Khuddus Matheen A, Basir Mir B, Palmer Aaron, Edidin Av
The Cardiac and Vascular Institute, Gainesville, Florida.
Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(5):101038. doi: 10.1016/j.jscai.2023.101038. eCollection 2023 Sep-Oct.
The Aortix percutaneous mechanical circulatory support (pMCS) 18F micromechanical axial impeller-driven pump is percutaneously placed and retrieved from the descending aorta above the renal arteries. Pump deployment and retrieval use defined steps to allow suture-mediated closure around the exiting power lead and for terminal hemostasis after device retrieval after therapy. The overall procedure was validated preclinically in ovine and porcine models and has since proven reliable in a recently completed IDE feasibility study (NCT04145635). This study describes the steps of a novel technique for reliable suture-mediated vessel closure when using the Aortix pMCS device.
The principal steps associated with the procedure comprised ultrasound-guided access of the femoral artery, preclose placement of 4 Perclose (Abbott) sutures, achievement of intermediate hemostasis by locking 3 of the 4 sutures around the 6F exiting power lead, breaking the 3 locked sutures to permit vessel reentry for device removal, and finally, vessel closure using the fourth preclose suture along with 1 or more postclose suture(s) to close the femoral artery using a hybrid dual-sheath technique.
The standardized steps described have been developed and used over the course of 21 clinical cases by 12 operators who were initially procedurally naïve but experienced in large-bore access.
Preclose and postclose suture-mediated closure is a reliable means of managing the exiting power lead of the Aortix pMCS and closing the large-bore arteriotomy after pump retrieval. The steps outlined in this study may have applicability to other procedures requiring large-bore access or using suture-mediated closure.
Aortix经皮机械循环支持（pMCS）18F微机械轴向叶轮驱动泵经皮放置并从肾动脉上方的降主动脉取出。泵的部署和取出使用特定步骤，以便在治疗后设备取出后围绕引出的电源线进行缝合介导的闭合并实现最终止血。该整体程序在绵羊和猪模型中进行了临床前验证，并且在最近完成的IDE可行性研究（NCT04145635）中已证明是可靠的。本研究描述了在使用Aortix pMCS设备时进行可靠的缝合介导血管闭合的新技术步骤。
与该程序相关的主要步骤包括超声引导下进入股动脉、预先放置4根Perclose（雅培）缝线、通过将4根缝线中的3根锁定在6F引出的电源线上实现中间止血、解开3根锁定的缝线以允许血管重新进入以便取出设备，最后，使用第四根预先放置的缝线以及1根或更多根闭合后缝线，采用混合双鞘技术闭合股动脉。
所描述的标准化步骤是由12名操作人员在21例临床病例过程中开发并使用的，这些操作人员最初对该程序不熟悉，但在大口径通路方面经验丰富。
预先放置和闭合后缝线介导的闭合是管理Aortix pMCS引出的电源线并在泵取出后闭合大口径动脉切开术的可靠方法。本研究中概述的步骤可能适用于其他需要大口径通路或使用缝线介导闭合的程序。
