Key result
The X3 generation endoscopic ablation system significantly reduced ablation time compared to historical HeartLight controls (77.3 vs 173.8 minutes; P<0.0001).
Why the study?
The HeartLight endoscopic ablation system demonstrated similar efficacy to radiofrequency PV isolation but with longer procedure times, prompting the development of a motor-driven system (X3) with a continuous ablation mode.
Does the novel motor-driven endoscopic ablation system (X3) reduce ablation time compared to historical controls in patients undergoing pulmonary vein isolation?
Does the novel motor-driven endoscopic ablation system (X3) reduce ablation time compared to historical controls in patients undergoing pulmonary vein isolation?
The novel X3 motor-driven endoscopic ablation system significantly reduces ablation and procedure times for pulmonary vein isolation compared to historical controls.
X3 may shorten ablation times in PVI; extends observational endoscopic data but leaves open randomized efficacy and safety comparisons.
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.
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Schmidt et al. (2021) studied Atrial fibrillation (n=60). X3 generation endoscopic ablation system (RAPID mode) vs. Historical controls (pivotal HeartLight study) was evaluated on Ablation time (time from insertion of the X3 catheter to the end of the last 30-minute wait period) (p=<0.0001). The X3 generation endoscopic ablation system significantly reduced ablation time compared to historical HeartLight controls (77.3 vs 173.8 minutes; P<0.0001).
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