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Pulsed Field Versus Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation: Efficacy, Safety, and Long-Term Follow-Up in a 400-Patient Cohort.
Circulation: Arrhythmia and Electrophysiology ( IF 8.4 ) Pub Date : 2023-05-31 , DOI: 10.1161/circep.123.011920
Lukas Urbanek 1 , Stefano Bordignon 1 , David Schaack 1 , Shaojie Chen 1 , Shota Tohoku 1 , Tolga Han Efe 1 , Ramin Ebrahimi 1 , Francesco Pansera 1 , Jun Hirokami 1 , Karin Plank 1 , Alexander Koch 1 , Britta Schulte-Hahn 1 , Boris Schmidt 1 , Kyoung-Ryul Julian Chun 1
Affiliation  

BACKGROUND The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques. METHODS Consecutive AF patients who underwent pulsed field ablation (PFA) and CB-based PVI were enrolled. CB PVI was performed using the second-generation 28-mm CB; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as freedom from atrial tachyarrhythmia after a 3-month blanking period. RESULTS Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age 70 [interquartile range, 59-77] years), 200 in each group (CB and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of CB patients (P=0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29-40] minutes) versus CB (50 [45-60] minutes; P<0.001), fluoroscopy time was similar. Overall procedural complications were 6.5% in CB and 3.0% in PFA (P=0.1), driven by a higher rate of phrenic nerve palsies using CB. The 1-year success rates in paroxysmal AF (CB, 83.1%; PFA, 80.3%; P=0.724) and persistent AF (CB, 71%; PFA, 66.8%; P=0.629) were similar for both techniques. CONCLUSIONS PFA compared with CB PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.

中文翻译:

脉冲场与冷冻球囊肺静脉隔离治疗心房颤动:400 名患者队列的有效性、安全性和长期随访。

背景冷冻球囊(CB)代表了心房颤动(AF)患者肺静脉隔离(PVI)的金标准单次装置。单次脉冲场 PVI 消融(非热、心脏组织选择性)最近已进入舞台。我们试图比较两种技术的程序数据和长期结果。方法连续接受脉冲场消融 (PFA) 和基于 CB 的 PVI 的 AF 患者纳入研究。使用第二代28毫米CB进行CB PVI;使用 31/35 毫米五花线导管进行 PFA。成功被定义为在 3 个月的空白期后不再出现房性快速心律失常。结果 纳入 400 名患者(56.5% 为男性;60.8% 阵发性 AF;年龄 70 [四分位距,59-77] 岁),每组 200 名(CB 和 PFA),基线特征没有差异。100% 的 PFA 和 98% (196/200) 的 CB 患者实现了急性 PVI(P=0.123;4 次修补消融)。PFA 的中位手术时间(34.5 [29-40] 分钟)明显短于 CB(50 [45-60] 分钟;P<0.001),透视时间相似。CB 的总体手术并发症发生率为 6.5%,PFA 的总体手术并发症为 3.0%(P=0.1),这是由于使用 CB 的膈神经麻痹发生率较高所致。两种技术的阵发性 AF(CB,83.1%;PFA,80.3%;P=0.724)和持续性 AF(CB,71%;PFA,66.8%;P=0.629)的 1 年成功率相似。结论 PFA 与 CB PVI 相比显示出相似的手术效果,但手术时间较短且无膈神经麻痹。重要的是,12 个月的临床成功率很高,但两组之间没有差异。
更新日期:2023-05-31
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