Department of Pediatric Cardiology, Institute of Cardio-Vascular Diseases, Madras Medical Mission, Chennai, India.
Cardiol Young. 2021 Jun;31(6):949-956. doi: 10.1017/S1047951120004771. Epub 2021 Jan 14.
Shape-memory abnormalities are seen in some nitinol atrial septal occluders. Variably described as cobra-head, tulip, and others, their incidence, mechanisms, clinical impact, and outcome have not been systematically analysed.
We retrospectively reviewed all consecutive device closures in the last 6 years for deformations. Type and size of the occluder, deployment technique, size, and angulation/kinking of the delivery sheath were analysed. Procedural success, duration, and other complications were studied.
A total of 112 devices (11.8%) among 950 occluders used in 936 patients showed deformities. Fourteen of 936 received 2 devices. Deformities were transient and self-correcting in 40%. Multivariate analysis showed significant associations with oversized sheaths (p = 0.004), kinked/angulated sheaths (p < 0.001), special deployment techniques (p < 0.001), and twist in the device waist (p = 0.011). Despite more frequent deformities with Figulla (15.6%) and Amplatzer (13.9%) occluders than Cera occluders (6.6%) and larger devices (>24 mm - 14.6%) than smaller devices (less than or equal to 24 mm - 9.7%), they were not significant on multivariate analysis. In vivo manipulations corrected most deformities; nineteen needed in vitro reformations and four needed a change of device. Despite prolongation of the procedure, repeated attempts (mean 2.76 ± 1.7 attempts, with a range from 1 to 9 attempts), and supraventricular tachycardia in two patients, there were no serious adverse effects.
Deformations were frequent in 11.8% of atrial septal occluders on a targeted search. Oversized and angulated/kinked sheaths, special techniques like pulmonary vein deployment and twist in device waist during procedure predisposed to deformities. While most deformities were corrected with manipulations, removal of the device was infrequently needed and change of device was rarely required. Long procedural time and multiple attempts for deployment did not affect procedural success.
一些镍钛诺房间隔缺损封堵器存在形状记忆异常。这些封堵器的形态各不相同，有“眼镜蛇头”形、“郁金香”形等，其发生率、机制、临床影响和结局尚未得到系统分析。
我们回顾性分析了过去 6 年中所有因封堵器变形而进行的连续装置封堵。分析了封堵器的类型和大小、展开技术、输送鞘管的大小、角度/扭曲情况。研究了手术成功率、手术时间和其他并发症。
在 936 例患者的 950 个封堵器中，共有 112 个（11.8%）装置出现变形。936 例中有 14 例患者植入了 2 个封堵器。40%的变形是短暂的，可自行矫正。多变量分析显示，与过大的鞘管（p=0.004）、扭曲的鞘管（p＜0.001）、特殊展开技术（p＜0.001）和封堵器腰部扭转（p=0.011）显著相关。尽管与 Cera 封堵器（6.6%）相比，Figulla（15.6%）和 Amplatzer（13.9%）封堵器的变形更为常见，与较小的封堵器（≤24mm-9.7%）相比，较大的封堵器（＞24mm-14.6%）更容易变形，但多变量分析并无统计学意义。体内操作可纠正大多数变形；19 例需要体外修复，4 例需要更换封堵器。尽管手术时间延长，反复尝试（平均 2.76±1.7 次，范围 1-9 次），2 例患者出现室上性心动过速，但无严重不良事件发生。
在有针对性的搜索中，11.8%的房间隔缺损封堵器出现了变形。过大和扭曲/成角的鞘管、特殊技术（如肺静脉展开）以及封堵器腰部在手术过程中的扭转，都可能导致封堵器变形。虽然大多数变形可通过操作来矫正，但很少需要取出封堵器，也很少需要更换封堵器。较长的手术时间和多次尝试部署并不影响手术成功率。
