Comparison between minimal fluoroscopy and conventional approaches for visually guided laser balloon pulmonary vein isolation ablation

Abstract

Introduction Although balloon‐based techniques, such as the laser balloon (LB) ablation have simplified pulmonary vein isolation (PVI), procedural fluoroscopy usage remains higher in comparison to radiofrequency PVI approaches due to limited 3‐dimensional mapping system integration. Methods In this prospective study, 50 consecutive patients were randomly assigned in alternating fashion to a low fluoroscopy group (LFG; n = 25) or conventional fluoroscopy group (CFG; n = 25) and underwent de novo PVI procedures using visually guided LB technique. Results There was no statistical difference in baseline characteristics or cross‐overs between treatment groups. Acute PVI was accomplished in all patients. Mean follow up was 318 ± 69 days. Clinical recurrence of atrial fibrillation after PVI was similar between groups (CFG: 19% vs LFG: 15%; P = .72). Total fluoroscopy time was significantly lower in the LFG than the CFG (1.7 ± 1.4 vs 16.9 ± 5.9 minutes; P < .001) despite similar total procedure duration (143 ± 22 vs 148 ± 22 minutes; P = .42) and mean LA dwell time (63 ± 15 vs 59 ± 10 minutes; P = .28). Mean dose area product was significantly lower in the LFG (181 ± 125 vs 1980 ± 750 μGym2; P < .001). Fluoroscopy usage after transseptal access was substantially lower in the LFG (0.63 ± 0.43 vs 11.70 ± 4.32 minutes; P < .001). Complications rates were similar between both groups (4% vs 2%; P = .57). Conclusions This study demonstrates that LB PVI can be safely achieved using a novel low fluoroscopy protocol while also substantially reducing fluoroscopy usage and radiation exposure in comparison to conventional approaches for LB ablation.

Utilization of 3D mapping systems in interventional electrophysiology and its impact on procedure time and fluoroscopy—Insights from the “Go for Zero Fluoroscopy” project

“…On the other hand, use of 3D mapping was associated with a longer procedure time. This finding is in contrast with the reported data of Huang et al 16 . This discrepancy could be attributed to the aforementioned features of the present study.…”

“…On the other hand, use of 3D mapping was associated with a longer procedure time. This finding is in contrast with the reported data of Huang et al 16 This discrepancy could be attributed to the aforementioned features of the present study. Furthermore, the studies analyzed from Huang et al had the primary aim to reduce fluoroscopy use, whereas our data present a "real world" image of 3D mapping use.…”

“…In case of ablation of atrial fibrillation, recent studies have shown the feasibility and safety of a zero or low fluoroscopy approach 16–19 . In a meta‐analysis of Huang et al.…”

“…In case of ablation of atrial fibrillation, recent studies have shown the feasibility and safety of a zero or low fluoroscopy approach. [16][17][18][19] In a meta-analysis of Huang et al including 2228 procedures, use of 3D mapping in order to achieve zero or low fluoroscopy exposure led to lower fluoroscopy time and DAP. This finding was confirmed in the present study as well, although not reaching statistical significance.…”

Clinical Applications of Laser Technology: Laser Balloon Ablation in the Management of Atrial Fibrillation

“…One area of development in LBA PVAI has aimed to reduce the procedural fluoroscopy time, which was high in early studies, though similar to RFA according to one large study (14 ± 9 min vs. 11 ± 9 min p = 0.08) [22]. A recent study using an ICE catheter to create a 3-D anatomic shell of the LA and guide pulmonary vein cannulation and LB catheter positioning (Figure 4) was shown to be effective at reducing the fluoroscopic time by 95% when compared to the conventional fluoroscopy methods for LBA (1.7 ± 1.4 vs. 16.9 ± 5.9 minutes; p < 0.001) [29]. This novel approach was not associated with increased intraprocedural time or increased complication rates.…”