Multicenter prospective comparison of conventional and high-power short duration radiofrequency application for pulmonary vein isolation: the high-power short-duration radiofrequency application for faster and safer pulmonary vein ablation (POWER FAST III) trial.

Autor: Castrejón-Castrejón S; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Martínez Cossiani M; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Jáuregui-Abularach M; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Basterra Sola N; Cardiology Department, Complejo Hospitalario de Navarra-IdiSNA (Navarra Institute for Health Research), Pamplona, Spain., Ibáñez Criado JL; Cardiology Department, Hospital General Universitario de Alicante-ISABIAL (Instituto de Investigación Sanitaria Y Biomédica de Alicante), Alicante, Spain., Osca Asensi J; Cardiology Department, Hospital La Fe, Valencia, Spain., Roca Luque I; Cardiology Department, Hospital Clínic, Barcelona, Spain., Moya Mitjans A; Arrhythmia Unit, Hospital Universitari Dexeus, Barcelona, Spain., Quesada Dorador A; Cardiology Department, Hospital General Universitario de Valencia, Valencia, Spain., Hidalgo Olivares VM; Cardiology Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain., Pérez Castellano N; Cardiology Department, Hospital Clínico, Madrid, Spain., Fernández Gómez JM; Cardiology Department, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain., Macías-Ruiz MR; Cardiology Department, Hospital Universitario Virgen de Las Nieves, Granada, Spain., Bochard Villanueva B; Cardiology Department, Hospital Público Universitario de La Ribera, Alzira, Spain., Gonzalo Bada N; Acute Care Unit, Department of Gastroenterology, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Fernández Prieto A; Neuroradiology Unit, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Guido López LE; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Martínez Maldonado ME; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Merino D; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Escobar Cervantes C; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain., Merino JL; Arrhythmia & Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz-IdiPaz, Madrid, Spain. lapaz@arritmias.net.
Jazyk: angličtina
Zdroj: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing [J Interv Card Electrophysiol] 2023 Nov; Vol. 66 (8), pp. 1889-1899. Date of Electronic Publication: 2023 Feb 18.
DOI: 10.1007/s10840-023-01509-9
Abstrakt: Background: Electrical isolation of pulmonary veins (PV) with high-power short-duration (HPSD) radiofrequency application (RFa) may reduce the duration of atrial fibrillation (AF) ablation, without compromising the procedural efficacy and safety in comparison with the conventional approach. This hypothesis has been generated in several observational studies; the POWER FAST III will test it in a randomized multicenter clinical trial.
Methods: It is a multicenter randomized, open-label and non-inferiority clinical trial with two parallel groups. AF ablation using 70 W and 9-10 s RFa is compared with the conventional technique using 25-40 W RFa guided by numerical lesion indexes. The main efficacy objective is the incidence of atrial arrhythmia recurrences electrocardiographically documented during 1-year follow-up. The main safety objective is the incidence of endoscopically detected esophageal thermal lesions (EDEL). This trial includes a substudy of incidence of asymptomatic cerebral lesions detected by magnetic resonance imaging (MRI) after ablation.
Results: A randomized clinical trial compares for the first time high-power short-duration and conventional ablation in order to obtain data about the efficacy and safety of the high-power technique in an adequate methodological context.
Conclusions: The results of the POWER FAST III could support the use of the high-power short-duration ablation in clinical practice.
Registration: ClinicalTrials.gov: NTC04153747.
(© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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