心房颤动和左心房扩大患者介入治疗中的远程磁引导导航与手动射频消融方法:倾向分数匹配评估

A. Romanov, V. Beloborodov, V. V. Shabanov, A. Filippenko, D.A. Elesin, V.A. Boboshko, S. Khrushchev, P. Ruzankin
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The data regarding comparison of the remote magnetic-guided navigation (RMN) and manual (MAN) radiofrequency ablation approaches for PVI in patients with AF and enlarged left atrium (LA) are limited.Objective: The study was aimed to comparison of the safety and long-term efficacy of the radiofrequency CA associated with RMN and MAN using in patients with AF and enlarged LA.Methods: The retrospective cohort included 534 patients (mean age 59.2 ± 8.7 years, 41.6% female) with different AF forms and LA >4.5 cm who underwent PVI between 2016 and 2019. The patients were divided into two groups: the RMN group (n = 267) and MAN group (n = 267). The primary safety objective was associated with preventing perisurgical complications, and the primary efficacy objective was disengagement from AF / atrial flutter (AFl) / AT (atrial tachycardia), lasting > 30 seconds, in the 3-month period after the index procedure without AAD. The comparison of the results with 1:1 propensity score matching (PSM) was applied on the basis of 11 covariates. After PSM, 235 patients were selected for each group. The entire cohort was additionally divided into the subgroups of paroxysmal AF (n = 355) and non-paroxysmal AF (n = 179) to increase efficacy assessment. After PSM, 310 and 136 patients with paroxysmal and non-paroxysmal AF were analyzed, respectively.Results: In the entire cohort after PSM (n = 470) patients were balanced completely according to AF forms. The mean values of LA diameter were 4.98 ± 0.61 cm and 4.94 ± 0.58 cm in the RMN and MAN groups, respectively. The long-term efficacy assessment was performed in 448 patients of the both groups excluding 22 (4.7%) patients due to failed contacts. The median follow-up period was 24 months (minimum 3 and maximum 72 months). In the matched cohorts, perisurgical complications were detected in 11 (4.7%) patients of the MAN group and 2 (0.9%) patients of the RMN group (Р = 0.021, OR = 5.7; 95% CI [1.22, 53.5]). The disengagement from AF/AFl/AT after 36 months of the follow up amounted to 62.6% in the RMN group and 47.9% in the MAN group (for entire follow up, P = 0.005, HR = 1.54; 95% CI [1.14, 2.08]). For paroxysmal AF subgroup (n = 310), the disengagement from AF/AFl/AT after 36 months of the follow was 67.1% in the RMN group and 60.6% in the MAN group (for entire follow up, P = 0.15, HR = 1.34; 95% CI [0.90, 1.98]). In the non-paroxysmal AF subgroup (n = 136), the disengagement from AF/AFl/AT after 36 months of the follow up was higher in the RMN group as compared to the MAN group (59.6% and 30.4%, respectively, for entire follow up, P = 0.005, HR = 2.01; 95% CI [1.23, 3.29]) predominantly due to persistent AF.Conclusion: The present propensity-score matching study evidentiated that RMN CA was superior over manual CA for the interventional treatment of patients with AF and enlarged LA with respect to perisurgical complications and long-term disengagement from AF/AFl/AT predominantly due to non-paroxysmal AF. Prospective randomized studies are recommended for the comparison of the outcomes related to RMN and manual CA in patients with AF and enraged LA.\nReceived 24 April 2024. Accepted 8 May 2024.\nFunding: Work by P.S. Ruzankin and S.E. 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引用次数: 0

