Best Practice Recommendations for the Safe use of Lung Ultrasound.

The safety of ultrasound is of particular importance when examining the lungs, due to specific bioeffects occurring at the alveolar air-tissue interface. Lung is significantly more sensitive than solid tissue to mechanical stress. The causal biological effects due to the total reflection of sound waves have also not been investigated comprehensively.On the other hand, the clinical benefit of lung ultrasound is outstanding. It has gained considerable importance during the pandemic, showing comparable diagnostic value with other radiological imaging modalities.Therefore, based on currently available literature, this work aims to determine possible effects caused by ultrasound on the lung parenchyma and evaluate existing recommendations for acoustic output power limits when performing lung sonography.This work recommends a stepwise approach to obtain clinically relevant images while ensuring lung ultrasound safety. A special focus was set on the safety of new ultrasound modalities, which had not yet been introduced at the time of previous recommendations.Finally, necessary research and training steps are recommended in order to close knowledge gaps in the field of lung ultrasound safety in the future.These recommendations for practice were prepared by ECMUS, the safety committee of the EFSUMB, with participation of international experts in the field of lung sonography and ultrasound bioeffects.

Professional Standards in Medical Ultrasound - EFSUMB Position Paper (Long Version) - General Aspects.

This first position paper of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) on professional standards presents a common position across the different medical professions within EFSUMB regarding optimal standards for the performing and reporting of ultrasound examinations by any professional ultrasound operator. It describes general aspects of professionality that ensure procedure quality, effectiveness, efficiency, and sustainability in virtually all application fields of medical ultrasound. Recommendations are given related to safety and indication of ultrasound examinations, requirements for examination rooms, structured examination, systematic reporting of results, and management, communication and archiving of ultrasound data. The print version of this article is a short version. The long version is published online.

Professional Standards in Medical Ultrasound - EFSUMB Position Paper (Short Version) - General Aspects.

This first position paper of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) on professional standards presents a common position across the different medical professions within EFSUMB regarding optimal standards for the performing and reporting of ultrasound examinations by any professional ultrasound operator. It describes general aspects of professionality that ensure procedure quality, effectiveness, efficiency, and sustainability in virtually all application fields of medical ultrasound. Recommendations are given related to safety and indication of ultrasound examinations, requirements for examination rooms, structured examination, systematic reporting of results, and management, communication and archiving of ultrasound data. The print version of this article is a short version. The long version is published online.

Safety Aspects of Perinatal Ultrasound.

Ultrasound safety is of particular importance in fetal and neonatal scanning. Fetal tissues are vulnerable and often still developing, the scanning depth may be low, and potential biological effects have been insufficiently investigated. On the other hand, the clinical benefit may be considerable. The perinatal period is probably less vulnerable than the first and second trimesters of pregnancy, and ultrasound is often a safer alternative to other diagnostic imaging modalities. Here we present step-by-step procedures for obtaining clinically relevant images while maintaining ultrasound safety. We briefly discuss the current status of the field of ultrasound safety, with special attention to the safety of novel modalities, safety considerations when ultrasound is employed for research and education, and ultrasound of particularly vulnerable tissues, such as the neonatal lung. This CME is prepared by ECMUS, the safety committee of EFSUMB, with contributions from OB/GYN clinicians with a special interest in ultrasound safety.

EFSUMB Clinical Safety Statement for Diagnostic Ultrasound - (2019 revision).

This document is the updated 2019 revision of the EFSUMB Clinically Safety Statement. A Safety Statement has been published by EFSUMB annually since 1994 by the Safety Committee (ECMUS) of the federation. The text is deliberately brief and gives a concise overview of safety in the use of diagnostic ultrasound.

Sonographic diagnostics in dermatology.

Ultrasonography non-invasively visualizes changes within the skin, skin appendages, subcutaneous tissue, subcutaneous (regional) lymph nodes and peripheral vessels. Thus it is an established diagnostic tool in dermatology. Compared to X-ray, MRI and PET, ultrasonography has some advantages; however, it is more dependent on the individual experience of the investigator. Therefore a structured education and continuous training are necessary. This review describes the physical and technical basics, the administrative requirements and the main indications in dermatology.

