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.

Determinants of gradient field-induced current in a pacemaker lead system in a magnetic resonance imaging environment.

BACKGROUND: The determinants of low-frequency-induced current by magnetic resonance imaging (MRI) gradient fields in a pacemaker lead system are largely unknown. OBJECTIVE: The purpose of this study was to determine the magnitude of MRI low-frequency-induced current in an implanted pacemaker lead system and to investigate in vivo determinants of low-frequency-induced current in an animal model. METHODS: Six mongrel dogs underwent conventional single-chamber pacemaker implantation with a current recorder connected in series. Pulse generator (PG) was programmed to VOO 120 bpm with subthreshold output. MRI was performed in a 1.5-T scanner. Low-frequency-induced current was recorded during unipolar pacing, bipolar pacing, and bipolar pacing with the PG case electrically isolated from the pocket. In each mode, low-frequency-induced current was recorded with and without a large loop of additional lead connected in series. RESULTS: With a conventional implant, low-frequency-induced current was < or =0.5 mA in all three pacing modes. With five external loops, the magnitude of low-frequency-induced current increased to >30 mA, with consistent myocardial capture in unipolar and bipolar pacing. However, in bipolar pacing with the PG electrically isolated from the pocket, low-frequency-induced current decreased to <0.5 mA with no myocardial capture even with additional looped leads. CONCLUSION: Under conventional implant conditions, the magnitude of low-frequency-induced current is <0.5 mA and is unlikely to cause myocardial capture; however, arrhythmia induction cannot be excluded. With sufficient increase in effective loop area (additional looped leads), direct myocardial capture by the low-frequency-induced current is possible. In this study, breaking the return pathway by electrically isolating the PG case from the circuit abolished low-frequency-induced current.