Pereira Renner, Pisani Cristiano, Aiello Vera, Cestari Idágene, Oyama Helena, Santos Osmar, Otubo Jorge, Moura Daniel, Scanavacca Mauricio
Arrhythmia Unit, Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.
Department of Materials and Processes, Aeronautics Institute of Technology, São José dos Campos, Brazil.
Heart Rhythm O2. 2023 Aug 9;4(9):565-573. doi: 10.1016/j.hroo.2023.07.010. eCollection 2023 Sep.
Esophageal thermal injury is a complication of atrial fibrillation (AF) ablation, and it can be avoided by esophageal deviation during left atrial posterior wall radiofrequency catheter ablation.
This study aimed to evaluate the safety of a nitinol-based mechanical esophageal displacement device (MEDD) and its performance.
This preclinical safety study was conducted on 20 pigs, with 10 undergoing radiofrequency AF ablation using the MEDD and 10 serving as a control group under anticoagulation but without radiofrequency application. Esophageal traumatic injuries were classified from 0 to 4 and were grouped as absent (grade 0), minor (grade 1 or 2), moderate (grade 3), or major risk lesions (grade 4) by anatomopathological study. Grades 1 and 2 were considered acceptable. Fluoroscopy was used to measure displacement.
Five (25%) pigs developed traumatic lesions, 4 with grade 1 and 1 with grade 2 (2-mm superficial ulcer). There was no difference in lesion occurrence between the radiofrequency and control groups (30% and 20%, respectively; = .43). Under rightward displacement, the right edge moved 23.9 (interquartile range [IQR] 21.3-26.3) mm and the left edge moved 16.3 (IQR 13.8-18.4) mm ( < .001) from baseline. Under leftward displacement, the right edge moved 13.5 (IQR 10.9-15.3) mm and the left edge moved 16.5 (IQR 12.3-18.5) mm ( = .07). A perforation to the pharyngeal diverticulum occurred in 1 pig, related to an accidental extubation.
In pigs, the MEDD demonstrated safety in relation to esophageal tissue, and successful deviation. Esophageal traumatic injuries were acceptable, but improper manipulation led to pharyngeal lesion.
食管热损伤是心房颤动（AF）消融的一种并发症，在左心房后壁射频导管消融期间可通过食管移位来避免。
本研究旨在评估一种基于镍钛诺的机械性食管移位装置（MEDD）的安全性及其性能。
对20头猪进行了这项临床前安全性研究，其中10头使用MEDD进行射频AF消融，10头作为对照组，接受抗凝治疗但不进行射频应用。通过解剖病理学研究将食管创伤性损伤分为0至4级，并分为无（0级）、轻度（1级或2级）、中度（3级）或重大风险病变（4级）。1级和2级被认为是可接受的。使用荧光透视法测量移位情况。
5头（25%）猪出现了创伤性病变，4头为1级，1头为2级（2毫米浅表溃疡）。射频组和对照组之间的病变发生率没有差异（分别为30%和20%；P = 0.43）。在向右移位时，右边缘从基线移动了23.9（四分位间距[IQR] 21.3 - 26.3）毫米，左边缘移动了16.3（IQR 13.8 - 18.4）毫米（P < 0.001）。在向左移位时，右边缘移动了13.5（IQR 10.9 - 15.3）毫米，左边缘移动了16.5（IQR 12.3 - 18.5）毫米（P = 0.07）。1头猪发生了咽憩室穿孔，与意外拔管有关。
在猪中，MEDD在食管组织方面显示出安全性，并成功实现了移位。食管创伤性损伤是可接受的，但操作不当会导致咽部病变。
