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脉冲场消融作为心房颤动的一线治疗:欧盟PORIA注册研究的一项子研究

Pulsed Field Ablation as First-Line Therapy for Atrial Fibrillation: A Substudy of the EU-PORIA Registry.

作者信息

Füting Anna, Neven Kars, Bordignon Stefano, Reichlin Tobias, Blaauw Yuri, Hansen Jim, Adelino Raquel, Ouss Alexandre, Roten Laurent, Mulder Bart A, Ruwald Martin H, Mené Roberto, van der Voort Pepijn, Reinsch Nico, Kueffer Thomas, Boveda Serge, Albrecht Elizabeth M, Raybuck Jonathan D, Sutton Brad, Chun Kyoung Ryul Julian, Schmidt Boris

机构信息

Department of Electrophysiology, Alfried Krupp Hospital, Essen, Germany (A.F., K.N., N.R.).

Department of Medicine, Witten/Herdecke University, Germany (A.F., K.N., N.R.).

出版信息

Circ Arrhythm Electrophysiol. 2024 Dec;17(12):e013088. doi: 10.1161/CIRCEP.124.013088. Epub 2024 Nov 27.

DOI:10.1161/CIRCEP.124.013088
PMID:39601122
Abstract

BACKGROUND

Recent studies have demonstrated the benefit of early ablation in preventing the progression of atrial fibrillation (AF). Clinical practice has reflected this shift in AF management and no longer requires patients to fail antiarrhythmic drugs (AADs) before receiving ablation. However, there is limited evidence on outcomes with pulsed field ablation (PFA) as a first-line therapy. Examination of real-world data may shed light on clinical practices and the effectiveness of PFA with and without a prior history of AAD usage.

METHODS

European Real World Outcomes with Pulsed Field Ablation is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter at 7 high-volume centers in Europe. This subanalysis evaluates patients with a history of class I/III AAD use versus those with no documented history of class I/III AAD use (first-line patients). Patients with incomplete AAD history, long-standing persistent AF, and those undergoing a repeat ablation procedure were excluded. Patients were treated and followed based on institutional standard of care. Any episode of atrial tachycardia or AF lasting longer than 30 s was considered an arrhythmia recurrence.

RESULTS

Of 1233 patients enrolled in European real world outcomes with pulsed field ablation, 1091 met the inclusion criteria (mean age, 66 years; 40% females; and persistent AF, 36%). Pulmonary vein isolation-only was used in 90% of the patients, and 10% received extra-PV ablation. Ablation as the first-line approach was chosen in 589 patients, and 502 patients had prior class I/III AAD use. In the first-line PFA group, paroxysmal AF was more frequent (68% versus 59%; <0.001), and pulmonary vein isolation-only was more frequent (93% versus 86%; <0.001). At 1-year follow-up, freedom from AF/atrial tachycardia recurrence was similar in the ablation-first versus the ablation after failed AAD group (78% versus 74%, respectively; =0.076).

CONCLUSION

In this large real-world PFA registry, freedom from AF/atrial tachycardia recurrence after 1 year was similar in patients undergoing PFA as a first-line treatment and those with prior failed AAD therapy.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05823818.

摘要

背景

近期研究已证明早期消融在预防心房颤动(AF)进展方面的益处。临床实践已反映出房颤管理的这种转变,不再要求患者在接受消融前抗心律失常药物(AADs)治疗失败。然而,关于脉冲场消融(PFA)作为一线治疗的疗效证据有限。对真实世界数据的研究可能有助于了解临床实践以及有无AAD使用史情况下PFA的有效性。

方法

欧洲脉冲场消融真实世界结局研究是一项纳入所有患者的房颤登记研究,连续纳入在欧洲7个高容量中心接受五叶形PFA导管治疗的患者。该亚组分析评估有I/III类AAD使用史的患者与无I/III类AAD使用记录史的患者(一线治疗患者)。排除AAD病史不完整、长期持续性房颤以及接受重复消融手术的患者。患者根据机构护理标准进行治疗和随访。任何持续超过30秒的房性心动过速或房颤发作均被视为心律失常复发。

结果

在欧洲脉冲场消融真实世界结局研究纳入的1233例患者中,1091例符合纳入标准(平均年龄66岁;40%为女性;持续性房颤占36%)。90%的患者仅采用肺静脉隔离术,10%接受了肺静脉外消融。589例患者选择消融作为一线治疗方法,502例患者曾使用过I/III类AAD。在一线PFA组中,阵发性房颤更为常见(68%对59%;<0.001),仅肺静脉隔离术更为常见(93%对86%;<0.001)。在1年随访时,一线消融组与AAD治疗失败后消融组的房颤/房性心动过速复发率相似(分别为78%和74%;P = 0.076)。

结论

在这项大型真实世界PFA登记研究中,接受PFA一线治疗的患者与先前AAD治疗失败的患者在1年后的房颤/房性心动过速复发率相似。

注册信息

网址:https://www.clinicaltrials.gov;唯一标识符:NCT05823818。

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