The application of high-performance ultrasound probes increases anatomic depiction in obese patients.

This study evaluated the impact of obesity on abdominal ultrasound diagnostics and assessed effect of high-performance ultrasound probes increased imaging quality. Lean and obese subjects (n = 40; 58% female) were categorized according to body mass index (BMI, 21 to 48 kg/m2). A highly standardized ultrasound examination of the abdomen was performed by trained examiners using three different probes in randomized order (standard probe versus two high-performance probes). Quality of B-mode and duplex ultrasound were assessed using a custom scoring approach for depiction of liver and kidney anatomy and vascularization. Across probes, imaging quality of hepatic and kidney anatomy was inversely related with BMI (P < 0.03, r < - 0.35). Age, sex, and BMI explained 51% of the variance within the ultrasound quality score, with ß = - 0.35, P < 0.0001 for BMI. Compared to the standard probe, high-performance probes allowed for a better depiction of kidney and liver anatomy in subjects above BMI 35 kg/m2 (n = 20, all P < 0.05), resulting in a less pronounced deterioration of imaging quality with increased BMI (all P < 0.05). In conclusion the study shows that obesity impairs ultrasound imaging quality of abdominal anatomy. The application of high-performance probes can increase anatomic depiction in obese patients.Registration number of the German Registry of Clinical Studies: DRKS00023498.

A comparative evaluation of three hydrophones and a numerical model in high intensity focused ultrasound fields.

The pressure fields of two different high intensity focused ultrasound (HIFU) transducers operated in burst mode were measured at acoustical power levels of 25 and 50 W (continuous wave equivalent) with three different hydrophones: A fiber-optic displacement sensor, a commercial HIFU needle hydrophone, and a prototype of a membrane hydrophone with a protective coating against cavitation effects. Additionally, the fields were modeled using a freely available simulations software package. The measured waveforms, the peak pressure profiles, as well as the spatial-peak temporal-average intensities from the different devices and from the modeling are compared and possible reasons for differences are discussed. The results clearly show that reliable pressure measurements in HIFU fields remain a difficult task concerning both the reliability of the measured values and the robustness of the sensors used: Only the fiber-optic hydrophone survived all four exposure regimes and the measured spatial-peak temporal-average intensities varied by a factor of up to 1.5 between the measurements and the modeling and between the measurements among themselves.

[Conventional ultrasound diagnostics in dermatology]. / Konventionelle Ultraschalldiagnostik in der Dermatologie.

The imaging of changes to the skin, the subcutis and especially the regional lymph nodes by high-resolution ultrasound is an integral part of routine dermatological diagnostics. This is mainly done with electronic scanners operating at frequencies between 7.5 and 20 MHz (conventional ultrasound diagnostics). In addition, there are very high-frequency ultrasound systems (frequencies up to 100 MHz) that are used for special scientific questions. Ultrasound diagnostics has a number of advantages over other cross-sectional imaging techniques but is more dependent than these on the individual experience of the examiner. Structured training and continuing education are therefore essential for ultrasound diagnostics, also in dermatology. The following overview describes the most important indications for conventional sonography in dermatology in addition to the physical, technical and administrative principles.

Liquid-Liver Phantom: Mimicking the Viscoelastic Dispersion of Human Liver for Ultrasound- and MRI-Based Elastography.