摘要

导言:对于抗心律失常药物治疗(AAD)难治的房颤(AF)患者,肺静脉造口隔离(PVI)是导管消融(CA)的主要方法。在房颤和左心房(LA)扩大的患者中,远程磁导导航(RMN)和手动(MAN)射频消融方法进行 PVI 的比较数据有限:该研究旨在比较房颤和 LA 扩大患者使用 RMN 和 MAN 射频 CA 的安全性和长期疗效:该回顾性队列纳入了2016年至2019年期间接受PVI治疗的534例患者(平均年龄(59.2±8.7)岁,41.6%为女性),这些患者具有不同的房颤形式,LA>4.5厘米。患者分为两组:RMN组(n = 267)和MAN组(n = 267)。主要安全性目标与预防围手术期并发症有关,主要疗效目标是在指数手术后 3 个月内脱离房颤/心房扑动(AFl)/房性心动过速(AT),持续时间大于 30 秒,且无 AAD。根据 11 个协变量,采用 1:1 倾向评分匹配法(PSM)对结果进行比较。经过倾向得分匹配后,每组选出 235 名患者。为增加疗效评估,整个组群又分为阵发性房颤(355 人)和非阵发性房颤(179 人)两组。PSM 后,分别对 310 名阵发性房颤患者和 136 名非阵发性房颤患者进行了分析:在 PSM 后的所有患者中(470 人),房颤形式完全均衡。RMN组和MAN组的LA直径平均值分别为4.98±0.61厘米和4.94±0.58厘米。对两组中的 448 名患者进行了长期疗效评估,排除了 22 名(4.7%)接触失败的患者。中位随访期为 24 个月(最短 3 个月,最长 72 个月)。在匹配队列中,MAN 组有 11 例(4.7%)患者出现了围手术期并发症,RMN 组有 2 例(0.9%)患者出现了围手术期并发症(Р = 0.021,OR = 5.7;95% CI [1.22,53.5])。随访 36 个月后,RMN 组脱离房颤/房颤/AT 的比例为 62.6%,MAN 组为 47.9%(整个随访期间,P = 0.005,HR = 1.54;95% CI [1.14,2.08])。在阵发性房颤亚组(n = 310)中,随访 36 个月后脱离房颤/房颤/AT 的比例,RMN 组为 67.1%,MAN 组为 60.6%(整个随访期间,P = 0.15,HR = 1.34;95% CI [0.90,1.98])。在非阵发性房颤亚组(n = 136)中,与 MAN 组相比,RMN 组在随访 36 个月后脱离房颤/AFl/AT 的比例更高(在整个随访期间,分别为 59.6% 和 30.4%,P = 0.005,HR = 2.01;95% CI [1.23,3.29]),主要原因是持续性房颤:本倾向得分匹配研究证明,在对房颤合并 LA 扩大的患者进行介入治疗时,RMN CA 在围手术期并发症和长期脱离房颤/AFl/AT(主要是非阵发性房颤)方面优于手动 CA。建议进行前瞻性随机研究,以比较 RMN 和人工 CA 对房颤和 LA 扩大患者的治疗效果。2024年5月8日接受:P.S. Ruzankin 和 S.E. Khrushchev 的工作是在俄罗斯科学院西伯利亚分院索波列夫数学研究所国家任务框架内进行的,项目编号为 FWNF-2024-0001:作者声明无利益冲突:A.B. Romanov、V.V. Beloborodov、V.V. Shabanov、A.G. Filippenko数据收集和分析:V.V. Beloborodov、A.B. Romanov、D.A. Elesin、V.A. Boboshko、V.V. Shabanov、A.G. Filippenko 统计分析:P.S. Ruzankin、S.Ye.赫鲁晓夫、A.B. 罗曼诺夫起草文章:A.B. Romanov、V.V. Beloborodov、P.S. Ruzankin、S.Ye.赫鲁晓夫文章的严格修订:A.B.罗曼诺夫、V.V.别洛博罗多夫、P.S.鲁赞金、S.叶赫鲁晓夫最终批准出版版本:A.B. Romanov、V.V. Beloborodov、V.V. Shabanov、A.G. Filippenko、D.A. Elesin、V.A. Boboshko、S.Ye. Khrushchev、P.S. Ruzankin。赫鲁晓夫、P.S. 鲁赞金
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Remote magnetic-guided navigation versus manual radiofrequency ablation approach in the interventional treatment of patients with atrial fibrillation and enlarged left atrium: propensity-score matching assessment
Introduction: Pulmonary vein ostia isolation (PVI) is the main method for catheter ablation (CA) in patients with atrial fibrillation (AF) who are refractory to antiarrhythmic drug therapy (AAD). The data regarding comparison of the remote magnetic-guided navigation (RMN) and manual (MAN) radiofrequency ablation approaches for PVI in patients with AF and enlarged left atrium (LA) are limited.Objective: The study was aimed to comparison of the safety and long-term efficacy of the radiofrequency CA associated with RMN and MAN using in patients with AF and enlarged LA.Methods: The retrospective cohort included 534 patients (mean age 59.2 ± 8.7 years, 41.6% female) with different AF forms and LA >4.5 cm who underwent PVI between 2016 and 2019. The patients were divided into two groups: the RMN group (n = 267) and MAN group (n = 267). The primary safety objective was associated with preventing perisurgical complications, and the primary efficacy objective was disengagement from AF / atrial flutter (AFl) / AT (atrial tachycardia), lasting > 30 seconds, in the 3-month period after the index procedure without AAD. The comparison of the results with 