Mattias Duytschaever1, Johan Vijgen2, Tom De Potter3, Daniel Scherr4, Hugo Van Herendael5, Sebastien Knecht1, Richard Kobza6, Benjamin Berte6, Niels Sandgaard7, Jean-Paul Albenque8, Gabor Szeplaki9, Yorick Jeroen Stevenhagen10, Philippe Taghji11, Matthew Wright12, Nathalie Macours13, Dhiraj Gupta14. 1. Department of Cardiology, AZ Sint-Jan Hospital, Bruges, Belgium. 2. Division of Electrophysiology, Hasselt Heart Center, Jessa Hospital, Hasselt, Belgium. 3. Department of Cardiology, OLV Hospital, Aalst, Belgium. 4. Division of Cardiology, Medical University Graz, Austria. 5. Department of Cardiology, Ziekenhuis Oost - Limburg, Genk, Belgium. 6. Department of Cardiology, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland. 7. Department of Cardiology, Odense University Hospital, Odense, Denmark. 8. Department of Cardiology, Clinique Pasteur, Toulouse, France. 9. Department of Cardiac Electrophysiology, Mater Private Hospital, Dublin, Ireland. 10. Department of Cardiology, Thoraxcentrum, Medisch Spectrum Twente, Enschede, The Netherlands. 11. Department of Cardiology, Private Hospital Clairval Marseille, Marseille, France. 12. Department of Cardiology, St. Thomas' Hospital London, London, UK. 13. Department of Clinical Research, Biosense Webster, Inc., Diegem, Belgium. 14. Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, UK.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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