OBJECTIVES: Tissue stiffness can guide medical diagnoses and is exploited as an imaging contrast in elastography. However, different elastography devices show different liver stiffness values in the same subject, hindering comparison of values and establishment of system-independent thresholds for disease detection. There is a need for standardized phantoms that specifically address the viscosity-related dispersion of stiffness over frequency. To improve standardization of clinical elastography across devices and platforms including ultrasound and magnetic resonance imaging (MRI), a comprehensively characterized phantom is introduced that mimics the dispersion of stiffness of the human liver and can be generated reproducibly. MATERIALS AND METHODS: The phantom was made of linear polymerized polyacrylamide (PAAm) calibrated to the viscoelastic properties of healthy human liver in vivo as reported in the literature. Stiffness dispersion was analyzed using the 2-parameter springpot model fitted to the dispersion of shear wave speed of PAAm, which was measured by shear rheometry, ultrasound-based time-harmonic elastography, clinical magnetic resonance elastography (MRE), and tabletop MRE in the frequency range of 5 to 3000 Hz. Imaging parameters for ultrasound and MRI, reproducibility, aging behavior, and temperature dependency were assessed. In addition, the frequency bandwidth of shear wave speed of clinical elastography methods (Aplio i900, Canon; Acuson Sequoia, Siemens; FibroScan, EchoSense) was characterized. RESULTS: Within the entire frequency range analyzed in this study, the PAAm phantom reproduced well the stiffness dispersion of human liver in vivo despite its fluid properties under static loading (springpot stiffness parameter, 2.14 [95% confidence interval, 2.08-2.19] kPa; springpot powerlaw exponent, 0.367 [95% confidence interval, 0.362-0.373]). Imaging parameters were close to those of liver in vivo with only slight variability in stiffness values of 0.5% (0.4%, 0.6%), 4.1% (3.9%, 4.5%), and -0.63% (-0.67%, -0.58%), respectively, between batches, over a 6-month period, and per °C increase in temperature. CONCLUSIONS: The liquid-liver phantom has useful properties for standardization and development of liver elastography. First, it can be used across clinical and experimental elastography devices in ultrasound and MRI. Second, being a liquid, it can easily be adapted in size and shape to specific technical requirements, and by adding inclusions and scatterers. Finally, because the phantom is based on noncrosslinked linear PAAm constituents, it is easy to produce, indicating potential widespread use among researchers and vendors to standardize liver stiffness measurements.

Characterization of a fiber-optic displacement sensor for measurements in high-intensity focused ultrasound fields.

A fiber-optic sensor is presented that is capable of measuring the particle displacement in high-intensity focused ultrasound (HIFU) fields. For this probe, a secondary calibration was performed, and the resulting complex frequency response is discussed. As a first practical application, the setup was used to measure the pressure in the field of a weakly focusing ultrasound transducer. The result is compared with that of a membrane hydrophone measurement. The feasibility of measurements in HIFU fields is demonstrated by means of measurements of the spatial distribution of the peak particle velocity within the focus of a HIFU transducer and of the dependence of the peak values on the acoustical power level.

Heating of Polymer Films Induced by HIFU: Study of Acoustic and Thermal Effects.

This article presents the study of the thermal and acoustic effects occurring in polymer samples of different thicknesses receiving high-intensity focused ultrasound (HIFU). Whereas the heating mechanisms in polymer plates immersed in water are well known, the physical mechanisms enabling the heating of polymer films using a solid waveguide transducer remain not fully understood. A coupled acoustothermal finite-element simulation is conducted to model the sound field and the heat generation inside polymer samples of different thicknesses. To validate the acoustic model, the acoustic particle velocities at the transducer waveguide tip are measured by vibrometry and compared with the simulation results. The heating effects in the samples are monitored using an infrared thermography system and compared with the measured particle velocities and with the acoustic and thermal simulation results. Correlations among particle velocities, sound intensity, and polymer heating are investigated. A qualitative and quantitative correlation between the simulation and the measurement results is found. Experiments show that the heating effects depend on the sample thickness. In samples thinner than 1 mm, the maximum temperature is lower than the one observed in samples thicker than 1 mm but rises faster. The simulation shows that the sound intensity in polymer samples thinner than 1 mm decreases sharply with the decrease in the thickness of the sample. This study contributes to the understanding of the challenges in heating thin polymer films by HIFU in a dry environment, using only a force to couple the transducer to the polymer films.

Ultrasonic radio-frequency spectrum analysis differentiates normal and edematous brain tissue from meningioma intraoperatively.

