Characterization of high-density mapping in catheter ablation for persistent atrial fibrillation: results from the Advisor™ HD Grid Mapping Catheter Observational study

Abstract

Background We quantified and characterized the outcomes of ablation in persistent atrial fibrillation (PersAF) subjects, and the utility of electroanatomical mapping with a market-released high-density (HD) mapping catheter. Methods PersAF subjects received electroanatomical mapping with the Advisor™ HD Grid mapping catheter, Sensor Enabled™ (HD Grid) and radiofrequency (RF) ablation to gather data regarding ablation strategies, mapping efficiency, quality, and outcomes. Subjects were enrolled from January 2019 to April 2020 across 25 international sites and followed for 12 months after the procedure. Results Three hundred thirty-four PersAF subjects (average age 64.2 years; 76% male; 25.4% previous AF ablation) were enrolled. Multiple map types were generated in a variety of rhythms using HD Grid. Significant differences in low voltage areas were identified in maps generated with the HD Wave Solution™ electrode configuration when compared to the standard configuration, which in some cases, influenced physicians’ ablation strategies. PV-only ablation strategy was used in 59.0% of subjects and 34.1% of subjects received PV ablation and additional lesions. Of the subjects, 82.0% were free from recurrent atrial arrhythmias at 12 months and new or increased dose of class I/III antiarrhythmic drugs. About 6.0% of subjects experienced a serious adverse event or serious adverse device effect through 12 months including 1 event deemed related to HD Grid and the index procedure by the investigator and 1 death unrelated to study devices. Conclusions The results of this study (NCT03733392) support the safety and utility of electroanatomical mapping with HD Grid in subjects with complex arrhythmias, such as PersAF in the real-world setting. Supplementary Information The online version contains supplementary material available at 10.1007/s10840-022-01442-3.

Initial experience, safety, and feasibility using remote access or onsite technical support for complex ablation procedures: results of the REMOTE study

“…All procedures were guided by EnsiteX EAM and related multielectrode mapping catheters (Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ and Advisor™ Mapping Catheter, and Sensor Enabled™). 11 For the remote group, all settings as well as the complete 3D mapping and analysis have been performed via remote access. For PVI, an EAM of the LA was performed after double TSP utilizing a multielectrode mapping catheter.…”

Uncovering the Invisible: The Role of High-density Catheters in Recognizing Fractionated Signals in Pulmonary Vein Isolation

“…Studies comparing the HD Grid catheter with circular mapping catheters, cryoablation catheters, and pacing the ablation line found the HD Grid catheter to be superior in identifying the gaps in ablation. 4 – 7 Approximately 52.5% of patients with recurrent AF had gaps in ablation detected by HD Grid compared to traditional catheters. The HD Grid offers the capability to perform high-density mapping to identify the anatomical substrate and low-voltage isthmus, which previously would have been missed.…”

Safety and feasibility of a novel multielectrode array catheter in mapping atrial and ventricular arrhythmias with high density: results from the multicenter OPTIMUM study

“…The EnSite Precision system uses a hybrid magnetic and impedance-based catheter technology, incorporating surface electrodes, a separate reference, and a magnetic field frame. Fielder et al evaluated electroanatomical mapping in 334 patients with PsAF using the Advisor HD Grid mapping catheter with EnSite Precision and HD Wave Solution electrode configuration to generate multiple map types in a variety of rhythms [ 5 ]. There are currently no published randomized trials comparing different mapping systems, and the current observational study was not set up to compare to other mapping systems.…”