Section of Cardiology, Baylor College of Medicine, Houston, Texas.
Department of Cardiology, Maimonides Medical Center, Brooklyn, New York; Section of Cardiovascular Research, Heart, Vascular, and Thoracic Department, Cleveland Clinic, Akron, Ohio.
Heart Rhythm. 2022 Aug;19(8):1289-1296. doi: 10.1016/j.hrthm.2022.03.1226. Epub 2022 Apr 28.
Leadless pacemakers have emerged as a viable alternative for traditional transvenous pacemakers to reduce the risk of device-related complications.
The purpose of this study was to examine the real-world clinical outcomes and complications associated with the implantation of leadless pacemaker devices.
Using the National Readmission Database (NRD), we examined patient demographics, and in-hospital and 30-day procedural outcomes after leadless pacemaker implantation from 2016-2018. Our cohort comprised adults (≥18 years) with an ICD-10 procedural code for leadless pacemaker implantation.
Our cohort included a total of 7821 patients who underwent leadless pacemaker implantation. Overall immediate procedure-related complications, as defined broadly in this study, occurred in 7.5% of patients. Pericardial effusion without the need for pericardiocentesis occurred in 1.9% of patients, with pericardiocentesis performed in 1.0%. Vascular complications occurred in 2.3% of patients; 0.33% required repair, and device dislodgment occurred in 0.51%. The most significant predictor for procedural complications was end-stage renal disease (odds ratio [OR] 1.65; 95% confidence interval [CI] 1.17-2.32; P = .004), congestive heart failure (OR 1.28; 95% CI 1.01-1.62; P = .04), and coagulopathy (OR 1.77; 95% CI 1.34-2.34; P <.001). All-cause readmission occurred in 17.9% of patients within 30 days from device implant, with 1.36% of readmissions being procedure related. At 30 days postimplant and after discharge, 0.25% of patients needed a new pacemaker, and 0.18% had pericardial complications.
In our large real-life cohort, we found the rate of serious complications after leadless pacemaker implantation to be relatively low and comparable to prior studies in a high-risk population with multiple comorbid conditions.
无导线起搏器的出现为降低器械相关并发症风险提供了一种可行的传统经静脉起搏器替代方案。
本研究旨在研究无导线起搏器植入相关的临床结局和并发症。
利用全国再入院数据库（NRD），我们分析了 2016 年至 2018 年期间无导线起搏器植入患者的人口统计学资料、住院期间和 30 天内的手术结果。我们的队列纳入了接受 ICD-10 编码为无导线起搏器植入的成年人（≥18 岁）。
我们的队列共纳入 7821 例接受无导线起搏器植入的患者。本研究广义定义的总体即刻手术相关并发症发生率为 7.5%。1.9%的患者发生心包积液但无需行心包穿刺引流，1.0%的患者行心包穿刺引流。血管并发症发生率为 2.3%；0.33%需要修复，0.51%发生器械移位。手术并发症的最重要预测因素是终末期肾病（比值比[OR] 1.65；95%置信区间[CI] 1.17-2.32；P =.004）、充血性心力衰竭（OR 1.28；95% CI 1.01-1.62；P =.04）和凝血障碍（OR 1.77；95% CI 1.34-2.34；P <.001）。术后 30 天内，所有患者中有 17.9%发生全因再入院，其中 1.36%的再入院与手术相关。植入后 30 天及出院后，0.25%的患者需要新的起搏器，0.18%的患者有心包并发症。
在我们的大型真实世界队列中，我们发现无导线起搏器植入后严重并发症的发生率相对较低，与高风险人群中伴有多种合并症的既往研究结果相当。