Intraoperative ultrasound imaging of the brain is used for tumor localization and resection control. The aim of the present study was to prove whether spectral analysis of radio-frequency (rf) signals is able to improve its diagnostic capabilities by adding quantitative acoustical parameters to pure visual analysis. Meningioma was chosen as a first model because of its distinct borders during surgery as well as in ultrasound imaging. Rf signals were captured intraoperatively. Spectral analysis of rf signals was performed off-line in areas of normal brain, edematous tissue, and meningioma within the bandwidth of the transducer. At 5.0 MHz, attenuation allowed significant differentiation for normal brain versus edema (P= .00002), normal brain versus meningioma (P= .000004), and edema versus meningioma (P= .002). The slope of attenuation reached significant levels among the three groups, too. Backscatter analysis consisted of determination of the power spectral density with a significant difference for edema versus meningioma at 5 MHz (P= .02). The same was true for a relative integrated backscatter coefficient (P= .01). Frequency-dependent backscatter coefficients were estimated using a standard phantom with edema showing the highest values followed by parenchyma and meningioma. Spectral analysis of rf signals has the potential of differentiating intracranial tissues as could be shown exemplarily with meningioma in this study. If this is also true for infiltrating tumors, the method might serve as a tool to better define tumor borders, thus improving the extent of resection.

Measurement of sound field in cavitating media by an optical fibre-tip hydrophone.

A fibre-optic technique was applied to measure the sound field in an ultrasonic cleaning vessel under practical conditions. A metal-coated fibre-tip is used as a sensor and a heterodyne interferometer detects the change in the optical path resulting from the movement of the fibre-tip in the sound field. Spectrally resolved sound field parameters such as the fundamental, the subharmonic or cavitation noise are extracted from the measurements and compared with results obtained by a piezo-electric hydrophone. It was found that the fibre sensor provides a signal related to the velocity in the sound field, but the information about cavitation-related parameters is similar to the information for pressure sensing techniques. The fibre-optic sensors have a uniquely high spatial resolution and the sound detection process is strongly influenced by single cavitation events close to the small fibre-tip. This paper shows that fibre-tip sensors are an alternative to common hydrophone techniques. They can open up new possibilities for measurement problems for which so far no solution exists, in particular when a high spatial resolution is required or when the measurement site is small.

Determination of the receiving range of sound field measurements in cavitating media.

Sound field measurements are widely used for the quantitative description of cavitation processes. For practical purposes it is important to know how local a sound field measurement information is, and therefore a technique is presented which allows the determination of the receiving range of such a measurement. The sound field is detected by two calibrated, similar hydrophones, mounted face to face in the cavitation cloud. The distance between the hydrophones is varied and the correlation between the two time-dependent signals is analyzed in the frequency domain defining a local parameter. The dependence of this parameter on the distance between the hydrophones describes the receiving range of a sound field measurement by means of a characteristic distance. The technique was applied to two different cavitation applications, and effective distances in the range 1-3mm were obtained. It is shown that the spatial resolution of a sound field measurement in a cavitation field is determined by the hydrophone size and does not depend on the cavitation conditions if at least a medium cavitation activity is provided.

Ultrasound elastography of the lower uterine segment in women with a previous cesarean section: Comparison of in-/ex-vivo elastography versus tensile-stress-strain-rupture analysis.

