基于多电极导管的脉冲电场与冷冻球囊用于房颤消融的比较：一项系统评价和荟萃分析。
Multielectrode catheter-based pulsed electric field vs. cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis.
作者信息
Vetta Giampaolo, Della Rocca Domenico Giovanni, Parlavecchio Antonio, Magnocavallo Michele, Sorgente Antonio, Pannone Luigi, Del Monte Alvise, Almorad Alexandre, Sieira Juan, Marcon Lorenzo, Doundoulakis Ioannis, Mohanty Sanghamitra, Audiat Charles, Nakasone Kazutaka, Bala Gezim, Ströker Erwin, Combes Stéphane, Overeinder Ingrid, Bianchi Stefano, Palmisano Pietro, Rossi Pietro, Boveda Serge, La Meir Marc, Natale Andrea, Sarkozy Andrea, de Asmundis Carlo, Chierchia Gian-Battista
机构信息
Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels 1090, Belgium.
Mediterranean Consortium for Arrhythmia Research (MediCAR), Rome, Italy.
出版信息
Europace. 2024 Dec 3;26(12). doi: 10.1093/europace/euae293.
AIMS
Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue-specific effect targeting cardiomyocytes and sparing adjacent tissues. Single-shot pentaspline system was the first PFA device to receive regulatory approval. We performed a meta-analysis to compare the efficacy and safety of PFA with the single-shot pentaspline system vs. currently available second-/third-/fourth-generation cryoballoon ablation (CRYO) technologies.
METHODS AND RESULTS
We systematically searched electronic databases for studies focusing on AF ablation employing the PFA single-shot pentaspline system or second-/third-/fourth-generation CRYO technologies. The primary endpoints were acute procedural success assessed on a vein and patient basis. Safety endpoints included overall periprocedural complications and major periprocedural complications. We also compared procedural, fluoroscopy times, and freedom from atrial tachyarrhythmias (ATs) at follow-up (secondary endpoints). Twenty and 70 studies were included for PFA and CRYO, respectively. Pulsed field ablation demonstrated greater acute procedural success on a vein basis (99.9% vs. 99.1%; P < 0.001), as well as per patient (99.5% vs. 98.4%; P < 0.001). Pulsed field ablation yielded lower overall periprocedural complications (3.1% vs. 5.6%; P < 0.001), shorter procedural time (75.9 min vs. 105.6 min; P < 0.001), and fluoroscopy time (14.2 min vs. 18.9 min; P < 0.001) compared with CRYO. No differences were found for major periprocedural complications (1.2% vs. 1.0%; P = 0.46) and freedom from ATs at 1 year (82.3% vs. 80.3%; log-rank P = 0.61).
CONCLUSION
Pulsed field ablation contributed to higher acute procedural success and safety compared with CRYO. No statistically significant differences in AT recurrence at 1-year follow-up were observed.
目的
脉冲场消融（PFA）是最近用于治疗心房颤动（AF）的一项创新技术。临床前和临床研究报告了其显著的安全性，这是由于其对心肌细胞具有组织特异性作用，同时可避免损伤相邻组织。单次发射五边形系统是首个获得监管批准的PFA设备。我们进行了一项荟萃分析，以比较采用单次发射五边形系统的PFA与目前可用的第二代/第三代/第四代冷冻球囊消融（CRYO）技术的疗效和安全性。
方法与结果
我们系统检索了电子数据库中聚焦于使用PFA单次发射五边形系统或第二代/第三代/第四代CRYO技术进行AF消融的研究。主要终点是基于静脉和患者评估的急性手术成功率。安全终点包括围手术期总体并发症和主要围手术期并发症。我们还比较了手术时间、透视时间以及随访时无房性快速性心律失常（ATs）的情况（次要终点）。分别纳入了20项关于PFA和70项关于CRYO的研究。脉冲场消融在基于静脉方面显示出更高的急性手术成功率（99.9%对99.1%；P<0.001），以及基于患者方面（99.5%对98.4%；P<0.001）。与CRYO相比，脉冲场消融产生的围手术期总体并发症更低（3.1%对5.6%；P<0.001），手术时间更短（75.9分钟对105.6分钟；P<0.001），透视时间更短（14.2分钟对18.9分钟；P<0.001）。在主要围手术期并发症（1.2%对1.0%；P = 0.46）和1年时无ATs情况（82.3%对80.3%；对数秩检验P = 0.61）方面未发现差异。
结论
与CRYO相比，脉冲场消融有助于提高急性手术成功率和安全性。在1年随访时，未观察到AT复发的统计学显著差异。
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