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脉冲场消融与冷冻球囊消融用于肺静脉隔离的比较。

Comparison of pulsed field ablation and cryoballoon ablation for pulmonary vein isolation.

作者信息

Schipper Jan-Hendrik, Steven Daniel, Lüker Jakob, Wörmann Jonas, van den Bruck Jan-Hendrik, Filipovic Karlo, Dittrich Sebastian, Scheurlen Cornelia, Erlhöfer Susanne, Pavel Friederike, Sultan Arian

机构信息

Department of Electrophysiology, Heart Center, University of Cologne, Köln, Germany.

出版信息

J Cardiovasc Electrophysiol. 2023 Oct;34(10):2019-2026. doi: 10.1111/jce.16056. Epub 2023 Sep 8.

Abstract

INTRODUCTION

Pulmonary vein isolation (PVI) remains the cornerstone in the treatment of atrial fibrillation (AF). PVI using cryoballoon (CB) technology has emerged as a standard procedure in many centers. Recently, pulsed field ablation (PFA) has been introduced and used to achieve PVI. First data show high acute and favorable long-term outcomes. So far, data comparing these new "single shot" devices are sparse. We sought to compare procedural and outcome data for first time PFA users versus CB in patients undergoing de novo PVI. Furthermore, potentially postprocedural discomfort and affection of autonomic ganglia were assessed.

METHODS AND RESULTS

A retrospective analysis and comparison of all de novo PVIs with PFA and CB was performed. Furthermore, PFA PVI learning curve was evaluated. During follow-up, repeat outpatient visits and Holter electrocardiogram were performed to analyze arrhythmia-free survival. Discomfort analysis was obtained by prescribed analgesic medication within first 48 h after PVI. Potential changes in heart rate (HR) between baseline and at 3-month follow-up were evaluated. A total of 108 patients (54 PFA and 54 CB; PFA; 33 (30%) female) with paroxysmal and persistent AF were analyzed. Type of AF was comparable (Patients suffering from PAF: PFA: 16 (30%), CB: 17 (31%), p = 1.0). In 107 (99%) patients, successful PVI was achieved. Transient phrenic palsy omitted complete PVI in one CB patient. A trend for a shorter overall procedure duration was observed in the PFA group (PFA: 64.5 ± 17.5 min; CB: 73.0 ± 24.8 min; p = 0.07). Excluding LA mapping time (first 14 cases), procedure time was significantly shorter using PFA (PFA: 58.0 ± 12.5 min, CB: 73.0 ± 24.8 min, p = 0.0001). Fluoroscopy time was significantly longer for PFA (PFA: 15.3 ± 4.7 min, CB: 12.3 ± 5.3 min; p = 0.001), but significantly less contrast medium was used (PFA: 12 ± 6 mL; CB: 51 ± 29 mL, p < 0.0001). Subgroup analysis of the PFA group revealed a significant shortening of procedure duration over time (first tertile: 72.7 ± 13.5 min, second tertile: 67.3 ± 21.7 min, third tertile: 53.4 ± 9.8 min, first vs. third tertile p < 0.0001). Two cardiac tamponades occurred in the PFA group (p = 0.495), of which one was most likely related to complex transseptal puncture. In the first 48 h after PVI, the number of prescribed analgesics due to postprocedural pain was equal between both groups (PFA: 7 (13%) patients, CB: 10 (19%) patients, p = 0.598). After a FU of 273 ± 129 days, 35 of 47 patients (74%) after PFA and 36 of 50 patients (72%) after CB PVI were free of any atrial arrhythmia (HR: 0.98, p = 0.88). Only in the PFA group, a significant increase in HR 3 months after PVI was observed (pre-PVI: 61 ± 8 beats/min, post-PVI: 65 ± 9 beats/min, p = 0.008).

CONCLUSION

The new PFA technology is equally effective and safe as compared to CB for complete PVI with potentially shorter procedure time and significantly less contrast medium. However, AF recurrence rates after PFA PVI seem to be comparable to CB PVI.

摘要

引言

肺静脉隔离(PVI)仍然是治疗心房颤动(AF)的基石。使用冷冻球囊(CB)技术进行PVI已在许多中心成为一种标准术式。最近,脉冲场消融(PFA)已被引入并用于实现PVI。初步数据显示其急性效果良好且长期预后佳。到目前为止,比较这些新型“单次”设备的数据很少。我们试图比较初次接受PFA治疗的患者与接受CB治疗的患者在进行初次PVI时的手术过程和预后数据。此外,还评估了术后可能出现的不适以及自主神经节的影响。

方法与结果

对所有初次使用PFA和CB进行的PVI进行回顾性分析和比较。此外,评估了PFA PVI的学习曲线。在随访期间,进行了门诊复查和动态心电图检查以分析无心律失常生存期。通过PVI后48小时内开具的止痛药物来分析不适情况。评估了基线与3个月随访时心率(HR)的潜在变化。共分析了108例阵发性和持续性AF患者(54例PFA组和54例CB组;PFA组中33例(30%)为女性)。AF类型具有可比性(阵发性AF患者:PFA组16例(30%),CB组17例(31%),p = 1.0)。107例(99%)患者成功完成PVI。1例CB患者因短暂性膈神经麻痹未完成完整PVI。PFA组观察到总体手术时间有缩短趋势(PFA组:64.5±17.5分钟;CB组:73.0±24.8分钟;p = 0.07)。排除左心房标测时间(前14例)后,使用PFA时手术时间显著缩短(PFA组:第1三分位数:72.7±13.5分钟,第2三分位数:67.3±21.7分钟,第3三分位数:53.4±9.8分钟,第1与第3三分位数比较p < 0.0001)。PFA组透视时间显著更长(PFA组:15.3±4.7分钟,CB组:12.3±5.3分钟;p = 0.001),但使用的造影剂显著更少(PFA组:12±6毫升;CB组:51±29毫升,p < 0.0001)。PFA组的亚组分析显示手术时间随时间显著缩短(第1三分位数:72.7±13.5分钟,第2三分位数:67.3±21.7分钟,第,3三分位数:53.4±9.8分钟,第1与第3三分位数比较p < 0.0001)。PFA组发生2例心包填塞(p = 0.495),其中1例很可能与复杂的经房间隔穿刺有关。在PVI后48小时内,两组因术后疼痛开具的止痛药物数量相等(PFA组:7例(13%)患者,CB组:10例(19%)患者,p = 0.598)。在273±129天的随访后,PFA术后47例患者中的35例(74%)和CB PVI术后50例患者中的36例(72%)无任何房性心律失常(HR:0.98,p =

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