Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Hermitage Lane, Maidstone, ME16?9QQ, UK.
Eastbourne Hospital, East Sussex Healthcare NHS Trust, East Sussex, UK.
Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.
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.
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.
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.
NCT01504451, http://clinicaltrials.gov/show/NCT01504451.
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。
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)。
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。
NCT01504451,http://clinicaltrials.gov/show/NCT01504451。