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Background: Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue., Methods: This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596., Findings: 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm 2 (SD 0·19) at baseline to 0·64 cm 2 (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias., Interpretation: This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible., Funding: Cardiawave., Competing Interests: Declaration of interests EM, AI, DT-Z, EP, BC, JH, RK, MvG, DT, VM, and GG are investigators of the study. EM reports being a co-founder and scientific advisory board member of, and holding shares in Cardiawave. DT-Z reports honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Pfizer, Hemofarm, and Amicus Therapeutics; support to attend meetings from and participation in data safety monitoring and advisory boards for Boehringer Ingelheim; and being the President of the Echocardiographic Society of Serbia. MT and MP are co-founders of and hold shares in Cardiawave. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Calcific aortic stenosis (CAS) is associated with advanced age and comorbidities, therefore a non-invasive therapy for it would be beneficial. We previously demonstrated that ultrasound therapy improved calcified bioprosthetic valve function in an open chest model. For translational applications, we tested non-invasive ultrasound therapy (NIUT) transthoracically on swine aortic valves and investigated the need for antithrombotic treatment as a follow-up. Primary objective: feasibility and safety of NIUT. Secondary objectives: occurrence, severity and evolution of side effects during therapy and at 1 month follow-up. The device (Valvosoft, Cardiawave) consisted of an electronically steered multi-element transducer and a 2D echocardiographic probe. Three groups of swine received treatment on aortic valves: NIUT (group 1; n = 10); NIUT and 1 month antithrombotic treatment (group 2; n = 5); sham group (group 3; n = 4). Feasibility was successfully reached in all treated swine (n = 15) and no life-threatening arrhythmia were detected. Non-sustained ventricular tachycardia occurred during the procedure in seven swine. Decrease or interruption of NIUT ended arrhythmia. Histopathology revealed no valve or surrounding tissue damage and echocardiography revealed no valvular dysfunction. Only one animal had side effects [right ventricle (RV) dilatation], but the RV normalized after therapy cessation with no sequelae at follow-up. No disturbance in biological markers nor valve thrombosis were observed at follow-up. Antithrombotic treatment did not demonstrate any advantage. Survival at 30 d was 100%. We demonstrated, in vivo, the feasibility and safety of transthoracic NIUT on aortic valves in a swine model without serious adverse events. We expect this first-time transthoracic delivery of NIUT to pave the way towards a new non-invasive approach to valve softening in human CAS to restore valve function.

Ultrasound shock wave therapy is increasingly used for non-invasive surgery. It requires the focusing of very high pressure amplitude in precisely controlled focal spots. In transcostal therapy of the heart or the liver, the high impedance mismatch between the bones and surrounding tissues gives rise to strong aberrations and attenuation of the therapeutic wavefront, with potential risks of injury at the tissue-bone interface. An adaptive propagation of the ultrasonic beam through the intercostal spaces would be required. Several solutions have been developed so far, but they require a prior knowledge of the patient's anatomy or an invasive calibration process, not applicable in clinic. Here, we develop a non-invasive adaptive focusing method for ultrasound therapy through the ribcage using a time reversal cavity (TRC) acting as an ultrasonic beam amplifier. This method is based on ribcage imaging through the TRC and a projection orthogonally to the strongest identified reflectors. The focal pressure of our device was improved by up to 30% using such self-adaptive processing, without degrading the focal spots size and shape. This improvement allowed lesion formation in an Ultracal ® phantom through a ribcage without invasive calibration of the device. This adaptive method could be particularly interesting to improve the efficiency and the safety of pulsed cavitational therapy of the heart or the liver.

