Development, Preclinical Validation, and Clinical Translation of a Cardiac Magnetic Resonance - Electrophysiology System With Active Catheter Tracking for Ablation of Cardiac Arrhythmia.

OBJECTIVES: This study sought to develop an actively tracked cardiac magnetic resonance-guided electrophysiology (CMR-EP) system and perform first-in-human clinical ablation procedures. BACKGROUND: CMR-EP offers high-resolution anatomy, arrhythmia substrate, and ablation lesion visualization in the absence of ionizing radiation. Implementation of active tracking, where catheter position is continuously transmitted in a manner analogous to electroanatomic mapping (EAM), is crucial for CMR-EP to take the step from theoretical technology to practical clinical tool. METHODS: The setup integrated a clinical 1.5-T scanner, an EP recording and ablation system, and a real-time image guidance platform with components undergoing ex vivo validation. The full system was assessed using a preclinical study (5 pigs), including mapping and ablation with histological validation. For the clinical study, 10 human subjects with typical atrial flutter (age 62 ± 15 years) underwent MR-guided cavotricuspid isthmus (CTI) ablation. RESULTS: The components of the CMR-EP system were safe (magnetically induced torque, radiofrequency heating) and effective in the CMR environment (location precision). Targeted radiofrequency ablation was performed in all animals and 9 (90%) humans. Seven patients had CTI ablation completed using CMR guidance alone; 2 patients required completion under fluoroscopy, with 2 late flutter recurrences. Acute and chronic CMR imaging demonstrated efficacious lesion formation, verified with histology in animals. Anatomic shape of the CTI was an independent predictor of procedural success. CONCLUSIONS: CMR-EP using active catheter tracking is safe and feasible. The CMR-EP setup provides an effective workflow and has the potential to change the way in which ablation procedures may be performed.

Evaluation of the RF heating of a generic deep brain stimulator exposed in 1.5 T magnetic resonance scanners.

The radio frequency (RF) electromagnetic field of magnetic resonance (MR) scanners can result in significant tissue heating due to the RF coupling with the conducting parts of medical implants. The objective of this article is to evaluate the advantages and shortcomings of a new four-tier approach based on a combined numerical and experimental procedure, designed to demonstrate safety of implants during MR scans. To the authors' best knowledge, this is the first study analyzing this technique. The evaluation is performed for 1.5 T MR scanners using a generic model of a deep brain stimulator (DBS) with a straight lead and a helical lead. The results show that the approach is technically feasible and provides sound and conservative information about the potential heating of implants. We demonstrate that (1) applying optimized tools results in reasonable uncertainties for the overall evaluation; (2) each tier reduces the overestimation by several dB at the cost of more demanding evaluation steps; (3) the implant with the straight lead would cause local temperature increases larger than 18 °C at the RF exposure limit for the normal operating mode; (4) Tier 3 is not sufficient for the helical implant; and (5) Tier 4 might be too demanding to be performed for complex implants. We conclude with a suggestion for a procedure that follows the same concept but is between Tier 3 and 4. In addition, the evaluation of Tier 3 has shown consistency with current scan practice, namely, the resulting heat at the lead tip is less than 3.5 °C for the straight lead and 0.7 °C for the helix lead for scans at the current applied MR scan restrictions for deep brain stimulation at a head average SAR of 0.1 W/kg.