Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System

Abstract

Background - The HeartLight™ endoscopic ablation system (HL-EAS), has proven similar efficacy as radiofrequency guided pulmonary vein isolation (PVI) 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 pre-defined speed for continuous ablation. We sought to determine the performance of the new EAS (X3). Methods - The study was prospective, two center, and historically controlled (comparison to pivotal HL study). The primary endpoint 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 two centers. Except one all PVs were treated with RAPID mode. Acute PVI was achieved in 225/228 of these PVs (98.7%). The ablation time, was significantly shorter with X3 than in the HL study (77.3 ± 25.8 min versus 173.8 ± 46.6 min; p<0.0001). Procedure time and fluoroscopy time were also significantly shorter (103.7 ± 32.3 min versus 236.0 ± 52.8min; p<0.0001; 6.9 ± 3.5 versus 35.6 ± 18.2; p<0.0001). PVI 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 AF-Free rates for X3 compare favorably with the rates reported for HL, 89.5% versus 75.0% and 71.9% versus 61.1%, respectively. Conclusions - The novel X3 generation EAS allows for rapid PVI 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.

Single‐sweep pulmonary vein isolation using the new third‐generation laser balloon—Evolution in ablation style using endoscopic ablation system

“…Multiphysics modeling predicted that 13 and 15 W continuous ablation was comparable to 8.5 and 10 W manual spot ablation in this regard, respectively. 7 In a turkey thigh model as well as in an in vivo pig model lesion contiguity and transmurality were confirmed by manufacturer. According to suggestion by the manufacturer, the energy setting was basically started with the RA-PID mode at 13 W. A 15 W ablation was used only in case of failed F I G U R E 1 Description of terminologywith representative images of laser trajectory.…”

“…In a pivotal study comparing X3 to the historical HeartLight EAS (EAS 1, Cardiofocus), however, the 12-month arrhythmia-free survival was favorable at 71.9% versus 61.1%, respectively. 7 Similarly, no excess adverse event rates were observed. In larger cohorts, the phrenic nerve injury rate using EAS was reported to be in the range of 1.4%-2%.…”

“…This is numerically less in comparison to previous studies using the EAS 1 with manual spot ablation (8%) or the X3 pivotal study (13.3%). 7 It may be speculated, however, that elimination of the "blind spot" by improving the field of view could further decrease the rate of pinhole.…”

“…4,5 The latest generation EAS (HeartLight X3; CardioFocus) offers a new contiguous ablation mode (RAPID™) during which the laser beam is continuously swept around the PV ostium at a pre-defined speed. 6,7 This new RAPID mode allows for PVI by a single laser energy application (single-sweep-PVI), which develops EAS-guided ablation to a "single-shot" fashioned ablation.…”

Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort

“…As previously described [15], using the deflectable sheath, the Excalibur (secondgeneration) or the X3 (third-generation) LB was positioned at the ostium of the target PV, and the balloon was inflated (Figure 1). Ablation was performed under visual guidance.…”