Background:
The visually guided laser balloon ablation system (LB) offers a unique endoscopic technology for pulmonary vein isolation (PVI). Utilizing the rapid mode, the novel third-generation LB (LB3) offers the possibility to apply an automated continuous 360° lesion, which enables effective and fast PVI. After a learning curve of 15 cases, we implemented a novel approach utilizing a single transseptal puncture. Furthermore, pre- and post-procedural 3D mapping was omitted. Data on clinical outcome of this novel ablation system is still limited.
Objective:
To report about our experience utilizing the LB3, and to evaluate safety, efficacy and learning curve of performing PVI with this novel ablation system in patients with AF as part of a single center non-randomized prospective study.
Methods:
30 consecutive patients with symptomatic AF (median age: 67 years; 50% male; 63% with paroxysmal AF) were enrolled. The first 15 patients were treated via a conventional approach with two transseptal punctures as well as pre- and post-procedural 3D mapping (control group). Patients 16-30 were treated utilizing a simplified approach (fast group).
Results:
All patients underwent PVI using the LB3 ablation system. Four patients had a left common pulmonary vein (LCPV). All 114 (100%) pulmonary veins could be successfully isolated utilizing the LB3. The median procedure time was 60.5 (IQR 53, 77) min (control group: 77 (IQR 68, 87) min, fast group: 52 (IQR 43, 60) min, p<0.001). The median LA dwelling time was 43 (IQR 35, 50) min (control group: 45 (IQR 40, 55) min, fast group: 35 (IQR 30, 46) min, p<0.001). Percentage of rapid mode was 98 (IQR 94, 100) % (control group: 97 (IQR 91, 99) min, fast group: 100 (IQR 95, 100) min, p=0.134). Rapid mode was only achieved in 54% of PVs. Single sweep PVI was achieved in 40% of PVs.
Severe adverse events occurred in a total of 1 out of 30 patients (3%): one case suffered from pericardial tamponade requiring pericardiocentesis. This adverse event occurred during the 6. case performed. No further patients with a relevant groin hematoma, retroperitoneal hematoma (requiring blood transfusion or surgical intervention), phrenic nerve palsy, stroke or atrio-esophageal fistula were observed.
Conclusion:
The fast PVI approach utilizing the LB3 offers an effective, safe and significantly faster PVI compared to the standard approach.