CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study

Abstract Background: Proposed to facilitate pulmonary vein isolation (PVI), high-power ablation may cause extracardiac damage. This study evaluated the safety and efficacy of ablation index (AI) guided high-power ablation first in an animal model and subsequently in a clinical study.Methods:Outcomes of radiofrequency (RF) applications were compared in a swine ventricular endocardial model (n=10 each for 50W, 40W and 30W; AI=500), and in 100 consecutive patients with paroxysmal AF undergoing PVI (40W [last n=50] vs. 30 W [first n=50]; target AI=400/500 on posterior/anterior wall, respectively). Acute PV reconnection was assessed post adenosine administration 20 minutes after ablation.Results: In swine ventricular endocardial RF applications, use of 50W and 40W vs. 30W was associated with greater tissue lesion depth (5.06±0.16 and 4.38±0.13mm vs. 3.95±0.16mm; P<0.001) and smaller lesion maximum diameter (7.81±0.15 and 8.42±0.18mm vs. 9.08±0.15mm; P<0.001). Tissue necrosis caused by 50W vs. 40W and 30W was the deepest and largest (3.15±0.18mm vs. 2.71±0.17 and 2.42±0.13mm; and 5.58±0.18mm vs. 5.18±0.16 and 3.94±0.17mm; respectively; P<0.001). In PVI, use of 40W vs. 30W was associated with shorter procedure time (56.54±1.81min vs. 76.55±2.34min; p<0.001) and ablation time (35.85±14.87min vs. 51.01±17.99min; p<0.001); lower RF energy per point (909.02±354.57J vs. 1045±376.60J; p<0.001); higher first-pass PVI (87% vs. 72%; P<0.01); lower acute PV reconnection (22% vs. 41%; P<0.01); no complications in either group; and similar sinus rhythm maintenance at 12 months (92% vs. 84%; P=0.22).Conclusions: AI-guided high-power (40W) vs. conventional (30W) PVI was related to a reduced time for procedure and was considered safe, with diminished acute PV reconnection.

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High- power radiofrequency ablation guided by ablation index for pulmonary vein isolation

10.21203/rs.3.rs-21367/v1 ◽

2020 ◽

Author(s):

Xuefeng Zhu ◽

Chunxiao Wang ◽

Jianping Li ◽

Wenjing Li ◽

Hongxia Chu ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

High Power ◽

Anterior Wall ◽

Maximum Diameter ◽

Ablation Index ◽

Adenosine Administration ◽

Rf Applications ◽

Posterior Anterior ◽

Pulmonary Vein Reconnection

Abstract Background Proposed to facilitate pulmonary vein isolation (PVI), high-power ablation may cause extracardiac damage. This study evaluated the safety and efficacy of ablation index (AI) guided high-power ablation first in an animal model and subsequently in a clinical study. Methods Outcomes of radiofrequency (RF) applications were compared in a swine ventricular endocardial model (n = 10 each for 50W, 40W and 30W; AI = 500), and in 100 consecutive patients with paroxysmal atrial fibrillation undergoing PVI (40W [last n = 50] vs. 30 W [first n = 50]; target AI = 400/500 on posterior/anterior wall, respectively). Acute PV reconnection was assessed post adenosine administration 20 minutes after ablation. Results In swine ventricular endocardial RF applications, use of 50W and 40W vs. 30W was associated with greater tissue lesion depth (5.06 ± 0.16 and 4.38 ± 0.13 mm vs. 3.95 ± 0.16 mm; P < 0.001) and smaller lesion maximum diameter (7.81 ± 0.15 and 8.42 ± 0.18 mm vs. 9.08 ± 0.15 mm; P < 0.001). Tissue necrosis caused by 50W vs. 40W and 30W was the deepest and largest (3.15 ± 0.18 mm vs. 2.71 ± 0.17 and 2.42 ± 0.13 mm; and 5.58 ± 0.18 mm vs. 5.18 ± 0.16 and 3.94 ± 0.17 mm; respectively; P < 0.001). In PVI, use of 40W vs. 30W was associated with shorter procedure time (56.54 ± 1.81 min vs. 76.55 ± 2.34 min; p < 0.001) and ablation time (35.85 ± 14.87 min vs. 51.01 ± 17.99 min; p < 0.001); lower RF energy per point (909.02 ± 354.57J vs. 1045 ± 376.60J; p < 0.001); higher first-pass PVI (87% vs. 72%; P < 0.01); lower acute PV reconnection (22% vs. 41%; P < 0.01); no complications in either group; and similar sinus rhythm maintenance at 12 months (92% vs. 84%; P = 0.22). Conclusions AI-guided high-power (40W) vs. conventional (30W) PVI was related to a reduced time for procedure and was considered safe, with diminished acute pulmonary vein reconnection.

