全国范围内心房颤动脉冲场消融的工作流程经验：学习曲线、效率及安全性
National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.
作者信息
Bisignani Antonio, Schiavone Marco, Solimene Francesco, Dello Russo Antonio, Filannino Pasquale, Magnocavallo Michele, Tondo Claudio, Schillaci Vincenzo, Casella Michela, Petretta Andrea, Rossi Pietro, Fassini Gaetano, Rossillo Antonio, Maggio Ruggero, Themistoclakis Sakis, Pandozi Claudio, Polselli Marco, Tundo Fabrizio, Arestia Alberto, Compagnucci Paolo, Valente Perrone Annelisa, Malacrida Maurizio, Iacopino Saverio, Bianchi Stefano
机构信息
Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy.
Monzino Cardiological Center, Milan, Italy.
出版信息
J Interv Card Electrophysiol. 2024 Dec;67(9):2127-2136. doi: 10.1007/s10840-024-01835-6. Epub 2024 May 30.
BACKGROUND
Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes.
METHODS
Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year.
RESULTS
Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported.
CONCLUSIONS
In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures.
CLINICAL TRIAL REGISTRATION
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.
背景
近期关于脉冲场消融（PFA）治疗心房颤动（AF）的数据表明手术时间在逐步缩短。关于PFA学习曲线与临床结果之间关系的真实世界数据很少。目的是评估PFA学习曲线及其对急性结果的影响。
方法
连续接受使用FARAPULSE™ PFA系统进行AF消融的患者被纳入一项前瞻性、非随机多中心研究。手术时间根据操作者的学习曲线进行分层。对同一操作者上一年进行的射频（RF）和冷冻消融（CB）肺静脉隔离（PVI）手术的皮肤到皮肤时间进行比较分析。
结果
在752例患者中，35.1%为女性，66.9%为阵发性AF；平均年龄为62.2±10岁。总共62.5%的手术由进行过超过20例PFA手术的操作者完成。在10例相关手术之后，达到肺静脉隔离的时间（25.6±10分钟对16.5±8分钟，p<0.0001）和透视时间（19.8±8分钟对15.9±8分钟，p = 0.0045）均显著改善，且与手术时间减少的一致线性趋势相关（在各种手术指标中R为0.92 - 0.68）。在217例（62.4%）手术中，当前PFA的皮肤到皮肤时间低于历史皮肤到皮肤时间；在112例（32.2%）病例中相似，在19例（5.5%）中高于历史皮肤到皮肤时间。未报告重大并发症。
结论
在这项全国性多中心经验中，新型PFA系统在阵发性和持续性AF患者中被证明是快速、安全且急性有效。学习曲线似乎很快，因为仅经过少数几次手术后就观察到手术参数有所改善。
临床试验注册
临床实践中成功消融AF的先进技术（ATHENA）。网址：http://clinicaltrials.gov/ 标识符：NCT05617456
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