Validation of a novel stand-alone software tool for image guided cardiac catheter therapy

Abstract

Comparison of the targeting accuracy of a new software method for MRI-fluoroscopy guided endomyocardial interventions with a clinically available 3D endocardial electromechanical mapping system. The new CARTBox2 software enables therapy target selection based on infarction transmurality and local myocardial wall thickness deduced from preoperative MRI scans. The selected targets are stored in standard DICOM datasets. Fusion of these datasets with live fluoroscopy enables real-time visualization of MRI defined targets during fluoroscopy guided interventions without the need for external hardware. In ten pigs (60–75 kg), late gadolinium enhanced (LGE) MRI scans were performed 4 weeks after a 90-min LAD occlusion. Subsequently, 10–16 targeted fluorescent biomaterial injections were delivered in the infarct border zone (IBZ) using either the NOGA 3D-mapping system or CARTBox2. The primary endpoint was the distance of the injections to the IBZ on histology. Secondary endpoints were total procedure time, fluoroscopy time and dose, and the number of ventricular arrhythmias. The average distance of the injections to the IBZ was similar for CARTBox2 (0.5 ± 3.2 mm) and NOGA (− 0.7 ± 2.2 mm; p = 0.52). Injection procedures with CARTBox2 and NOGA required 69 ± 12 and 60 ± 17 min, respectively (p = 0.36). The required endocardial mapping procedure with NOGA prior to injections, leads to a significantly longer total procedure time (p < 0.001) with NOGA. Fluoroscopy time with NOGA (18.7 ± 11.0 min) was significantly lower than with CARTBox2 (43.4 ± 6.5 min; p = 0.0003). Procedures with CARTBox2 show a trend towards less ventricular arrhythmias compared to NOGA. CARTBox2 is an accurate and fast software-only system to facilitate cardiac catheter therapy based on gold standard MRI imaging and live fluoroscopy.Electronic supplementary materialThe online version of this article (10.1007/s10554-019-01541-9) contains supplementary material, which is available to authorized users.

Interventional cardiac magnetic resonance imaging: current applications, technology readiness level, and future perspectives

“…Intramyocardial injections have been performed successfully under real-time MR guidance in animals by several authors. 50 – 52 However, the limited clinical application of stem cell therapy in ischemic heart disease limits the requirement of interventional CMR for this purpose.…”

“…Carlsson and Saeed, 49 Krombach et al, 50 Tomkowiak et al, 51 van Es et al 52 Pericardiocentesis TRL 5…”

Role of Digital Health During Coronavirus Disease 2019 Pandemic and Future Perspectives

“…There has been development of integrating fluoroscopy and electro-anatomical mapping with MRI is possible with ML. [ 23 , 24 ]…”

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“…In the paper by van Es et al, a novel stand-alone software tool was presented and validated for image guided cardiac ablation therapy in an animal study including 10 pigs [4]. The new CARTBox2 software enables therapy target selection based on infarction transmurality and local wall thickness measurements derived from preoperative MRI scans.…”