse contour cardiac output monitoring systems allow real-time and continuous estimation of hemodynamic variables such as cardiac output (CO) and stroke volume variation (SVV) by analysis of arterial blood pressure waveforms. However, evaluating the performance of CO monitoring systems to measure the small variations in these variables sometimes used to guide fluid therapy is a challenge due to limitations in clinical reference methods. We developed a non-clinical database as a tool for assessing the dynamic attributes of pressure-based CO monitoring systems, including CO response time and CO and SVV resolutions. We developed a mock circulation loop (MCL) that can simulate rapid changes in different parameters, such as CO and SVV. The MCL was configured to simulate three different states (normovolemic, cardiogenic shock, and hyperdynamic) representing a range of flow and pressure conditions. For each state, we simulated stepwise changes in the MCL flow and collected datasets for characterizing pressure-based CO systems. Nine datasets were generated that contain hours of peripheral pressure, central flow and pressure waveforms. The MCL-generated database is provided open access as a tool for evaluating dynamic characteristics of pressure-based CO algorithms and systems in detecting variations in CO and SVV indices. In an example application of the database, a CO response time of 10 s, CO and SVV resolutions with lower and upper limits of (-9.1%, 8.4%) and (-5.0%, 3.8%), respectively, were determined for a pressure-based CO benchtop system. This tool will support a more comprehensive assessment of pressure-based CO monitoring systems and algorithms.

Corrections to "Risks and Benefits of Using a Commercially Available Ventricular Assist Device for Failing Fontan Cavopulmonary Support: A Modeling Investigation".

In [1], there are errors in Table I and equation (3) which are corrected here. This does not affect the study results. We sincerely apologize for the errors and any confusion they may have caused. \begin{equation*} \Delta {\mathrm {P}} = {\mathrm {A}}{\mathrm {Q}}^3 + \mathrm {B}{\mathrm {Q}}^2 + \text{CQ} + \mathrm {D} \tag{3} \end{equation*}.

Simulating Radial Pressure Waveforms with a Mock Circulatory Flow Loop to Characterize Hemodynamic Monitoring Systems.

PURPOSE: Mock circulatory loops (MCLs) can reproducibly generate physiologically relevant pressures and flows for cardiovascular device testing. These systems have been extensively used to characterize the performance of therapeutic cardiac devices, but historically MCLs have had limited use for assessing patient monitoring systems. Here, we adapted an MCL to include peripheral components and evaluated its utility for qualitative and quantitative benchtop testing of hemodynamic monitoring devices. METHODS: An MCL was designed to simulate three physiological hemodynamic states: normovolemia, cardiogenic shock, and hyperdynamic circulation. The system was assessed for stability in pressure and flow values over time, repeatability, waveform morphology, and systemic-peripheral pressure relationships. RESULTS: For each condition, cardiac output was controlled to the nearest 0.2 L/min, and flow rate and mean arterial pressure remained stable and repeatable over a 60-s period (n = 5, standard deviation of ± 0.1 L/min and ± 0.84 mmHg, respectively). Transfer function analyses showed that the systemic-peripheral relationships could be adequately manipulated. The results from this MCL were comparable to those from other published MCLs and computational simulations. However, resolving current limitations of the system would further improve its utility. Three pulse contour analysis algorithms were applied to the pressure and flow data from the MCL to demonstrate the potential role of MCLs in characterizing hemodynamic monitoring systems. CONCLUSION: Overall, the development of robust analysis methods in conjunction with modified MCLs can expand device testing applications to hemodynamic monitoring systems. Properly validated MCLs can create a stable and reproducible environment for testing patient monitoring systems over their entire operating ranges prior to clinical use.

Model-based approach to investigate equipment-induced error in pressure-waveform derived hemodynamic measurements.

Objective.Advanced hemodynamic monitoring systems have provided less invasive methods for estimating pressure-derived measurements such as pressure-derived cardiac output (CO) measurements. These devices apply algorithms to arterial pressure waveforms recorded via pressure recording components that transmit the pressure signal to a pressure monitor. While standards have been developed for pressure monitoring equipment, it is unclear how the equipment-induced error can affect secondary measurements from pressure waveforms. We propose an approach for modelling different components of a pressure monitoring system and use this model-based approach to investigate the effect of different pressure recording configurations on pressure-derived hemodynamic measurements.Approach.The proposed model-based approach is a three step process. (1) Modelling the response of pressure recording components using bench tests; (2) verifying the identified models through nonparametric equivalence tests; and (3) assessing the effects of pressure recording components on pressure-derived measurements. To delineate the application of this approach, we performed a series of model-based analyses to quantify the combined effect of a wide range of tubing configurations with various damping ratios and natural frequencies and monitors with different bandwidths on pressure waveforms and CO measurements by six pulse contour algorithms.Results.Model-based results show the error in pressure-derived CO measurements because of tubing configurations with different natural frequencies and damping ratios. Tubing configurations with low natural frequencies (<23 Hz) altered characteristics of pressure waveforms in a way that affected the CO measurement, some by as much as 20%.Significance.Our method can serve as a tool to quantify the performance of pressure recording systems with different dynamic properties. This approach can be applied to investigate the effects of physiologic signal recording configurations on various pressure-derived hemodynamic measurements.

Target Flow-Pressure Operating Range for Designing a Failing Fontan Cavopulmonary Support Device.

