Evolution in lesion index durability using the new third generation laser balloon catheter for pulmonary vein isolation – does the mechanical innovation mean also clinical innovation?

Abstract Background The new second- and third-generation endoscopic ablation systems (EAS 2 and EAS 3) have been launched in recent years. We aimed to assess the index lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (AF). Methods Consecutive patients who underwent the second ablation for recurrent AF following the initial pulmonary vein isolation (PVI) with EAS 2 or EAS 3 were investigated. The persistent durability of PVI and gap localization at the second procedure were analyzed using spiral mapping catheter and three-dimensional mapping system. Results A total of 34 patients (EAS3: N=13, 50 PVs, EAS2: N=21, 82 PVs) were enrolled. Repeat procedure was performed mean 11.9±9.3 months after the initial procedure. Persistent durable isolation of all four PVs was recorded in 6 (46.2%) patients in EAS3 and 4 (19.1%) patients in EAS2 (P=0.130). Ninety-one out of 132 (68.9%) PVs were persistently isolated with a higher rate in EAS3 (EAS3: 82.0% vs. EAS2: 61.0%, P=0.0113). A total of 45 gaps were recorded in 41 PVs, of which right superior PV (RSPV) was the predominantly common reconnected vein (15 gaps in 14 PVs) irrespective of generation difference (EAS 3: 4 gaps in 3 PVs and EAS 2: 12 gaps in 11 PVs). Anterior-segment of RSPV was the most common gap distribution (EAS 3: 2 gaps and EAS 2: 6 gaps). Logistic multivariate regression analysis revealed high-dose (≥8.5W) only ablation as an independent predictor of durable PVI (adjusted OR: 3.70, 95% CI [1.408 - 10.003], P=0.008) Conclusion The multigenerational technical innovation resulted in a higher index lesion durability in EAS3 guided PVI in patients with recurrent AF. The specific gap patterns frequent at RSPV, especially at the anterior-superior segment, and the feasibility of high-dose ablation were confirmed in successor EASs. FUNDunding Acknowledgement Type of funding sources: None.

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Validation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation

Journal of Cardiology ◽

10.1016/j.jjcc.2021.07.001 ◽

2021 ◽

Author(s):

Shota Tohoku ◽

Stefano Bordignon ◽

Shaojie Chen ◽

Fabrizio Bologna ◽

Lukas Urbanek ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Balloon Catheter ◽

Third Generation ◽

Recurrent Atrial Fibrillation ◽

Laser Balloon

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Single‐Sweep Pulmonary Vein Isolation using the new third‐generation laser balloon – Evolution in ablation style using endoscopic ablation system

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.15245 ◽

2021 ◽

Author(s):

Shota Tohoku ◽

Stefano Bordignon ◽

Shaojie Chen ◽

Simone Zanchi ◽

Lorenzo Bianchini ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Third Generation ◽

Endoscopic Ablation ◽

Laser Balloon

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Single sweep pulmonary vein isolation using the endoscopic ablation system. Dream or reality?

EP Europace ◽

10.1093/europace/euab116.066 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

B Schmidt ◽

S Tohoku ◽

S Bordignon ◽

S Chen ◽

S Zanchi ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Superior Vena ◽

Safety Data ◽

Vena Cava ◽

Private Company ◽

Endoscopic Ablation ◽

First Pass ◽

Diagnostic Catheter

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): CardioFocus Background The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with paroxysmal and persistent atrial fibrillation (AF). In randomized studies, however, point-by-point laser ablation resulted in longer procedure times. The novel X3 EAS is now equipped with a motor driven laser generator that sweeps the diode laser beam around the individual PV ostium at a pre-defined speed (2.25°/sec) thus allowing for contiguous circumferential ablation (RAPID mode). Purpose To determine the feasibility of single sweep ablation using the new X3 EAS. Methods Consecutive AF patients were enrolled. After single transseptal puncture selective PV angiographies were performed. A 3D enabled circular mapping catheter was used to record PV potentials and to create a 3D map of the left atrium. Then, the transseptal sheath was exchanged for the 12F EAS delivery sheath. The EAS was inflated to obtain optimal circumferential contact to the PV ostium. Before ablation, the laser generator was retracted to ensure optimal contact behind the catheter shaft (blind spot). Ideally, RAPID mode ablation was employed at 13-15W. In case of esophageal heating >39°C or suboptimal tissue exposure point-by-point ablation (5.5-12W for 20-30 secs) was used instead. During ablation at the septal PVs phrenic nerve pacing was performed via a diagnostic catheter in the superior vena cava. Single sweep ablation was defined as one single RAPID energy application per PV to complete the singular, circular lesion set. PV conduction was re-assessed after all PVs had been treated. In case of residual PV conduction, gap mapping followed by EAS guided ablation was performed. If EAS failed to achieve complete PVI, touch up ablation was allowed at the discretion of the operator. Hemostasis was achieved by means of a figure of 8 suture. Procedure time was defined as initial groin puncture to groin closure. Follow-up included office visits at 3, 6 and 12 months including 72 h Holter monitoring. Results One-hundred AF patients (56% male, mean age 6810 years, 66% PAF) with normal LV ejection fraction (mean 60 ± 10%) and normal LA size (41 ± 6mm) underwent X3 EAS ablation. Of 382 PVs 378 (99%) were isolated with the X3 EAS. In 214 PVs (56%) single sweep isolation was achieved. First pass isolation and RAPID mode only PVI was achieved in 362 (95%) and 357 (94%), respectively. Single sweep isolation rates varied across PVs from 46% at LIPV to 64% at RSPV. The mean total procedure and fluoroscopy times were 43 ± 10 and 4 ± 2 mins, respectively. Safety data and the complete follow-up will be reported. Conclusion The new X3 EAS equipped with a motor driven laser generator allows for single sweep PVI in 56% of PVs. Almost all PVs (94%) may be isolated with RAPID mode only leading to a very high first pass isolation rate. Altogether, this leads to substantially faster procedure times compared to the predecessor EAS.

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