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Alexandre Le Guyader,1 Mathieu Pernot,2 Clément Delmas,3 Stéphane Roze,4 Isabelle Fau,5 Erwan Flecher,6 Guillaume Lebreton7 1Department of Thoracic and Cardiovascular Surgery, Dupuytren University Hospital, Limoges, France; 2Department of Cardiology and Cardio‐Vascular Surgery, Haut-Lévèque University Hospital, Bordeaux, France; 3Cardiology Department, Rangueil University Hospital, Toulouse, France; 4Vyoo Agency, Lyon, France; 5SGE Consulting, Paris, France; 6Department of Cardio-Thoracic and Vascular Surgery, Pontchaillou University Hospital, Rennes, France; 7Cardiac Surgery Department, Pitié-Salpétrière Hospital, Sorbonne University, Paris, FranceCorrespondence: Isabelle Fau Email isabelle.fau@sge-consulting.orgAim: Cardiogenic shock (CS), if not diagnosed and treated rapidly, can lead to irreversible multiorgan damage and death. An economic analysis was conducted to determine the budget impact of the introduction of Impella 5.0®, a mechanical circulatory support (MCS) device that directly unloads the left ventricle, into clinical practice in patients with left ventricular CS in France.Methods: A budget impact model was developed to compare the cost of Impella 5.0 with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) from the perspective of the French national healthcare insurer. Costs associated with Impella 5.0, plus complication-related costs for VA-ECMO or Impella 5.0 from 2019 were included and clinical input data relating to complication rates and time spent on device were sourced from published literature. Extensive scenario and one-way deterministic sensitivity analyses were performed to explore the influence of uncertainty around key input parameters.Results: Over a time horizon of 5 years, the introduction of Impella 5.0 was associated with cumulative savings of EUR 4.3 million. The results were driven by the lower risk of device-related complications associated with Impella 5.0. Savings were apparent from Year 1 onwards, with savings in excess of EUR 375,000 projected in Year 1 alone. On a per-patient level, in Year 1, estimated savings with the introduction of Impella 5.0 totaled EUR 616 per patient. Sensitivity analyses showed that the findings of the analysis were robust.Conclusion: The Impella 5.0 device was associated with cumulative cost savings in excess of EUR 4 million over a 5-year period compared with current practice. Projected savings were driven by a lower rate of device-related complications with Impella 5.0 compared with VA-ECMO.Keywords: cardiogenic shock, left-ventricular assist devices, Impella 5.0®, budget impact, France

Coronary flow rate remains complex to assess in clinical practice using non-invasive, non-ionizing imaging tools. In this study, we introduce 3D ultrafast Doppler coronary angiography (3D UDCA), an ultrasound-based method to assess coronary blood flows in three-dimensions at high volume-rate and in one single heartbeat. We demonstrate that 3D UDCA can visualize the coronary vasculature with high temporal and spatial resolution and quantify the absolute flow. The feasibility of the technique was demonstrated in an open-chest swine model. The flow rate of the left-anterior descending artery (LAD) assessed by 3D UDCA was reconstructed successfully at the early diastolic and late diastolic phases and was in good agreement with an invasive gold-standard flowmeter during baseline, reactive hyperemia and coronary stenosis (r2 = 0.84). Finally, we demonstrate that a coronary stenosis on the LAD can be visualized as well as its associated flow acceleration. [ABSTRACT FROM AUTHOR]

