Advocating for the implementation of SonoVue microbubbles as pressure sensors: a call to action for clinical noninvasive pressure estimation.
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ABSTRACT:
SUBMITTER: Wen A
PROVIDER: S-EPMC11336535 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
Publications
Advocating for the implementation of SonoVue microbubbles as pressure sensors: a call to action for clinical noninvasive pressure estimation.
Wen Ao A Yang Lingxiao L Lv Tao T Yang Huayu H Li Fei F Mao Yilei Y Xu Gang G Yang Jia-Yin JY
Hepatobiliary surgery and nutrition 20240718 4
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Project description:Purpose To investigate if the right ventricular (RV) systolic and left ventricular (LV) diastolic pressures can be obtained noninvasively using the subharmonic-aided pressure estimation (SHAPE) technique with Sonazoid microbubbles. Materials and Methods Individuals scheduled for a left and/or right heart catheterization were prospectively enrolled in this institutional review board-approved clinical trial from 2017 to 2020. A standard-of-care catheterization procedure was performed by advancing fluid-filled pressure catheters into the LV and aorta (n = 25) or RV (n = 22), and solid-state high-fidelity pressure catheters into the LV and aorta in a subset of participants (n = 18). Study participants received an infusion of Sonazoid microbubbles (GE HealthCare), and SHAPE data were acquired using a validated interface developed on a SonixTablet (BK Medical) US scanner, synchronously with the pressure catheter data. A conversion factor, derived using cuff-based pressure measurements with a SphygmoCor XCEL PWA (ATCOR) and subharmonic signal from the aorta, was used to convert the subharmonic signal into pressure values. Errors between the pressure measurements obtained using the SHAPE technique and pressure catheter were compared. Results The mean errors in pressure measurements obtained with the SHAPE technique relative to those of the fluid-filled pressure catheter were 1.6 mm Hg ± 1.5 [SD] (P = .85), 8.4 mm Hg ± 6.2 (P = .04), and 7.4 mm Hg ± 5.7 (P = .09) for RV systolic, LV minimum diastolic, and LV end-diastolic pressures, respectively. Relative to the measurements with the solid-state high-fidelity pressure catheter, the mean errors in LV minimum diastolic and LV end-diastolic pressures were 7.2 mm Hg ± 4.5 and 6.8 mm Hg ± 3.3 (P ≥ .44), respectively. Conclusion These results indicate that SHAPE with Sonazoid may have the potential to provide clinically relevant RV systolic and LV diastolic pressures. Keywords: Ultrasound-Contrast, Cardiac, Aorta, Left Ventricle, Right Ventricle ClinicalTrials.gov registration no.: NCT03245255 © RSNA, 2024.
| S-EPMC10912883 | biostudies-literature
Project description:BackgroundIn several recent articles, authors have called for aligning the fields of implementation and improvement science. In this paper, we call for implementation science to also align with improvement practice. Multiple implementation scholars have highlighted the importance of designing implementation strategies to fit the existing culture, infrastructure, and practice of a healthcare system. Worldwide, healthcare systems are adopting improvement models as their primary approach to improving healthcare delivery and outcomes. The prevalence of improvement models raises the question of how implementation scientists might best align their efforts with healthcare systems' existing improvement infrastructure and practice.Main bodyWe describe three challenges and five benefits to aligning implementation science and improvement practice. Challenges include (1) use of different models, terminology, and methods, (2) a focus on generalizable versus local knowledge, and (3) limited evidence in support of the effectiveness of improvement tools and methods. We contend that implementation science needs to move beyond these challenges and work toward greater alignment with improvement practice. Aligning with improvement practice would benefit implementation science by (1) strengthening research/practice partnerships, (2) fostering local ownership of implementation, (3) generating practice-based evidence, (4) developing context-specific implementation strategies, and (5) building practice-level capacity to implement interventions and improve care. Each of these potential benefits is illustrated in a case study from the Centers for Disease Control and Prevention's Cancer Prevention and Control Research Network.ConclusionTo effectively integrate evidence-based interventions into routine practice, implementation scientists need to align their efforts with the improvement culture and practice that is driving change within healthcare systems worldwide. This paper provides concrete examples of how researchers have aligned implementation science with improvement practice across five implementation projects.
