Imricor (United States)

BackgroundInterventional cardiovascular magnetic resonance imaging (MRI) offers real-time, radiation-free guidance for complex procedures such as myocardial ablation, marking a promising advance in electrophysiology. However, further development is limited by challenges in magnetic resonance (MR)-compatible instrument testing, MRI sequence validation, and accurate correlation with histopathology, hindered by the limitations of in vivo tissue evaluation.ObjectiveThis study investigated the feasibility of real-time MR-guided radiofrequency (RF) ablation in an MR-compatible isolated beating pig heart platform and characterized ablation lesions using MRI and histopathology.MethodsA heart from a pig slaughtered for human consumption was prepared under regulatory guidelines and connected to a custom-built, MR-compatible perfusion platform supporting left ventricular function in both Langendorff and working modes. Autologous heparinized blood circulated at physiological pressures and temperatures. MR-guided catheter navigation and RF ablation were performed on a Philips 3T scanner using active catheter tracking. Native T1 and T2 mapping were acquired before and after ablation. Lesions were confirmed by histologic analysis.ResultsRF ablation (50 W, 60 seconds) was successfully performed at 5 left ventricular sites. MRI showed focal reductions in T1 (936 ± 80 ms) surrounded by elevated T1 (1357 ± 18 ms) and T2 values (86 ± 10 ms) compared with nonablated myocardium (T1 1192 ± 26 ms; T2 66 ± 6 ms), consistent with necrosis and edema. Histology confirmed a necrotic core with a surrounding rim showing contraction band necrosis and erythrocyte extravasation.ConclusionThis study demonstrates the feasibility of real-time MR-guided ablation in a beating pig heart platform. The setup allows high-resolution lesion assessment and histologic correlation, supporting future developments in MR-guided therapies.

Abstract Background Fluoroscopy-guided catheter ablation has become the gold standard for treatment of cardiac arrhythmias. High resolution electro-anatomical mapping systems have become fundamental to perform these procedures. Recently, interventional cardiac magnetic resonance (iCMR) has been proposed as an alternative for fluoroscopy to guide atrial flutter ablations. The clinical experience with iCMR and dedicated three-dimensional mapping systems is growing. NorthStar is currently the first available vendor-neutral mapping system. Case summary We performed a real-time CMR-guided cavotricuspid isthmus (CTI) catheter ablation (CA) on a 69-year-old man using a novel mapping system (NorthStar Mapping System, Imricor Medical Systems, MN, USA). Starting from the CMR imaging, a pre-rendered segmentation model was loaded on NorthStar and used to guide the catheters, display voltage and activation maps, show mapping and ablation points. NorthStar can also take full control of the CMR scanner (i.e. start/stop sequences for anatomical information, tissue characterization, and catheter visualization) and communicate with the recorder/stimulator system (Advantage-MR EP, Imricor Medical Systems, MN, USA). With comparable procedural time to standard fluoroscopy-guided CA, CTI bidirectional block was achieved, without any complication. Discussion Using the NorthStar Mapping System, we managed to achieve a successful CMR-guided CTI ablation without any complication. Its further use should be explored, especially in more complex arrhythmias where a substrate-guided ablation is critical, as it could significantly improve results in terms of arrhythmia recurrence.

The MIGRATE (MrI Guided RegenerAtive ThErapy) consortium is a combined scientific and industrial effort to establish an MRIguided intramyocardial injection platform. By collaborating within the MIGRATE consortium we were able to combine state-of-theart interventional imaging hardware, software, MRI-compatible catheters, and biomaterials. In this pilot study, we demonstrated the feasibility of intramyocardial injections of an MRI-visible biomaterial by interventional MRI using a combination of active tracking and passive visualisation.

RF-induced heating of ablation catheters under 1.5T magnetic resonance image (MRI) is studied using combined computational modeling and bench testing. The transfer function of ablation catheters are measured experimentally without simplification. A high-resolution anatomical human model was then used to simulate clinical MRI RF exposure environment. The upper limit of the temperature rise was calculated around two types of catheters, namely a single wire catheter and twin wire catheter. Four different insertion depths between 17.5 cm to 70 cm inside human body model were evaluated, simulating procedure for brain or cardiac ablation. A temperature hotspot was observed around the tip of the catheter with an estimated maximum temperature rise higher than 100oC for the single lead catheter and around 94oC for twin lead catheter, with patient landmark varying from −200 mm to 1000 mm with respect to human eye-center. Three experiments were conducted in a standard phantom to validate this coupled method and it showed a good agreement between direct measurements and predicted heating results.

This study aims at a systematic assessment of five computational models of a birdcage coil for magnetic resonance imaging (MRI) with respect to accuracy and computational cost. The models were implemented using the same geometrical model and numerical algorithm, but different driving methods (i.e., coil "defeaturing"). The defeatured models were labeled as: specific (S2), generic (G32, G16), and hybrid (H16, [Formula: see text]). The accuracy of the models was evaluated using the "symmetric mean absolute percentage error" ("SMAPE"), by comparison with measurements in terms of frequency response, as well as electric ( ||→E||) and magnetic ( || →B ||) field magnitude. All the models computed the || →B || within 35% of the measurements, only the S2, G32, and H16 were able to accurately model the ||→E|| inside the phantom with a maximum SMAPE of 16%. Outside the phantom, only the S2 showed a SMAPE lower than 11%. Results showed that assessing the accuracy of || →B || based only on comparison along the central longitudinal line of the coil can be misleading. Generic or hybrid coils - when properly modeling the currents along the rings/rungs - were sufficient to accurately reproduce the fields inside a phantom while a specific model was needed to accurately model ||→E|| in the space between coil and phantom. Computational modeling of birdcage body coils is extensively used in the evaluation of radiofrequency-induced heating during MRI. Experimental validation of numerical models is needed to determine if a model is an accurate representation of a physical coil.

Summary In recent years MRI-guided interventional electrophysiology (EP) has rapidly emerged as a promising alternative to conventional X-ray guided ablation. We present a novel MRI-compatible electrophysiologic ablation and recording system, performing realistic biatrial simulated procedures. Background To date, preclinical studies evaluating MRI-guided ablation have used non-irrigated catheters limited to test lesions in the right heart. Modern complex EP procedures require externally irrigated catheters to produce adequate lesion depth. We present the first feasibility study of an externally-irrigated MRI-compatible ablation catheter, and integrated EP pacing and recording system. We demonstrate the feasibility of pulmonary vein (PV) and cavotricuspid isthmus (CTI) ablation, the targets of ablation in atrial fibrillation and typical atrial flutter respectively. Methods An externally irrigated MRI-compatible ablation and diagnostic electrophysiology catheters and integrated EP recording system (Imricor Medical Systems, Burnsville, MN) were tested in n=11 sheep, in a 1.5T MRI scanner. The diagnostic catheters were placed in the coronary sinus, and right ventricula ra pex. Power controlled (40W, 120 second duration) lesions were formed at the pulmonary veins and cavotricuspid isthmus with the ablation catheter. Real-time intracardiac electrograms were recorded during MR imaging. Steady state free precession (SSFP) non-breath-hold images were repeatedly acquired to guide the catheter to the target region using passive catheter tracking. Markers in the catheter were used to ensure adequate visualization of the catheter. Lesion visualization was performed using both noncontrast (T2-weighted turbo spin echo pulse sequence) and gadolinium-DTPA enhanced T1-weighted imaging (inversion-recovery gradient echo pulse sequence).