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Very high-power short-duration temperature-controlled ablation versus conventional power-controlled ablation for pulmonary vein isolation: The fast and furious - AF study

IJC Heart & Vasculature ◽

10.1016/j.ijcha.2021.100847 ◽

2021 ◽

Vol 35 ◽

pp. 100847

Author(s):

Roland Richard Tilz ◽

Makoto Sano ◽

Julia Vogler ◽

Thomas Fink ◽

Roza Saraei ◽

...

Keyword(s):

Pulmonary Vein ◽

Short Duration ◽

Pulmonary Vein Isolation ◽

High Power ◽

Temperature Controlled ◽

Very High

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Acute and long-term efficacy and safety with a single cryoballoon application as compared with the standard dual application strategy: a prospective randomized study using the second-generation cryoballoon for pulmonary vein isolation in patients with symptomatic atrial fibrillation

EP Europace ◽

10.1093/europace/euy014 ◽

2018 ◽

Vol 20 (10) ◽

pp. 1598-1605 ◽

Cited By ~ 7

Author(s):

David Mörtsell ◽

Helena Malmborg ◽

Stefan Lönnerholm ◽

Victoria Jansson ◽

Carina Blomström-Lundqvist

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Second Generation ◽

Randomized Study ◽

Prospective Randomized Study ◽

Efficacy And Safety ◽

Term Efficacy

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How much is enough? An appraisal of high‐power short‐duration radiofrequency ablation for pulmonary vein isolation

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.14124 ◽

2019 ◽

Vol 30 (11) ◽

pp. 2205-2208

Author(s):

Deep Chandh Raja ◽

Prashanthan Sanders ◽

Rajeev K. Pathak

Keyword(s):

Radiofrequency Ablation ◽

Pulmonary Vein ◽

Short Duration ◽

Pulmonary Vein Isolation ◽

High Power

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Update on high‐power short‐duration ablation for pulmonary vein isolation

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.14649 ◽

2020 ◽

Vol 31 (9) ◽

pp. 2499-2508 ◽

Cited By ~ 1

Author(s):

Jie Qiu ◽

Yan Wang ◽

Dao Wen Wang ◽

Mei Hu ◽

Guangzhi Chen

Keyword(s):

Pulmonary Vein ◽

Short Duration ◽

Pulmonary Vein Isolation ◽

High Power

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Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial

EP Europace ◽

10.1093/europace/euaa157 ◽

2020 ◽

Vol 22 (11) ◽

pp. 1645-1652

Author(s):

Mattias Duytschaever ◽

Johan Vijgen ◽

Tom De Potter ◽

Daniel Scherr ◽

Hugo Van Herendael ◽

...

Keyword(s):

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Randomized Study ◽

Standard Of Care ◽

Posterior Wall ◽

Anterior Wall ◽

Atrial Arrhythmia ◽

Clinical Trial Registration ◽

First Pass

Abstract Aims To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. Methods and results This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4–86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8–82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8–87.0%). Freedom fromrepeat ablations by the Kaplan–Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9–6.3%). Conclusions The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres. Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.

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