| S-EPMC8424169 | biostudies-literature
Project description:PurposeTo compare subharmonic aided pressure estimation (SHAPE) with pressure catheter-based measurements in human patients with chronic liver disease undergoing transjugular liver biopsy.Materials and methodsThis HIPAA-compliant study had U.S. Food and Drug Administration and institutional review board approval, and written informed consent was obtained from all participants. Forty-five patients completed this study between December 2010 and December 2011. A clinical ultrasonography (US) scanner was modified to obtain SHAPE data. After transjugular liver biopsy with pressure measurements as part of the standard of care, 45 patients received an infusion of a microbubble US contrast agent and saline. During infusion, SHAPE data were collected from a portal and hepatic vein and were compared with invasive measurements. Correlations between data sets were determined by using the Pearson correlation coefficient, and statistical significance between groups was determined by using the Student t test.ResultsThe 45 study patients included 27 men and 18 women (age range, 19-71 years; average age, 55.8 years). The SHAPE gradient between the portal and hepatic veins was in good overall agreement with the hepatic venous pressure gradient (HVPG) (R = 0.82). Patients at increased risk for variceal hemorrhage (HVPG ≥ 12 mm Hg) had a significantly higher mean subharmonic gradient than patients with lower HVPGs (1.93 dB ± 0.61 [standard deviation] vs -1.47 dB ± 0.29, P < .001), with a sensitivity of 100% and a specificity of 81%, indicating that SHAPE may be a useful tool for the diagnosis of clinically important portal hypertension.ConclusionPreliminary results show SHAPE to be an accurate noninvasive technique for estimating portal hypertension.
| S-EPMC3721058 | biostudies-literature
Project description:Intracranial pressure (ICP) is affected in many neurological conditions. Clinical measurement of pressure on the brain currently requires placing a probe in the cerebrospinal fluid compartment, the brain tissue, or other intracranial space. This invasiveness limits the measurement to critically ill patients. Because ICP is also clinically important in conditions ranging from brain tumors and hydrocephalus to concussions, noninvasive determination of ICP would be desirable. Our model-based approach to continuous estimation and tracking of ICP uses routinely obtainable time-synchronized, noninvasive (or minimally invasive) measurements of peripheral arterial blood pressure and blood flow velocity in the middle cerebral artery (MCA), both at intra-heartbeat resolution. A physiological model of cerebrovascular dynamics provides mathematical constraints that relate the measured waveforms to ICP. Our algorithm produces patient-specific ICP estimates with no calibration or training. Using 35 hours of data from 37 patients with traumatic brain injury, we generated ICP estimates on 2665 nonoverlapping 60-beat data windows. Referenced against concurrently recorded invasive parenchymal ICP that varied over 100 millimeters of mercury (mmHg) across all records, our estimates achieved a mean error (bias) of 1.6 mmHg and SD of error (SDE) of 7.6 mmHg. For the 1673 data windows over 22 hours in which blood flow velocity recordings were available from both the left and the right MCA, averaging the resulting bilateral ICP estimates reduced the bias to 1.5 mmHg and SDE to 5.9 mmHg. This accuracy is already comparable to that of some invasive ICP measurement methods in current clinical use.
| S-EPMC4010388 | biostudies-other
Project description: Not available
| S-EPMC11621896 | biostudies-literature
Project description:The flow fields generated by the acoustic behavior of microbubbles can significantly increase cell permeability. This facilitates the cellular uptake of external molecules in a process known as ultrasound-mediated drug delivery. To promote its clinical translation, this study investigated the relationships among the ultrasound parameters, acoustic behavior of microbubbles, flow fields, and delivery results. SonoVue microbubbles were activated by 1 MHz pulsed ultrasound with 100 Hz pulse repetition frequency, 1:5 duty cycle, and 0.20/0.35/0.70 MPa peak rarefactional pressure. Micro-particle image velocimetry was used to detect the microbubble behavior and the resulting flow fields. Then HeLa human cervical cancer cells were treated with the same conditions for 2, 4, 10, 30, and 60 s, respectively. Fluorescein isothiocyanate and propidium iodide were used to quantitate the rates of sonoporated cells with a flow cytometer. The results indicate that (1) microbubbles exhibited different behavior in ultrasound fields of different peak rarefactional pressures. At peak rarefactional pressures of 0.20 and 0.35 MPa, the dispersed microbubbles clumped together into clusters, and the clusters showed no apparent movement. At a peak rarefactional pressure of 0.70 MPa, the microbubbles were partially broken, and the remainders underwent clustering and coalescence to form bubble clusters that exhibited translational oscillation. (2) The flow fields were unsteady before the unification of the microbubbles. After that, the flow fields showed a clear pattern. (3)The delivery efficiency improved with the shear stress of the flow fields increased. Before the formation of the microbubble/bubble cluster, the maximum shear stresses of the 0.20, 0.35, and 0.70 MPa groups were 56.0, 87.5 and 406.4 mPa, respectively, and the rates of the reversibly sonoporated cells were 2.4% ± 0.4%, 5.5% ± 1.3%, and 16.6% ± 0.2%. After the cluster formation, the maximum shear stresses of the three groups were 9.1, 8.7, and 71.7 mPa, respectively. The former two could not mediate sonoporation, whereas the last one could. These findings demonstrate the critical role of flow fields in ultrasound-mediated drug delivery and contribute to its clinical applications.