OBJECTIVES: The purpose of this study was to assess, if the biomechanical properties of the lower uterine segment (LUS) in women with a previous cesarean section (CS) can be determined by ultrasound (US) elastography. The first aim was to establish an ex-vivo LUS tensile-stress-strain-rupture(break point) analysis with the possibility of simultaneously using US elastography. The second aim was to investigate the relationship between measurement results of LUS stiffness using US elastography in-/ex-vivo with results of tensile-stress-strain-rupture analysis, and to compare different US elastography LUS-stiffness-measurement methods ex-vivo. STUDY DESIGN: An explorative experimental, in-/ex-vivo US study of women with previous CS was conducted. LUS elasticity was measured by point Shear Wave Elastography (pSWE) and bidimensional Shear-Wave-Elastography (2D-SWE) first in-vivo during preoperative examination within 24 h before repeat CS (including resection of the thinnest part of the LUS = uterine scar area during CS), second within 1 h after operation during the ex-vivo experiment, followed by tensile-stress-strain-rupture analysis. Pearson's correlation coefficient and scatter plots, Bland-Altman plots and paired T-tests, were used. RESULTS: Thirty three women were included in the study; elastography measurements n = 1412. The feasibility of ex-vivo assessment of LUS by quantitative US elastography using pSWE and 2D-SWE to detect stiffness of LUS was demonstrated. The strongest correlation with tensile-stress-strain analysis was found in the US elastography examination carried out with 2D-SWE (0.78, p < 0.001, 95%CI [0.48, 0.92]). The laboratory experiment illustrated that, the break point - as a surrogate marker for the risk of rupture of the LUS after CS - is linearly dependent on the thickness of the LUS in the scar area (Coefficient of correlation: 0.79, p < 0.001, 95%CI [0.55, 0.91]). Two extremely stiff LUS-specimens (outlier or extreme values) rupture even at less stroke/strain than would be expected by their thickness. CONCLUSION: This study confirms that US elastography can help in determining viscoelastic properties of the LUS in women with a previous CS. The data from our small series are promising. However whether individual extreme values of high stiffness and consecutive restricted biomechanical resilience can explain the phenomenon of rupture during TOLAC in cases of LUS with adequate thickness remains a question which prospective trials have to analyze before US elastography can be introduced into clinical practice.

Ultrasonic radio-frequency spectrum analysis of normal brain tissue.

Acoustic tissue properties can be estimated using texture and/or spectral parameter analysis. Spectral analysis is based on the rf-signals whose frequency-content is commonly neglected in conventional B-mode imaging. Attenuation and backscatter values of normal brain tissue were analyzed. Unprocessed rf-data of 20 patients were sampled intraoperatively after craniotomy using a modified conventional ultrasonic device (Hitachi CS 9600) and analyzed off-line by a custom-made software routine. Before parameter estimation, influences of the diffraction pattern were compensated by means of a correction function obtained using a tissue-mimicking phantom. Attenuation of white matter showed a linear frequency dependence with a slope of 0.94 +/- 0.13 dB cm(-1) MHz(-1). The spectral slope was determined using 10 distinct frequencies between 2.5 and 5.75 MHz. Backscattering properties were analyzed by determining the power spectral density (PSD) and a relative backscatter coefficient (rel BSC) against the values derived from the tissue-mimicking phantom. PSD and rel BSC values were frequency-dependent, with highest PSD values at the probe's center frequency (-75.69 +/- 8.26 dB V(2) Hz(-1)). The corresponding rel BSC value at 5 MHz was determined as 15.39 +/- 8.26 dB. Finally, backscatter coefficients (BSC) of brain tissue were computed using the known BSC of the phantom. The data provided in this study are meant to serve as a base for intended future characterization of brain tissue that potentially allows intraoperative differentiation between normal and pathologic areas and therefore provides the surgeon with additional information for defining the extent of resection in brain more precisely.

Effects of HIFU induced cavitation on flooded lung parenchyma.

BACKGROUND: High intensity focused ultrasound (HIFU) has gained clinical interest as a non-invasive local tumour therapy in many organs. In addition, it has been shown that lung cancer can be targeted by HIFU using One-Lung Flooding (OLF). OLF generates a gas free saline-lung compound in one lung wing and therefore acoustic access to central lung tumours. It can be assumed that lung parenchyma is exposed to ultrasound intensities in the pre-focal path and in cases of misguiding. If so, cavitation might be induced in the saline fraction of flooded lung and cause tissue damage. Therefore this study was aimed to determine the thresholds of HIFU induced cavitation and tissue erosion in flooded lung. METHODS: Resected human lung lobes were flooded ex-vivo. HIFU (1,1 MHz) was targeted under sonographic guidance into flooded lung parenchyma. Cavitation events were counted using subharmonic passive cavitation detection (PCD). B-Mode imaging was used to detect cavitation and erosion sonographically. Tissue samples out of the focal zone were analysed histologically. RESULTS: In flooded lung, a PCD and a sonographic cavitation detection threshold of 625 Wcm- 2(pr = 4, 3 MPa) and 3.600 Wcm- 2(pr = 8, 3 MPa) was found. Cavitation in flooded lung appears as blurred hyperechoic focal region, which enhances echogenity with insonation time. Lung parenchyma erosion was detected at intensities above 7.200 Wcm- 2(pr = 10, 9 MPa). CONCLUSIONS: Cavitation occurs in flooded lung parenchyma, which can be detected passively and by B-Mode imaging. Focal intensities required for lung tumour ablation are below levels where erosive events occur. Therefore focal cavitation events can be monitored and potential risk from tissue erosion in flooded lung avoided.

