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

Laser balloon (LB) has emerged as an interesting strategy for pulmonary vein isolation in paroxysmal atrial fibrillation (AF). A third-generation LB has recently been developed, allowing a continuous ablation set. We aimed to compare the results from our center’s experience with second and third-generation LBs to a cohort of matched patients who had undergone radiofrequency ablation (RFA) with contact-force catheters. This retrospective monocenter case-control study included our first 50 LB paroxysmal AF ablations (26 second and 24 third-generation LB) and 50 RFA controls, matched on age, sex and left atrial dilation. The two groups had similar baseline parameters. LB procedures were significantly shorter than RFA (129 (110–160) vs. 160 (119–198) min, p = 0.007). During AF ablation, two major complications occurred in each group. At the one-year follow-up, AF recurrence was diagnosed in 7 (14%) of the LB group vs. 14 (28%) of the RFA group (p = 0.14). Moreover, we observed that third-generation LB procedures were associated with shorter laser applications (22 (19–29) vs. 69 (55–76) min, p < 0.001) and procedural durations (111 (100–128) vs. 151.5 (128.5–167) min, p < 0.001) compared to second-generation LB procedures. In the context of the major increase in the number of AF ablations, LB demonstrated consistent results in terms of clinical success, complications and also reduced procedure durations compared to RFA.

Real use of a novel automatic motorized laser balloon for the ablation of atrial fibrillation

Background Electric isolation of the pulmonary veins (PVs) can successfully treat patients with atrial fibrillation (AF). Isolation of pulmonary veins can be achieved by several methods: radiofrequency, cryoballoon or laser balloon ablation (LBA). The main procedural challenge with either method is to achieve a continuous circumferential lesion at the left atrium-PVs junction, with the persistence of functional gaps. Purpose A novel endoscopic ablation system equipped with a precise motor control system (MCS) has been evaluated. The balloon is used with an endoscope to directly visualize and ablate tissue at the left atrial-PVs junction with laser energy. This system enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. The MCS is intended to reduce procedure time and to ensure continuity of ablation lesions. The feasibility of the motorized ablation in terms of extent of applicability along each PV-left atrium junction and time of use of the manual point-by-point mode has been investigated. Methods 27 consecutive patients (male 70.3%, age 61.2±8.7 years) with paroxysmal or persistent AF who underwent LBA were enrolled in our institution. Exclusion criteria were any contraindication for the procedure including the presence of intracavitary thrombosis and contraindications to general anesthesia or deep sedation. After transseptal puncture, the balloon-based endoscopic ablation system was advanced to each PV ostium, and laser energy were projected onto the target. Results A total of 110 PVs were treated with LBA; in 9 patients there was a redundant right intermediate pulmonary vein; in 4 patients there was a right common ostium and in 2 a left common ostium. MCS was used for 82 PVs (74.5%): in particular, MCS was used continuously between 180° and 325° degrees (50 to 90% of PV circumference) for 35 PVs (31.8%) and between 326° and 359° degrees (91 to 99% of PV circumference) for 25 veins (22.7%). In 13 PVs (12%) MCS was used for the entire circumference. During 8508 (19.6%) seconds out of a total of 43.368 seconds, laser energy delivery occurred in the rapid mode by MCS. No clinical complications, either local or systemic (stroke or TIA, pericardial effusion, pericardial tamponade, pulmonary vein stenosis, esophageal injury, temporary or permanent phrenic nerve palsy), were observed neither during the use of MSC nor during the use of manual point-by-point mode. Of note, a pinhole rupture of the balloon occurred in 3 cases of our series, during the use of MCS, without harm to the patient and requiring only replacement of the LBA. Conclusions In our case series, laser balloon ablation with the help of motor control system appears safe and feasible in most cases for large portions of pulmonary vein circumference, providing considerable time sparing (74.5% of total ablation extent in 19.6% of total ablation time). FUNDunding Acknowledgement Type of funding sources: None.

Third-generation laser balloon ablation for atrial fibrillation treatment: a multicenter experience

Background Laser balloon ablation is a promising option for performing pulmonary vein isolation (PVI) which is the cornerstone of invasive atrial fibrillation (AF) treatment. Purpose We aimed to investigate the acute efficacy and safety of the novel third-generation of the laser balloon system in an initial multicenter experience. Methods First and consecutive patients who underwent PVI with LB3 for drug-resistant paroxysmal or persistent AF at 7 Italian sites were included in this analysis. Study endpoints were acute procedural efficacy, defined as successful isolation of all identified PVs without radiofrequency touch-up, total and fluoroscopy times, and periprocedural complications. Results Our population included 86 patients (81% males, mean age 60.6±9.5 years) who underwent a procedure of PVI using LB3 between June 2020 and March 2021. Most patients had paroxysmal AF (74%) and were in sinus rhythm at the beginning of the procedure. The mean procedure time was 138±60 min; fluoroscopy time was 22±17 min and the mean ablation time was 44±40 min. Of the 313 targeted PVs, 311 (99.4%) could be isolated with first-pass LB3 application, while 2 (0.6%) required radiofrequency touchup. At the end of the procedure, all patients were in sinus rhythm and 26 (32%) received electrical cardioversion to achieve stable sinus rhythm. The total rate of major compilations was 1.2% (1/82 patients): one pericardial tamponade requiring epicardial puncture. No surgical intervention was necessary, and the patient recovered without any sequalae. There were no vascular access complications or phrenic nervy palsy. Three pinhole balloon raptures (3.5%) were observed during energy applications that required replacement of the whole system but had no effect on patient safety. Conclusions In a first multicenter experience, the LB3 system for PVI was safe with excellent acute efficacy. FUNDunding Acknowledgement Type of funding sources: None.

Third-generation laser balloon ablation: rapid mode applicability is associated with shorter time to pulmonary vein isolation

Background The rapid mode feature implemented in the latest version of the laser balloon system (LB3, HeartLight, X3, Cardiofocus) offers an automated continuous 360° lesion for pulmonary vein isolation (PVI). However, data on its clinical applicability and the potential reduction of procedural times are not yet available. Purpose To explore the use of the rapid mode and its association with PV total and fluoroscopy times in our initial experience with LB3. Methods This analysis included consecutive patients who underwent PVI procedure with LB3. We attempted to perform a complete circular ablation line using the rapid mode at 13 W, but if needed to achieve successful isolation, rapid mode was interrupted and manual mode (5.5–8.5 W) applications were used. The percentage of rapid mode use on the 360° lesion was measured for each PV. Total and fluoroscopy times to complete PVI were also collected. Results A total of 110 PVs were identified in 27 LB3 procedures and successfully isolated with a mean procedural time of 85±31 min. Sixty (55%) PVs were treated by using rapid mode for more than 50% (180°) lesion and 13 (12%) of them had a pure rapid mode ablation (without necessity of manual mode applications). Right inferior PV had the highest use of rapid mode (median value 70%). The main reasons for manual applications were poor PV occlusion, imperfect ostium visualization and presence of blood. PVs with &gt;50% rapid mode use were treated in a significantly shorter time (21.2±13.7 vs 26.8±12.4, p=0.043). Fluoroscopy time did not differ significantly (4.7±4.2 vs 5.4±4.9, p=0.48). Three pinhole balloon ruptures were observed during rapid mode energy application in the second, third and twenty-fifth procedure. No other complications occurred. Conclusions Few PVs could be isolated using pure rapid mode; however, its applicability for more than 50% lesion was observed more frequently and significantly reduced the time to isolation. FUNDunding Acknowledgement Type of funding sources: None. Time to isolation using Rapid Mode