Borregaard Rune, Jensen Henrik Kjærulf, Tofig Bawer Jalal, Thrysøe Samuel Alberg, Gerdes Christian, Nielsen Jens Cosedis, Lukac Peter
a Department of Cardiology , Aarhus University Hospital , Aarhus , Denmark.
b School of Engineering , Aarhus University , Aarhus , Denmark.
Scand Cardiovasc J. 2017 Jun;51(3):129-137. doi: 10.1080/14017431.2017.1285043. Epub 2017 Feb 16.
To investigate the effect of the operator knowing the real-time contact force (CF) on the efficacy of pulmonary vein antrum isolation (PVAI).
Fifty patients with paroxysmal atrial fibrillation (AF) or short lasting persistent AF were randomized to CF guided PVAI (n = 25) or conventional PVAI (n = 25). In the CF guided group, CF between 10 and 40 g was aimed at. Efficacy of PVAI was measured as reduction in AF burden (AFB) and time to AF recurrence detected by implantable cardiac monitor (ICM), inserted three months before PVAI. Blanking period was three months and follow-up 12 months.
All pulmonary veins were isolated in the CF guided group and all but one in the conventional group. Mean CF was 25 g in the CF guided group and 24 g in the conventional group (p = 0.75). Compared to pre-ablation, median [IQR] relative reduction in AFB 3-12 months after ablation was 100 [99-100]% in the CF guided group (p < 0.001) and 99.4 [25-100]% in the conventional group (p < 0.001), not different between groups (p = 0.09). Nine patients (36%) had AF recurrence in the CF guided group and 13 (52%) in the conventional group (p = 0.21, log-rank test). CF differed between operators. When adjusted for operator by regression analysis, patients without recurrent AF had lower proportion of ablation time with CF <10 g than recurrent patients (p = 0.034). No complications occurred.
Operator knowledge of real-time CF had no significant effect on AFB reduction or time to AF recurrence. Larger trials should be done to study benefit of real-time CF.
探讨术者知晓实时接触力（CF）对肺静脉前庭隔离术（PVAI）疗效的影响。
将50例阵发性心房颤动（AF）或短程持续性AF患者随机分为CF引导下PVAI组（n = 25）和传统PVAI组（n = 25）。在CF引导组中，目标是使CF在10至40克之间。PVAI的疗效通过AF负荷（AFB）的降低以及植入式心脏监测器（ICM）检测到的AF复发时间来衡量，ICM在PVAI前三个月植入。空白期为三个月，随访12个月。
CF引导组所有肺静脉均被隔离，传统组除一例之外所有肺静脉也被隔离。CF引导组的平均CF为25克，传统组为24克（p = 0.75）。与消融前相比，消融后3至12个月CF引导组AFB的中位数[四分位间距]相对降低为100[99 - 100]%（p < 0.001），传统组为99.4[25 - 100]%（p < 0.001），两组之间无差异（p = 0.09）。CF引导组9例患者（36%）发生AF复发，传统组13例（52%）（p = 0.21，对数秩检验）。不同术者之间CF有所不同。通过回归分析对术者进行校正后，无AF复发的患者CF < 10克的消融时间比例低于复发患者（p = 0.034）。未发生并发症。
术者对实时CF的了解对AFB降低或AF复发时间无显著影响。应进行更大规模的试验以研究实时CF的益处。
