Automated rhythm-based control of radiofrequency ablation close to the atrioventricular node: Preclinical, animal, and first-in-human testing

Abstract

The risk of heart block during radiofrequency ablation of atrioventricular (AV) nodal reentrant tachycardia and septal accessory pathways is minimized by rapidly ceasing ablation in response to markers of risk, such as atrioventricular dissociation, fast junctional rhythm, PR interval prolongation, or 2 consecutive atrial or ventricular depolarizations. Currently this is done manually. The objectives of this study were to build and test a control system able to monitor cardiac rhythm and automatically terminate ablation energy when required. The device was built from off-shelf componentry. Preclinical testing involved real-time input of electrogram/electrocardiogram data from 209 ablation procedures (20 patients) over slow (n = 19) and fast (n = 1) AV nodal pathways. The device response speed was compared with the human response speed. The device's ability to prevent heart block was tested in 5 sheep. First-in-human testing was then performed in 12 patients undergoing AV nodal reentrant tachycardia ablation. Risk conditions necessitating shutoff of ablation (200 total; 111 preclinical and 89 first-in-human) were detected by the device with 100% sensitivity and 94% specificity, automatically terminating ablation while still allowing successful ablation in all patients. Device shutoff of ablation was always faster than human response (median difference 1.24 seconds). In each of 5 sheep, 40 consecutive attempts to cause heart block by ablating over the His bundle were unsuccessful because of automatic shutoff in response to rhythm change. Automated shutoff of ablation close to the AV node in response to markers of the risk of heart block is feasible with high accuracy as well as faster response than human response. The system may improve the safety of ablation near the AV node by preventing heart block.