scholarly journals Differences in quality of life improvement with pulmonary vein isolation alone vs. more extensive ablation of persistent atrial fibrillation: insights from the EARNEST-PVI trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Kanda ◽  
M Masuda ◽  
K Inoue ◽  
Y Furukawa ◽  
A Hirata ◽  
...  

Abstract Background Improving the quality of life (QoL) is one of the main purposes of catheter ablation (CA) of persistent atrial fibrillation (AF). QoL improvement in persistent AF patients has not been fully clarified. The EARNEST-PVI trial was a multi-center randomized trial comparing clinical outcomes of pulmonary vein isolation (PVI) alone and more intensive ablation in addition to PVI including complex fractionated atrial electrogram (CFAE) and linear ablation (PVI plus). Purpose To investigate the QoL change after persistent AF ablation and the differences between the PVI-alone strategy and the PVI plus strategy. Methods In the EARNEST-PVI trial, patients with persistent AF who underwent an initial catheter ablation (n=512) were randomly assigned in a 1:1 ratio to either PVI alone or PVI plus. Quality of life was assessed at baseline and at 12 months after ablation for AF using the 36-Item Short Form Health Survey. Scores were also converted to a physical health component summary (PCS), a mental health component summary (MCS) and a role/social component summary (RCS). Results In the EARNEST-PVI trial, the PVI alone strategy was associated with higher recurrence rate compared with the PVI plus additional ablation strategy. After excluding 68 patients for whom preoperative or postoperative QoL assessment was not available, 222 patients were evaluated respectively. Overall, significant improvements in PCS (46.2±11.4 to 48.7±11.4]), MCS (50.1±8.8 to 54.3±8.6) and RCS (44.6±13.3 to 48.6±11.3) occurred 12 months after ablation (P<0.001, respectively). Although significant QoL improvement occurred in both PVI alone and PLI plus strategies, the changes in PCS was greater in the PVI-plus than that in PVI-alone (3.5±10.3 vs 1.5±10.6, P=0.04). Conclusions Ablation for persistent atrial fibrillation improved both physical and mental quality of life. The PVI-plus strategy showed greater improvement in physical QoL. FUNDunding Acknowledgement Type of funding sources: None. QoL improvement

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
K Nakajima ◽  
T Kimura ◽  
T Fujisawa ◽  
Y Katsumata ◽  
T Nishiyama ◽  
...  

EP Europace ◽  
2020 ◽  
Author(s):  
Koichi Inoue ◽  
Shungo Hikoso ◽  
Masaharu Masuda ◽  
Yoshio Furukawa ◽  
Akio Hirata ◽  
...  

Abstract Aims Previous studies could not demonstrate any benefit of more intensive ablation in addition to pulmonary vein isolation (PVI) including complex fractionated atrial electrogram (CFAE) and linear ablation for recurrence in the initial catheter ablation of persistent atrial fibrillation (AF). This study aimed to establish the non-inferiority of PVI alone to PVI plus these additional ablation strategies. Methods and results Patients with persistent AF who underwent an initial catheter ablation (n = 512, long-standing persistent AF; 128 cases) were randomly assigned in a 1:1 ratio to either PVI alone (PVI-alone group) or PVI plus CFAE and/or linear ablation (PVI-plus group). After excluding 15 cases who did not receive procedures, we analysed 249 and 248 patients, respectively. The primary endpoint was recurrence of AF, atrial flutter, and/or atrial tachycardia, and the non-inferior margin was set at a hazard ratio of 1.43. In the PVI-plus group, 85.1% of patients had linear ablation and 15.3% CFAE ablation. After 12 months, freedom from the primary endpoint occurred in 71.3% of patients in the PVI-alone group and in 78.3% in the PVI-plus group [hazard ratio = 1.56 (95% confidence interval: 1.10–2.24), non-inferior P = 0.3062]. The procedure-related complication rates were 2.0% in the PVI-alone group and 3.6% in the PVI-plus group (P = 0.199). Conclusion This randomized trial did not establish the non-inferiority of PVI alone to PVI plus linear ablation or CFAE ablation in patients with persistent AF, but implied that the PVI plus strategy was promising to improve the clinical efficacy (NCT03514693).


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