Time reversal cavities (TRC) have been proposed as an efficient approach for 3D ultrasound therapy. They allow the precise spatio-temporal focusing of high-power ultrasound pulses within a large region of interest with a low number of transducers. Leaky TRCs are usually built by placing a multiple scattering medium, such as a random rod forest, in a reverberating cavity, and the final peak pressure gain of the device only depends on the temporal length of its impulse response. Such multiple scattering in a reverberating cavity is a complex phenomenon, and optimisation of the device's gain is usually a cumbersome process, mostly empirical, and requiring numerical simulations with extremely long computation times. In this paper, we present a semi-analytical model for the fast optimisation of a TRC. This model decouples ultrasound propagation in an empty cavity and multiple scattering in a multiple scattering medium. It was validated numerically and experimentally using a 2D-TRC and numerically using a 3D-TRC. Finally, the model was used to determine rapidly the optimal parameters of the 3D-TRC which had been confirmed by numerical simulations.

Object: This work aimed at evaluating the accuracy of MR-guided high-intensity focused ultrasound (MRgHIFU) brain therapy in human cadaver heads., Methods: Eighteen heads of fresh human cadavers were removed with a dedicated protocol preventing intracerebral air penetration. The MR images allowed determination of the ultrasonic target: a part of the thalamic nucleus ventralis intermedius implicated in essential tremor. Osseous aberrations were corrected with simulation-based time reversal by using CT data from the heads. The ultrasonic session was performed with a 512-element phased-array transducer system operating at 1 MHz under stereotactic conditions with thermometric real-time MR monitoring performed using a 1.5-T imager., Results: Dissection, imaging, targeting, and planning have validated the feasibility of this human cadaver model. The average temperature elevation measured by proton resonance frequency shift was 7.9°C ± 3°C. Based on MRI data, the accuracy of MRgHIFU is 0.4 ± 1 mm along the right/left axis, 0.7 ± 1.2 mm along the dorsal/ventral axis, and 0.5 ± 2.4 mm in the rostral/caudal axis., Conclusions: Despite its limits (temperature, vascularization), the human cadaver model is effective for studying the accuracy of MRgHIFU brain therapy. With the 1-MHz system investigated here, there is millimetric accuracy.

Recent studies have demonstrated the feasibility of transcostal high intensity focused ultrasound (HIFU) treatment in liver. However, two factors limit thermal necrosis of the liver through the ribs: the energy deposition at focus is decreased by the respiratory movement of the liver and the energy deposition on the skin is increased by the presence of highly absorbing bone structures. Ex vivo ablations were conducted to validate the feasibility of a transcostal real-time 3D movement tracking and correction mode. Experiments were conducted through a chest phantom made of three human ribs immersed in water and were placed in front of a 300 element array working at 1 MHz. A binarized apodization law introduced recently in order to spare the rib cage during treatment has been extended here with real-time electronic steering of the beam. Thermal simulations have been conducted to determine the steering limits. In vivo 3D-movement detection was performed on pigs using an ultrasonic sequence. The maximum error on the transcostal motion detection was measured to be 0.09 ± 0.097 mm on the anterior-posterior axis. Finally, a complete sequence was developed combining real-time 3D transcostal movement correction and spiral trajectory of the HIFU beam, allowing the system to treat larger areas with optimized efficiency. Lesions as large as 1 cm in diameter have been produced at focus in excised liver, whereas no necroses could be obtained with the same emitted power without correcting the movement of the tissue sample.

The clinical applicability of high-intensity focused ultrasound (HIFU) for noninvasive therapy is currently hampered by the lack of robust and real-time monitoring of tissue damage during treatment. The goal of this study is to show that the estimation of local tissue elasticity from shear wave imaging (SWI) can lead to a precise mapping of the lesion. HIFU treatment and monitoring were respectively performed using a confocal setup consisting of a 2.5-MHz single element transducer focused at 34 mm on ex vivo samples and an 8-MHz ultrasound diagnostic probe. Ultrasound-based strain imaging was combined with shear wave imaging on the same device. The SWI sequences consisted of 2 successive shear waves induced at different lateral positions. Each wave was created with pushing beams of 100 μs at 3 depths. The shear wave propagation was acquired at 17,000 frames/s, from which the elasticity map was recovered. HIFU sonications were interleaved with fast imaging acquisitions, allowing a duty cycle of more than 90%. Thus, elasticity and strain mapping was achieved every 3 s, leading to real-time monitoring of the treatment. When thermal damage occurs, tissue stiffness was found to increase up to 4-fold and strain imaging showed strong shrinkages that blur the temperature information. We show that strain imaging elastograms are not easy to interpret for accurate lesion characterization, but SWI provides a quantitative mapping of the thermal lesion. Moreover, the concept of shear wave thermometry (SWT) developed in the companion paper allows mapping temperature with the same method. Combined SWT and shear wave imaging can map the lesion stiffening and temperature outside the lesion, which could be used to predict the eventual lesion growth by thermal dose calculation. Finally, SWI is shown to be robust to motion and reliable in vivo on sheep muscle.