Intra- and inter-observer variation and accuracy using different shear wave elastography methods to assess circumscribed objects - a phantom study.

AIMS: The elastic properties of circumscribed tissues (e.g., tendons, lymph nodes, prostates, brain tumors) are of considerable clinical interest. The purpose of this study was thus to compare the Intra-/Inter-observer variation and accuracy in vitro of point shear wave elastography (pSWE) with that of 2D-SWE and to assess 2D-SWE's precision with variable ROI (vROI) incircumscribed objects. MATERIAL AND METHODS: Round targets (Elasticity QA Phantom Model 049) were examined for varying degrees of stiffness (8, 14, 45, and 80 kPa) and diameters (20/10 mm). Three ultrasound systems and four probes were applied (pSWE: Acuson/S3000 9L4/4C1 and Epiq7 C51, 2D-SWE: Aplio/500 PVT375BT). Three different ROIs were used, namely fixed ROI (fROI) and variable ROI: rectangular-best-fitted ROI, and round-best-fitted ROI. Each measurement was performed twice by four observers. RESULTS: A total of 3,604 measurements were conducted. The intra-observer variation of 2D-SWE measurements indicated better agreement (Intraclass Correlation Coefficient (ICC) = 0.971; 95% CI=[0.945; 0.985]), than for the pSWE measurements (ICC = 0.872; 95% CI=[0.794; 0.92]). With both methods, the shear wave elastography applied showed low inter-observer variation: ICC = 0.980; 95% CI=[0.970; 0.987]. However, a significant difference was observed between fROI (pSWE) and vROI (2D-SWE) on circumscribed objects in terms of accuracy. The lowest degree of observationerror was detected in situations where the ROI was not "best fitted", but placed within the target of 3mm from the border (target diameter: 20mm; mean relative error = 0.15). CONCLUSIONS: When estimating the elastic properties of circumscribed tissues, the different measurement techniques performed by commercial shear wave elastography systems reveal a strong susceptibility for observational errors, depending upon the fixed vs. variable ROI of the pSWE vs. 2D-SWE technique.

A Focused Low-Intensity Pulsed Ultrasound (FLIPUS) System for Cell Stimulation: Physical and Biological Proof of Principle.

Quantitative ultrasound (QUS) is a promising technique for bone tissue evaluation. Highly focused transducers used for QUS also have the capability to be applied for tissue-regenerative purposes and can provide spatially limited deposition of acoustic energy. We describe a focused low-intensity pulsed ultrasound (FLIPUS) system, which has been developed for the stimulation of cell monolayers in the defocused far field of the transducer through the bottom of the well plate. Tissue culture well plates, carrying the cells, were incubated in a special chamber, immersed in a temperature-controlled water tank. A stimulation frequency of 3.6 MHz provided an optimal sound transmission through the polystyrene well plate. The ultrasound was pulsed for 20 min daily at 100-Hz repetition frequency with 27.8% duty cycle. The calibrated output intensity corresponded to I(SATA) = 44.5 ± 7.1 mW/cm2, which is comparable to the most frequently reported nominal output levels in LIPUS studies. No temperature change by the ultrasound exposure was observed in the well plate. The system was used to stimulate rat mesenchymal stem cells (rMSCs). The applied intensity had no apoptotic effect and enhanced the expression of osteogenic markers, i.e., osteopontin (OPN), collagen 1 (Col-1), the osteoblast-specific transcription factor-Runx-2 and E11 protein, an early osteocyte marker, in stimulated cells on day 5. The proposed FLIPUS setup opens new perspectives for the evaluation of the mechanistic effects of LIPUS.