Isabel Deisenhofer, Jean-Paul Albenque, Sonia Busch, Edouard Gitenay, Stavros E. Mountantonakis, Antoine Roux, Jerome Horvilleur, Babe Bakouboula, Saumil Oza, Selim Abbey, Guillaume Theodore, Antoine Lepillier, Yves Guyomar, Francis Bessiere, Jaap Jan Smit, Theophile Mohr Durdez, Paola Milpied, Anthony Appetiti, Daniel Guerrero, Tom De Potter, Christian De Chillou, Seth Goldbarg, Atul Verma, John D. Hummel, , Jaap Jan Smit, Tom De Potter, Christian De Chillou <<<

Abstract Although pulmonary vein isolation (PVI) has become the cornerstone ablation procedure for atrial fibrillation (AF), the optimal ablation procedure for persistent and long-standing persistent AF remains elusive. Targeting spatio-temporal electrogram dispersion in a tailored procedure has been suggested as a potentially beneficial alternative to a conventional PVI-only procedure. In this multicenter, randomized, controlled, double-blind, superiority trial, patients with drug-refractory persistent AF were randomly assigned to a tailored ablation procedure targeting areas of spatio-temporal dispersion, as detected by an artificial intelligence (AI) algorithm, in addition to PVI (tailored arm, n = 187, 23% women) or to a conventional PVI-only procedure (anatomical arm, n = 183, 19% women). The primary efficacy endpoint was freedom from documented AF with or without antiarrhythmic drugs at 12 months after a single ablation procedure. Secondary endpoints included freedom from any atrial arrhythmic events, and the secondary composite safety endpoint consisted of death, cerebrovascular events, or treatment-related serious adverse events. One year post-procedure, the trial met its primary efficacy endpoint, which was achieved in 88% of patients in the tailored arm compared with 70% of patients in the anatomical arm (log-rank P < 0.0001 for superiority). However, no significant difference between arms was observed for the freedom from any atrial arrhythmia endpoint after one ablation. The safety endpoint did not differ between arms, with procedure and ablation times being twice as long in the tailored arm. These results show that AI-guided ablation of spatio-temporal dispersion areas in addition to PVI is superior to PVI alone in eliminating AF at 1-year follow-up in patients with persistent and long-standing persistent AF. Ablation of subsequent organized atrial tachycardias may be needed to maintain sinus rhythm long term. ClinicalTrials.gov identifier: NCT04702451. <<<

Caihua Sang, Qiang Liu, Yiwei Lai, Shijun Xia, Ruhong Jiang, Songnan Li, Qi Guo, Qifan Li, Mingyang Gao, Xueyuan Guo, Lihong Huang, Nian Liu, Chenxi Jiang, Song Zuo, Xiaoxia Liu, Mengmeng Li, Weili Ge, Shangming Song, Lianghua Chen, Shuanglun Xie, Jiangang Zou, Ke Chen, Xiangfei Liu, Hesheng Hu, Xinhua Wang, Jinlin Zhang, Zhaojun Wang, Chi Wang, Liu He, Chao Jiang, Ribo Tang, Ning Zhou, Yunlong Wang, Deyong Long, Xin Du, Chenyang Jiang, Laurent Macle, Jianzeng Dong, Changsheng Ma, , Wei Wang, Xin Zhao, Changyi Li, Zhuo Liang, Xu Li, Xiangyi Kong, Wenli Dai, Yufeng Wang, Lu Yu, Xueyan Ding, Hui Cheng, Jianwei Lin, Pei Zhang, Yaxun Sun, Xiaofeng Hou, Yao Wang, Yumei Xue, Rong Bai, Jing Du <<<

ImportanceSuccess rates of pulmonary vein isolation (PVI) are modest for persistent atrial fibrillation (AF). Additional linear ablation beyond PVI has not been proved superior to PVI alone in randomized trials. Ethanol infusion of the vein of Marshall (EIVOM) facilitates ablation at the mitral isthmus and may lead to improved effectiveness of a linear ablation strategy.ObjectiveTo determine whether linear ablation with radiofrequency energy combined with EIVOM added to PVI improves sinus rhythm maintenance compared with PVI alone in patients with persistent AF.Design, Setting, and ParticipantsThe PROMPT-AF trial is an investigator-initiated, multicenter, open-label, randomized trial involving 12 tertiary hospitals in China. A total of 498 patients aged 18 to 80 years, with AF persisting for more than 3 months, undergoing first-time AF ablation, were enrolled and randomized from August 27, 2021, to July 16, 2023.InterventionsPatients were randomized to undergo PVI alone or PVI plus EIVOM and linear ablation (intervention). The latter group first underwent EIVOM, followed by PVI and linear ablation of the left atrial roof, mitral isthmus, and cavotricuspid isthmus.Main Outcomes and MeasuresThe primary end point was freedom from any documented atrial arrhythmias lasting more than 30 seconds, without the use of antiarrhythmic drugs within 12 months. Secondary outcomes included freedom from atrial arrhythmia recurrence, AF, atrial arrhythmia recurrence after multiple procedures, and documented atrial tachycardia or atrial flutter with or without antiarrhythmic drugs; AF burden; and improvement in quality of life. Patients were monitored with wearable single-lead electrocardiographic (ECG) patches, worn for 24 hours a week, supplemented by symptom-triggered ECGs and Holter monitoring.ResultsAmong 498 randomized patients, 495 (99.4%) were included in the primary analysis (mean age, 61.1 years [SD, 9.7] years, 361 male [72.9%]). After 12 months, 174 of 246 patients (70.7%) assigned to undergo PVI plus EIVOM and linear ablation and 153 of 249 patients (61.5%) assigned to undergo PVI alone remained free from atrial arrhythmias without taking antiarrhythmic drugs (hazard ratio, 0.73; 95% CI, 0.54-0.99, P = .045). The intervention effect was consistent across all prespecified subgroups. The comparison of secondary outcomes did not demonstrate significant results.ConclusionAmong patients with persistent AF, linear ablation combined with EIVOM in addition to PVI significantly improved freedom from atrial arrhythmias within 12 months compared with PVI alone.Trial RegistrationClinicalTrials.gov Identifier: NCT04497376 <<<