Recent studies have demonstrated the feasibility of transcranial high-intensity focused ultrasound (HIFU) therapy in the brain using adaptive focusing techniques. However, the complexity of the procedures imposes provision of accurate targeting, monitoring and control of this emerging therapeutic modality in order to ensure the safety of the treatment and avoid potential damaging effects of ultrasound on healthy tissues. For these purposes, a complete workflow and setup for HIFU treatment under magnetic resonance (MR) guidance is proposed and implemented in rats. For the first time, tissue displacements induced by the acoustic radiation force are detected in vivo in brain tissues and measured quantitatively using motion-sensitive MR sequences. Such a valuable target control prior to treatment assesses the quality of the focusing pattern in situ and enables us to estimate the acoustic intensity at focus. This MR-acoustic radiation force imaging is then correlated with conventional MR-thermometry sequences which are used to follow the temperature changes during the HIFU therapeutic session. Last, pre- and post-treatment magnetic resonance elastography (MRE) datasets are acquired and evaluated as a new potential way to non-invasively control the stiffness changes due to the presence of thermal necrosis. As a proof of concept, MR-guided HIFU is performed in vitro in turkey breast samples and in vivo in transcranial rat brain experiments. The experiments are conducted using a dedicated MR-compatible HIFU setup in a high-field MRI scanner (7 T). Results obtained on rats confirmed that both the MR localization of the US focal point and the pre- and post-HIFU measurement of the tissue stiffness, together with temperature control during HIFU are feasible and valuable techniques for efficient monitoring of HIFU in the brain. Brain elasticity appears to be more sensitive to the presence of oedema than to tissue necrosis.

Brain treatment through the skull with high-intensity focused ultrasound can be achieved with multichannel arrays and adaptive focusing techniques such as time reversal. This method requires a reference signal to be either emitted by a real source embedded in brain tissues or computed from a virtual source, using the acoustic properties of the skull derived from computed tomography images. This noninvasive computational method focuses with precision, but suffers from modeling and repositioning errors that reduce the accessible acoustic pressure at the focus in comparison with fully experimental time reversal using an implanted hydrophone. In this paper, this simulation-based targeting has been used experimentally as a first step for focusing through an ex vivo human skull at a single location. It has enabled the creation of a cavitation bubble at focus that spontaneously emitted an ultrasonic wave received by the array. This active source signal has allowed 97 +/- 1.1% of the reference pressure (hydrophone-based) to be restored at the geometrical focus. To target points around the focus with an optimal pressure level, conventional electronic steering from the initial focus has been combined with bubble generation. Thanks to step-by-step bubble generation, the electronic steering capabilities of the array through the skull were improved.

A non-invasive protocol for transcranial brain tissue ablation with ultrasound is studied and validated in vitro. The skull induces strong aberrations both in phase and in amplitude, resulting in a severe degradation of the beam shape. Adaptive corrections of the distortions induced by the skull bone are performed using a previous 3D computational tomography scan acquisition (CT) of the skull bone structure. These CT scan data are used as entry parameters in a FDTD (finite differences time domain) simulation of the full wave propagation equation. A numerical computation is used to deduce the impulse response relating the targeted location and the ultrasound therapeutic array, thus providing a virtual time-reversal mirror. This impulse response is then time-reversed and transmitted experimentally by a therapeutic array positioned exactly in the same referential frame as the one used during CT scan acquisitions. In vitro experiments are conducted on monkey and human skull specimens using an array of 300 transmit elements working at a central frequency of 1 MHz. These experiments show a precise refocusing of the ultrasonic beam at the targeted location with a positioning error lower than 0.7 mm. The complete validation of this transcranial adaptive focusing procedure paves the way to in vivo animal and human transcranial HIFU investigations.