1:1 propensity score matching (PSM) was applied on the basis of 11 covariates. After PSM, 235 patients were selected for each group. The entire cohort was additionally divided into the subgroups of paroxysmal AF (n = 355) and non-paroxysmal AF (n = 179) to increase efficacy assessment. After PSM, 310 and 136 patients with paroxysmal and non-paroxysmal AF were analyzed, respectively.Results: In the entire cohort after PSM (n = 470) patients were balanced completely according to AF forms. The mean values of LA diameter were 4.98 ± 0.61 cm and 4.94 ± 0.58 cm in the RMN and MAN groups, respectively. The long-term efficacy assessment was performed in 448 patients of the both groups excluding 22 (4.7%) patients due to failed contacts. The median follow-up period was 24 months (minimum 3 and maximum 72 months). In the matched cohorts, perisurgical complications were detected in 11 (4.7%) patients of the MAN group and 2 (0.9%) patients of the RMN group (Р = 0.021, OR = 5.7; 95% CI [1.22, 53.5]). The disengagement from AF/AFl/AT after 36 months of the follow up amounted to 62.6% in the RMN group and 47.9% in the MAN group (for entire follow up, P = 0.005, HR = 1.54; 95% CI [1.14, 2.08]). For paroxysmal AF subgroup (n = 310), the disengagement from AF/AFl/AT after 36 months of the follow was 67.1% in the RMN group and 60.6% in the MAN group (for entire follow up, P = 0.15, HR = 1.34; 95% CI [0.90, 1.98]). In the non-paroxysmal AF subgroup (n = 136), the disengagement from AF/AFl/AT after 36 months of the follow up was higher in the RMN group as compared to the MAN group (59.6% and 30.4%, respectively, for entire follow up, P = 0.005, HR = 2.01; 95% CI [1.23, 3.29]) predominantly due to persistent AF.Conclusion: The present propensity-score matching study evidentiated that RMN CA was superior over manual CA for the interventional treatment of patients with AF and enlarged LA with respect to perisurgical complications and long-term disengagement from AF/AFl/AT predominantly due to non-paroxysmal AF. Prospective randomized studies are recommended for the comparison of the outcomes related to RMN and manual CA in patients with AF and enraged LA. Received 24 April 2024. Accepted 8 May 2024. Funding: Work by P.S. Ruzankin and S.E. Khrushchev was carried out within the framework of the state assignment of the Sobolev Institute of Mathematics of the Siberian Branch of the Russian Academy of Sciences, project FWNF-2024-0001. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. FilippenkoData collection and analysis: V.V. Beloborodov, A.B. Romanov, D.A. Elesin, V.A. Boboshko, V.V. Shabanov, A.G. Filippenko Statistical analysis: P.S. Ruzankin, S.Ye. Khrushchev, A.B. RomanovDrafting the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevCritical revision of the article: A.B. Romanov, V.V. Beloborodov, P.S. Ruzankin, S.Ye. KhrushchevFinal approval of the version to be published: A.B. Romanov, V.V. Beloborodov, V.V. Shabanov, A.G. Filippenko, D.A. Elesin, V.A. Boboshko, S.Ye. Khrushchev, P.S. Ruzankin
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Patologiya krovoobrashcheniya i kardiokhirurgiya
Patologiya krovoobrashcheniya i kardiokhirurgiya Medicine-Cardiology and Cardiovascular Medicine
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发文量
42
审稿时长
12 weeks
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