Esophageal temperature change and esophageal thermal lesions after pulmonary vein isolation using the novel endoscopic ablation system

Background: The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The novel X3 EAS is now equipped with a contiguous circumferential ablation mode (RAPID mode). Aim: To determine the feasibility of single-sweep ablation using X3. Methods: Consecutive patients who underwent AF ablation using X3 were enrolled. We assessed the acute procedural data focusing on “Single-sweep PVI” defined as PVI with a single energy application using RAPID mode to complete the circular lesion set, and on “first-pass isolation” defined as successful visually guided PVI after initial circular lesion set. Results: One-hundred AF patients (56% male, age 68±10 years, 66% paroxysmal AF) were analyzed. A total of 379 of 383 PVs (99%) were isolated with X3. Single-sweep isolation and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep isolation rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs:49.5%, P=0.0239) and at PVs with maximal ostial diameter <24mm (57.6% vs. >24mm: 36.8%, P=0.0151). The mean total procedure and fluoroscopy times were 43.0±10 and 4.0±2 mins, respectively. In none of the patients an acute thromboembolic event (stroke or transient ischemic attack) or a pericardial effusion/tamponade occurred. A single transient phrenic nerve palsy was observed. Conclusion: The new X3 EAS allows for single-sweep PVI in 56% of PVs. The new RAPID ablation mode leads to an improved rate of first-pass isolation associated with very short procedure times without compromising safety.

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One-year clinical outcome after pulmonary vein isolation using the novel endoscopic ablation system in patients with paroxysmal atrial fibrillation

Heart Rhythm ◽

10.1016/j.hrthm.2011.02.030 ◽

2011 ◽

Vol 8 (7) ◽

pp. 988-993 ◽

Cited By ~ 40

Author(s):

Andreas Metzner ◽

Boris Schmidt ◽

Alexander Fuernkranz ◽

Erik Wissner ◽

Roland R. Tilz ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Outcome ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Paroxysmal Atrial Fibrillation ◽

The Novel ◽

Endoscopic Ablation ◽

One Year

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First insight into a novel irrigated radiofrequency ablation balloon

EP Europace ◽

10.1093/europace/euab116.092 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

S Bordignon ◽

S Tohoku ◽

S Chen ◽

F Bologna ◽

C Throm ◽

...

Keyword(s):

Real Time ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Single Shot ◽

Esophageal Temperature ◽

Phrenic Nerve Palsy ◽

Funding Sources ◽

Thermal Lesions ◽

Ostial Lesion ◽

Mean Time

Abstract Funding Acknowledgements Type of funding sources: None. Background A novel irrigated RF balloon (RFB) for pulmonary vein isolation (PVI) was recently released in selected centers . It is a 28 mm open irrigated balloon with 10 unipolar electrodes on its surface to deploy a circular ostial lesion set around the PVs. An inner lumen spiral catheter allows for real time PVI visualization during the ablation. Methods Data from consecutive RFB procedures were collected and analysed. After a single transseptal puncture and selective PV angiograms a 3D map of the left atrium was acquired. Sequential PVI was performed using the RFB: each application lasted 60 seconds, the posterior electrodes were identified to stop the energy delivery after 20 seconds. Real time to isolation data were acquired. A 3D bipolar remap was finally performed to observe the level of isolation. A temperature probe was used to monitor the local esophageal temperature (LET) with a cut off of 39°C. Acute procedural data and complication were collected. Endoscopy was scheduled the day after procedure. Results Data from 10 consecutive RFB procedures were analyzed: 6/10 patients were male, 67 ± 9 years old, 8/10 with history of paroxysmal AF. A total of 36 PVs were targeted and isolated with the RFB, with a mean of 7,3 ± 4,0 applications per patient and 2,0 ± 1,2 applications per PV. First pass "single shot" isolation was achieved in 22/36 (61%), time to isolation during the first application was observed in 29/36 (80%) PVs, but an acute reconnection was observed in 10/29 (35%) isolated PVs. Mean time to sustained isolation was 13 ± 5 sec., mean time to non-sustained isolation was significantly longer (29 ± 17 sec; p = 0,001). Procedure time was 57 ± 16 min., left atrial dwell time 50 ± 14 min, ablation phase time 29 ± 14 min and fluoroscopy time was 10 ± 4 minutes. An esophageal temperature above 39°C was recorded in 2/36 PVs. No phrenic nerve palsy was recorded. 7/10 patients underwent endoscopy and no thermal lesions were detected. No other complications were recorded. Conclusion The novel irrigated RFB seems to allow an effective, safe and fast pulmonary vein isolation. More studies are needed to optimize energy dosing to possibly increase the rate of durable single shot PVI.