Bursts of focused ultrasound energy a billion times more intense than diagnostic ultrasound have become a non-invasive option for tumor ablation, from prostate cancer to uterine fibroid, during the last decade. Despite this progress, many issues still need to be addressed. First, for brain targeting, the correction of distortions induced by the skull remains today a technological achievement that still needs to be validated clinically. Secondly, the problem of motion artifacts for abdominal treatments becomes today an important research topic. For all these issues, the potential of new ultrasonic therapy devices able to work both in Transmit and Receive modes will be emphasized and clinical results on monkeys and pigs will be presented.

Bursts of focused ultrasound energy a thousand times more intense than diagnostic ultrasound have become a non-invasive option for treating cancer, from breast to prostate or uterine fibroid, during the last decade. Despite this progress, many issues still need to be addressed. First, the distortions caused by defocusing obstacles, such as the skull or ribs, on the ultrasonic therapeutic beam are still being investigated. Multi-element transducer technology must be used in order to achieve such transcranial or transcostal adaptive focusing. Second, the problem of motion artifacts, a key component in the treatment of abdominal lesions, has been shown significantly to influence the efficacy and treatment time. Though many methods have been proposed for the detection of organ motion, little work has been done to develop a comprehensive solution including motion tracking and feedback correction in real time. This paper is a review of the work achieved by authors in transcranial high-intensity focused ultrasound (HIFU), transcostal HIFU and motion compensated HIFU. For these three issues, the optimal solution can be reached using the same technology of multi-element transducers devices able to work both in transmit and receive modes.

Bursts of focused ultrasound energy three orders of magnitude more intense than diagnostic ultrasound became during the last decade a noninvasive option for treating cancer from breast to prostate or uterine fibroid. However, many challenges remain to be addressed. First, the corrections of distortions induced on the ultrasonic therapy beam during its propagation through defocusing obstacles like skull bone or ribs remain today a technological performance that still need to be validated clinically. Secondly, the problem of motion artifacts particularly important for the treatment of abdominal parts becomes today an important research topic. Finally, the problem of the treatment monitoring is a wide subject of interest in the growing HIFU community. For all these issues, the potential of new ultrasonic therapy devices able to work both in Transmit and Receive modes will be emphasized. A review of the work under achievement at L.O.A. using this new generation of HIFU prototypes on the monitoring, motion correction and aberrations corrections will be presented.

The feasibility of blood-brain barrier (BBB) opening in the hippocampus of wild-type mice using focused ultrasound (FUS) through the intact skull and skin was investigated. Needle hydrophone measurements through ex vivo skulls revealed minimal attenuation ( approximately 18% of the pressure amplitude), a well-focused beam pattern and minute focus displacement through the parietal bone. In experiments in vivo, the brains of three mice were sonicated transcranially. Pulsed ultrasound sonications at 1.5 MHz and acoustic pressures ranging from 0.8 to 2.7 MPa were used at 20% duty cycle. Before sonication, a bolus of 10 microL of an ultrasound contrast agents (Optison) was injected intravenously. Contrast-enhanced high-resolution magnetic resonance imaging (9.4 T) revealed BBB opening and allowed for the monitoring of the slow permeation of gadolinium in the hippocampus. The region of the brain where BBB opening occurred increased with the pressure amplitude. These findings thus demonstrated the feasibility of locally opening the BBB in mice using FUS through intact skull and skin and serve as the first step in determining and assessing feasibility of drug delivery to specific regions in the mouse brain using FUS.