| S-EPMC7025580 | biostudies-literature
Project description:Noninvasive methods for intracranial pressure (ICP) monitoring have emerged, but none has successfully replaced invasive techniques. This observational study developed and tested a machine learning (ML) model to estimate ICP using waveforms from a cranial extensometer device (brain4care [B4C] System). The model explored multiple waveform parameters to optimize mean ICP estimation. Data from 112 neurocritical patients with acute brain injuries were used, with 92 patients randomly assigned to training and testing, and 20 reserved for independent validation. The ML model achieved a mean absolute error of 3.00 mmHg, with a 95% confidence interval within ±7.5 mmHg. Approximately 72% of estimates from the validation sample were within 0-4 mmHg of invasive ICP values. This proof-of-concept study demonstrates that noninvasive ICP estimation via the B4C System and ML is feasible. Prospective studies are needed to validate the model's clinical utility across diverse settings.
| S-EPMC11770073 | biostudies-literature
Project description:Microbubbles (MBs) are considered as an important enhancer for high intensity focused ultrasound (HIFU) treatment of benign or malignant tumors. Recently, different sizes of gas-filled bubbles have been investigated to improve the therapeutic efficiency of HIFU thermal ablation and reduce side effects associated with ultrasound power and irradiation time. However, nanobubbles (NBs) as an ultrasound contrast agent for synergistic therapy of HIFU thermal ablation remain controversial due to their small nano-size in diameter. In this study, phospholipid-shell and gas-core NBs with a narrow size range of 500-600 nm were developed. The synergistic effect of NBs for HIFU thermal ablation was carefully studied both in excised bovine livers and in breast tumor models of rabbits, and made a critical comparison with that of commercial SonoVue microbubbles (SonoVue MBs). In addition, the pathological changes of the targeted area in tumor tissue after HIFU ablation were further investigated. Phosphate buffer saline (PBS) was used as the control. Under the same HIFU parameters, the quantitative echo intensity of B-mode ultrasound image and the volume of coagulative necrosis in lipid NBs groups were significantly higher and larger than that in PBS groups, but could not be demonstrated a difference to that in SonoVue MBs groups both ex vivo and in vivo. These results showed that the synergistic effect of lipid NBs for HIFU thermal ablation were similar with that of SonoVue MBs, and further indicate that lipid NBs could potentially become an enhancer for HIFU thermal ablation of tumors.
| S-EPMC4768712 | biostudies-literature
Project description:BACKGROUND:Transvalvular peak pressure drops are routinely assessed noninvasively by echocardiography using the Bernoulli principle. However, the Bernoulli principle relies on several approximations that may not be appropriate, including that the majority of the pressure drop is because of the spatial acceleration of the blood flow, and the ejection jet is a single streamline (single peak velocity value). METHODS AND RESULTS:We assessed the accuracy of the Bernoulli principle to estimate the peak pressure drop at the aortic valve using 3-dimensional cardiovascular magnetic resonance flow data in 32 subjects. Reference pressure drops were computed from the flow field, accounting for the principles of physics (ie, the Navier-Stokes equations). Analysis of the pressure components confirmed that the spatial acceleration of the blood jet through the valve is most significant (accounting for 99% of the total drop in stenotic subjects). However, the Bernoulli formulation demonstrated a consistent overestimation of the transvalvular pressure (average of 54%, range 5%-136%) resulting from the use of a single peak velocity value, which neglects the velocity distribution across the aortic valve plane. This assumption was a source of uncontrolled variability. CONCLUSIONS:The application of the Bernoulli formulation results in a clinically significant overestimation of peak pressure drops because of approximation of blood flow as a single streamline. A corrected formulation that accounts for the cross-sectional profile of the blood flow is proposed and adapted to both cardiovascular magnetic resonance and echocardiographic data.
| S-EPMC5265685 | biostudies-literature
Project description: Not available
| S-EPMC10432296 | biostudies-literature