Zou Jiangang, Chen Keping, Liu Xingbin, Xu Yuanning, Jiang Lingyun, Dai Yan, Lin Jinxuan, Hou Xiaofeng, Qiu Yuanhao, Himes Adam, Lucas Ryan, Demmer Wade, Mara Nicki, Zhou Xiaohong, Lu Hongyang
Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Arrhythmia Center, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
J Cardiovasc Electrophysiol. 2023 Mar;34(3):718-725. doi: 10.1111/jce.15843. Epub 2023 Feb 14.
Left bundle branch area pacing (LBBAP) is achieved by advancing the lead tip deep in the septum. Most LBBAP implants are performed using the Medtronic SelectSecure™ MRI SecureScan™ Model 3830 featuring a unique 4 Fr fixed helix lumenless design. Details of lead use conditions and long-term reliability have not been reported. This study was designed to quantify the mechanical use conditions for the 3830 lead during and after LBBAP implant, and to evaluate reliability using bench testing and simulation.
Fifty bradycardia patients with implantation of the 3830 lead for LBBAP were enrolled. Use conditions of lead deployment at implantation were collected and computed tomography (CT) scans were performed at 3-month follow-up. Curvature amplitude along the pacing lead was determined with CT images. Fatigue bending was performed using accelerated testing in a more severe environment than routine clinical use conditions. Conductor fracture rate in a simulated patient population was estimated based on clinical use conditions and fatigue test results.
The number of attempts to place the 3830 lead for LBBAP was 2.1 ± 1.3 (range: 1-7) with 13 ± 6 lead rotations at the final attempt. Extreme implant conditions were simulated in bench testing with 5 applications of 20 turns followed by up to 400 million bending cycles. Reliability modeling predicted a 10-year fracture rate of 0.02%.
LBBAP implants require more lead rotations than standard pacing implants and result in unique lead bending. Application of simulated LBBAP use conditions to the 3830 lead in an accelerated in-vitro model does not produce excess conductor fractures. IMAGE-LBBP Study ID of ClinicalTrial.GOV: NCT04119323.
左束支区域起搏（LBBAP）是通过将导线尖端推进到间隔深处来实现的。大多数LBBAP植入手术使用美敦力SelectSecure™ MRI SecureScan™ 3830型号导线，其具有独特的4 Fr固定螺旋无腔设计。导线使用条件和长期可靠性的细节尚未见报道。本研究旨在量化LBBAP植入过程中和植入后3830型号导线的机械使用条件，并通过台架测试和模拟评估其可靠性。
纳入50例植入3830型号导线进行LBBAP的心动过缓患者。收集植入时导线展开的使用条件，并在3个月随访时进行计算机断层扫描（CT）。利用CT图像确定沿起搏导线的曲率幅度。在比常规临床使用条件更恶劣的环境中进行加速测试以进行疲劳弯曲。根据临床使用条件和疲劳测试结果估计模拟患者群体中的导线断裂率。
用于LBBAP的3830型号导线放置尝试次数为2.1±1.3次（范围：1 - 7次），最后一次尝试时导线旋转13±6次。在台架测试中模拟极端植入条件，进行5次20圈的应用，随后进行多达4亿次弯曲循环。可靠性建模预测10年断裂率为0.02%。
LBBAP植入比标准起搏植入需要更多的导线旋转次数，并导致独特的导线弯曲。在加速体外模型中将模拟的LBBAP使用条件应用于3830型号导线不会导致过多的导线断裂。ClinicalTrial.GOV的IMAGE - LBBP研究识别号：NCT04119323。
