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Duytschaever, M; Vijgen, J; De Potter, T; Scherr, D; Van Herendael, H; Knecht, S; Kobza, R; Berte, B; Sandgaard, N; Albenque, JP; Szeplaki, G; Stevenhagen, YJ; Taghji, P; Wright, M; Macours, N; Gupta, D.
Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial.
Europace. 2020; 22(11):1645-1652
Doi: 10.1093/europace/euaa157
Web of Science
PubMed
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- Co-authors Med Uni Graz
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Scherr Daniel
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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.
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%).
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.
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
- Find related publications in this database (Keywords)
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Atrial fibrillation
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Atrial arrhythmia
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Radiofrequency ablation
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Pulmonary vein isolation
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Contact force catheter
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VISITAG SURPOINT