Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions : the multicentre VISTAX trial
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology - 22(2020), 11 vom: 01. Nov., Seite 1645-1652 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Duytschaever, Mattias [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.06.2021 Date Revised 31.05.2022 published: Print ClinicalTrials.gov: NCT03062046 Citation Status MEDLINE |
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| doi: |
10.1093/europace/euaa157 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM314529063 |
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| 100 | 1 | |a Duytschaever, Mattias |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions |b the multicentre VISTAX trial |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Completed 25.06.2021 | ||
| 500 | |a Date Revised 31.05.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT03062046 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Atrial arrhythmia | |
| 650 | 4 | |a Atrial fibrillation | |
| 650 | 4 | |a Contact force catheter | |
| 650 | 4 | |a Pulmonary vein isolation | |
| 650 | 4 | |a Radiofrequency ablation | |
| 650 | 4 | |a VISITAG SURPOINT | |
| 700 | 1 | |a Vijgen, Johan |e verfasserin |4 aut | |
| 700 | 1 | |a De Potter, Tom |e verfasserin |4 aut | |
| 700 | 1 | |a Scherr, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Van Herendael, Hugo |e verfasserin |4 aut | |
| 700 | 1 | |a Knecht, Sebastien |e verfasserin |4 aut | |
| 700 | 1 | |a Kobza, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Berte, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a Sandgaard, Niels |e verfasserin |4 aut | |
| 700 | 1 | |a Albenque, Jean-Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Szeplaki, Gabor |e verfasserin |4 aut | |
| 700 | 1 | |a Stevenhagen, Yorick Jeroen |e verfasserin |4 aut | |
| 700 | 1 | |a Taghji, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Wright, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Macours, Nathalie |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Dhiraj |e verfasserin |4 aut | |
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