Intradevice misalignment predicts residual leak in patients undergoing left atrial appendage closure

Aims: 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. Methods: 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. Results: 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). Conclusion: 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.