aCampus Bio-Medico University of Rome bUniversity of Rome Tor Vergata, Rome cPresidio Ospedaliero 'Monaldi', University of Naples Federico II, Naples, Italy.
J Cardiovasc Med (Hagerstown). 2017 Nov;18(11):900-907. doi: 10.2459/JCM.0000000000000566.
Postdeployment mutual orientation between the disk and the lobe in patients undergoing left atrial appendage closure with Amplatzer cardiac plug/Amulet device might impact on the risk of residual leak during follow-up. Thus, we evaluated in an exploratory, pilot study whether the degree of intradevice misalignment, measured by cardiac computed tomography (CT), discriminates the occurrence of peridevice leak in those patients.
All patients (N = 15) undergoing percutaneous left atrial appendage closure with those specific devices between April 2013 and January 2015 were prospectively included. All patients received follow-up evaluation by cardiac CT at 6 months after the intervention to calculate the angle of misalignment within the device and to detect presence of residual peridevice leak.
The angle of misalignment between the disk and the lobe of the device significantly discriminated between patients with and without peridevice leak (area under the curve 0.96, 95% confidence interval 0.88-1.0; P = 0.003), with an angle more than 20° being associated with nine-fold higher risk of residual leak. This angle of intradevice misalignment calculated by cardiac CT was significantly correlated with that measured by two-dimensional transesophageal echocardiography or X-rays in the cath lab after the device deployment (r = 0.943 and r = 0.938, respectively).
A marked intradevice misalignment after Amplatzer cardiac plug/Amulet device implantation significantly predicts the occurrence of postprocedural leak in patients with atrial fibrillation; if confirmed by larger studies, these findings may impact on practice patterns.
在接受 Amplatzer 心脏塞/Amulet 装置左心耳封堵术的患者中，术后磁盘与叶瓣之间的相互定位可能会影响随访期间残余漏的风险。因此，我们在一项探索性的初步研究中评估了，通过心脏计算机断层扫描（CT）测量的装置内错位程度是否可以区分那些患者发生装置周围漏的情况。
所有于 2013 年 4 月至 2015 年 1 月期间接受经皮左心耳封堵术的患者（N=15）均前瞻性纳入本研究。所有患者在干预后 6 个月接受心脏 CT 随访评估，以计算装置内的错位角度，并检测残余装置周围漏的存在。
装置的磁盘和叶瓣之间的错位角度在有和无装置周围漏的患者之间有显著差异（曲线下面积 0.96，95%置信区间 0.88-1.0；P=0.003），角度大于 20°与残余漏的风险增加九倍相关。通过心脏 CT 计算的装置内错位角度与二维经食管超声心动图或在装置放置后在导管室的 X 射线测量的角度（r=0.943 和 r=0.938）显著相关。
Amplatzer 心脏塞/Amulet 装置植入后明显的装置内错位显著预测了房颤患者术后漏的发生；如果在更大的研究中得到证实，这些发现可能会影响实践模式。
