摘要
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Objectives
This study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment.Background
<p>Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results.Methods
<p>This multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel).Results
<p>The location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 卤 16.3%of device height below the plane of the lower sinus border versus 32.6 卤 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 卤 1.43 mm, range: 鈭?.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 卤 1.4 mm vs. 0.75 卤 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49%higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = 鈭?.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width.Conclusions
<p>The final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment.