Background Ultrasound Shear Wave Elastography has been widely used in clinical practice to access tissues' stiffness non-invasively. However, the application of this technique to access myocardial stiffness clinically and non-invasively was yet not demonstrated. In this study, we introduce a new prototype for clinical application purposes, the Myocardial Shear Wave Elastography imaging (MSWEi) device. Methods The MSWEi device lays on a linear phased-array probe (2.75-MHz, Vermon S.A., Tours, France) connected to an ultrafast ultrasound scanner (Aixplorer, Supersonic Imagine, Aix-en-Provence, France), a dedicated sequence of Shear Wave Elastography and unfocused emissions at very high frame rate for myocardial stiffness evaluation, and a dedicated graphical user interface for physicians use in clinical settings. Results This prototype was evaluated and validated in-vitro using calibrated mimicking tissue phantoms, providing accurate and robust measurements for tissues' stiffness up to 25 kPa. The device was also validated for stiffness estimation on different thin layers for thickness superior to 5-mm, showing a bias estimation inferior to 15%. Finally, the in-vivo and non-invasive application of the prototype was also evaluated on a patient. Conclusion This study presented a new device to evaluate non-invasively myocardial stiffness using an ultrafast ultrasound scanner in a clinical setting. The in-vivo, non-invasive and clinical feasibility was demonstrated showing the potential of the device to evaluate myocardial stiffness accurately up to 25 KPa and for myocardial wall thickness superior to 5-mm. [ABSTRACT FROM AUTHOR]

Use of sulphur hexafluoride microbubbles (MB) with ultrasound can provide arterial wall enhancement. The use of ultrafast imaging with MB super-localization offers the possibility of ultrasound localization microscopy (ULM) and thus a visualization of in vivo carotid vasa vasorum. We aim to perform in vivo Vasa vasorum imaging in the carotid wall in Takayasu's arteritis and to provide a correlation with the disease's activity. Patients with Takayasu arteritis were consecutively included in the national referral centre. Assessment of activity was performed by NIH activity index, with measurement of biological inflammation, morphological evaluation by computed tomography (CT) angiography, and 18-fluorodeoxyglucose CT scan. Ultrafast ultrasound imaging was performed with a 7 MHz central frequency linear probe. A dedicated contrast imaging sequence (plane waves with 8 angles, frame rate 500 Hz, voltage 8 V, duration of 8 s), coupled with the intravenous injection of sulphur hexafluoride MB allow us to store the raw radio frequency data of the MBpassage. After a pre-processing step to accumulate frames properly including a frames selection and a movement correction, the MB were localized then tracked, allowing reconstruction of the vasa vasorum. The inflammation was quantified through MB tracked and normalized for inter acquisition comparison. Sixteen patients were included. 5 patients (median age 35.8 [24.5–46.0] years, 3 women) had active disease and 11 patients (37.2 [31.7–47.3] years, 9 women) had quiescent disease. The passage of MB allowed the visualisation of microvessels within the arterial wall for active cases (Fig. 1A). The number of MB detected per second in the wall was 118 [80–169] for active cases vs. 13 [10–15] for quiescent cases (P = 0.0005) (Fig. 1B). The sum of the length of the tracks, i.e., the MB path per second of acquisition, was computed with a significant difference between the two groups (43.0 mm [32.9–65.5] in active TA vs. 4.6 mm [2.9–5.4]). ULM allows visualization of microvessels within the carotid wall, with significantly greater MB passage in active Takayasu arteritis. ULM provides for the first time a precise visualization in vivo of the vasa vasorum and gives access to quantification of the vascularity of the arterial wall. [ABSTRACT FROM AUTHOR]

Shear wave imaging (SWI) maps soft tissue elasticity by measuring shear wave propagation with ultrafast ultrasound acquisitions (10 000 frames s−1). This spatiotemporal data can be used as an input for an inverse problem that determines a shear modulus map. Common inversion methods are local: the shear modulus at each point is calculated based on the values of its neighbour (e.g. time-of-flight, wave equation inversion). However, these approaches are sensitive to the information loss such as noise or the lack of the backscattered signal. In this paper, we evaluate the benefits of a global approach for elasticity inversion using a least-squares formulation, which is derived from full waveform inversion in geophysics known as the adjoint method. We simulate an acoustic waveform in a medium with a soft and a hard lesion. For this initial application, full elastic propagation and viscosity are ignored. We demonstrate that the reconstruction of the shear modulus map is robust with a non-uniform background or in the presence of noise with regularization. Compared to regular local inversions, the global approach leads to an increase of contrast (∼+3 dB) and a decrease of the quantification error (∼+2%). We demonstrate that the inversion is reliable in the case when there is no signal measured within the inclusions like hypoechoic lesions which could have an impact on medical diagnosis. [ABSTRACT FROM AUTHOR]