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Incidence of Significant Delayed Esophageal Temperature Drop After Cryoballoon-Based Pulmonary Vein Isolation

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.13008 ◽

2016 ◽

Vol 27 (8) ◽

pp. 913-917 ◽

Cited By ~ 4

Author(s):

SEBASTIAN DEISS ◽

ANDREAS METZNER ◽

FEIFAN OUYANG ◽

ROLAND R. TILZ ◽

SHIBU MATHEW ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Temperature Drop ◽

Esophageal Temperature

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Gastric Hypomotility After Luminal Esophageal Temperature Guided Second-Generation Cryoballoon Pulmonary Vein Isolation

Circulation Arrhythmia and Electrophysiology ◽

10.1161/circep.118.006691 ◽

2018 ◽

Vol 11 (8) ◽

Cited By ~ 1

Author(s):

Kanae Hasegawa ◽

Shinsuke Miyazaki ◽

Kaori Hisazaki ◽

Kenichi Kaseno ◽

Naoki Amaya ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Second Generation ◽

Esophageal Temperature

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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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58-04: Initial results of pulmonary vein isolation using the novel third-generation cryoballoon

EP Europace ◽

10.1093/europace/18.suppl_1.i169b ◽

2016 ◽

Vol 18 (suppl_1) ◽

pp. i169-i169 ◽

Cited By ~ 14

Author(s):

Alexander Fürnkranz ◽

Bordignon Stefano ◽

Daniela Dugo ◽

Perotta Laura ◽

Fabrizio Bologna ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Third Generation ◽

The Novel ◽

Initial Results

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P1415Wide antral circumferential pulmonary vein isolation ablation using a novel balloon cryoablation catheter

EP Europace ◽

10.1093/europace/euaa162.203 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

A P Martin ◽

M Fowler ◽

N Lever

Keyword(s):

Atrial Fibrillation ◽

Left Atrium ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Paroxysmal Atrial Fibrillation ◽

Left Atrial ◽

Pulmonary Veins ◽

Posterior Wall ◽

The Novel ◽

Median Treatment

Abstract Background Pulmonary vein isolation using cryotherapy is an established treatment for the management of patients with paroxysmal atrial fibrillation. Ablation using the commercially available balloon cryocatheter has been shown to create wide antral pulmonary vein isolation. A novel balloon cryocatheter (BCC) has been designed to maintain uniform pressure and size during ablation, potentially improving contact with the antral anatomy. The extent of ablation created using the novel BCC has not previously been established. Purpose To determine the anatomical extent of pulmonary vein isolation using electroanatomical mapping when performing catheter ablation for paroxysmal atrial fibrillation using the novel BCC. Methods Nine consecutive patients underwent pre-procedure computed tomography angiography of the left atrium to quantify the chamber dimensions. An electroanatomical map was created using the cryoablation system mapping catheter and a high definition mapping system. A bipolar voltage map was obtained following ablation to determine the extent of pulmonary vein isolation ablation. A volumetric technique was used to quantify the extent of vein and posterior wall electrical isolation in addition to traditional techniques for proving entrance and exit block. Results All patients had paroxysmal atrial fibrillation, mean age 56 years, 7 (78%) male. Electrical isolation was achieved for 100% of the pulmonary veins; mean total procedure time was 109 min (+/- 26 SD), and fluoroscopy time 14.9 min (+/- 2.4 SD). The median treatment applications per vein was one (range one - four), and median treatment duration 180 sec (range 180 -240). Left atrial volume 32 mL/m2 (+/- 7 SD), and mean left atrial posterior wall area 22 cm2 (+/- 4 SD). Data was available for quantitative assessment of the extent of ablation for eight patients. No lesions (0 of 32) were ostial in nature. The antral surface area of ablation was not statistically different between the left and right sided pulmonary veins (p 0.63), which were 5.9 (1.6 SD) and 5.4 (2.1 SD) cm2 respectively. In total 50% of the posterior left atrial wall was ablated. Conclusion Pulmonary vein isolation using a novel BCC provides a wide and antral lesion set. There is significant debulking of the posterior wall of the left atrium. Abstract Figure.

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