Ricciardi Danilo, Arena Giuseppe, Verlato Roberto, Iacopino Saverio, Pieragnoli Paolo, Molon Giulio, Manfrin Massimiliano, Allocca Giuseppe, Cattafi Giuseppe, Sirico Giusy, Rovaris Giovanni, Sciarra Luigi, Nicolis Daniele, Tondo Claudio
Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo 200, 00128, Rome, Italy.
Nuovo Ospedale delle Apuane, Massa, Italy.
J Interv Card Electrophysiol. 2019 Oct;56(1):9-18. doi: 10.1007/s10840-019-00601-3. Epub 2019 Aug 26.
Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C.
Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C.
From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHADS-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025).
According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males.
NCT01007474.
使用冷冻消融术进行肺静脉隔离（PVI-C）是治疗有症状的复发性心房颤动（AF）的一种广泛应用的疗法。在实际临床实践中，性别对PVI-C疗效和安全性的影响尚不清楚。在一个多中心前瞻性项目中，我们评估了接受PVI-C治疗的患者在临床特征、手术参数、手术并发症、长期房颤复发率和/或房颤相关症状方面是否因性别而异。
研究人群的数据是在1STOP ClinicalService®项目框架内收集的，该项目涉及47个意大利心脏病中心。进行多变量统计分析以确定任何基线临床特征是否会影响PVI-C的疗效。
从2012年4月起，2125例患者（27%为女性，年龄59±11岁，73%为阵发性房颤，平均左心房直径=42±8mm）接受了PVI-C治疗。根据基线特征，女性更可能年龄较大，临床风险评分较高（如CHADS-VASc），并且在首次PVI-C手术前接受过更多种类的抗心律失常药物检测。男性和女性队列的手术时间相当（平均=107.7±46.8分钟），围手术期并发症发生率相似（总体为4.5%），即使在对基线特征进行调整后也是如此（P=0.880）。多变量分析表明，房颤复发的最强预测因素是性别（0.74；95%CI 0.58-0.93；P=0.011）。在倾向评分调整后，包含年龄和房颤类型（持续性）作为协变量的多变量模型的风险比为0.76（0.60-0.97）（P=0.025）。
根据1STOP项目，在实际临床环境中，无论患者性别如何，PVI-C相对安全；然而，在考虑手术疗效时，女性患者的长期疗效低于男性。
NCT01007474。