The harmonic motion imaging (HMI) technique for simultaneous monitoring and generation of ultrasound therapy using two separate focused ultrasound transducer elements was previously demonstrated. In this study, a new HMI technique is described that images tissue displacement induced by a harmonic radiation force using a single focused-ultrasound element. A wave propagation simulation model first indicated that, unlike in the two-beam configuration, the amplitude-modulated beam produced a stable focal zone for the applied harmonic radiation force. The AM beam thus offered the unique advantage of sustaining the application of the spatially-invariant radiation force. Experiments were performed on gelatin phantoms and ex vivo tissues. The radiation force was generated by a 4.68 MHz focused ultrasound (FUS) transducer using a 50 Hz amplitude-modulated wave. A 7.5 MHz pulse-echo transducer was used to acquire rf echoes during the application of the harmonic radiation force. Consecutive rf echoes were acquired with a pulse repetition frequency (PRF) of 6.5 kHz and 1D cross-correlation was performed to estimate the resulting axial tissue displacement. The HMI technique was shown capable of estimating stiffness-dependent displacement amplitudes. Finally, taking advantage of the real-time capability of the HMI technique, temperature-dependent measurements enabled monitoring ofHIFU sonication in ex vivo tissues. The new HMI method may thus enable a highly-localized force and stiffness-dependent measurements as well as real-time and low-cost HIFU monitoring.

Brain therapy using focused ultrasound remains very limited due to the strong aberrations induced by the skull. A technique using time-reversal was validated recently in-vivo on 20 sheep. The principal handicap of this technique is the need of an hydrophone at the focal point for the first step of the time-reversal procedure, which is minimally invasive but lightly traumatizing. A completely noninvasive therapy requires a reliable model of the acoustical properties of the skull in order to simulate this first step. 3-D simulations based on high-resolution CT images of a skull have been successfully performed with a finite differences code developed in our Laboratory. Thanks to the skull porosity, directly extracted from the CT images, we reconstructed acoustic speed, density and absorption maps and performed the computation. Computed wavefronts are in good agreement with experimental wavefronts acquired through the same part of the skull and this technic was validated in-vitro in the laboratory. A stereotactic frame has been designed and built in order to perform non invasive transcranial focusing. Here we will describe all the steps of our new protocol, from the CT-scans to the therapy treatment and the first in vivo results on monkeys will be presented. This protocol is based on protocols already existing in radiotherapy.

A method for tracking locally the 3D motion of biological tissues is developed and applied to the correction of motion during high intensity focused ultrasound (HIFU) therapy. The motion estimation technique is based on an accurate ultrasonic speckle tracking method. A pulse-echo sequence is performed for a subset of the transducers of a phased array. For each of these sub-apertures, the displacement is estimated by computing the 1D cross-correlation of the backscattered signals acquired at two consecutive times. The local 3D motion vector is then computed using a inversion algorithm. This technique is experimentally validated in vivo on anesthetized pigs. The 3D motion of liver tissues is tracked in real-time. The technique is combined with HIFU sequences and a real-time feedback correction of the HIFU beam is achieved by adjusting the delays of each channel. The sonications "locked on target" are interleaved with very motion estimation sequences.

A method for tracking the 3-D motion of tissues in real-time is combined with a 2-D high-intensity focused ultrasound (US), or HIFU, multichannel system to correct for respiratory motion during HIFU therapy. Motion estimation is based on an accurate ultrasonic speckle-tracking method. A pulse-echo sequence is performed for a subset of the transducers of the phased array. For each of these subapertures, the displacement is estimated by computing the 1-D cross-correlation of the backscattered signals acquired at two different times. The 3-D motion vector is then computed by a triangulation algorithm. This technique is experimentally validated in phantoms moving as fast as 40 mm s(-1), and combined with HIFU sequences. A real-time feedback correction of the HIFU beam is achieved by adjusting the delays of each channel. The sonications "locked on target" are interleaved with very short motion-estimation sequences. Finally, in vitro experiments of "locked on target" HIFU therapy are performed in fresh moving tissues.

