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消融流出道室性期前收缩的附加病灶集:一项随机临床试验。

Additional Lesion Sets in Ablation of Outflow Tract Premature Ventricular Contractions: A Randomized Clinical Trial.

机构信息

Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an, China.

出版信息

JAMA Cardiol. 2024 Nov 1;9(11):1039-1046. doi: 10.1001/jamacardio.2024.2975.

Abstract

IMPORTANCE

Recurrence remains a challenge after ablation of outflow tract premature ventricular contractions (OT-PVCs). Although adding additional lesions next to the index effective ablation site is sometimes performed to reinforce the ablation, it remains uncertain whether this approach is effective.

OBJECTIVE

To test the hypothesis that additional ablation lesions would reduce the recurrence rate compared with single-point ablation at the index effective site for the ablation of OT-PVCs.

DESIGN, SETTING, AND PARTICIPANTS: This study was a multicenter, prospective, randomized clinical trial. Patients receiving their first catheter ablation for OT-PVCs were enrolled from 18 hospitals in China between October 2021 and February 2023. Scheduled follow-up duration was 3 months after the procedure.

INTERVENTION

After identifying the target point and eliminating the PVC by a single-point ablation, patients were randomized 1:1 into an additional ablation group or a control group.

MAIN OUTCOMES AND MEASURES

The primary end point of the study was freedom from PVC recurrence (≥80% reduction of PVC burden, which is the number of PVCs in 24 hours/total heartbeats in 24 hours × 100%) from baseline to 3 months postprocedure.

RESULTS

Of 308 patients enrolled in the study, 286 (mean [SD] age, 49.2 [14.6] years; 173 female [60.5%]) were randomized to the additional ablation or the control group. The additional ablation group had a mean (SD) of 6.3 (1.1) radiofrequency applications, whereas the control group (single-point ablation group) had a mean (SD) of 1 (0) radiofrequency application. After a median (IQR) follow-up of 3.2 (0) months, the rate of freedom from PVCs was significantly higher in the additional ablation group (139 of 142 [97.9%]) compared with the control group (115 of 139 [82.7%]; P < .001). Patients in the additional ablation group also had a more substantial reduction in PVC burden than the control group (mean [SD] reduction, 23.0% [10.5%] vs 19.0% [10.4%]; P = .002). There were no severe periprocedural complications in either group.

CONCLUSIONS AND RELEVANCE

This randomized clinical trial showed a benefit of additional ablation in reducing the recurrence of OT-PVCs compared with the single-point ablation strategy, without increased complication risk. Additional ablations surrounding the index effective ablation point should be considered in OT-PVC ablation.

TRIAL REGISTRATION

Chinese Clinical Trials Registry Identifier: ChiCTR2200055340.

摘要

重要性

消融流出道室性早搏 (OT-PVCs) 后仍存在复发的挑战。虽然有时会在索引有效消融部位旁边添加额外的消融病灶以加强消融,但仍不确定这种方法是否有效。

目的

检验假设,即在 OT-PVCs 的消融中,与单点消融索引有效部位相比,附加消融病灶将降低复发率。

设计、设置和参与者:这是一项多中心、前瞻性、随机临床试验。2021 年 10 月至 2023 年 2 月,从中国 18 家医院招募首次接受 OT-PVC 导管消融的患者。计划的随访时间为术后 3 个月。

干预

在确定目标点并通过单点消融消除 PVC 后,患者以 1:1 的比例随机分为附加消融组或对照组。

主要结局和测量

研究的主要终点是从基线到术后 3 个月,无 PVC 复发(≥80% PVC 负荷减少,即 24 小时内 PVC 数/24 小时内总心跳数×100%)。

结果

在纳入研究的 308 名患者中,286 名(平均[SD]年龄,49.2[14.6]岁;173 名女性[60.5%])被随机分配到附加消融组或对照组。附加消融组平均(SD)进行了 6.3(1.1)次射频应用,而对照组(单点消融组)平均(SD)进行了 1(0)次射频应用。中位(IQR)随访 3.2(0)个月后,附加消融组的 PVC 无复发率(139/142[97.9%])明显高于对照组(115/139[82.7%];P<.001)。与对照组相比,附加消融组的 PVC 负荷也有更大的降低(平均[SD]降低,23.0%[10.5%] vs 19.0%[10.4%];P=.002)。两组均无严重围手术期并发症。

结论和相关性

这项随机临床试验表明,与单点消融策略相比,附加消融在降低 OT-PVC 复发方面具有优势,且不增加并发症风险。在 OT-PVC 消融中,应考虑在索引有效消融点周围进行附加消融。

试验注册

中国临床试验注册中心标识符:ChiCTR2200055340。

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Determining the optimal duration for premature ventricular contraction monitoring.确定室性期前收缩监测的最佳持续时间。
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