Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System

Supplemental Digital Content is available in the text. Background: The HeartLight endoscopic ablation system has proven similar efficacy as radiofrequency guided pulmonary vein (PV) isolation in prospective randomized studies though longer procedure times were reported. Recently, the option of a new ablation mode (RAPID) was added, during which the laser arc generator is swept around the PV antrum by an integrated motor drive at a predefined speed for continuous ablation. We sought to determine the performance of the new endoscopic ablation system (X3). Methods: The study was prospective, 2-center, and historically controlled (comparison to pivotal HeartLight study). The primary end point was ablation time (time from insertion of the X3 catheter to the end of the last 30-minute wait period). Transtelephonic monitoring was performed from 90 days to 12 months after ablation. Results: A total of 60 patients were enrolled at 2 centers. Except one, all PVs were treated with RAPID mode. Acute PV isolation was achieved in 225/228 of these PVs (98.7%). The ablation time was significantly shorter with X3 than in the HeartLight study (77.3±25.8 versus 173.8±46.6 min; P<0.0001). Procedure time and fluoroscopy time were also significantly shorter (103.7±32.3 versus 236.0±52.8 min; P<0.0001; 6.9±3.5 versus 35.6±18.2; P<0.0001). PV isolation after the first circular lesion was achieved in 91.6% of PVs (206/225). Two strokes and one late pericardial effusion were noted in the treatment group that were not deemed device related. The 6-month and 12-month atrial fibrillation–free rates for X3 compare favorably with the rates reported for HeartLight, 89.5% versus 75.0% and 71.9% versus 61.1%, respectively. Conclusions: The novel X3 generation endoscopic ablation system allows for rapid PV isolation by continuous lesion deployment. This was associated with a significant reduction in ablation and procedure times while maintaining the safety and chronic effectiveness in comparison to historical controls. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03470636.

[1]  K. Chun,et al.  Phrenic nerve injury in atrial fibrillation ablation using balloon catheters: Incidence, characteristics, and clinical recovery course , 2020, Journal of cardiovascular electrophysiology.

[2]  B. Schmidt,et al.  Analysis of procedural data of pulmonary vein isolation for atrial fibrillation with the second‐generation laser balloon , 2019, Pacing and clinical electrophysiology : PACE.

[3]  P. Neužil,et al.  Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study , 2017, Circulation. Arrhythmia and electrophysiology.

[4]  B. Schmidt,et al.  Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. , 2017, Heart rhythm.

[5]  Dhanunjaya R. Lakkireddy,et al.  Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. , 2015, Journal of the American College of Cardiology.

[6]  P. Noseworthy,et al.  Risk of stroke after catheter ablation versus cardioversion for atrial fibrillation: A propensity-matched study of 24,244 patients. , 2015, Heart rhythm.

[7]  P. Neužil,et al.  Visually guided laser ablation: a single-centre long-term experience. , 2014, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[8]  J. Ruskin,et al.  Pulmonary Vein Isolation Using a Visually Guided Laser Balloon Catheter: The First 200-Patient Multicenter Clinical Experience , 2013, Circulation. Arrhythmia and electrophysiology.

[9]  K. Kuck,et al.  The influence of varying energy settings on efficacy and safety of endoscopic pulmonary vein isolation. , 2012, Heart rhythm.

[10]  P. Neužil,et al.  The durability of pulmonary vein isolation using the visually guided laser balloon catheter: multicenter results of pulmonary vein remapping studies. , 2012, Heart rhythm.

[11]  K. Kuck,et al.  Feasibility of Circumferential Pulmonary Vein Isolation Using a Novel Endoscopic Ablation System , 2010, Circulation. Arrhythmia and electrophysiology.