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首例研究者发起的 nMARQTM、PVACTM 和胸腔镜消融治疗阵发性心房颤动的随机临床试验结果。

Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation.

机构信息

Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Hermitage Lane, Maidstone, ME16?9QQ, UK.

Eastbourne Hospital, East Sussex Healthcare NHS Trust, East Sussex, UK.

出版信息

Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.

DOI:10.1093/europace/eux267
PMID:29092038
Abstract

AIMS

To investigate the effect of minimally invasive thoracoscopic surgical ablation and nMARQ irrigated multi-electrode phased radiofrequency (RF) ablation to treat paroxysmal atrial fibrillation (AF) compared with PVAC multi-electrode phased RF ablation, with beat-to-beat device-derived Holter monitoring throughout the study duration.

METHODS AND RESULTS

An investigator-initiated prospective trial of patients with paroxysmal AF randomized (1:1:1) to initial surgical, nMARQ or PVAC ablation. All patients had continuous beat-to-beat monitoring with an ILR or pacemaker to evaluate and document AF recurrence. There was a strong trend (P = 0.050) toward difference in AF outcome, with surgical AF ablation more efficacious than catheter ablation. At one year, the proportion of patients with less than 1% AF burden after one procedure and off all antiarrhythmic drugs was 63, 56, and 90% for PVAC, nMARQ and surgical ablations respectively. There were significantly more repeat ablations in the catheter ablation groups (P = 0.008): 25% PVAC, 27% nMARQ, 0% surgery. However, 7 of 20 (35%) of patients undergoing surgical ablation suffered a procedural complication, including two sternotomies for bleeding and one death. This was higher than for catheter ablation (P < 0.001). Surgical ablation took longer to perform (P < 0.001) and had a longer hospital admission (P < 0.001) than catheter ablation.

CONCLUSION

Surgical AF ablation required significantly fewer repeat procedures than catheter ablation, and there was a clear trend towards improved arrhythmia outcome. However, it was associated with a significantly higher rate of procedural complications. Surgical ablation for paroxysmal AF is promising, however more prospective outcome data is required.

CLINICAL TRIAL REGISTRATION

NCT01504451, http://clinicaltrials.gov/show/NCT01504451.

摘要

目的

通过使用微创胸腔镜手术消融和 nMARQ 灌流多电极相控射频(RF)消融来治疗阵发性心房颤动(AF),与 PVAC 多电极相控 RF 消融进行比较,同时在整个研究过程中使用设备进行实时逐搏 Holter 监测。

方法和结果

一项针对阵发性 AF 患者的研究者发起的前瞻性试验,患者按 1:1:1 的比例随机分为初始手术、nMARQ 或 PVAC 消融组。所有患者均使用 ILR 或起搏器进行连续实时逐搏监测,以评估和记录 AF 复发情况。虽然存在手术消融治疗 AF 效果优于导管消融的趋势(P=0.050),但仍存在差异。在一年时,一次手术后 AF 负荷<1%且停用所有抗心律失常药物的患者比例分别为 63%、56%和 90%,适用于 PVAC、nMARQ 和手术消融。导管消融组需要重复消融的比例显著更高(P=0.008):PVAC 为 25%,nMARQ 为 27%,手术为 0%。然而,20 名接受手术消融的患者中有 7 名(35%)发生了手术并发症,包括 2 例因出血行开胸手术和 1 例死亡。这一比例明显高于导管消融组(P<0.001)。手术消融的操作时间更长(P<0.001),住院时间更长(P<0.001)。

结论

与导管消融相比,手术消融治疗阵发性 AF 所需的重复操作明显更少,并且明显改善了心律失常的治疗效果。然而,它与更高的手术并发症发生率相关。对于阵发性 AF,手术消融是有前途的,然而还需要更多前瞻性的结果数据。

临床试验注册

NCT01504451,http://clinicaltrials.gov/show/NCT01504451。

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Comparative efficacy and safety of catheter ablation interventions for atrial fibrillation: comprehensive network meta-analysis of randomized controlled trials.导管消融治疗心房颤动的疗效和安全性比较:随机对照试验的综合网络荟萃分析。
J Interv Card Electrophysiol. 2021 Oct;62(1):199-211. doi: 10.1007/s10840-020-00878-9. Epub 2020 Oct 4.
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Catheter vs thoracoscopic ablation for atrial fibrillation: Meta-analysis of randomized trials.
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