短期和长期的 Lead Dislodgement 事件风险：来自产品监测登记处的真实世界经验。
Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.
机构信息
New England Heart and Vascular Institute, Catholic Medical Center, Manchester, NH (D.Q.).
Department of Medicine, Lowell General Hospital, Lowell, MA (A.F.).
出版信息
Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.
BACKGROUND
Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant.
METHODS
This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333).
RESULTS
During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, =0.041), lower sensing amplitude (right ventricle defibrillating lead, =0.020), and lower lead impedance at implant (right atrium pacing lead, =0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, =0.008) and higher body mass index (hazard ratio, 1.012, =0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (=0.012).
CONCLUSIONS
Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT01524276.
背景
心血管植入式电子设备植入后，导丝移位（LD）一直是最常见的早期并发症之一。然而，关于 LD 事件的临床特征和长期结果的数据有限。本研究旨在探讨心血管植入式电子设备植入后 LD 事件的危险因素、临床意义和管理策略。
方法
这是一项对 20683 例 2010 年 1 月 1 日至 2020 年 1 月 31 日期间在美敦力产品监测注册中心接受心血管植入式电子设备植入的患者进行的回顾性队列分析，平均随访时间为 3.3±2.5 标准差年。研究人群分为两组：A 组有 LD 事件（N=350），B 组无 LD 事件（N=20333）。
结果
在此期间，350 例患者（1.69%）发生 371 根导丝（0.95%）的 LD 事件，共植入 39060 根导丝。被动固定型（右心房起搏导丝，=0.041）、较低的感知幅度（右心室除颤导丝，=0.020）和植入时较低的导丝阻抗（右心房起搏导丝，=0.009）与 LD 风险增加相关。多变量分析显示，女性（危险比，1.520，=0.008）和较高的体重指数（危险比，1.012，=0.001）与 LD 事件的风险增加独立相关。LD 事件与心脏和总体死亡率的长期风险无显著变化相关。在 A 组中，与植入新导丝相比，重新定位脱位导丝增加了再次发生 LD 事件的风险（=0.012）。
结论
女性和较高的体重指数与产品监测登记处的 LD 事件风险增加相关。在导丝脱位的患者中，植入新导丝与未来 LD 事件的风险较低相关。需要进一步研究如何降低 LD 风险和改善这些事件的管理。
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