Key result
The second-generation laser balloon achieved 98% acute pulmonary vein isolation success, with median procedure time significantly decreasing from 132 minutes in the first 15 cases to 91 minutes in the last 15 cases.
Why the study?
Radiofrequency-based PVI demands a long learning curve, and the 2nd-generation laser balloon with optimized features was developed to address these limitations.
Is the 2nd-generation visually guided laser balloon ablation system safe and effective for pulmonary vein isolation, and what is the associated learning curve?
Observational (n=45)
No
Is the 2nd-generation visually guided laser balloon ablation system safe and effective for pulmonary vein isolation, and what is the associated learning curve?
The second-generation laser balloon system is safe and effective for pulmonary vein isolation, with procedure and fluoroscopy times significantly decreasing after a learning curve of 15 cases.
LB2 supports safe, effective PVI with short learning curve even for novices; leaves open need for randomized trials versus established modalities.
BACKGROUND: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI. METHODS AND RESULTS: A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1-3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience. CONCLUSIONS: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.
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Heeger et al. (2019) conducted an observational in Atrial fibrillation (n=45). Second-generation visually guided laser balloon (LB2) vs. Early experience (T1 group, first 15 cases) was evaluated on Median procedure time (minutes) (p=0.0009). The second-generation laser balloon achieved 98% acute pulmonary vein isolation success, with median procedure time significantly decreasing from 132 minutes in the first 15 cases to 91 minutes in the last 15 cases.
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