The feasibility of temperature estimation during high-intensity focused ultrasound therapy using pulse-echo diagnostic ultrasound data has been demonstrated. This method is based upon the measurement of thermally-induced modifications in backscattered RF echoes due to thermal expansion and local changes in the speed of sound. It has been shown that strong ripple artifacts due to the thermo-acoustic lens effect severely corrupt the temperature estimates behind the heated region. We propose here a new imaging technique that improves the temperature estimation behind the heated region and reduces the variance of the temperature estimates in the entire image. We replaced the conventional beamforming on transmit with multiple steered plane wave insonifications using several subapertures. A two-dimensional temperature map is estimated from axial displacement maps between consecutive RF images of identically steered plane wave insonifications. Temperature estimation is then improved by averaging the two-dimensional maps from the multiple steered plane wave insonifications. Experiments were conducted in a tissue-mimicking gelatin-based phantom and in fresh bovine liver.

Thermally-induced lesions are generally stiffer than surrounding tissues. We propose here to use the supersonic shear imaging technique (SSI) for monitoring high-intensity focused ultrasound (HIFU) therapy. This new elasticity imaging technique is based on remotely creating shear sources using an acoustic radiation force at different locations in the medium. In these experiments, an HIFU probe is used to generate lesions in fresh tissue samples. A diagnostic transducer, controlled by our ultrafast scanner, is located in the therapeutic probe focal plane. It is used for both generating the shear waves and imaging the resulting propagation at frame rates reaching 5,000 images/s. Movies of the shear wave propagation can be computed off-line. The therapeutic and imaging sequences are interleaved and a set of wave propagation movies is performed during the heating process. From each movie, elasticity estimations have been performed using an inversion algorithm. It demonstrates the feasibility of detecting and quantifying the hardness of HIFU-induced lesions using SSI.

A sparse phased array is specially designed for non-invasive ultrasound transskull brain therapy. The array is made of 200 single elements corresponding to a new generation of high power transducers developed in collaboration with Imasonic (Besançon, France). Each element has a surface of 0.5 cm2 and works at 0.9 MHz central frequency with a maximum 20 W cm(-2) intensity on the transducer surface. In order to optimize the steering capabilities of the array, several transducer distributions on a spherical surface are simulated: hexagonal, annular and quasi-random distributions. Using a quasi-random distribution significantly reduces the grating lobes. Furthermore, the simulations show the capability of the quasi-random array to electronically move the focal spot in the vicinity of the geometrical focus (up to +/- 15 mm). Based on the simulation study, the array is constructed and tested. The skull aberrations are corrected by using a time reversal mirror with amplitude correction achieved thanks to an implantable hydrophone, and a sharp focus is obtained through a human skull. Several lesions are induced in fresh liver and brain samples through human skulls, demonstrating the accuracy and the steering capabilities of the system.

Developing minimally invasive brain surgery by high-intensity focused ultrasound beams is of great interest in cancer therapy. However, the skull induces strong aberrations both in phase and amplitude, resulting in a severe degradation of the beam shape. Thus, an efficient brain tumor therapy would require an adaptive focusing, taking into account the effects of the skull. In this paper, we will show that the acoustic properties of the skull can be deduced from high resolution CT scans and used to achieve a noninvasive adaptive focusing. Simulations have been performed with a full 3-D finite differences code, taking into account all the heterogeneities inside the skull. The set of signals to be emitted in order to focus through the skull can thus be computed. The complete adaptive focusing procedure based on prior CT scans has been experimentally validated. This could have promising applications in brain tumor hyperthermia but also in transcranial ultrasonic imaging.

Atrial fibrillation is associated with increased risk of stroke and heart failure. Currently it can be treated with minimally invasive radio-frequency catheter ablation. However, the lack of monitoring and assessment of the transmural extent of the lesion currently limits the success rate of this technique. In this study we have developed a novel dual-mode intracardiac echocardiography catheter capable of performing ultrasound imaging and high-intensity focused ultrasound ablation. Using the same device we demonstrate in vivo the feasibility of intracardiac shear-wave elastography to evaluate thermal ablation as well as the feasibility of creating transmural and linear lesions (up to 10-mm wide) in the atrial wall. [ABSTRACT FROM AUTHOR]