Fontan operation as the current standard of care for the palliation of single ventricle defects results in significant late complications. Using a mechanical circulatory device for the right circulation to serve the function of the missing subpulmonary ventricle could potentially stabilize the failing Fontan circulation. This study aims to elucidate the hydraulic operating regions that should be targeted for designing cavopulmonary blood pumps. By integrating numerical analysis and available clinical information, the interaction of the cavopulmonary support via the IVC and full assist configurations with a wide range of simulated adult failing scenarios was investigated; with IVC and full assist corresponding to the inferior venous return or the entire venous return, respectively, being routed through the device. We identified the desired hydraulic operating regions for a cavopulmonary assist device by clustering all head pressures and corresponding pump flows that result in hemodynamic improvement for each simulated failing Fontan physiology. Results show that IVC support can produce beneficial hemodynamics in only a small fraction of failing Fontan scenarios. Cavopulmonary assist device could increase cardiac index by 35% and decrease the inferior vena cava pressure by 45% depending on the patient's pre-support hemodynamic state and surgical configuration of the cavopulmonary assist device (IVC or full support). The desired flow-pressure operating regions we identified can serve as the performance criteria for designing cavopulmonary assist devices as well as evaluating off-label use of commercially available left-side blood pumps for failing Fontan cavopulmonary support.

Risks and Benefits of Using a Commercially Available Ventricular Assist Device for Failing Fontan Cavopulmonary Support: A Modeling Investigation.

Fontan patients often develop circulatory failure and are in desperate need of a therapeutic solution. A blood pump surgically placed in the cavopulmonary pathway can substitute the function of the absent sub-pulmonary ventricle by generating a mild pressure boost. However, there is currently no commercially available device designed for the cavopulmonary application; and the risks and benefits of implanting a ventricular assist device (VAD), originally designed for the left ventricular application, on the right circulation of failing Fontan patients is not yet clear. Moreover, further research is needed to compare the hemodynamics between the two clinically-considered surgical configurations for cavopulmonary assist, with Full and inferior vena cava (IVC) support corresponding to the entire venous return or only the inferior venous return, respectively, being routed through the VAD. In this study, we used a numerical model of the failing Fontan physiology to evaluate the Fontan hemodynamic response to a left VAD during the IVC and Full support scenarios. We observed that during Full support, the VAD improved the cardiac output while maintaining blood pressures within safe ranges, and lowered the IVC pressure to <15 mmHg; however, we found a potential risk of lung damage at higher pump speeds due to the excessive pulmonary pressure elevation. IVC support, on the other hand, did not benefit the hemodynamics in the patient cases simulated, resulting in the superior vena cava pressure increasing to an unsafe level of >20 mmHg. The findings in this study may be helpful to surgeons for recognizing the risks of a cavopulmonary VAD and developing coherent clinical strategies for the implementation of cavopulmonary support.

An algorithm for coupling multibranch in vitro experiment to numerical physiology simulation for a hybrid cardiovascular model.

The hybrid cardiovascular modeling approach integrates an in vitro experiment with a computational lumped-parameter simulation, enabling direct physical testing of medical devices in the context of closed-loop physiology. The interface between the in vitro and computational domains is essential for properly capturing the dynamic interactions of the two. To this end, we developed an iterative algorithm capable of coupling an in vitro experiment containing multiple branches to a lumped-parameter physiology simulation. This algorithm identifies the unique flow waveform solution for each branch of the experiment using an iterative Broyden's approach. For the purpose of algorithm testing, we first used mathematical surrogates to represent the in vitro experiments and demonstrated five scenarios where the in vitro surrogates are coupled to the computational physiology of a Fontan patient. This testing approach allows validation of the coupling result accuracy as the mathematical surrogates can be directly integrated into the computational simulation to obtain the "true solution" of the coupled system. Our algorithm successfully identified the solution flow waveforms in all test scenarios with results matching the true solutions with high accuracy. In all test cases, the number of iterations to achieve the desired convergence criteria was less than 130. To emulate realistic in vitro experiments in which noise contaminates the measurements, we perturbed the surrogate models by adding random noise. The convergence tolerance achievable with the coupling algorithm remained below the magnitudes of the added noise in all cases. Finally, we used this algorithm to couple a physical experiment to the computational physiology model to demonstrate its real-world applicability.

A Hybrid Experimental-Computational Modeling Framework for Cardiovascular Device Testing.

Significant advances in biomedical science often leverage powerful computational and experimental modeling platforms. We present a framework named physiology simulation coupled experiment ("PSCOPE") that can capitalize on the strengths of both types of platforms in a single hybrid model. PSCOPE uses an iterative method to couple an in vitro mock circuit to a lumped-parameter numerical simulation of physiology, obtaining closed-loop feedback between the two. We first compared the results of Fontan graft obstruction scenarios modeled using both PSCOPE and an established multiscale computational fluid dynamics method; the normalized root-mean-square error values of important physiologic parameters were between 0.1% and 2.1%, confirming the fidelity of the PSCOPE framework. Next, we demonstrate an example application of PSCOPE to model a scenario beyond the current capabilities of multiscale computational methods-the implantation of a Jarvik 2000 blood pump for cavopulmonary support in the single-ventricle circulation; we found that the commercial Jarvik 2000 controller can be modified to produce a suitable rotor speed for augmenting cardiac output by approximately 20% while maintaining blood pressures within safe ranges. The unified modeling framework enables a testing environment which simultaneously operates a medical device and performs computational simulations of the resulting physiology, providing a tool for physically testing medical devices with simulated physiologic feedback.